Bioadaptive therapeutic environments
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- THERAPOD LLC
- Filing Date
- 2024-06-18
- Publication Date
- 2026-04-22
AI Technical Summary
There is a need for personalized, immersive, and multi-sensory bioadaptive therapeutic environments that enhance and augment altered states of consciousness, such as psychedelic experiences, while minimizing adverse events and maximizing therapeutic outcomes.
The development of bioadaptive environments that use a combination of visual, auditory, tactile, and olfactory stimuli, adjusted in real-time based on biofeedback from subjects, to create a personalized and adaptive therapeutic experience. This includes the use of devices like Neurable Smart Headphones, fNIRS, and LIFU for biofeedback input, and lighting systems, audio equipment, and tactile materials to provide tailored stimuli.
The bioadaptive environments enhance the therapeutic experience by increasing neuroplasticity and reducing stress, promoting deeper self-awareness and therapeutic insights, thereby improving mental health outcomes and minimizing adverse events during psychedelic-assisted therapy.
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Abstract
Description
BIOADAPTIVE THERAPEUTIC ENVIRONMENTSINVENTOR: Justice LeakCROSS-REFERENCE
[0001] Priority is claimed under PCT Art. 8(1) and Rule 4.10 to U.S. Prov. App. No. 63 / 521,682, filed June 18, 2023, and incorporated by reference for all purposes as if fully set forth herein.FIELD OF THE INVENTION
[0002] The disclosure relates to bioadaptive therapeutic environments, including those that respond to biofeedback from a subject within the environment, and provide interactive and synergistic visual, auditory, tactile, and olfactory stimuli. In some aspects the environments are designed to enhance the therapeutic benefits from non-ordinary states of consciousness, including both non-pharmacologically and pharmacologically induced, and including by enhancing the setting for psychedelic experiences.BACKGROUND OF THE INVENTION
[0003] For thousands of years and across many cultures, human beings have developed methods of attaining altered states of consciousness, which may be characterized by transient shifts of perception relative to normal waking consciousness. Methods of attaining such states include both pharmacological means (e.g., by consuming psychoactive substances) and non-pharmacological means (e.g. meditation or breathwork). These methods can produce distinct altered states of consciousness characterized by distinct phenomenological characteristics. However, they often share an ability to induce mystical-type experiences, expansions of awareness, psychological flexibility, feelings of insight or revelation, and reappraisal of values and meaning. These phenomenological features are associated with long-lasting effects on measures of psychological well-being, and thus various methods of attaining altered states of consciousness, and enhancing the therapeutic value of such states, have value in developing new mental health therapies.
[0004] In particular, psychedelics have in recent years seen a great resurgence, not only for recreational use, but also for sacramental and ceremonial purposes, as well as for administration together with psychological support and psychotherapy (“psychedelic-assisted therapy”). Psychedelic-assisted therapy, in particular, has seen a revitalization of interest and study as a method of treating individuals for a variety of ailments, and treatment with psychedelics has been associated with improvements in behavioral, mental, and physical health. Besides their use as potential medicines for the treatment and prevention of behavioral, mental, and physical disorders, psychedelics also hold extraordinary promise for the improvement of mental health and wellness more broadly, including for the betterment of well people. In addition to psychedelic-assisted therapy, the expansion of supervised and facilitated use in legal adult use markets such as Oregon and Colorado, as well as decriminalization efforts across the United States, has created a need for personalized therapeutic environments which enhance the psychedelic experience and its effects.
[0005] As long recognized, “set and setting” are critical aspects of a safe and therapeutic experience with an altered state of consciousness, including under the effects of a psychedelic, and achieving a more positive set and setting has long been thought to be correlated with more positive experiences (including therapeutic outcomes). Historically, methods of attaining altered states of consciousness were practiced in cultural-specific spiritual, medicinal, creative, and / or contemplative contexts. However, the impact of modern set and setting contexts have largely gone unexplored, as have the means by which to achieve a positive set and setting. Today, there is a need to provide access to personally and therapeutically appropriate contexts to administer psychedelics and to practice other means of attaining altered states of consciousness, thereby maximizing the positive aspects of the experience while also minimizing the risk of adverse events.
[0006] Provided herein are personalized, immersive, and multi-sensory bioadaptive therapeutic environments the use of which will enhance and augment an altered state of consciousness, such as a psychedelic experience, psychedelic dosing session, or session of psychedelic-assisted therapy, and which have such other advantages and improvements as will become apparent through the disclosure below.INCORPORATION BY REFERENCE
[0007] Each cited patent, publication, and non-patent literature is incorporated by reference in its entirety, as if each was incorporated by reference individually, and as if each is fully set forth herein. However, no such citation should be construed as an admission that a cited reference is from an area that is analogous or directly applicable to the invention, nor should any citation be construed as an admission that a document or underlying information, in any jurisdiction, is prior art or part of the common general knowledge in the art.BRIEF SUMMARY OF THE INVENTION
[0008] The following presents a simplified summary of some embodiments of the invention in order to provide a basic understanding thereof. It is not an extensive overview of the invention, and is not intended to identify key or critical elements of the invention, or to delineate its full scope. Its sole purpose is to present some embodiments of the invention in a simplified form as a prelude to the more detailed description below.
[0009] In some aspects are provided methods for enhancing a therapeutic experience of a human subject in a bioadaptive environment, comprising: providing to the subject, at a first presentation time point, using at least one stimulus means: a first visual stimulus; a first auditory stimulus; a first tactile stimulus; and a first olfactory stimulus; receiving, with at least one receiving means: an identification input from the subject; an intention input from the subject; a first biofeedback input from the subject at a first biofeedback time point; and a second biofeedback input from the subject at a second biofeedback time point; producing, with at least one processing means: a personalization score, from the identification input and the intention input; and a biofeedback score, from the first biofeedback input and the second biofeedback input; further producing, with at least one processing means: a bioadaptive visual score, from the personalization score and the biofeedback score; a bioadaptive auditory score, from the personalization score and the biofeedback score; a bioadaptive tactile score, from the personalization score and the biofeedback score; and a bioadaptiveolfactory score, from the personalization score and the biofeedback score; transmitting, with at least one transmitting means, the bioadaptive visual score, the bioadaptive auditory score, the bioadaptive tactile score, and the bioadaptive olfactory score; and providing to the subject, at a second presentation time point, using at least one stimulus means: a second visual stimulus, wherein the second visual stimulus is updated based on the bioadaptive visual score; a second auditory stimulus, wherein the second auditory stimulus is updated based on the bioadaptive auditory score; a second tactile stimulus, wherein the second tactile stimulus is updated based on the bioadaptive tactile score; and a second olfactory stimulus, wherein the second olfactory stimulus is updated based on the bioadaptive olfactory score; wherein the bioadaptive environment is a bounded physical environment sized to hold at least one subject.
[0010] In some embodiments, the visual stimulus comprises lights, patterns, or geometric shapes. In embodiments, the audio stimulus comprises any one or more of soundscapes, songs, music, narration, sub-frequencies, and ambient sounds. In embodiments, the tactile stimulus comprises any one or more of an undulating surface, a vibrating surface, a moist surface, a heated surface, and a textured surface. In embodiments, the olfactory stimulus comprises an aroma. In embodiments, the gustatory stimulus comprises a food, a beverage, or a taste that is any one or more of sweet, salty, sour, bitter, umami, fatty, and spicy. In embodiments, at least two of the visual stimulus, the auditory stimulus, and the tactile stimulus, comprise a stimulus at a frequency of about 40 Hz. In embodiments, the stimulus at a frequency of about 40 Hz provides gamma stimulation or gamma entrainment.
[0011] In some embodiments, the biofeedback input is the provided by a Neurable Smart Headphone device, a functional Near Infrared Spectroscopy (fNIRS) device, a Low Intensity Focused Ultrasound (LIFU), a Mindware Technologies device, an Open-LIFU 2.0, an Open-Motion 3.0, a compression garment, a watch, a wrist strap, a chest strap, a ring, a belt, a shoe, a insole, glasses, a patch, a wrist bracelet, an ankle bracelet, a non-compression garment, a headband, a neckband, a hat, a smartwatch, a fitness tracker, a heart rate monitor, an ECG monitor, a blood pressure monitor, a smart ring, smart glasses, a bioharness, smart clothing, smart socks, smart shoes, smart earbuds, a respiration monitor, a smart belt, a body temperature monitor, a smart bracelet, a stress monitor, a hydration monitor, a smart patch, a mood ring, smart clothing, a wearable EMG sensor, a smart headband, a smart neckband, smart headphones, or a wearable brain sensing headband.
[0012] In some embodiments, the method further comprises providing to the subject, at a first presentation time point, a first gustatory stimulus; further producing, with at least one processing means, a bioadaptive gustatory score, from the personalization score and the biofeedback score; and providing to the subject, at a second presentation time point, a second gustatory stimulus, wherein the second gustatory stimulus is updated based on the bioadaptive gustatory score.
[0013] In some embodiments, the gustatory stimulus comprises a food, a beverage, or a taste that is any one or more of sweet, salty, sour, bitter, umami, fatty, and spicy. In embodiments, the therapeutic experienceis a state of increased neuroplasticity. In embodiments, the therapeutic experience is an altered state of consciousness. In embodiments, the therapeutic experience is a non-pharmacological intervention. In embodiments, the non-pharmacological intervention is any of breathwork, meditation, sound therapy, transcranial magnetic stimulation (TMS), movement therapy, physical rehabilitation exercises, dance therapy, yoga, hypnosis, art therapy, gamma stimulation, vibration therapy, and a calming protocol. In embodiments, the therapeutic experience is a pharmacological intervention. In embodiments, the pharmacological intervention comprises the administration of a psychoactive substance, a psychedelic, an entactogen, a dissociative, a psychoplastogen, a neuroplastogen, or a neuroplasticity-inducing agent. In embodiments, the pharmacological intervention comprises the administration of any of psilocybin, lysergic acid diethylamide (LSD), 5-methoxy-di methyltryptamine (5-MeO-DMT), N,N-dimethyltryptamine (DMT), ayahuasca, pharmahuasca, 2,5-dimethoxy-4-bromophenethylamine (2C-B), mescaline, 3,4-methylenedioxymethamphetamine (MDMA), methylone, ketamine, esketamine, a single enantiomer thereof, a non-racemic mixture thereof, a pharmaceutically-acceptable salt thereof, and any combination thereof. In embodiments, the pharmacological intervention comprises the administration of a psychedelic. In embodiments, the psychedelic is psilocybin or LSD.
[0014] In some embodiments, the pharmacological intervention further comprises psychedelic-assisted therapy (PAT), psychological support, or monitoring. In embodiments, the method further comprises increasing feelings of wellbeing. In embodiments, the method further comprises reducing feelings of stress. In embodiments, the method further comprises treating a medical condition. In embodiments, the medical condition is a mental health disorder. In embodiments, the mental health disorder is selected any of post-traumatic stress disorder (PTSD), adjustment disorder, affective disorder, a depressive disorder, atypical depression, postpartum depression, catatonic depression, a depressive disorder due to a medical condition, premenstrual dysphoric disorder, seasonal affective disorder, dysthymia, an anxiety disorder, a phobia disorder, a binge disorder, body dysmorphic disorder, alcohol or drug abuse or dependence disorders, a substance use disorder, substance-induced mood disorder, a mood disorder related to another health condition, a disruptive behavior disorder, an eating disorder, an impulse control disorder, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), a personality disorder, an attachment disorder, and a dissociative disorder. In embodiments, the substance use disorder is any of alcohol use disorder, nicotine dependency, opioid use disorder, sedative, hypnotic, or anxiolytic use disorder, stimulant use disorder, and tobacco use disorder. In embodiments, the medical condition is a neurodegenerative disorder. In embodiments, the neurodegenerative disorder is any of multiple sclerosis, Parkinson’s disease, dementia, Alzheimer’s disease, Huntington’s disease, amyotrophic lateral sclerosis (ALS), and motor neuron disease. In embodiments, the neurodegenerative disorder is Alzheimer’s disease. In embodiments, the Alzheimer’s disease is posterior cortical atrophy (PCA) or Benson's syndrome. In embodiments, the neurodegenerative disorder is caused by or associated with traumatic brain injury (TBI) ormild traumatic brain injury (mTBI). In embodiments, the medical condition is pain or a pain disorder.
[0015] In some aspects are provided bioadaptive environments for enhancing a therapeutic experience of a human subject, comprising: at least one receiving means, adapted to receive: an identification input from the subject; an intention input from the subject; a first biofeedback input from the subject at a first biofeedback time point; and a second biofeedback input from the subject at a second biofeedback time point; at least one processing means, adapted to produce: a personalization score, from the identification input and the intention input; and a biofeedback score, from the first biofeedback input and the second biofeedback input; at least one processing means, adapted to further produce: a bioadaptive visual score, from the personalization score and the biofeedback score; a bioadaptive auditory score, from the personalization score and the biofeedback score; a bioadaptive tactile score, from the personalization score and the biofeedback score; and a bioadaptive olfactory score, from the personalization score and the biofeedback score; at least one transmitting means, adapted to transmit the bioadaptive visual score, the bioadaptive auditory score, the bioadaptive tactile score, and the bioadaptive olfactory score; a means for providing a visual stimulus, adapted to receive the bioadaptive visual score; a means for providing an auditory stimulus, adapted to receive the bioadaptive auditory score; a means for providing a tactile stimulus, adapted to receive the bioadaptive tactile score; a means for providing an olfactory stimulus, adapted to receive the bioadaptive olfactory score; wherein each of the means for providing a visual stimulus, the means for providing an auditory stimulus, the means for providing a tactile stimulus, and the means for providing an olfactory stimulus are adapted to update the stimulus in response to the bioadaptive score; and wherein the bioadaptive environment is a bounded physical environment sized to hold at least one subject.
[0016] In some embodiments, the means for providing the visual stimulus comprises a lighting system or a display system. In embodiments, the means for providing the auditory stimulus comprises audio equipment for providing audio content. In embodiments, the means for providing the auditory stimulus comprises a vibroacoustic lounger or means for providing vibroacoustic therapy (VAT). In embodiments, the means for providing the tactile stimulus comprises a tactile material, tactile seating, or a vibroacoustic lounger. In embodiments, the means for providing the olfactory stimulus comprises an aroma diffuser. In embodiments, the environment further comprises at least one processing means, adapted to further produce a bioadaptive gustatory score, from the personalization score and the biofeedback score; at least one transmitting means, adapted to transmit the bioadaptive gustatory score; and a means for providing a gustatory stimulus, adapted to receive the bioadaptive gustatory score; wherein the means for providing a gustatory stimulus is adapted to update the gustatory stimulus in response to the bioadaptive gustatory score.
[0017] In some embodiments, the means for providing the gustatory stimulus comprises a food dispenser, a beverage dispenser, or a dispenser for a comestible item or simulation thereof. In = embodiments, the environment further comprises one or more design features. In = embodiments, the design features are any one or more of curvilinear design features, biophilic design features, modern design features, futuristicdesign features, and adaptive design features. In = embodiments, the environment is sized to hold between 1-10 people, between 10-15 people, or greater than 15 people.
[0018] The foregoing has outlined broadly some pertinent features of certain exemplary embodiments of the present disclosure so that the detailed description of the invention that follows may be better understood and so that the present contribution to the art can be more fully appreciated. Additional features of the invention will be described hereinafter which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the disclosed aspects and embodiments may be readily utilized as a basis for modifying or designing other embodiments for carrying out the same purposes of the present disclosure. It should be also realized that such equivalent embodiments do not depart from the spirit and scope of the invention as set forth in the appended claims. Hence, this summary has been made with the understanding that it is to be considered as a brief and general synopsis of only some of the aspects and embodiments disclosed herein, is provided solely for the benefit and convenience of the reader, and is not intended to limit in any manner the scope, or range of equivalents, to which the claims are lawfully entitled.BRIEF SUMMARY OF THE DRAWINGS
[0019] To further clarify various aspects of the invention, a more particular description thereof is rendered by reference to certain exemplary embodiments thereof as illustrated in the figures. It will be appreciated that the figures depict only illustrated embodiments of the invention and are not to be considered limiting of its scope. They are simply provided as exemplary illustrations of some embodiments of the invention. It also will be appreciated that, when used in reference to the figures and to other embodiments herein, description using any one or more of terms such as “immersive,” “multi-sensory,” “bioadaptive,” “therapeutic,” and the like, are merely exemplary rather than limiting, and the use of a single term shall not be construed to mean the absence of aspects that can be described as the other term; accordingly, a “bioadaptive environment” may also be an environment that is “immersive,” “multi-sensory,” “therapeutic,” and the like, unless context or other description clearly indicates otherwise.
[0020] Certain aspects of the invention are therefore further described and explained with additional specificity and detail, but still by way of example only, with reference to the following accompanying figures:
[0021] FIG. 1 illustrates an exemplary bioadaptive therapeutic environment comprising multiple connected environments, each of which is illustrated in further detail in FIGS. 2-4, which accommodate variable occupancy, and which provide different immersive and multi-sensory bioadaptive therapeutic experiences.
[0022] FIG. 2 illustrates an exemplary bioadaptive environment for one subject, for example a “Solo Sensory Pod,” which in some embodiments also is styled by Applicant as a “Solo SENSATION POD™.
[0023] FIG. 3 illustrates an exemplary bioadaptive environment for up to 15 people, for example a “Tribal Experience Pod,” which in some embodiments also is styled as a “TRIBAL EXPERIENCE™.”
[0024] FIG. 4 illustrates an exemplary bioadaptive environment for up to 10 people, for example a “Nature Experience Pod” and which in some embodiments also is styled as a “NATURE EXPERIENCE™.”
[0025] FIG. 5 illustrates an exemplary therapeutic environment, for instance to support and enhance psychedelic therapies, for example a “Therapod,” which in embodiments also is styled as a “THERAPOD™.”
[0026] FIG. 6 illustrates an exemplary “expanded” or “multi-area” Therapod (or THERAPOD) environment.DETAILED DESCRIPTION OF THE INVENTION
[0027] While various aspects and features of certain embodiments are summarized above, the following detailed description illustrates several exemplary embodiments in further detail to enable one of skill in the art to practice such embodiments, and to make and use the full scope of the invention claimed. The described examples are provided for illustrative purposes and are not intended to limit the scope of the invention or its applications. It will be understood that many modifications, substitutions, changes, and variations in the described examples, embodiments, applications, and details of the invention illustrated herein can be made by those skilled in the art without departing from the spirit of the invention, or the scope of the invention as described in the appended claims.
[0028] The scope of the invention includes all embodiments and equivalents thereof, not only those expressly described below, and it will be understood that many modifications, substitutions, changes, and variations in the described embodiments, applications, and details of the invention illustrated herein can be made by those skilled in the art without departing from the spirit of the invention, or the scope of the invention as set forth in the appended claims.
[0029] The headings within this document are being utilized only to expedite its review by a reader. They should not be construed as limiting the invention in any manner.A. General Definitions and Terms
[0030] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. The terms “comprising,” “including,” “such as,” and “having” are intended to be inclusive and not exclusive (i.e., there may be other elements in addition to the recited elements). Thus, the term “including” as used herein means, and is used interchangeably with, the phrase “including but not limited to.” The term “or” is used herein to mean, and is used interchangeably with, the term “and / or,” unless context clearly indicates otherwise.
[0031] Unless defined otherwise, all technical and scientific terms herein have the meaning as commonly understood by one having ordinary skill in the art to which this invention belongs, who as a shorthand may be referred to simply as a “person of skill” or “one of skill.”
[0032] Further definitions that may assist a reader in understanding disclosed embodiments are as follows; however, it will be appreciated that such definitions are not intended to limit the scope of the invention, which shall be properly interpreted and understood by reference to the full specification, as well as any plain and ordinary meaning known to one of skill, in view of the language used in the claims. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.
[0033] Generally, the nomenclature used and procedures performed herein are those known in fieldsrelating to one or more aspects of the invention, such as a person of skill in the art in the fields of biology, chemistry, biochemistry, pharmacology, medicine, psychiatry, psychotherapy, architecture, material science, design, art therapy, music therapy, light therapy, aromatherapy and the like, and are those that will be well known and commonly employed in such fields. Standard techniques and procedures will be those generally performed according to conventional methods in the art.
[0034] In some embodiments, a disclosed environment, which will be understood to also mean one or more specific aspects of the disclosed environment, is personalized for a subject. “Personalized” herein refers to selecting, determining, changing, updating, or the like, one or more settings, variables, parameters, programs, or the like, such as a type of content, for a subject, and based on the subject, such as based on a direct choice, decision, or request made by the subject, which may be made before and / or during the use of the environment (e.g., based on one or more pre-selected or selected parameters chosen by the subject), and / or based on an indirect characteristic of the subject, such as biofeedback data and / or one or more behavioral, physiological, or digital biomarkers of the subject, which also may be determined before and / or during the use of the environment.
[0035] Where an environment is personalized based on a subject, it means for example that the environment is not only responsive to changes in the subject biofeedback data, but also that it is responsive to those changes as they specifically relate to the subject. As an example, an environment may change based on changes in heart rate or stress response of a subject associated with symptoms of or a diagnosis of anxiety differently than to a subject not associated with anxiety.
[0036] Certain exemplary embodiments of personalized environments, e.g., personalized content, are described herein, and other examples will be known by reference to the teachings herein and the general knowledge in the art. In some embodiments, environments are personalized automatically to a subject, such as by facial recognition, electronic transmission of an identification code (e.g., by a wearable or other personal device), or other such means. In other embodiments, environments are personalized by direct user input, such as by user identification information or code entry. In some embodiments, automatic personalization is confirmed by direct user input. In embodiments, the environment is personalized based on a subject’s previous experience(s) in the same or another environment as disclosed herein.
[0037] Still additional definitions and abbreviations are provided elsewhere herein.B. Bioadaptive Environments for Enhancing Therapeutic Experiences
[0038] In one aspect are provided environments for enhancing a therapeutic experience in a subject. i. Therapeutic Experiences
[0039] In some embodiments (equivalently, and used simply for shorthand, “in embodiments”), disclosed bioadaptive environments are used to enhance the experience of a subject undergoing a therapeutic experience, which may improve therapeutic outcomes as described further herein.
[0040] As used herein, the terms “subject,” “user,” “participant,” “patient,” and “individual” are usedinterchangeably, and refer to a person who uses or may benefit from a disclosed environment or method. A “subject” or “patient” need not be diagnosable or diagnosed with any disorder, and will include not only subjects seeking therapeutic benefit for a medical condition (e.g., for a mental health disorder, a neurodegenerative disorder, a pain disorder) and subjects seeking therapeutic benefit for a non-medical condition (e.g., for the general improvement of mental or physical health and wellbeing), but also subjects seeking betterment in any regard, as well as subjects seeking purely experiential or entertainment value.
[0041] In some embodiments, the subject has a state of increased neuroplasticity or an altered state of consciousness. As used herein, “altered state of consciousness” (or equivalently, “altered state”) refers to a mental state that is different from one's ordinary waking consciousness. In some embodiments, an altered state is induced in a controlled and intentional manner to facilitate a therapeutic outcome.
[0042] In some embodiments, a state of increased neuroplasticity or an altered state of consciousness is characterized by heightened awareness, wherein a subject experiences increased sensitivity to internal and / or external stimuli, which in embodiments leads to deeper self-awareness and therapeutically productive insights. In some embodiments, a state of increased neuroplasticity or an altered state of consciousness is characterized by focused attention, which in embodiments enhances the subject’s ability to concentrate on their thoughts, sensations, or emotions; in embodiments this is beneficial for introspection and therapeutic intervention. In some embodiments, a state of increased neuroplasticity or an altered state of consciousness is characterized by enhanced suggestibility, wherein a subject is more open to positive suggestions and guidance, such as those provided by the bioadaptive environment. In some embodiments, a state of increased neuroplasticity or an altered state of consciousness is characterized by increased relaxation, which in embodiments reduces the subject’s stress and anxiety and promotes physical and mental healing. In some embodiments, a state of increased neuroplasticity or an altered state of consciousness is characterized by a shift in perception and cognition, which in embodiments allows the subject to break free from preconceived thought patterns and adopt new perspectives.
[0043] A state of increased neuroplasticity or an altered state of consciousness may be achieved through various methods, such as by administration of a psychoactive substance (whether self-administered or as part of drug-assisted therapy), administration of a compound that increases neuroplasticity (e.g., a neuroplastogen or psychoplastogen, or generically a “neuroplasticity-inducing agent”), meditation, hypnosis, breathwork, sound therapy, transcranial magnetic stimulation (TMS), movement therapy (including, e.g., yoga and dance therapy), art therapy, and others, as will be appreciated in view of the teachings herein and the general knowledge in the art. All such methods may be used alone or in combination.
[0044] A state of increased neuroplasticity or an altered state of consciousness may comprise various points or periods (“phases”) of time during which a subject experiences different physical and / or psychological deviations from their ordinary state of being. For purposes of illustration, the phases of a psychedelic experience (as an exemplary altered state of consciousness) may be as follows (for beginning,ascent, peak, descent, and end):
[0045] “Beginning” refers to the initial subjective or objective measurable effects of the psychedelic substance such as the onset of the subjective experience, which may be characterized by sensory alterations, changes in perception, and shifts in mood or consciousness.
[0046] “Ascent” refers to the progressive intensification of the psychedelic effects, where the subject may experience heightened sensory perception, altered thought patterns, increased emotional sensitivity, and a sense of entering a state of increased neuroplasticity or an altered state of consciousness.
[0047] “Peak” refers to the most intense and profound stage of the psychedelic experience. During the peak, subjects may experience a loss of ego boundaries, profound insights, vivid visual hallucinations, intense emotional states, and a deep connection to the inner self or the external environment.
[0048] “Descent” marks the diminishing of the psychedelic effects from the peak state, as the experience starts to taper off, and the return to baseline. The descent phase may be associated with a gradual return to normal perception, thought patterns, and emotional states.
[0049] “End” represents the conclusion of the psychedelic experience, where the effects of the substance have subsided to a certain predetermined level (e.g., normal cognition, lack of significant or noticeable subjective effects, ability to drive), predetermined time point (e.g., 8 hours following administration of psilocybin) or completely. This phase may involve reflection, integration of insights, and the resumption of normal or baseline consciousness.
[0050] When used in relation to a dosing session, “prior” refers to the time leading up to the dosing session or the drug administration therein, including preparation, such as setting the intentions for the journey.1 . Psychoactives, Psychedelics, Psychoplastogens, and Other Substances
[0051] In embodiments, an altered state of consciousness results from the administration of a psychoactive substance to a subject. In some embodiments, the psychoactive substance is cannabis or a cannabinoid from cannabis, such as THC or CBD. In some embodiments, the psychoactive substance is a psychedelic.
[0052] A psychedelic may be defined generally as a substance which produces certain “psychedelic” effects at sufficient dosages, e.g., visual and auditory perceptual changes, often accompanied by intense emotional, mystical, or spiritual experiences. Certain “classic” psychedelics include the known agonists of serotonin 2A (S-HTJA) receptors, in chemical classes such as tryptamines (e.g., N,N-dimethyltryptamine (DMT), found in the traditional brew ayahuasca, and psilocybin and psilocin found in “magic” mushrooms), phenethylamines (e.g., mescaline, from peyote and San Pedro cacti), and lysergamides (most notably lysergic acid diethylamide (LSD)). Other substances which can be referred to as “psychedelics” include, as examples, 5-MeO-DMT, 3,4-methylenedioxymethamphetamine (MDMA), beta-keto amphetamines and cathinones such as methylone and ethylone, 2C-B and other “2C-x” compounds, substituted amphetamines such as DOI and other “DOx” compounds, ibogaine and its metabolites (e.g., noribogaine) and analogs (e.g., tabernanthalog, oxo-ibogaine, oxo-noribogaine), ketamine and its metabolites (e.g., HNK) and analogs (e.g., MXE), salvinorinA, nitrous oxide, high-dose THC or high-dose cannabis, and numerous others, which have hallucinogenic, “entheogenic,” “entactogenic” or “empathogenic,” dissociative, and other psychoactive effects.
[0053] Herein, the term “psychedelic” also includes compounds that include plasticity (e.g., neural plasticity, such as brain structural plasticity), whether or not the compounds induce subjective effects associated with classic psychedelics. Some such compounds are referred to as “psychoplastogens,” “neuroplastogens,” “non-hallucinogenic psychedelics,” or “non-psychedelic psychedelics,” and these also will be understood to be within the definition of “psychedelic” used herein, and such compounds (e.g., AAZ-A-154) can be or are used in disclosed methods. See, e.g., Ly et al. Cell Rep. 2018;23(11):3170-3182; Olson. Exp Neurosci. 2018;12:1-4. Plasticity-inducing agents generally are useful as compounds for administration to or by subjects using the disclosed environments, and such agents will be appreciated by those in the art.
[0054] While the term “psychedelic” therefore may have multiple meanings, its uses and definitions will be known to those in the art, and any particular use herein will be understood in view of the context of its use when describing one or more embodiments of the disclosure.
[0055] Additionally, one will appreciate that for any such psychedelics one may also use in the practice of the disclosed invention their single enantiomers or non-racemic mixtures; their salts and solid forms such as polymorphs, hydrates, solvates, and co-crystals; their deuterated and halogenated versions; and their prodrugs, metabolites, analogs, and derivatives; as well as combinations of any of the foregoing; and further including novel chemical compounds or NCEs having similar structures, effects, and / or uses.
[0056] The term “psychedelic” herein encompasses the psychedelic compound itself (e.g., psilocybin) as well as any plant or fungal sources thereof (e.g., a psilocybin-containing fungus, such as a mushroom of the Psilocybe genus). In embodiments, a psychedelic may be obtained, isolated, and / or purified from a natural source, may be chemically synthesized, may be produced by biosynthesis, as well as combinations thereof (e.g., semisynthesis or partial chemical synthesis from a natural isolate). For example, an exemplary psychedelic that may be used by subjects in disclosed environments and methods is ayahuasca. In other embodiments, the psychedelic is any formulation comprising DMT and an MAOI, known as “pharmahuasca.”
[0057] In embodiments, the psychedelic is a phenethylamine or a tryptamine.
[0058] In embodiments, the psychedelic is a phenethylamine. “Phenethylamines” are as readily understood by those in the art, and non-limiting examples of psychedelic phenethylamines useful in the practice of the invention include those described in Shulgin and Shulgin. PIHKAL: A Chemical Love Story. Transform Press; 1991 (“PiHKAL”), and Oeri. Psychopharmacol. 2021 ;35(5):512-536, both of which are incorporated by reference as if fully set forth herein, as well as a pharmaceutically acceptable salt, hydrate, solvate, prodrug, stereoisomer, or tautomer thereof, or a combination thereof.
[0059] In embodiments, the psychedelic is a tryptamine. “Tryptamines” are as readily understood by those in the art, and non-limiting examples of psychedelic tryptamines useful in the practice of the invention include those described in Shulgin and Shulgin. TIHKAL: The Continuation. Transform Press; 1997 (“TiHKAL”),which is incorporated by reference as if fully set forth herein, as well as a pharmaceutically acceptable salt, hydrate, solvate, prodrug, stereoisomer, or tautomer thereof, or a combination thereof. In embodiments, the “psychedelic” is an empathogen (also referred to as an entactogen), such as MDMA. In embodiments, the “psychedelic” is a dissociative anesthetic, such as ketamine. In embodiments, the “psychedelic” is an atypical psychedelic, such as ibogaine, nitrous oxide, salvinorin A, certain high dose cannabis or THC, and the like.
[0060] In embodiments, a “psychedelic” is (or is a substance comprising) any of psilocybin, MDMA, LSD, 5-MeO-DMT, DMT, mescaline, 2C-B, methylone, ketamine, esketamine, enantiomers and non-racemic mixtures thereof, pharmaceutically-acceptable salts thereof, and combinations of any one or more thereof.
[0061] In embodiments, the altered state of consciousness is a psychedelic experience. In embodiments, a subject has a psychedelic experience after ingesting or being administered a psychedelic not for therapeutic or medical use (e.g., for spiritual use, self-exploration, creativity, “recreation,” or such other purposes as will be readily appreciated to those in the art). In other embodiments, a subject has a psychedelic experience after ingesting or being administered a psychedelic for therapeutic or medical use. In some such embodiments, the subject will participate in psychedelic-assisted therapy. a. Psychedelic- and Other Drug-Assisted Therapy
[0062] In some aspects a subject ingests or is administered a psychedelic or other substance in a disclosed environment as part of psychedelic- or other drug-assisted therapy (herein, both may be referred to as “psychedelic-assisted therapy” unless context indicates otherwise).
[0063] “Psychedelic-assisted therapy” or “PAT” broadly refers herein to any embodiment wherein a subject ingests or is administered a psychedelic by a trained professional such as a therapist, doctor, guide, facilitator, or the like. In embodiments, a subject ingests or is administered a psychedelic and is monitored, supported, and / or otherwise engaged by one or more trained professional while under the effects of the psychedelic (see, e.g., Schenberg. Frontiers Pharmacol. 2018;9:733; Tullis. Nature. 2012;598:506-509; Olson. ACS Pharmacol Trans Sci. 2021 ;4(2):413— 415.
[0064] Herein, “psychedelic-assisted therapy” or “PAT” will be understood to broadly include all such modalities and experiences generally (e.g., any of drug-assisted therapy or psychotherapy, administration of a psychedelic together with psychological support, administration of a psychedelic together with supervision or monitoring, guided or facilitated psychedelic use or provided services, and the like), unless an intent to refer to a specific type of therapy or use is clear from the context. In embodiments, a psychedelic experience is achieved during one or more dosing sessions of psychedelic-assisted therapy (PAT).
[0065] Protocols have been developed for the standardization of procedures to be used with PAT, such as the provision of psychological support. See, e.g., Johnson et al. J Psychopharmacol. 2008; 22:603-620; and Mithoefer et al. A Manual for MDMA-Assisted Psychotherapy in the Treatment of PTSD. Multidisciplinary Association for Psychedelic Studies (MAPS); 2015; Guss et al. The Yale Manual for Psilocybin-Assisted Therapy of Depression. PsyArXiv. 2020; Tai et al. Front Psychiatry. 2021 ;12:586682. However, it will bereadily appreciated that such protocols and procedures are merely exemplary of the types that may be utilized, and PAT may or may not involve one or more psychotherapeutic modalities, and also may or may not involve any specific form of psychological support; for example, esketamine (Spravato®, Janssen / Johnson & Johnson) is typically administered according to a Risk Evaluation and Mitigation Strategy (REMS) that only requires the observation and monitoring of the subject by a healthcare provider, without any psychotherapeutic intervention.
[0066] Typically, PAT comprises: (1) one or more psychedelic dosing (drug administration) session(s) wherein one or more psychedelics is administered, such as psilocybin, LSD, MDMA, DMT, 5-MeO-DMT, ketamine including esketamine, ibogaine, a psychedelic tryptamine, a psychedelic phenethylamine, a psychedelic ergoline or lysergamide, an entactogen, a dissociative, or such other psychedelics as disclosed herein and known in the art, or including substances comprising a psychedelic (e.g., psilocybin-containing mushrooms, ayahuasca, iboga); (2) one or more preparation sessions before the one or more psychedelic dosing session(s); and (3) one or more integration sessions after the psychedelic dosing session(s).
[0067] Optionally, in some embodiments, there will be an initial “screening” session to determine the subject’s suitability for PAT, such as by assessing whether the subject has an exclusion criteria, including a diagnosis of schizophrenia or bipolar of the subject or a member of the subject’s close family, severe acute anxiety with a prevalence to panic attacks, and / or a diagnosis of a physiological condition such as high blood pressure or a heart arrhythmia. Optionally, in some embodiments, there will be one or more “after-care” sessions to provide a regimen of after-care and / or relapse management after the integration session(s). In embodiments, and as will be appreciated by those of skill, whether an initial screening session and / or an after-care session is necessary depends on the mental health condition being treated, the outcome(s) of the dosing and other sessions, and the like.
[0068] It will be readily appreciated that the number and relative timing and order of the sessions will be chosen based on the therapeutic goal(s), the protocol (s) or clinical manual(s) followed, the psychedelic(s) used, the characteristics of the subject(s) and the disorder(s) to be treated (or improvements in mental health sought), and such other characteristics as will be readily appreciated by those of ordinary skill in the art.
[0069] During a PAT session (e.g., a preparatory session, dosing session, or integration session), the subject may receive supervision from one or more trained therapists, who may offer psychological support to the subject as needed. Although it will be recognized as a term of art in the field, in embodiments, “psychological support” may refer to actions taken by the therapist during a subject’s PAT session to ensure the subject's safety and improve the therapeutic efficacy of the session. For instance, psychological support may involve ensuring the subject’s psychological well-being and safety, allowing the subject’s subjective experience to unfold naturally within the therapeutic intention set during preparation, maintaining the subject’s attention and present-moment awareness to facilitate the exposure and processing of challenging emotional states and personal memories, and / or generating insights and solutions for resolving challengingpersonal situations, conflicts, and traumatic experiences. In embodiments, the support may involve therapeutic touch, verbal reassurance, guided imagery, relaxation exercises, or breathing techniques. In embodiments, the support may include reminders, encouragement, or active guidance. The level and type of psychological support may vary during different stages of the subject’s psychedelic experience, such as the pre-dosing stage, ascent stage, peak stage, descent stage, or post-dosing stage.
[0070] In embodiments, the subject participates in an integration session with a therapist. In an integration session, the subject may retrospectively analyze a prior session with either cognitive behavioral therapy, somatic therapy, or eye-movement desensitization and reprocessing. In embodiments, the subject may reflect on the body, mind, emotions, memories, themes, or thoughts during a prior session. In embodiments, the subject may identify and introspect on patterns in behavior or interpersonal dynamics that may arise. In embodiments, an integration session may include one or more core dimensions of spiritual integration, emotional integration, and physical integration. In embodiments, integration takes place in interaction circles or in a group setting to help maximize therapeutic benefit. In embodiments, integration takes place individually between the subject and the therapist.
[0071] A subject may receive psychosocial or behavioral therapy, which may be selected based on the indication treated or benefit sought, and will include such modalities as will be recognized in the art.
[0072] In embodiments, group therapy is provided. Group therapy involves creating a supportive environment within the therapeutic setting that allows subjects to share experiences, receive emotional support, and learn relaxation techniques from one another. Sessions of PAT, including any one or more of the preparation sessions, dosing sessions, and integration sessions, may be provided as group therapy.2. Breathwork
[0073] In some embodiments, the altered state of consciousness is achieved by the subject engaging in therapeutic breathwork. “Breathwork” refers generally to a practice that involves conscious manipulation and control of the breath to promote various physical, mental, and emotional benefits. Breathwork can induce altered states of consciousness similar to those produced by psychedelics, and can be associated with similar therapeutic benefits such as reduced stress and anxiety (Havenith et al. Research Square. 2024; Preprint, doi: 10.21203 / rs.3.rs-3976380 / v1 ; Fincham et al. Sci Rep. 2023; 13(1 ):432).
[0074] In some embodiments, breathwork includes guided and self-guided breathing techniques, such as diaphragmatic breathing, box breathing, Holotropic Breathwork®, Vivation®, Transformational Breath®, Clarity Breathwork™, Rebirthing Breathwork, and others known to one of skill.
[0075] In some embodiments, the altered state of consciousness is achieved by the subject engaging in breathwork during any phase of a psychedelic experience. In some embodiments, the altered state of consciousness is achieved by the subject engaging in breathwork without ingesting or being administered a psychedelic or psychoactive compound. In some embodiments, the bioadaptive environment guides the subject through breathwork as described further in embodiments herein.3. Meditation
[0076] In some embodiments, the altered state of consciousness is achieved by the subject engaging in meditation or a mindfulness practice. “Mindfulness” is the practice of intentionally focusing attention on the present moment with an attitude of non-judgmental awareness and acceptance. “Meditation” is a technique or practice that involves training the mind to achieve a state of focused attention, relaxation, inner calm, and emotional regulation. There are various similarities between the neural correlates of meditation practices and psychedelic states, which may underlie certain shared subjective and therapeutic benefits (Milliere et al. Front Psychol. 2018;9:1475).
[0077] Non-limiting examples of meditation include focused attention meditation, body scan meditation, noting meditation, visualization meditation, loving kindness meditation, skillful compassion meditation, resting awareness meditation, reflection meditation, zen meditation, mantra meditation, transcendental meditation, yoga meditation, vipassana meditation, chakra meditation, qigong meditation, and sound bath meditation.
[0078] In some embodiments, the altered state of consciousness is achieved by the subject engaging in meditation during any phase of a psychedelic experience. In some embodiments, the altered state of consciousness is achieved by the subject engaging in meditation without ingesting or being administered a psychedelic or psychoactive compound. In some embodiments, the bioadaptive environment guides the subject through meditation as described further in embodiments herein.4. Sound Therapy
[0079] In some embodiments, the altered state of consciousness is achieved by providing the subject with sound therapy. Sound therapy (e.g. music, sound bowls, binaural beats, or isochronic tones) use repetitive and synchronized audio stimuli to influence the predominance of brainwave range patterns. Brainwave range patterns, such as gamma (30-70 Hz), beta (13-30 Hz), alpha (8-13 Hz), theta (4-8 Hz), and delta (1-4 Hz) are associated with different states of consciousness (Aparecido-Kanzler et al. Rev Mex Neurocienc. 2022;22(6):238-247; Hassan et al. 2012 ICCAIS. 2012:176-180). Sound therapy is often used to induce the predominance of delta and theta states, which are associated with deep meditation, relaxation, and heightened focus (Lavallee et al. J Altern Complement Med. 2011 ;17(4):351-355; Kim & Choi. Int J Environ Res Public Health. 2023;20(12): 6180). Sound therapy may also induce brainwave states also associated with working memory, pain reduction, increased attention, and anxiety reduction (Aparecido-Kanzler et al. Rev Mex Neurocienc. 2022;22(6):238-247).
[0080] In some embodiments, the altered state of consciousness is achieved by providing the subject with sound therapy during any phase of a psychedelic experience. In some embodiments, the altered state of consciousness is achieved by the subject being provided with sound healing without the subject ingesting or being administered a psychedelic or psychoactive compound. In some embodiments, the bioadaptive environment comprises a means for providing the subject with sound therapy as described further in embodiments herein. In some embodiments, the bioadaptive environment provides the subject with soundtherapy as described further in embodiments herein.5. Transcranial Magnetic Stimulation
[0081] In some embodiments, the altered state of consciousness is achieved by providing the subject with transcranial magnetic stimulation (TMS). TMS uses magnetic fields to non-invasively stimulate specific areas of the brain (Hallet. Neuron. 2007;55:187-199). TMS can induce a state of increased neuroplasticity or an altered state of consciousness by modulating brain regions associated with mood, perception, and cognitive processes (Chervyakov et al. Front Hum Neurosci. 2015;9:303).
[0082] In some embodiments, the altered state of consciousness is achieved by providing the subject with transcranial magnetic stimulation during any phase of a psychedelic experience. In some embodiments, the altered state of consciousness is achieved by the subject being provided with TMS without the subject ingesting or being administered a psychedelic or psychoactive compound. In some embodiments, the bioadaptive environment comprises a means for providing the subject with transcranial magnetic stimulation as described further in embodiments herein. In some embodiments, the bioadaptive environment provides the subject with transcranial magnetic stimulation as described further in embodiments herein.6. Movement Therapy
[0083] In some embodiments, the altered state of consciousness is achieved by providing the subject with movement therapy (e.g., dance, yoga). Movement therapy can induce a state of increased neuroplasticity or an altered state of consciousness by integrating physical activity with mindful awareness (e.g., similar to that achieved during meditation or mindfulness practice), which can enhance the subject’s body-mind connection and promote relaxation (Ivtzan & Jegatheeswaran. J Yoga Phys Then 2014;5(3):1000204; Hartfiel et al. Scand J Work Environ Health. 2011;37(1):70-76). Further, coordinated movements can induce neural synchrony and modulate the release of neurohormones, which further contribute to altered states of consciousness (Basso et al. Front Hum Neurosci. 2021; 14:584312; Jeong et al. Int J Neurosci. 2005; 115(12): 1711-1720).
[0084] In some embodiments, the altered state of consciousness is achieved by the subject engaging in movement therapy during any phase of a psychedelic experience. In some embodiments, the altered state of consciousness is achieved by the subject engaging in movement therapy without ingesting or being administered a psychedelic or psychoactive compound. In some embodiments, the bioadaptive environment comprises a means for providing the subject with movement therapy as described further in embodiments herein. In some embodiments, the bioadaptive environment provides the subject with movement therapy as described further in embodiments herein. ii. Bioadaptive Environments
[0085] In one aspect of the disclosure is provided an environment (e.g., a bioadaptive environment) for enhancing therapeutic experience in a subject. In some embodiments, the environment enhances the therapeutic experience by enhancing set and setting for a state of increased neuroplasticity or an alteredstate of consciousness, such as a psychedelic experience. The terms “set” and “setting” as used herein refer to the factors related to the person (set, or mindset) as well as the environment (setting) of a therapeutic session. The “set” consists of factors related to the person such as personality, preparation, expectation, and intention of the person having the experience. The “setting” relates to the physical, social, and cultural environment in which the experience takes place.
[0086] In some embodiments, a “setting” is used herein to refer to a bioadaptive environment of the disclosure. In embodiments, a “setting” is used herein to refer to the space in which an environment of the disclosure is located. While the use of the term “setting” and its referent may differ, such use will be readily understood by a reader in view of the context.
[0087] In some embodiments, a disclosed environment is a bioadaptive environment. In some embodiments, a “bioadaptive” environment refers generally to an environment that adapts to biological signals or responses of the subject, thereby providing an enhanced therapeutic experience.
[0088] In some embodiments, disclosed environments provide the subject with combinations of any of visual, auditory, tactile, and olfactory stimuli. In some embodiments, the environment enhances the therapeutic experience through the synergistic combination of: the physical parameters of the environment; the environment’s means for providing visual, auditory, tactile, and / or olfactory stimuli; the environment’s means for receiving and processing subject data (such as biofeedback data) from the subject; and the environment’s means for modulating the physical parameters and / or stimuli in response to said subject data.1 . Biofeedback
[0089] In some embodiments, a disclosed environment comprises a means for receiving biofeedback data from the subject undergoing a therapeutic experience. Such an environment may be referred to herein as a “bioadaptive environment.”
[0090] Biofeedback data includes, for example, biomarkers, behavioral, and / or physiological parameters. In embodiments, the biofeedback data comprises any of heart rate, changes in heart rate, heart rate variability, blood pressure, facial expression, galvanic skin response (GSR) and other electrodermal activity (EDA), skin flush responses, pupil response, eye movement, saccadic response, content or latency of speech, muscle tenseness, and movement, such as 3D movement in space.
[0091] Biofeedback data, including any of the above biofeedback data, will be understood to include data at a single measured point in time, changes in data over time (e.g., increases, decreases), the rate of changes in data over time, and any of these compared to data for any one or more other types of biofeedback.
[0092] Biofeedback data may be provided automatically (e.g., using a wearable biofeedback device), and may also include data provided from direct input from the subject, or from external monitoring of the subject.
[0093] In embodiments, biofeedback data comprises facial expression. Facial expression data may be processed to measure the subject’s emotions, e.g., happiness, anger, sadness, contempt, surprise, anger, shame, guilt, satisfaction, frustration, and pride. In some embodiments, facial expression is processed tomeasure a subject’s positive or negative sensory experience, e.g., pain, discomfort, comfort, and the like. Facial expression data can also in embodiments be processed to detect the movement of a facial muscle. In some embodiments, facial muscle movements are taxonomized using the Facial Action Coding System (FACS), then associated with corresponding emotions. In embodiments, facial expression data is measured using physiological biofeedback signals, such as electromyography (EMG), skin conductance, or heart rate.
[0094] In embodiments, biofeedback data comprises movement, such as 3D movement. 3D movement data includes the movement of a subject or a subject’s joint positions and rotations across time, and may signal emotional state, including as examples, head movement, shoulder movement (including shoulder protraction, which may fluctuate with emotional state, such as sadness), arm, hand, or finger movement, chest movement (which may indicate heavy breathing), leg movement, foot movement, toe movement, hip movement, torso movement, movement of facial features, including movement of the mouth, movement of the ears, movement of the nose, movement of the tongue, movement of the eyebrows, body sway, body balance, body rhythm, asymmetries between the left and right sides of the body, smoothness of body motion, jerkiness of body movement, kinetic energy in the body, reaction time, total amount of body movement “jitter,” a measure of 3D movement over time that is correlated with agitation, nervousness, and anxiety. The collection, analysis, and use of 3D human movement data is described for example in WO2022 / 232933A1 and US2023 / 0172536A1 , both of which are incorporated by reference as if fully set forth herein.
[0095] In embodiments, a disclosed bioadaptive environment functionally couples to (which may include transmitting and receiving) biofeedback data to modulate stimuli in response to the subject’s experience. “Modulating” refers to adding or removing a stimulus, increasing or decreasing the intensity of the stimulus, or changing the content of the stimulus. In one non-limiting example, modulating a visual stimulus may comprise activating a lighting system (e.g., a light source), increasing the intensity (e.g., the brightness) of a lighting system, deactivating a lighting system, reducing the intensity (e.g., the brightness) of a lighting system, altering the color or hue of a light source, altering the pattern of light in the environment, synchronizing or desynchronizing a light source with an auditory stimulus (e.g., music or speech), or similar adjustments to the controllable visual aspects of the environment.
[0096] In embodiments, the environment, in response to biofeedback data, modulates a visual stimulus. In embodiments, the environment, in response to biofeedback data, modulates an auditory stimulus. In embodiments, the environment, in response to biofeedback data, modulates a tactile stimulus. In embodiments, the environment, in response to biofeedback data, modulates an olfactory stimulus. In embodiments, the environment, in response to biofeedback data, modulates multiple stimuli to provide a synergistic combination of stimuli to the subject.
[0097] In embodiments, biofeedback data is collected by a wearable biofeedback device that is worn by the subject. Preferred wearable biofeedback devices may be those that do not restrict or interfere with the subject’s movement or otherwise detract from the therapeutic experience, such as by distracting the subjectfrom their perceptions and cognition. In some embodiments, the wearable device is a watch, wrist strap, chest strap, ring, belt, shoe, insole, glasses, patch, wrist bracelet, ankle bracelet, garment, headband, neckband, hat, or similar garment or accessory. In some embodiments the wearable device is a smartwatch, fitness tracker, heart rate monitor, ECG monitor, blood pressure monitor (e.g., a sphygmomanometer), smart ring, smart glasses, bioharness, smart clothing, smart socks, smart shoes, smart earbuds, respiration monitor, smart belt, body temperature monitor, smart bracelet, stress monitor, hydration monitor, smart patch, mood ring, smart clothing, wearable EMG sensor, smart headband, smart neckband, smart headphones, or wearable brain sensing headband (e.g., EEG headband).
[0098] In embodiments, biofeedback data is wirelessly provided to the environment from a wearable device using a method known in the art. Such methods include, for example, any of Radio Frequency Identification (RFID) systems, Bluetooth, Wi-Fi, Near Field Communication (NFC), Infrared (IR), Zigbee, Z-Wave, LoRa, Li-Fi, 1 G, 2G, 3G, 4G, or 5G. In some embodiments, data is provided wirelessly from a wearable bracelet using an RFID system.
[0099] In some embodiments, the wearable biofeedback device is a smart headphone device. In some embodiments, the smart headphone device is capable of wirelessly measuring the subject’s brain signals. In some embodiments, the smart headphone device measures and collects the subject’s brain signals using electroencephalogram (EEG) sensors. In some embodiments the wearable device is a Neurable Smart Headphone device (Neurable Inc., Boston, Massachusetts).
[0100] In some embodiments, the wearable device is a functional Near Infrared Spectroscopy (fNIRS) device. In some embodiments, the fNIRS device uses real-time Diffuse Optical Tomography (DOT) data from the subject. In some embodiments, the fNIRS device comprises an adjustable headband. In some embodiments, the fNIRS device is the NIRSIT System, the NIRSIT LITE, or the NIRSIT ON (Soterix Medical Inc., Woodbridge, New Jersey).
[0101] In some embodiments, the wearable device uses Low Intensity Focused Ultrasound (LIFU) to collect biofeedback data. In some embodiments the wearable uses low intensity near-infrared light to measure the subject’s blood flow, blood volume, and sub-tissue micro-motions. In some embodiments, the wearable device is the Open-LIFU 2.0 (OpenWater, California). In some embodiments, the wearable device is the Open-Motion 3.0 (OpenWater, San Francisco, California).
[0102] In some embodiments, the wearable biofeedback device is a health monitoring system integrated into a compression garment. In some embodiments the wearable device comprises one or more sensors embedded into a garment that are used to collect biofeedback data. In some embodiments the wearable device is less restrictive than a VR headset. In some embodiments the wearable device collects parasympathetic and sympathetic nervous system activity data. In some embodiments the wearable device collects biofeedback data signals from the sinoatrial node. In some embodiments the wearable device collects biofeedback data signals from the sinoatrial node using impedance cardiography. In someembodiments, the wearable device collects variation data in sinoatrial node signaling that are indicative of a stress response. In some embodiments, the wearable device collects variation data in sinoatrial node signaling that are indicative of a relaxed, parasympathetic state. In some embodiments, the wearable device can detect the emotional state of a user such as fear, love, or gratitude.
[0103] In some embodiments the data collected using the wearable device is received wirelessly by a docking station or central computer-implemented system for processing and analysis. In some embodiments multiple wearable devices can be synced with a docking station or computer-implemented system to allow for the simultaneous receipt and processing of data during group therapeutic sessions. In some embodiments, the processed data can be used to modulate the bioadaptive environment in real-time. In some embodiments, the wearable device is a wearable designed by Mindware™ Technologies (Mindware Technologies LTD, Westerville, Ohio).
[0104] Other means of collecting biofeedback data are those known in the art, and may include devices or methods for monitoring any of body temperature, skin temperature, heart rate (HR), resting heart rate (RHR), oxygen saturation (SpO2), respiratory rate, blood oxygenation, photoplethysmography (PPG), blood pressure (BP) and its variables, including systolic (SBP), diastolic (DBP), mean arterial (MAP), and pulse (PP); continuous non-invasive beat-by-beat blood pressure (CNIBP); measurements from an electrocardiogram (ECG), including RR interval or its variability, QT interval or its variability, heart rate variability (HRV) (or measured by devices other than an ECG); sleep patterns, hemodynamic response (HR), levels of glucose, cortisol, serotonin, dopamine, and cholesterol; brain activity (e.g., encephalography such as electroencephalography (EEG), quantitative EEG (qEEG), magnetoencephalography (MEG), electrocorticography (ECoG), rheoencephalography (REG), endovascular interfaces, functional magnetic resonance imaging (fMRI), magnetic resonance imaging (MRI), positron emission tomography (PET), nuclear magnetic resonance (NMR), spectroscopy or magnetic resonance spectroscopy (MSR), single-photon emission computed tomography (SPECT), near infrared spectroscopy (NIRS), functional NIRS (fNIRS), brain computer interfaces (BCIs), electrooculography (EOG), or event-related optical signal (EROS)), ECG traces, temperature or C02content of exhaled air, heart sounds, body resonance, cardiovascular and pulmonary function, body entropy, brain entropy, electrodermal activity (e.g., skin conductance), and the like.
[0105] In embodiments, biofeedback data is collected by a guide who is monitoring the subject. As used herein, “guide” refers to an individual attending to the subject before, during, and / or after the therapeutic experience. The guide may be a medical professional, such as physician, nurse practitioner, physician’s assistant, nurse, psychologist, or psychiatrist. The guide may also be a mental health coach, life coach, yoga instructor, fitness instructor, meditation teacher, breathwork practitioner, holistic health practitioner, ayurvedic practitioner, energy healer, spiritual counselor, sound healer, hypnotherapist, psychedelic guide, psychedelic integration coach, shaman, traditional healer, herbalist, art therapist, mindfulness instructor, integrative healthcoach, wellness coach, peer counselor, or the like. In some embodiments, the guide is an individual specifically trained to attend to a subject in a disclosed bioadaptive environment. While in some embodiments a guide may be desired, a guide may not be necessary for a subject to undergo a therapeutic experience in a disclosed environment.
[0106] In embodiments, the guide is present in the environment along with the subject. In embodiments, the guide monitors the subject in real time from a location outside of the environment. In some such embodiments, the environment comprises one or more means for remotely monitoring the subject, including for instance wearable biofeedback devices (such as those described herein and others known to those of skill), video monitoring systems, audio monitoring systems, motion detection systems, and the like.
[0107] In some embodiments, the guide is a virtual guide. In some embodiments, “virtual therapist” refers to a digital object, such as a holographic, extended reality (XR), augmented reality (AR), or virtual reality (VR) construct, with human-like properties. In some embodiments, the virtual guide fulfills the role of a human guide, and is bioadaptive and responsive to the subject.
[0108] In some embodiments, the virtual guide is a digital human model. In some embodiments, the digital human model is a representation of a living guide. In some embodiments, the digital human model is generated using a method of animation comprising volumetric capture of a human guide. In some embodiments, volumetric capture is used to aggregate images and / or video frames from multiple angles for processing and digital reconstruction into a 3D model. In some embodiments, volumetric capture and animation is performed using Unify Solver technology (Wild Capture, Inc., Los Angeles, CA). In some embodiments, the digital human model is generated using a means of pose-estimation. In some embodiments, the pose-estimation comprises a kinematic mode. In some embodiments, the pose-estimation comprises a planar model. In some embodiments, the pose-estimation comprises a volumetric model.
[0109] In some embodiments, the virtual guide verbally communicates with subjects. In some embodiments the verbal communication comprises pre-recorded instructions, narrations, conversations, and the like. In some embodiments, the verbal communication comprises generated auditory content. In some embodiments, the generated auditory content is a recording or digital representation of a living guide’s voice. In some embodiments the auditory content is generated using an auditory generation technique, such as generative algorithms, adaptive auditory techniques, machine learning, and artificial intelligence. In some embodiments, the virtual guide is responsive to verbal cues and is capable of real-time interactive communication, which may be based on real-time analysis of biofeedback data.
[0110] In some embodiments, the virtual guide has a simulated personality, which may vary from subject to subject, or from experience to experience, depending on subject preferences. In some embodiments, the personality of a virtual guide may be trained by a human guide. In some embodiments, the subject provides real-time feedback during a therapeutic experience in the form of subject input or biofeedback data, and the virtual guide adjusts the personality accordingly. In other embodiments, the virtual guide is programmed witha variety of predetermined personalities to provide an optimized therapeutic experience.
[0111] In some embodiments, the virtual guide is programmed to guide the subject through a psychedelic experience. In some embodiments, the virtual guide is programmed to guide the subject through a breathwork technique. In some embodiments, the virtual guide is programmed to guide the subject through movement therapy (e.g., yoga, dance therapy).
[0112] In some embodiments, a disclosed bioadaptive environment comprises an automatic means for processing (e.g., analyzing) biofeedback data collected and received from the subject, such as biofeedback data from a wearable biofeedback device, inputs from a guide, direct inputs from the subject, or a combination thereof. Such automatic means include, for example, computer-implemented systems. In some embodiments, biofeedback data is electronically analyzed by a computer-implemented system having specialized software programs configured to tailor therapeutic experiences by modulating stimuli based, for example, the physiological, emotional, or behavioral state of the subject.
[0113] In embodiments, automatic means for processing biofeedback data include artificial intelligence, deep learning, general machine learning, and statistical models. Exemplary such models include perceptron, feed forward, radial basis network, deep feed forward, recurrent neural network, long / short term memory, gated recurrent unit, auto encoder, variational autoencoder, sparse autoencoder, denoising auto encoder, Markus chain, Hopfield network, Boltzman machine, restricted Boltzman machine, deep belief network, deep convolutional network, deep network, deep convolutional inverse graphics network, generative adversarial network, liquid state machine, extreme learning machine, echo network machine, Kohonen network, deep residual network, support vector machine, neural Turing machine, transformer, attention mechanisms, capsule networks, self-organizing map, neural ordinary differential equation, graph neural networks, Bayesian neural networks, reinforcement learning models, residual neural network, DenseNet, and CapsNet.
[0114] In some embodiments, biofeedback data is received from its source (e.g., from a wearable biofeedback device) to an integrated device or dashboard. In some embodiments, biofeedback data received by such a dashboard is manually evaluated by a monitoring individual, such as a guide that is not located within the environment alongside the subject. In some embodiments, biofeedback data received such a dashboard is automatically evaluated by a computer-implemented method as described herein.
[0115] In embodiments, biofeedback data is used to monitor the subject for behavioral, emotional, and / or physical parameters that provide information about the subject’s therapeutic experience. Additional examples of such parameters include measures of subject movement, conversations, agitation, restlessness, relaxation, stress, anxiety, fear, satisfaction, enjoyment, positive feeling, love, joy, gratitude, and the like.
[0116] In some embodiments, biofeedback data is used to monitor the subject to detect a challenging psychological event, such as any of feelings of grief, fear, death, insanity, isolation, physical distress, paranoia, and others known to those of skill (see, e.g., Barrett et al. J Psychopharmacol. 2016;30(12):1279— 1295). In embodiments, biofeedback data is used to monitor the subject to predict theonset of a challenging psychological event before it manifests. For example, a wearable device worn by the subject collects biofeedback data (e.g., temporal heart rate trends), provides the data to the environment, which has a means for processing said data (e.g., by way of a machine learning model), then adapting the visual stimulus to avert the predicted psychological event or state. In embodiments, wherein a challenging event has been detected or predicted, the bioadaptive environment responds, e.g., by modulating stimuli. In such embodiments, the environment may respond by modulating stimuli to reduce, reverse or prevent the challenging experience, such as by initiating a calming sequence (or equivalently "calming protocol") of stimuli that encourage the subject to return to a more positive state, for example, relaxed, focused, unagitated, positive affect, or reduced emotional excitability; and can adaptively provide the user with positive and comfortable environments that help to induce and maintain this therapeutic mental state. In doing so, a disclosed environment may improve the safety profile, increase a therapeutic effect, or the durability of the therapeutic experience after it has concluded. Conversely, the environment may respond by intentionally not modulating stimuli, or modulating stimuli such that the subject is maintained in the challenging experience, which may have therapeutic benefit; for example, by encouraging the subject to “work through” a difficult experience, which can have therapeutic value (see, e.g., Carbonaro et al. J Psychopharmacol. 2016;30(12):1286-1278). In embodiments, disclosed methods comprises a combinatory sensory stimuli that provides calming protocols.
[0117] In embodiments, a calming protocol refers to a structured plurality of procedures or techniques implemented by the environment (in embodiments, by the environment providing choreographed stimuli to the subject) to promote a state of relaxation, tranquility, and emotional stability. In embodiments, a calming protocol comprises guided visualization. The guided visualization may comprise guided imagery techniques wherein a subject is led through relaxing visualizations of peaceful settings or positive experiences to evoke a sense of calm. In embodiments, a calming protocol comprises movement and physical activity such as yoga, stretching, Tai Chi, or Qigong. Gentle yoga poses or stretching exercises may promote physical relaxation and release muscle tension. In embodiments, a calming protocol comprises guiding a subject through slow, flowing movements and mindfulness-based practices like Tai Chi or Qigong, which may help a subject achieve a state of relaxation and balance. In embodiments, a calming protocol comprises guiding a subject through progressive muscle relaxation. In some embodiments, progressive muscle relaxation comprises guiding a subject through exercises that involve tensing and releasing muscle groups in a systematic manner, which may help subjects release tension and achieve a state of relaxation.
[0118] In embodiments, a calming protocol comprises guiding a subject through mindfulness and / or meditation. In embodiments, a calming protocol comprises providing a subject with sensory stimuli that result in a reduction of the subject’s stress. In embodiments, reducing a subject’s stress can alleviate or manage one or more negative effects of stress on physical, mental, and emotional well-being. In embodiments, reducing a subject’s stress can alleviate or manage one or more negative effects of a psychedelicexperience, or the stress caused thereby.
[0119] In embodiments, a calming protocol comprises guiding a subject through interactive breathwork. In embodiments, a protocol for interactive breathwork minimizes stress by guiding the subject through programmed somatic exercises.
[0120] In embodiments, biofeedback data is collected prior to the therapeutic experience. In embodiments, biofeedback data is collected periodically throughout the therapeutic experience. In embodiments, biofeedback data is collected continuously throughout the therapeutic experience. In embodiments, biofeedback data is collected intermittently throughout the therapeutic experience. In embodiments, biofeedback data is collected every 15 minutes, every 30 minutes, every 45 minutes, or every hour during the therapeutic experience. In embodiments, biofeedback data is collected after the experience. In embodiments, biofeedback data is collected during an integration session after the therapeutic experience.
[0121] After biofeedback data is collected, the biofeedback data may be transmitted, such as biofeedback data at a first time point (which may be a baseline time point, a time point upon entering an environment, a time point upon ingesting a substance, a time point upon beginning a non-pharmacological intervention, a time point upon beginning a program or protocol, and the like, as will be appreciated). Biofeedback data is transmitted at a second time point, and may be subsequently transmitted at multiple additional time points.
[0122] In embodiments, wherein the subject has a psychedelic experience, biofeedback data is collected during the beginning of the psychedelic experience. In embodiments, wherein the subject has a psychedelic experience, biofeedback data is collected during the ascent of the psychedelic experience. In embodiments, wherein the subject has a psychedelic experience, biofeedback data is collected during the peak of the psychedelic experience. In embodiments, wherein the subject has a psychedelic experience, biofeedback data is collected during the descent of the psychedelic experience. In embodiments, wherein the subject has a psychedelic experience, biofeedback data is collected during the end of the psychedelic experience.
[0123] In embodiments, prior to the therapeutic experience the subject undergoes a preparation process, during which biofeedback data is collected. In embodiments, biofeedback data collected prior to the therapeutic experience is used to select a psychedelic to be administered during the subsequent therapeutic experience. In some such embodiments, biofeedback data comprises data collected from the subject’s use of a mobile application, software application, virtual journal (e.g., LOTIC Al™), remote therapy session, or virtual guide. In one example, biofeedback data is collected from the subject’s use of a mobile application called TRAVLER™ prior to their therapeutic experience. In this example, TRAVLER guides the subject through setting intentions, journaling, goal setting, reflection, autobiographical recounts, and the like; then, this biofeedback data generated from the subject’s use of TRAVLER is processed and analyzed (manually, automatically, or both, as described in embodiments herein) and used to select a set of stimuli provided by the bioadaptive environment during the subsequent therapeutic experience. Further, in this example, biofeedback data collected from the subject’s use of TRAVLER is used to select a psychedelic to beadministered during the subsequent therapeutic experience.
[0124] In some embodiments, the bioadaptive environment adapts one or more stimuli based on the unique characteristics or specific goals of a subject— for example: pre-existing medical conditions, therapeutic goals or clinical objectives (e.g., information regarding the subject’s intentions and motivations for seeking a therapeutic experience, which may be collected from the subject’s use of the TRAVLER app, or clinician directives). As an example, subjects can be identified through the use of RFID bracelets that enable the bioadaptive environment to locate and differentiate between subjects in the environment. Once a unique subject has been identified, the environment’s means for providing stimuli can provide personalized stimuli, thereby providing an enhanced therapeutic experience. For example, in embodiments, a subject with a history of photosensitive seizures is not prevented with visual stimuli that could trigger a photosensitive seizure (e.g., strobing lights). In another embodiment, a subject with a specific medical diagnosis (e.g., a panic disorder), is presented with a calming sequence (e.g., as described further in embodiments herein) at the first sign of a panic attack.2. Means for Providing a Visual Stimulus
[0125] In embodiments, a disclosed environment comprises a means for providing a visual stimulus.
[0126] Herein, a means for providing a visual stimulus (or a means for providing another type of stimulus, such as a type of stimulus discussed below) also may be referred to as shorthand as a “stimulus means.”
[0127] In embodiments, the means for providing a visual stimulus comprises a lighting system, display system, or another suitable means described herein or otherwise known to those of skill in the art, and their equivalents.
[0128] In embodiments, a disclosed visual stimulus may be presented prior to the therapeutic experience. In embodiments, a disclosed visual stimulus may be presented at the beginning of the therapeutic experience. In embodiments, a disclosed visual stimulus may be presented periodically throughout the therapeutic experience. In embodiments, a disclosed visual stimulus may be presented at the ascent of the therapeutic experience. In embodiments, a disclosed visual stimulus may be presented at the peak of the therapeutic experience. In embodiments, a disclosed visual stimulus may be presented at the descent of the therapeutic experience. In embodiments, a disclosed visual stimulus may be presented at the end of the therapeutic experience. In embodiments, a disclosed visual stimulus may be presented for the entirety of, one or more parts of, or none of the experience.
[0129] In embodiments, the same visual stimulus may be presented throughout the experience. For example, in some embodiments, muted tones of color and dimly lit lights may provide a comfortable environment throughout the duration of the experience as a means of maintaining a self-regulating state. In embodiments, different visual stimuli may be presented throughout the experience (e.g., different geometric shapes, natural or imagined environments, light intensities, colors, hues). In embodiments, different visual stimuli may be presented based on the preference of a subject having the therapeutic experience.
[0130] In embodiments, in the event a subject does not enjoy colorful light shows, underwater immersion, or space, they may switch the visual stimulus according to their preference or taste. In embodiments, the visual stimulus may be synchronized with the intensity or characteristics of a therapeutic experience. In embodiments, visual stimulus may change based on the difficulty of one’s experience (e.g., is a user having a challenging experience or a “bad trip”).
[0131] In embodiments, a disclosed environment comprises a means for providing a visual stimulus, wherein the visual stimulus comprises visual content.
[0132] In embodiments, the visual content is personalized for a subject. The visual content may be personalized for a subject based on pre-selected parameters chosen by the subject or by another (e.g., by the therapist, guide, or facilitator), based on characteristics of the subject, and / or based on biofeedback data of the subject. In embodiments, the visual content is personalized before a therapeutic experience. In embodiments, the visual content is personalized once or more during a therapeutic experience. In embodiments, the visual content is personalized periodically during a therapeutic experience. In embodiments, the visual content is personalized continuously during a therapeutic experience. In embodiments, the visual content is personalized during a therapeutic experience based on one or more biomarkers of the subject. In embodiments, the visual content is personalized during a therapeutic experience based on the requests of the subject made before the experience. In embodiments, the visual content is personalized during a therapeutic experience based on the requests of the subject made during the experience.
[0133] In embodiments, the visual stimulus is automatically personalized using a visual generation technique, such as generative algorithms, adaptive visual techniques, machine learning, and artificial intelligence. In embodiments, biofeedback data is used to personalize generated visual stimuli. For example, a disclosed bioadaptive environment may be cued to generate calming visual stimuli in response to an increase in collected measures that correspond to subject stress levels or anxiety. Conversely, the environment may be cued to maintain or augment a style of visual stimulus in response to collected measures that correspond to resonance, calmness, transcendence, or other therapeutically beneficial emotional, behavioral, or physiological states.
[0134] In embodiments, the visual stimulus is generated using Sora™ (OpenAI, San Francisco, California).
[0135] In embodiments, biofeedback data collected from a subject is received, processed, and used to modify the bioadaptive environment by modulating a visual stimulus. In some embodiments, biofeedback data is used to automatically cue changes to the lighting system. For example, the bioadaptive environment may dim lights in the environment or make subtle changes to the hue of emitted light in response to biomarkers that indicate a subject’s state of relaxation. In some embodiments, biofeedback data is used to automatically cue changes to the display system. For example, the bioadaptive environment may display a virtual breathwork session led by a virtual guide in response to biofeedback data that indicate a subject’sincreasing level of anxiety. In some embodiments, biofeedback data is used to automatically cue changes to projected visual patterns. For example, the bioadaptive environment may adapt the intensity or types of patterns displayed based on biofeedback data that indicate the temporal state of a user’s psychedelic experience.
[0136] In embodiments, the visual stimulus enhances a therapeutic experience. In embodiments, the visual stimulus increases or increases the likelihood of one or more therapeutic benefits of a therapeutic experience, such as a beneficial mental health outcome. In embodiments, the visual stimulus decreases or decreases the risk of one or more adverse events related to a therapeutic experience, such as the possibility of a challenging therapeutic experience or bad trip. In embodiments, the visual stimulus decreases or decreases the risk of one or more adverse events related to a therapeutic experience by displaying a calming sequence to a subject.
[0137] In embodiments, the visual stimulus will synergistically integrate or synchronize with, be synergistically presented together with, or be synergistically perceived together with, another stimulus to increase the sense of immersion and to enhance one or more aspects of the therapeutic experience, such as by increasing a benefit or a therapeutic outcome, or by decreasing a risk or an adverse outcome. “Synergistic effects” refers to the effects of multiple (i.e., two or more) stimuli that are greater than the additive contributions of the individual stimuli acting alone, thereby producing “1 +1 > 2” (likewise, “1+1 +1 > 3” or “1+1 +1 +1 > 4”). “Greater” may refer to an amount that is an “increase” or a “reduction” depending on how the effect is described, and both may be an “improvement” (e.g., an “increase” in anxiolytic effects may be the same as a “reduction” in anxiety, and both may be the result of a synergy that produces “greater” than expected additive effects). Numerous methods will be known to those of skill to determine whether there are synergistic effects (equivalently, “synergy” or “synergism”).
[0138] Below are non-limiting examples of some of the means for providing a visual stimulus that are present within the environment. Other means for providing a visual stimulus may be another suitable means described herein or otherwise known to those of skill in the art, and their equivalents. a. Lighting System
[0139] In embodiments, a disclosed environment comprises a means for providing a visual stimulus, wherein the means for providing a visual stimulus comprises a lighting system.
[0140] In embodiments, the lighting system comprises a plurality of light emitting diodes (LEDs) or cold cathode fluorescent lamps (CCFL). In embodiments, the lighting system may be incorporated within one or more wall panel segments. In embodiments, the lighting system is incorporated into floor panel segments or tiles. Other types of lighting systems are as described herein and known in the art.
[0141] In embodiments, the lighting system comprises programmable features. “Programmable” refers to the ability of a device or system to be controlled and instructed through a set of programmed instructions, allowing for customization and flexibility in its functionality. In embodiments, programmable features canenable devices to execute specific tasks or operations based on user-defined instructions, facilitating adaptability and versatility in their use. In embodiments the programmable features may pertain to hue, light intensity, brightness, emittance, or a combination thereof. In embodiments, the programmable features may include dimming or increasing hue, light intensity, brightness, emittance, or a combination thereof. In embodiments, the lighting system may be capable of synchronizing with auditory stimulus. In embodiments, the programmable features comprises of aligning hue, light intensity, brightness, emittance, color, or frequency of illumination with various parts of a song (e.g., before the beat drops, at any point from the beginning of a song to the end of a song, any transitions from one song to another, or any combination thereof). In embodiments, the programmable features disclosed may include alignment with an auditory component. In embodiments, the auditory component may be narration, sub-frequencies, ambient sounds, or any combination thereof. For example, LED and kinetic systems from CN Totem (Hong Kong) or JS Profession Illumination (Hong Kong) may be incorporated into the environment as programmable elements.
[0142] In embodiments, the frequency of one or more visual stimuli corresponds with one or more neural oscillation rhythms. In embodiments, the one or more neural oscillation rhythms include any of delta waves, theta waves, alpha waves, beta waves, and gamma waves.
[0143] In embodiments, the frequency of one or more visual stimuli is synced to one or more neural oscillation rhythms. Neural oscillation rhythms may be monitored using means known to those of skill, such as electroencephalography (EEG) and quantitative EEG (qEEG). In embodiments, the frequency of one or more visual stimuli is synced with one or more neural oscillation rhythms, including any of delta waves, theta waves, alpha waves, beta waves, and gamma waves.
[0144] In embodiments, the frequency of one or more visual stimuli is from about 0.5 Hz to about 100 Hz. In embodiments, the frequency of one or more visual stimuli is from about 0.5 Hz to about 4.0 Hz (e.g., correspond with or are synced to delta waves). In embodiments, the frequency of one or more visual stimuli is from about 4.0 Hz to about 8.0 Hz (e.g., correspond with or are synced to theta waves). In embodiments, the frequency of one or more visual stimuli is from about 8.0 Hz to about 12.0 Hz (e.g., correspond with or are synced to alpha waves). In embodiments, the frequency of one or more visual stimuli is from about 12.0 Hz to about 30.0 Hz (e.g., correspond with or are synced to beta waves). In embodiments, the frequency of one or more visual stimuli is from about 30.0 Hz to about 100 Hz (e.g., correspond with or are synced to gamma waves). In embodiments, one or more visual stimuli of about 40 Hz is used for gamma stimulation or gamma entrainment, such as “Gamma Entrainment Using Sensory stimulation” (“GENUS”). In embodiments, the one or more visual stimuli of about 40 Hz that is used for gamma stimulation or gamma entrainment is used together with one or more visual stimuli of about 40 Hz. In embodiments, the one or more visual stimuli of about 40 Hz that is used for gamma stimulation or gamma entrainment is used together with one or more visual stimuli of about 40 Hz. In embodiments, the one or more visual stimuli of about 40 Hz that is used for gamma stimulation or gamma entrainment is used together with one or more visual stimuli of about 40 Hzand one or more tactile stimuli of about 40 Hz.
[0145] In embodiments, a co-administration of both an auditory and a visual gamma stimulation may lead to enhanced therapeutic outcomes by reduction of beta-amyloid plaques or white matter atrophy in subjects with Alzheimer’s disease (Martorell et al. Cell. 2019;177(2):256-271.e22; Da et al. J Alzheimers Dis. 2024;97(1):359-372; Traikapi et al. Front Syst Neurosci. 2021 ;15:782399). In embodiments, a co-administration of both a tactile and a visual gamma stimulation may lead to enhanced therapeutic outcomes by reduction of beta-amyloid plaques or white matter atrophy in subjects with Alzheimer’s disease. In embodiments, a co-administration of both a tactile and an auditory gamma stimulation may lead to enhanced therapeutic outcomes by reduction of beta-amyloid plaques or white matter atrophy in subjects with Alzheimer’s disease. In embodiments, a co-administration of all three of a visual gamma stimulation, an auditory gamma stimulation, and a tactile stimulation may lead to enhanced therapeutic outcomes by reduction of beta-amyloid plaques or white matter atrophy in subjects with Alzheimer’s disease.
[0146] In embodiments, the lighting system provides ambience to disclosed environments. In embodiments, the lighting system provides a soothing ambiance. A soothing ambiance refers to an environment or atmosphere that promotes relaxation, tranquility, and a sense of calm. The soothing ambiance typically involves elements that create a peaceful and harmonious setting. In embodiments, the lighting system can provide a soothing ambiance through emitting gentle and warm lighting, such as dimmed lights or simulating the glow of candles. In embodiments, the lighting system can provide a soothing ambiance through emitting colors that are muted, pastel, or neutral. In embodiments, the lighting system can provide a soothing ambiance through emitting blues, greens, and earth tones. In embodiments, the soothing ambiance can be beneficial for subjects undergoing stressful or challenging circumstances. In embodiments, the soothing ambiance can facilitate a safe space for subjects undergoing a therapeutic experience. In embodiments, the soothing ambiance can reduce the uneasiness of participating in a therapeutic experience.
[0147] In embodiments, the lighting system comprises a source of natural light. In embodiments, the source of natural light is a fire. In embodiments, the fire is a gas, optionally enclosed within a transparent (e.g., glass) enclosure. In embodiments, the source of natural light is sunlight. In embodiments, the source of natural light is moonlight. In embodiments, the source of natural light is an open flame (e.g., from a candle, lantern, or firepit).
[0148] In embodiments, the lighting system comprises a source of artificial light. In embodiments, the source of artificial light is an artificial fire (or “display fire”). In embodiments, the artificial fire is illuminated vapor. In embodiments, the artificial fire is projected light. In embodiments, the artificial fire is illuminated fabric. In embodiments, the artificial fire is holographic. In embodiments, the artificial fire is generated by a 3D holographic projector.
[0149] In embodiments, the lighting system illuminates a display surface with a plurality of light sources. In embodiments, the lighting system uses a method of projection mapping. For example, projection mappingdisplays from Palnoise may be used in the bioadaptive environment (Palnoise, Barcelona, Spain).
[0150] In embodiments, the lighting system provides a sensational ambiance. A “sensational ambiance” refers to an environment or atmosphere that stimulates the senses and creates an exciting, vibrant, or exhilarating experience. The sensational ambiance aims to evoke strong emotions and capture attention. In embodiments, the lighting system can provide a soothing ambiance through emitting dynamic and dramatic lighting effects, such as colorful spotlights, changing LED lights, illuminated vapor, or pulsating strobes, so as to create a visually striking atmosphere. In embodiments, the lighting system can provide a soothing ambiance through emitting intense and saturated colors like red, purple, electric blue, or neon shades so as to create a sense of energy and excitement. In embodiments, the sensational ambiance can be beneficial for subjects undergoing stressful or challenging circumstances. In embodiments, the sensational ambiance provides a subject with a sense of interest and excitement. In embodiments, the sensational ambiance can improve the well-being of a subject. In embodiments, the sensational ambiance can reduce the uneasiness of participating in a psychedelic experience. For example, dynamic visual displays from Collectif Scale (Scale, Paris, France), “Color Curtain” by Ksawery Kirklewski, or Reuben Margolin (Emeryville, California) may be used for creating sensorial ambiance.
[0151] In embodiments, the lighting system is capable of providing ambience by adjusting the light frequencies emitted (e.g. by LED, CCFL). In embodiments, the lighting system is capable of emitting a variety of light wavelengths. In embodiments, the lighting system emits warm hues (e.g., tungsten, soft yellows, dim white). In embodiments, the lighting system may emit soft hues (e.g., pale pink, pale blue). In embodiments, the lighting system may emit cool or cold hues (e.g., bright whites with a blueish-white tone). In embodiments, the lighting system may emit daylight hues (e.g. light that mimics the color of natural daylight). In embodiments, the lighting system may emit colored hues (e.g., blue, green, red, purple). In embodiments, the lighting system can be hidden, addressable light emitting diodes (LEDs). In embodiments, the lighting system highlights the physical environment. In embodiments, the lighting highlights undulating curves throughout the environment. In embodiments, addressable light emitting diodes (LEDs) allow for instant shifts in the ambiance from soothing to sensational. In embodiments, the shift in ambience is gradual. In embodiments, the shift in ambiance is immediate.
[0152] In embodiments, the lighting system is synchronized with audio content. For example, the lighting system may project a light show onto a surface in the bioadaptive environment that is coordinated or synchronized with music. In some embodiments, intentional beam projections are synchronized or coordinated with music.
[0153] In some embodiments, the lighting system is integrated into another stimulus source. For example, tactile fabrics may be illuminated with fiber optic lighting. b. Display System
[0154] In embodiments, a disclosed environment comprises a means for providing a visual stimulus,wherein the means for providing a visual stimulus comprises a display system.
[0155] In embodiments, the display system comprises equipment or means for delivering or displaying video or videographic content, such as a television screen, a smartphone, a tablet, a computer screen, a projector and projection screen, a virtual reality (VR) device, a mixed reality (MR) device, an extended reality (XR) device, an augmented reality (AR) device, a 3D projection device and a 3D projection screen, and the like. For example, in some embodiments, the display system comprises a 3D projection device. In embodiments, the display system comprises a combination of any one or more of a television screen, smartphone, tablet, computer screen, projector and projection screen, virtual reality device, 3D projection device, and 3D projection screen. Other types of display systems are described herein and known in the art.
[0156] In embodiments, the visual stimulus is video or videographic content. The term “video” should be interpreted to be a visual medium capable of being displayed on a computer screen, television, projection screen, projection surface or multi-surface, tablet device, smartphone, or smartwatch, and of being played by digital media devices, single projector or multi-projector setups, multimedia players, communication devices, computing devices, VR, AR, XR, and MR devices, and the like. The term “video” should be interpreted without limitation, and to include (except where otherwise specified) general videographic styles, such as live action, motion graphics, whiteboard videos, typography videos, screencast, and animation. For example, screens implemented as visual display systems can be sourced from Screen Solutions International (SSI Displays, Rocklin, California).
[0157] In embodiments, the environment comprises high-definition 3D projections. A “3D projection” is a technique that creates a visual representation of a three-dimensional object or scene onto a two-dimensional surface, providing a sense of depth and spatial perception. In embodiments, 3D projections can be useful for immersive experiences, allowing subjects to engage with virtual environments that can enhance relaxation, exposure therapy, or visualization exercises, potentially facilitating therapeutic outcomes through realistic and interactive simulations. In embodiments, the 3D projections are displayed on a screen (e.g., a TV screen). In embodiments, the 3D projections are displayed on the ceiling, walls, floor, or a combination thereof. In embodiments, the 3D projections provide a mirror image of the interior of the environment.
[0158] In embodiments, the display system is capable of displaying light, color, and immersive bioadaptive environments. An immersive environment refers to a setting or experience that deeply engages and captivates the senses, creating a realistic and all-encompassing sensory experience. In embodiments, the immersive environment comprises themes of nature or natural landscapes. In embodiments, the themes of nature or natural landscapes are projections of reality. In embodiments, the themes of nature or natural landscapes are imagined (e.g., Al generated or human generated). In embodiments, themes of nature or natural landscapes are photo-realistic destinations. In embodiments, the themes of nature or natural landscapes depict scenes of mountain tops with eagles soaring off into the distance. In embodiments, the themes of nature or natural landscapes depict scenes beneath the surface of water. In embodiments, thethemes of nature or natural landscapes depict light dancing across ripples of water. In embodiments, the themes of nature or natural landscapes depict a desert night sky under a canopy of stars. In embodiments, the environment comprises scenes that depict celestial bodies, such as the sun, stars, moon, and or celestial clouds of the milky way. In embodiments, the themes of nature of natural landscapes are a combination of themes of nature or natural landscapes. For example, creations from Studio Drift (Amsterdam, The Netherlands), Aquatique Show International™ (Aquatique Show International, Strasbourg, France), or Lachlan Turczan (Studio Lachlan Turczan, Los Angeles, California) may illustrate an immersive environment combining natural landscapes or water with visual artistic displays.
[0159] In embodiments, the environment comprises interactive video content. In embodiments, the interactive video content comprises visual cues. In embodiments, the visual cues are timers or breathing animations. In embodiments, a “visual cue” for a breathing exercise is a visual stimulus or indicator that guides subjects to regulate and synchronize their breath, promoting mindfulness and relaxation. In embodiments, the visual cues may be integrated into interactive video content. In embodiments, the video cue is a timer. In embodiments, the timer guides the participant on how long to inhale and how long to exhale. In embodiments, the environment may cue a user. In embodiments, the user may cue the environment. In embodiments, the cue may be triggered in response to biofeedback data. For example, the video content may be cued interactive video content from Daniel Rozin (Smoothware, New York, New York).
[0160] In embodiments, interactive video content may respond to auditory cues provided by the user (i.e., spoken word or vocalizations). For example, in some embodiments, disclosed interactive video content may include a flower animation. In embodiments, a flower first pops its head above the surface of the ground and grows to maturity if received auditory cues are positive (i.e., words of kindness). In embodiments, the flower droops and shrivels if received auditory cues are negative (i.e., insults or phrases of negativity). This may invoke a sense of positive reinforcement in the user and cue the user to a shift in their thought patterns of self talk. In embodiments, the video content may be projected onto surfaces, allowing them to change dynamically or respond to the subject’s movements.
[0161] In embodiments, the environment contains movement sensors. In embodiments, sensors can pick up on a user’s movement. In embodiments, videographic content can be tailored to the user based on their movements, which can be collected according to means described in embodiments herein and known to those in the art. Disclosed interactive elements can provide a more immersive experience and engage a subject’s senses. c. Patterns
[0162] In embodiments, a disclosed environment comprises a means for providing a visual stimulus, wherein the visual stimulus comprises one or more patterns or geometric shapes.
[0163] In embodiments, the patterns or geometric shapes can be wall designs. In embodiments, the patterns or geometric shapes can be ceiling designs. In embodiments, the patterns or geometric shapes canbe floor patterns.
[0164] In embodiments, the patterns or geometric shapes may feature intricate patterns, such as mandalas, fractals, or tessellations. In embodiments, the patterns or geometric shapes can be designed to promote relaxation, stimulate creativity, or induce a sense of tranquility. A sense of tranquility refers to a state of calmness, peace, and inner harmony. A sense of tranquility is further characterized by a feeling of serenity, relaxation, and freedom from stress or agitation.
[0165] In embodiments, the patterns or geometric shapes can incorporate geometric shapes such as triangles, hexagons, spirals, or a combination thereof. In embodiments, the patterns or geometric shapes can be implemented in a repetitive pattern.
[0166] In embodiments, the patterns or geometric shapes can be visually appealing. Visually appealing refers to something that is aesthetically pleasing, attractive, evokes a positive response, and is considered visually satisfying. In embodiments, the patterns or geometric shapes create a visually engaging environment. Visual engaging refers to something that captures and holds one's attention, stimulating and captivating the viewer through its visual elements.
[0167] In embodiments, the patterns or geometric shapes further comprise color. In embodiments, the patterns or geometric shapes are selected to align with therapeutic goals. For example, in some embodiments, cool tones such as blues and greens can promote relaxation. In another example, in some embodiments, warm tones such as oranges and yellows can elicit feelings of serenity and comfort. In embodiments, disclosed environments comprise the color white. In embodiments, disclosed environments comprise cool tones, warm tones, white, black, or a combination thereof.
[0168] In embodiments, disclosed environments provide a palate for custom art creations featuring sacred geometry, abstract washes of color, and biophilic patterns. Sacred geometry are geometric patterns and shapes that are believed to hold spiritual significance, exploring the mathematical principles, and ratios underlying the universe and various aspects of life. Abstract washes of color refer to a technique in art wherein translucent layers of media (e.g., ink, paint) are applied in a flowing or diluted manner, creating fluid and non-representational patterns or fields of color without specific recognizable forms. Biophilic patterns are design elements inspired by nature, incorporating organic shapes and representations of flora and fauna, aimed at fostering a connection to the natural environment and promoting well-being.3. Means for Providing an Auditory Stimulus
[0169] In embodiments, a disclosed environment comprises a means for providing an auditory stimulus.
[0170] In embodiments, the means for providing an auditory stimulus may be presented by audio equipment (e.g., speakers or a separate pair of headphones). In embodiments, at least one of the speakers is a subwoofer. In embodiments, the audio equipment may be embedded in the environment (e.g., camouflaged, concealed within walls or furniture, or incorporated with decorative elements). The means for providing audio or another auditory stimulus may be another suitable means described herein or otherwiseknown to those of skill in the art, and their equivalents. The term “audio” should be interpreted without limitation, and to include (except where otherwise specified) general audio styles, such as music, narration, and the like. The term “audio” should further be interpreted to be an auditory medium capable of being transmitted through speakers, telephones, earphones, headphones, and the like. For example, a means of providing the auditory stimulus within the environment is LUMIN™ (Pixel Magic Systems Ltd., Hong Kong).
[0171] In embodiments, a disclosed auditory stimulus may be presented prior to the psychedelic experience. In embodiments, a disclosed auditory stimulus may be presented at the beginning of the psychedelic experience. In embodiments, a disclosed auditory stimulus may be presented periodically throughout the psychedelic experience. In embodiments, a disclosed auditory stimulus may be presented at the ascent of the psychedelic experience. In embodiments, a disclosed auditory stimulus may be presented at the peak of the psychedelic experience. In embodiments, a disclosed auditory stimulus may be presented at the descent of the psychedelic experience. In embodiments, a disclosed auditory stimulus may be presented at the end of the psychedelic experience. In embodiments, a disclosed auditory stimulus may be presented for the entirety of, one or more parts of, or none of the experience.
[0172] In embodiments, the same auditory stimulus may be presented throughout the experience. In embodiments, different auditory stimuli may be presented throughout the experience. In embodiments, different auditory stimuli may be presented based on the preference of a subject having the psychedelic experience.
[0173] In embodiments, a disclosed environment comprises a means for providing an auditory stimulus, wherein the auditory stimulus comprises auditory content.
[0174] In embodiments the auditory content comprises soundscapes or songs. In embodiments the auditory content comprises music. In embodiments, the auditory stimulus comprises narration. In embodiments, the auditory stimulus comprises a combination of one or more of soundscapes, songs, music, narration, sub-frequencies, and ambient sounds. For example, Spotify™ (Spotify AB, Stockholm, Sweden), SoundCloud™ (SoundCloud Global Limited & Co. KG, Berlin, Germany), or other music streaming service may be utilized for audio stimulus playback.
[0175] In embodiments, the auditory content is personalized for a subject. The auditory content may be personalized for a subject based on pre-selected parameters chosen by the subject or by another (e.g., by the therapist, guide, or facilitator), based on characteristics of the subject, and / or based on behavioral, physiological, and / or digital biomarkers of the subject. In embodiments, the auditory content is personalized before a psychedelic experience. In embodiments, the auditory content is personalized once or more during a psychedelic experience. In embodiments, the auditory content is personalized periodically during a psychedelic experience. In embodiments, the auditory content is personalized continuously during a psychedelic experience. In embodiments, the auditory content is personalized during a psychedelic experience based on one or more biomarkers of the subject. In embodiments, the auditory content ispersonalized during a psychedelic experience based on the requests of the subject made before the experience. In embodiments, the auditory content is personalized during a psychedelic experience based on the requests of the subject made during the experience.
[0176] In embodiments, the auditory stimulus is automatically personalized using an auditory generation technique, such as generative algorithms, adaptive auditory techniques, machine learning, and artificial intelligence. For example, Casperaki may be used to generate music using artificial intelligence (Casperaki, London, United Kingdom).
[0177] In embodiments, biofeedback data is used to personalize generated auditory stimuli. For example, a disclosed bioadaptive environment may be cued to generate calming auditory stimuli in response to an increase in collected measures that correspond to subject stress levels or anxiety. Conversely, the environment may be cued to maintain or augment a style of auditory stimulus in response to collected measures that correspond to resonance, calmness, transcendence, or other therapeutically beneficial emotional, behavioral, or physiological states.
[0178] In embodiments, biofeedback data collected from a subject is received, processed, and used to modify the bioadaptive environment through changes in auditory stimulus. In some embodiments, biofeedback data is used to automatically cue changes to the auditory content. For example, the bioadaptive environment may adapt the emotional theme, intensity, and duration of music in the environment to stimulate change in the emotional states of subjects as measured by collected biofeedback data. In some embodiments, biofeedback data is used to automatically cue changes to the integrated vibroacoustic therapy system.
[0179] In embodiments, the auditory stimulus enhances a psychedelic experience. In embodiments, the auditory stimulus increases or increases the likelihood of one or more therapeutic benefits of a psychedelic experience, such as a beneficial mental health outcome (see, e.g., Kaelen et al. Psychopharmacology. 2018;235(2):505-519). In embodiments, the auditory stimulus decreases or decreases the risk of one or more adverse events related to a psychedelic experience, such as the possibility of a challenging psychedelic experience or bad trip.
[0180] In embodiments, the auditory stimulus will synergistically integrate or synchronize with, be synergistically presented together with, or be synergistically perceived together with, another stimulus to increase the sense of immersion and to enhance one or more aspects of the psychedelic experience, such as by increasing a benefit or a therapeutic outcome, or by decreasing a risk or an adverse outcome.
[0181] Below are non-limiting examples of some of the means for providing an auditory stimulus that are present within the environment. Other means for providing an auditory stimulus may be another suitable means described herein or otherwise known to those of skill in the art, and their equivalents. b. Auditory Content
[0182] In embodiments, a disclosed environment comprises a means for providing an auditory stimulus,wherein the auditory stimulus comprises auditory content. In embodiments, the auditory content comprises soundscapes or songs. In embodiments, the auditory content comprises music. In embodiments, the auditory content comprises narration. In embodiments, the auditory content comprises a combination of one or more of soundscapes, songs, music, narration, sub-frequencies, and ambient sounds.
[0183] In embodiments, a subject will have the option to personalize the therapeutic environment by selecting their preferred music. In embodiments, the subject may choose from various genres (e.g., Alternative, Rock, Classical, Electronic, as well as subgenres thereof). In embodiments, the subject may bring their own playlist or playlists, allowing individual subjects to create a personalized audio experience that enhances their well-being. In embodiments, the music will be selected by the therapist or facilitator. In embodiments, the music will be selected by a third party having the role of music specialist or music curator for the subject, the environment, or the experience.
[0184] Music has a large and important role as part of psychedelic-assisted therapy (e.g., Kaelen et al. Psychopharmacol. 2015;232(19):3607-14 and Kaelen et al. Psychopharmacol. 2018;235(2):505-519). Outside of psychedelic-assisted therapy, commonly known combinations of music and psychedelics exist at music festivals and raves, at home, and within religious ceremonies (e.g., traditional Shipibo, Mazatec, and Native American Church ceremonies). Music can dramatically alter psychedelic experience (O’callaghan et al. J Music Ther. 2020;57(3):282-314). Some styles of music are standard in psychedelic assisted therapy, such as melodic house and classical music, and especially music without or with minimal words or lyrics, and that therefore permit a subject to go inward without linguistic distraction.
[0185] In embodiments, music may be presented for the entirety of the experience. In embodiments, music may be presented at the beginning of the experience, peak of the experience, end of the experience, or any combination thereof. In embodiments, music may be selected and presented based on the timing of the beginning of the experience, peak of the experience, end of the experience, or any combination thereof.
[0186] In embodiments, the same music may be presented for the entire experience. For example, in some embodiments, a long continuous playlist may blend together songs from a specific genre as a means to guide a subject through the experience. In embodiments, different music may be presented throughout the experience (e.g., different genres, different tracks). In embodiments, different music may be presented based on the preferences of the subject participating in the psychedelic experience. For example, in some embodiments, in the event a subject participant does not enjoy the music being played, they may switch the music according to their preference or taste. In embodiments, the music may be synchronized with the intensity or characteristics of a trip. In embodiments, music may change based on the difficulty of one’s experience. For example, the difficult experience may be an experience that induces stress, anxiety, sadness, fear, or a combination thereof. The music may be adjusted to create a more melodic, soothing, or relaxing experience. In embodiments, biofeedback and monitoring systems may be implemented, wherein the biofeedback and monitoring systems pick up on heightened heart rate or changes in blood pressure, andprogrammed systems within the environment may change the music to something more soothing in order to rescue a challenging or “bad” trip and promote one or more positive aspects of the experience.
[0187] In embodiments, the subject manually adjusts one or more sound output controls according to their personal preference. For example, the subject may adjust one or more of the bass, treble, mid, and volume settings. In embodiments, the bass, treble, mid, and volume settings are automatically adapted based on the processed biofeedback data of one or more subjects.
[0188] In embodiments, the bioadaptive environment comprises a plurality of speakers so as to create an immersive surround sound effect. In embodiments, sound output settings for each speaker may be independently controlled manually by the user or automatically in response to processed biofeedback data. In embodiments, sound output settings for each speaker may be collectively controlled manually by the user or automatically in response to processed biofeedback data.
[0189] In embodiments, the auditory content comprises a narrative animation. For example, in some embodiments, the narrative animation may include words of wisdom from great thinkers like Alan Watts, Ram Dass, and Eckart Tolle. In embodiments, the narrative animation may include words about or relevant to a psychedelic experience from psychedelic luminaries like Alexander “Sasha” Shulgin, Ann Shulgin, or Terrence McKenna.
[0190] In embodiments, a narrative animation may provide helpful frameworks for the integration process. The integration process involves incorporating the insights and experiences gained from a psychedelic journey into everyday life for personal growth and healing. The integration process may include reflection, practices, and support to apply lessons learned and foster positive changes. For example, in some embodiments, a narrative animation that informs the integration process comprises Joseph Campbell’s “Hero with a Thousand Faces” or Carl Jung’s “Incorporation of the Shadow.”
[0191] In embodiments, the auditory content comprises one or more ambient sounds. In embodiments, the environment is designed to present soothing ambient sounds, such as gentle nature sounds (e.g., flowing water, birds chirping) or calming instrumental music. In embodiments, ambient sounds will help create a serene atmosphere and aid relaxation. A serene atmosphere refers to a calm, peaceful, and tranquil environment that can promote a sense of relaxation and harmony.
[0192] In embodiments, the auditory content is tailored to complement the visual stimulus in the bioadaptive environment. For example, auditory content can be generated to match the expected sounds of a natural environment being visually displayed in the bioadaptive environment. c. Vibroacoustic Therapy
[0193] In embodiments, a disclosed environment comprises a means for providing an auditory stimulus, wherein the auditory stimulus comprises vibroacoustic therapy. “Vibroacoustic therapy” (“VAT”) is a type of sound therapy that involves passing low frequency sine wave vibrations into the body via a device with embedded speakers. In embodiments, the vibroacoustic therapy is provided by an ergonomic vibroacousticlounger or “Vibrolounger.”
[0194] In embodiments, the ergonomic vibroacoustic lounger (Vibrolounger) comprises a sound system capable of outputting frequencies, such as sub-frequencies (e.g., infrasound, brainwave entrainment, Solfeggio Frequencies, Schumann Resonance). Therapeutic frequencies or sub-frequencies are low-frequency sound waves used in various modalities and are capable of promoting relaxation, stress reduction, and overall well-being.
[0195] In embodiments, the frequency of one or more auditory stimuli corresponds with one or more neural oscillation rhythms. In embodiments, the one or more neural oscillation rhythms include any of delta waves, theta waves, alpha waves, beta waves, and gamma waves.
[0196] In embodiments, the frequency of one or more auditory stimuli is synced to one or more neural oscillation rhythms. Neural oscillation rhythms may be monitored using means known to those of skill, such as electroencephalography (EEG) and quantitative EEG (qEEG). In embodiments, the frequency of one or more auditory stimuli is synced with one or more neural oscillation rhythms, including any of delta waves, theta waves, alpha waves, beta waves, and gamma waves.
[0197] In embodiments, the frequency of one or more auditory stimuli is from about 0.5 Hz to about 100 Hz. In embodiments, the frequency of one or more auditory stimuli is from about 0.5 Hz to about 4.0 Hz (e.g., correspond with or are synced to delta waves). In embodiments, the frequency of one or more auditory stimuli is from about 4.0 Hz to about 8.0 Hz (e.g., correspond with or are synced to theta waves). In embodiments, the frequency of one or more auditory stimuli is from about 8.0 Hz to about 12.0 Hz (e.g., correspond with or are synced to alpha waves). In embodiments, the frequency of one or more auditory stimuli is from about 12.0 Hz to about 30.0 Hz (e.g., correspond with or are synced to beta waves). In embodiments, the frequency of one or more auditory stimuli is from about 30.0 Hz to about 100 Hz (e.g., correspond with or are synced to gamma waves).
[0198] In certain preferred embodiments, the frequency of one or more auditory stimuli is about 40 Hz, and is used for gamma stimulation or gamma entrainment, such as “Gamma Entrainment Using Sensory stimulation” (“GENUS”). In embodiments, the one or more auditory stimuli of about 40 Hz that is used for gamma stimulation or gamma entrainment is used together with one or more visual stimuli of about 40 Hz. In embodiments, the one or more auditory stimuli of about 40 Hz that is used for gamma stimulation or gamma entrainment is used together with one or more tactile stimuli of about 40 Hz. In embodiments, the one or more auditory stimuli of about 40 Hz that is used for gamma stimulation or gamma entrainment is used together with one or more tactile stimuli of about 40 Hz and one or more tactile stimuli of about 40 Hz.
[0199] In embodiments, the ergonomic vibroacoustic lounger (Vibrolounger) emits delta, theta, alpha, beta, sub-frequencies alone or in a combination thereof. In embodiments, the sub-frequencies may be synced with another auditory stimulus. In embodiments, frequencies from about 30.0 Hz to about 100 Hz are provided to a subject in the environment together with a psychedelic experience or the administration of a psychedelic. Incertain preferred embodiments, a gamma stimulation is provided at a frequency of about 40.0 Hz. In certain preferred embodiments, gamma stimulation is used as gamma entrainment (see e.g., Sharpe R, Brain Inform, 2020, 7(1); 17). In embodiments, gamma stimulation is provided to a subject in the environment without a psychedelic experience or the administration of a psychedelic.
[0200] In embodiments of gamma frequency administration, the subject suffers from a disease or disorder. In embodiments of gamma frequency administration, the subject is treated for a disease or disorder. In embodiments of gamma frequency administration, the subject sees a reduction in at least one sign or symptom of a disease or disorder. In embodiments of gamma frequency administration, the subject has a therapeutic benefit or an improvement in a therapeutic outcome relating to a disease or disorder.
[0201] In embodiments of gamma frequency administration, the subject suffers from Alzheimer's disease. In embodiments of gamma frequency administration, the subject is treated for Alzheimer's disease. In embodiments of gamma frequency administration, the subject sees a reduction in at least one sign or symptom of Alzheimer's disease. In embodiments of gamma frequency administration, the subject has a therapeutic benefit or an improvement in a therapeutic outcome relating to Alzheimer's disease.
[0202] In embodiments, an auditory stimulus alone is used to deliver sub-frequencies. In embodiments, an auditory stimulus and a tactile stimulus are used in combination to deliver sub-frequencies. In embodiments, an auditory and a visual stimulus are used in combination to deliver sub-frequencies. In embodiments, an auditory stimulus, a tactile stimulus, and a visual stimulus are used in combination to deliver sub-frequencies.
[0203] In embodiments, the ergonomic vibroacoustic lounger (Vibrolounger) further comprises motors or hydropumps to provide massages, deep tissue stimulation, or a combination thereof. In embodiments, the ergonomic vibroacoustic lounger (Vibrolounger) is capable of temporarily relieving minor aches and pains, muscle soreness, stiffness, tension, or a combination thereof. In embodiments, the ergonomic vibroacoustic lounger (Vibrolounger) increases circulation in local areas where massaged. In embodiments, the ergonomic vibroacoustic lounger reduces stress and anxiety. In embodiments, the ergonomic vibroacoustic lounger enhances a feeling of well-being. In embodiments, the ergonomic vibroacoustic lounger promotes deep relaxation.4. Means for Providing a Tactile Stimulus
[0204] In embodiments, a disclosed environment comprises a means for providing a tactile stimulus.
[0205] In embodiments, a disclosed tactile stimulus may be presented prior to the psychedelic experience. In embodiments, a disclosed tactile stimulus may be presented at the beginning of the psychedelic experience. In embodiments, a disclosed tactile stimulus may be presented periodically throughout the psychedelic experience. In embodiments, a disclosed tactile stimulus may be presented at the ascent of the psychedelic experience. In embodiments, a disclosed tactile stimulus may be presented at the peak of the psychedelic experience. In embodiments, a disclosed tactile stimulus may be presented at the descent of the psychedelic experience. In embodiments, a disclosed tactile stimulus may be presented at the end of thepsychedelic experience. In embodiments, a disclosed tactile stimulus may be presented for the entirety of, one or more parts of, or none of the experience.
[0206] In embodiments, the same tactile stimulus may be presented throughout the experience. In embodiments, different tactile stimuli may be presented throughout the experience. In embodiments, different tactile stimuli may be presented based on the preference of a subject having the psychedelic experience. In embodiments, different tactile stimuli may be interacted without throughout the experience. For example, the tactile stimuli, when interacted with, may provide the user with feedback, produce an audio stimulus and / or produce a visual stimulus.
[0207] In embodiments, the tactile stimulus is personalized for a subject. The tactile stimulus may be personalized for a subject based on pre-selected parameters chosen by the subject or by another (e.g., by the therapist, guide, or facilitator), based on characteristics of the subject, and / or based on behavioral, physiological, and / or digital biomarkers of the subject. In embodiments, the tactile stimulus is personalized before a psychedelic experience. In embodiments, the tactile stimulus is personalized once or more during a psychedelic experience. In embodiments, the tactile stimulus is personalized periodically during a psychedelic experience. In embodiments, the tactile stimulus is personalized continuously during a psychedelic experience. In embodiments, the tactile stimulus is personalized during a psychedelic experience based on one or more biomarkers of the subject. In embodiments, the tactile stimulus is personalized during a psychedelic experience based on the requests of the subject made before the experience. In embodiments, the tactile stimulus is personalized during a psychedelic experience based on the requests of the subject made during the experience.
[0208] In embodiments, biofeedback data collected from a subject is received, processed, and used to modify the bioadaptive environment through changes in tactile stimulus. In some embodiments, bioadaptive data is used to automatically cue changes to integrated haptic floor tiles. For example, the bioadaptive environment may receive and analyze biofeedback data measuring the effect of hepatic tile vibrations on user heart or brain activity. The bioadaptive environment may further modulate hepatic tile vibrations to lower user heart rate or achieve desired brain activity.
[0209] In embodiments, the tactile stimulus enhances a psychedelic experience. In embodiments, the tactile stimulus increases or increases the likelihood of one or more therapeutic benefits of a psychedelic experience, such as a beneficial mental health outcome. In embodiments, the tactile stimulus decreases or decreases the risk of one or more adverse events related to a psychedelic experience, such as the possibility of a challenging psychedelic experience or bad trip.
[0210] In embodiments, the tactile stimulus will synergistically integrate or synchronize with, be synergistically presented together with, or be synergistically perceived together with, another stimulus to increase the sense of immersion and to enhance one or more aspects of the psychedelic experience, such as by increasing a benefit or a therapeutic outcome, or by decreasing a risk or an adverse outcome.
[0211] Below are non-limiting examples of means for providing a tactile stimulus that may be present within the environment. Other means for providing a tactile stimulus may be another suitable means described herein or otherwise known to those of skill in the art, and their equivalents. a. Tactile Materials
[0212] In embodiments, a means for providing a tactile stimulus is a tactile material.
[0213] In embodiments, a tactile material is a soft material. Exemplary soft materials include cushions, pillows, and upholstered walls. In embodiments, soft materials will add a comforting and cozy aspect to the environment.
[0214] In embodiments, a tactile material is a textured material, such as a textured surface. “Textured” refers to the tactile as well as visual qualities of a surface or other material. In embodiments, a textured surface will contribute to a sense of security and relaxation. In embodiments, a textured surface that is soft, smooth, and gentle to the touch will evoke a soothing sensation and promote relaxation. In embodiments, a textured material is a textured fabric such as plush velvet, silk, or high-quality cotton. In embodiments, a textured fabric will create a sense of comfort and coziness. In embodiments, the textured material is present on one or more ceiling surfaces, on one or more floor surfaces, on one or more wall surfaces, or is otherwise present within the environment. In embodiments, the textured material is present on one or more vertical or substantially vertical surfaces. In embodiments, the textured material is present on one or more horizontal or substantially horizontal surfaces. In embodiments, the textured material comprises a variation in textures. In embodiments, the variation in textures will provide a multi-sensory experience, providing subjects with different tactile sensations. For example, in some embodiments, the range of tactile textures could include sections of surfaces with smooth surfaces, sections of surfaces with rough, grooved, or bumpy textures, or combinations thereof. In embodiments, varied tactile surfaces contributing to a sense of security and relaxation can be sourced from Steps Material (Foshan Syi Painting Co. Ltd, Foshan City, China).
[0215] In embodiments, a ceiling surface or another horizontal or substantially horizontal surface of the environment is adorned with one or more textured elements, such as hanging fabric, hanging strings, or other hanging or suspended objects. In embodiments, a wall surface or another vertical or substantially vertical surface of the environment is adorned with one or more textured elements, such as hanging fabric, hanging strings, or other hanging or suspended objects. In embodiments, the textured elements will create an aesthetically pleasing environment and evoke a sense of wonder and exploration.
[0216] In embodiments, the tactile material comprises padded floor tiles. In embodiments, the padded floor tiles appear as another material (e.g., bamboo, dirt, a forest floor, sand). In embodiments, the padded floor tiles comprise ethylene-vinyl acetate (EVA) rubber. In embodiments, the padded floor tiles are Forest Floor® ethylene-vinyl acetate (EVA) rubber padded tiles. In embodiments, the padded floor tiles provide proprioceptive feedback for the feet while enhancing safety and stability when engaging the body. In embodiments, the padded floor tiles improve grip to support movement. In embodiments, the padded floortiles are designed for shoeless (e.g., barefoot) movement. In embodiments, the padded floors are designed to limit fatigue from standing or movement.
[0217] In embodiments, the tactile material comprises fabric flooring. In embodiments, the fabric flooring is a rug. In embodiments, the tactile material comprises haptic floor tiles. In some embodiments, each hepatic floor tile comprises one or more transducers. In embodiments, the haptic floor tiles are capable of producing frequencies below 50 Hz. In some embodiments, the haptic floor tile is designed by Crescendo Research. In some embodiments, frequencies below 50 Hz are produced in haptic floor tiles using Crescendo Bass Tiles (Crescendo Research, Walnut Creek, CA).
[0218] In embodiments, the floor tiles are interactively connected with the audio system in the bioadaptive environment. In embodiments, one or more subjects can engage with the floor tiles to produce audio stimulus. For example, when a subject walks along the interactive floor tiles, audible notes or vibrations are emitted through a plurality of speakers or transducers within the bioadaptive environment. b. Tactile Seating
[0219] In embodiments, a means for providing a tactile stimulus is tactile seating.
[0220] In embodiments, the tactile seating is a seating surface. In embodiments, the seating surface is a chair, sofa, couch, loveseat, bench, stool, ottoman, chaise lounge, bar stool, or a combination thereof. In embodiments, the seating surface is a textured seating surface.
[0221] In embodiments, the seating surface is a vibrating seating surface. In embodiments, the vibrating seating surface is a massage chair. In embodiments, the massage chair is an ergonomic vibroacoustic lounger, or “Vibrolounger.” In embodiments, a Vibrolounger or other massage chair comprises motors or hydropumps to provide massages, deep tissue stimulation, or a combination thereof.
[0222] In embodiments, a Vibrolounger or other massage chair is capable of temporarily relieving or will temporarily relieve minor aches and pains, muscle soreness, stiffness, tension, or a combination thereof. In embodiments, a Vibrolounger or other massage chair is capable of increasing or will increase circulation in local areas where massaged. In embodiments, a Vibrolounger or other massage chair is capable of reducing or will reduce stress and anxiety. In embodiments, a Vibrolounger or other massage chair is capable of enhancing or will enhance a feeling of well-being. In embodiments, a Vibrolounger or other massage chair is capable of promoting or will promote deep relaxation.
[0223] In embodiments, the frequency of one or more tactile stimuli corresponds with one or more neural oscillation rhythms. In embodiments, the one or more neural oscillation rhythms include any of delta waves, theta waves, alpha waves, beta waves, and gamma waves.
[0224] In embodiments, the frequency of one or more tactile stimuli is synced to one or more neural oscillation rhythms. Neural oscillation rhythms may be monitored using means known to those of skill, such as electroencephalography (EEG) and quantitative EEG (qEEG). In embodiments, the frequency of one or more tactile stimuli is synced with one or more neural oscillation rhythms, including any of delta waves, thetawaves, alpha waves, beta waves, and gamma waves.
[0225] In embodiments, the frequency of one or more tactile stimuli is from about 0.5 Hz to about 100 Hz. In embodiments, the frequency of one or more tactile stimuli is from about 0.5 Hz to about 4.0 Hz (e.g., correspond with or are synced to delta waves). In embodiments, the frequency of one or more tactile stimuli is from about 4.0 Hz to about 8.0 Hz (e.g., correspond with or are synced to theta waves). In embodiments, the frequency of one or more tactile stimuli is from about 8.0 Hz to about 12.0 Hz (e.g., correspond with or are synced to alpha waves). In embodiments, the frequency of one or more tactile stimuli is from about 12.0 Hz to about 30.0 Hz (e.g., correspond with or are synced to beta waves). In embodiments, the frequency of one or more tactile stimuli is from about 30.0 Hz to about 100 Hz (e.g., correspond with or are synced to gamma waves).
[0226] In certain preferred embodiments, the frequency of one or more tactile stimuli is about 40 Hz, and is used for gamma stimulation or gamma entrainment, such as “Gamma Entrainment Using Sensory stimulation” (“GENUS”). In embodiments, the one or more tactile stimuli of about 40 Hz that is used for gamma stimulation or gamma entrainment is used together with one or more visual stimuli of about 40 Hz. In embodiments, the one or more tactile stimuli of about 40 Hz that is used for gamma stimulation or gamma entrainment is used together with one or more auditory stimuli of about 40 Hz. In embodiments, the one or more tactile stimuli of about 40 Hz that is used for gamma stimulation or gamma entrainment is used together with one or more auditory stimuli of about 40 Hz and one or more visual stimuli of about 40 Hz.
[0227] In embodiments, a tactile gamma stimulation may lead to enhanced therapeutic outcomes by reduction of beta-amyloid plaques or white matter atrophy in subjects with Alzheimer’s disease.
[0228] In embodiments, frequencies from about 30.0 Hz to about 100 Hz are provided to a subject in the environment together with a psychedelic experience or the administration of a psychedelic. In certain preferred embodiments, a gamma stimulation is provided at a frequency of about 40.0 Hz. In certain preferred embodiments, gamma stimulation is used as gamma entrainment. In embodiments, gamma stimulation is provided to a subject in the environment without a psychedelic experience or the administration of a psychedelic.
[0229] In embodiments of gamma frequency administration, the subject suffers from a disease or disorder. In embodiments of gamma frequency administration, the subject is treated for a disease or disorder. In embodiments of gamma frequency administration, the subject sees a reduction in at least one sign or symptom of a disease or disorder. In embodiments of gamma frequency administration, the subject has a therapeutic benefit or an improvement in a therapeutic outcome relating to a disease or disorder.
[0230] In embodiments of gamma frequency administration, the subject suffers from Alzheimer's disease. In embodiments of gamma frequency administration, the subject is treated for Alzheimer's disease. In embodiments of gamma frequency administration, the subject sees a reduction in at least one sign or symptom of Alzheimer's disease. In embodiments of gamma frequency administration, the subject has atherapeutic benefit or an improvement in a therapeutic outcome relating to Alzheimer's disease.
[0231] In embodiments, a tactile stimulus alone is used to deliver sub-frequencies. In embodiments, a tactile stimulus and a visual stimulus are used in combination to deliver sub-frequencies. In embodiments, a tactile stimulus and an auditory stimulus are used in combination to deliver sub-frequencies. In embodiments, a tactile stimulus, an auditory stimulus, and a tactile stimulus are used in combination to deliver sub-frequencies.5. Means for Providing an Olfactory Stimulus
[0232] In embodiments, a disclosed environment comprises a means for providing an olfactory stimulus.
[0233] In embodiments, a disclosed olfactory stimulus may be presented prior to the psychedelic experience. In embodiments, a disclosed olfactory stimulus may be presented at the beginning of the psychedelic experience. In embodiments, a disclosed olfactory stimulus may be presented periodically throughout the psychedelic experience. In embodiments, a disclosed olfactory stimulus may be presented at the ascent of the psychedelic experience. In embodiments, a disclosed olfactory stimulus may be presented at the peak of the psychedelic experience. In embodiments, a disclosed olfactory stimulus may be presented at the descent of the psychedelic experience. In embodiments, a disclosed olfactory stimulus may be presented at the end of the psychedelic experience. In embodiments, a disclosed olfactory stimulus may be presented for the entirety of, one or more parts of, or none of the experience.
[0234] In embodiments, the same olfactory stimulus may be presented throughout the experience. In embodiments, different olfactory stimuli may be presented throughout the experience). In embodiments, different olfactory stimuli may be presented based on the preference of a subject having the psychedelic experience.
[0235] In embodiments, a disclosed environment comprises a means for providing an olfactory stimulus, wherein the olfactory stimulus comprises olfactory content.
[0236] In embodiments, the olfactory content is personalized for a subject. The olfactory content may be personalized for a subject based on pre-selected parameters chosen by the subject or by another (e.g., by the therapist, guide, or facilitator), based on characteristics of the subject, and / or based on behavioral, physiological, and / or digital biomarkers of the subject. In embodiments, the olfactory content is personalized before a psychedelic experience. In embodiments, the olfactory content is personalized once or more during a psychedelic experience. In embodiments, the olfactory content is personalized periodically during a psychedelic experience. In embodiments, the olfactory content is personalized continuously during a psychedelic experience. In embodiments, the olfactory content is personalized during a psychedelic experience based on one or more biomarkers of the subject. In embodiments, the olfactory content is personalized during a psychedelic experience based on the requests of the subject made before the experience. In embodiments, the olfactory content is personalized during a psychedelic experience based on the requests of the subject made during the experience.
[0237] In embodiments, biofeedback data collected from one or more subjects are received, processed, and used to modify the bioadaptive environment through changes in olfactory stimulus. In some embodiments, biofeedback data is used to automatically cue changes to the aroma diffusion in the bioadaptive environment. For example, the bioadaptive environment may disperse a calming scent in response to processed biofeedback data that indicates a subject is in need of support with relaxation.
[0238] In embodiments, the olfactory stimulus enhances a psychedelic experience. In embodiments, the olfactory stimulus increases or increases the likelihood of one or more therapeutic benefits of a psychedelic experience, such as a beneficial mental health outcome. In embodiments, the olfactory stimulus decreases or decreases the risk of one or more adverse events related to a psychedelic experience, such as the possibility of a challenging psychedelic experience or bad trip.
[0239] In embodiments, the olfactory stimulus will synergistically integrate or synchronize with, be synergistically presented together with, or be synergistically perceived together with, another stimulus to increase the sense of immersion and to enhance one or more aspects of the psychedelic experience, such as by increasing a benefit or a therapeutic outcome, or by decreasing a risk or an adverse outcome.
[0240] Below are non-limiting examples of some of the means for providing an olfactory stimulus that are present within the environment. Other means for providing an olfactory stimulus may be another suitable means described herein or otherwise known to those of skill in the art, and their equivalents. a. Aroma Diffusion
[0241] In embodiments, a means for providing an olfactory stimulus comprises aroma diffusion. “Aroma diffusion” refers to the dispersing of scents or essential oils into the air. In embodiments, aroma diffusion will create a fragrant ambiance. In embodiments, aroma diffusion will create a therapeutic ambiance. In embodiments, the aroma diffusion is presented by or complemented by direct inhalation, steam inhalation, or a combination thereof.
[0242] In embodiments, aroma diffusion comprises medical aromatherapy, massage aromatherapy, olfactory aromatherapy, psycho-aromatherapy, or a combination thereof. In embodiments, aroma diffusion comprises essential oils, herbs, spices, or a combination thereof.
[0243] Example aromas include, but are not limited to, aniseed, basil, benzoin, bergamot, black pepper, camphor, carrot, cedarwood, chamomile german, chamomile maroc, chamomile roman, clary, sage, cinnamon leaf, clove buds, cypress, dill, eucalyptus globulus, fennel, frankincense, geranium, ginger, grand fir, grapefruit, grapeseed, hazel, hyssop, jasmine, jojoba, juniper, juniper berry, lavender, lemon, lemon grass, marjoram, melaleuca, melissa, mint, mountain savory, myrrh, myrtle red, neem, neroli, niaouli, orange, oregano, palma rosa, patchouli, peppermint, pine, red myrtle, rescue remedy, rose geranium, rosemary, rosewood, sage, sandalwood, Spanish marjoram, spearmint, sweet marjoram, sweet thyme, spearmint tagestes, tea tree, tangerine, thyme red, thyme, and ylang ylang. In embodiments, aromas can be sourced from Synerzine (Synerzine, Inc., Ellenwood, Georgia)
[0244] In embodiments, the aroma diffusion will excite the senses and calm the nerves. In embodiments, the aroma diffusion will synchronize with another stimulus, such as visual or auditory stimulus, to increase the immersion of the psychedelic experience.C. Physical Parameters of the Environment
[0245] In embodiments, a disclosed environment comprises physical parameters.
[0246] In embodiments, the physical parameters are architectural features. In embodiments, the architectural features comprise a layout that includes multiple rooms. In embodiments, the architectural features comprise a layout that includes one room.
[0247] In embodiments, the architectural feature comprise a layout that includes one room with separate and distinct areas. In embodiments, the architectural feature comprises a layout that includes more than one room, each with separate and distinct areas. In embodiments, the separate and distinct areas comprise different layouts or designs. In some embodiments, separate and distinct areas can include a movement space, an athletic space, a primary talk space, a primary therapeutic space, a secondary therapeutic space, a therapeutic lounge, an experiential corridor, an integration chamber, a tribal experience area, a nature experience area, a seating area, and an entryway.
[0248] In embodiments, separate and distinct areas feature one or more visual, auditory, tactile, and / or olfactory stimuli that respond differently to the collected and processed biofeedback data of one or more subjects. In embodiments, separate and distinct areas feature one or more visual, auditory, tactile, and / or olfactory stimuli that interact differently with the actions of one or more subjects.
[0249] In embodiments, the one or more rooms or separate and distinct areas can include an altar, kinetic sand pit, hot tub, infrared sauna, cold plunge pool, a textured surface for hanging, a living tree, an artificial tree, and a waterfall. In embodiments, the separate and distinct areas, and features therein, are functionally tailored to the temporal evolution of a psychedelic experience. In embodiments, the separate and distinct areas are functionally designed to support preparation for a psychedelic experience. In embodiments, the separate and distinct areas are functionally designed to support the ascent of a psychedelic experience. In embodiments, the separate and distinct areas are functionally designed to support the peak for a psychedelic experience. In embodiments, the separate and distinct areas are functionally designed to support the descent of a psychedelic experience. In embodiments, the separate and distinct areas are functionally designed to support the end of a psychedelic experience. In embodiments, the separate and distinct areas are functionally designed to support integration following a psychedelic experience.
[0250] In embodiments, separate and distinct areas and features therein are functionally designed for one or more specific subject types. In embodiments, separate and distinct areas and features therein are functionally designed for a guide. In embodiments, separate and distinct areas and features therein are functionally designed for a subject. In embodiments, separate and distinct areas and features therein are functionally designed to support interactions between subjects.
[0251] In embodiments, the layout of the environment comprises a room for an occupancy of one person. In embodiments, the layout of the environment comprises a room for an occupancy of between one and two people. In embodiments, the layout of the environment comprises a room for an occupancy of between one and three people. In embodiments, the layout of the environment comprises a room for an occupancy of between one and four people. In embodiments, the layout of the environment comprises a room for an occupancy of between one and five people. In embodiments, the layout of the environment comprises a room for an occupancy of between one and six people. In embodiments, the layout of the environment comprises a room for an occupancy of between one and seven people. In embodiments, the layout of the environment comprises a room for an occupancy of between one and eight people. In embodiments, the layout of the environment comprises a room for an occupancy of between one and nine people. In embodiments, the layout of the environment comprises a room for an occupancy of between one and 10 people.
[0252] In embodiments, the layout of the environment comprises a room designed specifically for an occupancy of one person. In embodiments, the layout of the environment comprises a room designed specifically for an occupancy of two people. In embodiments, the layout of the environment comprises a room designed specifically for an occupancy of three people. In embodiments, the layout of the environment comprises a room designed specifically for an occupancy of four people. In embodiments, the layout of the environment comprises a room designed specifically for an occupancy of five people. In embodiments, the layout of the environment comprises a room designed specifically for an occupancy of six people. In embodiments, the layout of the environment comprises a room designed specifically for an occupancy of seven people. In embodiments, the layout of the environment comprises a room designed specifically for an occupancy of eight people. In embodiments, the layout of the environment comprises a room designed specifically for an occupancy of nine people. In embodiments, the layout of the environment comprises a room designed specifically for an occupancy of ten people. In embodiments, the layout of the environment comprises a room designed specifically for an occupancy of at least 10 people.
[0253] In embodiments, the layout of the environment comprises a room for an occupancy of two people, three people, four people, five people, six people, seven people, eight people, nine people, or up to 10 people. In embodiments, the layout of the environment comprises a room for an occupancy of between one and 10 people. In embodiments, the layout of the environment comprises a room for an occupancy of up to 10 people. In embodiments, the layout of the environment comprises a room for an occupancy of up to 15 people. In embodiments, the layout of the environment comprises a room for an occupancy of up to 20 people. In embodiments, the layout of the environment comprises a room for an occupancy of up to 25 people. In embodiments, the layout of the environment comprises a room for an occupancy of up to 50 people. In embodiments, the layout of the environment comprises a room for an occupancy of up to 75 people. In embodiments, the layout of the environment comprises a room for an occupancy of up to 100people. In embodiments, the layout of the environment comprises a room for an occupancy of over 100 people, including over 125 people, over 150 people, and over 200 people.
[0254] In embodiments, the environment comprises a layout that includes two rooms. In embodiments, the layout of the environment comprises a room for the occupancy of one person and a room for an occupancy of up to 10 people. In embodiments, the layout comprises a room for the occupancy of one person and a room for an occupancy of up to 15 people. In embodiments, the layout comprises a room for an occupancy of up to 10 people and a room for an occupancy of up to 15 people. In embodiments, the environment comprises a layout that includes three rooms. In embodiments, the layout comprises a room for the occupancy of one person, a room for an occupancy of up to 10 people, and a room for an occupancy of up to 15 people. Other variations between the occupancy of the rooms will be known by reference to this disclosure and the knowledge of one in the art.
[0255] In embodiments, the architectural features comprise a layout that includes more than two rooms. In embodiments, the environment comprises a layout that includes three rooms, four rooms, five rooms, and more than five rooms, including up to and over 10 rooms.
[0256] In embodiments, the architectural features comprise a number of walls. In embodiments, a “wall” refers to a vertical or substantially vertical surface.
[0257] In embodiments, the architectural features comprise a number of ceilings. In embodiments, a “ceiling” refers to a horizontal or substantially horizontal surface positioned above or substantially above the head or top portion of a subject.
[0258] In embodiments, the architectural features comprise a number of floors. In embodiments, a “floor” refers to a horizontal or substantially horizontal surface positioned below or substantially below the feet or bottom portion of a subject.
[0259] In embodiments, the architectural features comprise a number of passageways between rooms. In embodiments, the environment comprises a number of walkways. In embodiments, the environment comprises a number of windows.
[0260] In embodiments, the architectural features comprise a number of decorative elements (e.g., wall art, mirror, visual stimulus, pillows, rugs, vases, sculptures, candles, plants, flowers, wall coverings). Examples of decorative elements include Mechanical Magic kinetic art (MechanicalMagic, Berlin, German) and art by Poetic Kinetics (Poetic Kinetics, Inc., Elbert, Colorado).
[0261] In embodiments, the architectural features comprise a number of interactive elements (e.g., visual stimulus, textured surfaces, furniture, VR devices).
[0262] In embodiments, the architectural features comprise a number of environmental control units (e.g., air conditioners, heating elements, accessibility interfaces).
[0263] In embodiments, the physical parameters are design features.
[0264] In embodiments, the design features comprise curvilinear design features. In embodiments, the“curvilinear” design features may be characterized by curved lines, forms, or contours, evoking a sense of fluidity, harmony, and natural connectivity within a space. In embodiments, the curvilinear designs may include curved ceilings to maximize acoustics. In embodiments, the curvilinear designs may include soft lighting projected onto curved forms, arched openings, and circular rooms. In embodiments, the environment comprises curvilinear walls. In embodiments, the environment comprises curvilinear ceilings. In embodiments, the environment comprises curvilinear floors. In embodiments, the environment comprises curvilinear passageways between rooms. In embodiments, the environment comprises curvilinear walkways. In embodiments, the environment comprises curvilinear windows. In embodiments, the environment comprises curvilinear decorative elements. In embodiments, the environment comprises curvilinear interactive elements. In embodiments, the environment comprises curvilinear audio elements. In embodiments, the environment comprises curvilinear environmental control units.
[0265] In embodiments, the environment comprises biophilic design features. In embodiments, “biophilic” design features may be characterized by the incorporation of natural elements, natural materials, and nature-inspired patterns into a built environment, which is known to foster a sense of well-being, productivity, and relaxation. In embodiments, biophilic elements may include access to natural light, indoor plants, views of nature, and the use of natural materials. In embodiments, the environment comprises biophilic walls. In embodiments, the environment comprises biophilic ceilings. In embodiments, the environment comprises biophilic floors. In embodiments, the environment comprises biophilic passageways between rooms. In embodiments, the environment comprises biophilic walkways. In embodiments, the environment comprises biophilic windows. In embodiments, the environment comprises biophilic decorative elements. In embodiments, the environment comprises biophilic interactive elements. In embodiments, the environment comprises biophilic audio visual elements. In embodiments, the environment comprises biophilic environmental control units. In embodiments, the environment may simulate biophilic design features (e.g., via visual stimulus, tactile stimulus, auditory stimulus, olfactory stimulus, or a combination thereof).
[0266] In embodiments, the environment comprises modern design features. In embodiments, “modern” design features may be characterized by simplicity, functionality, and the integration of new materials and technologies. In embodiments, modern designs may incorporate clean lines, geometric forms, and open floor plans. In embodiments, the environment comprises modern walls. In embodiments, the environment comprises modern ceilings. In embodiments, the environment comprises modern floors. In embodiments, the environment comprises modern passageways between rooms. In embodiments, the environment comprises modern walkways. In embodiments, the environment comprises modern windows. In embodiments, the environment comprises modern decorative elements. In embodiments, the environment comprises modern interactive elements. In embodiments, the environment comprises modern audio visual elements. In embodiments, the environment comprises modern environmental control units.
[0267] In embodiments, the environment comprises futuristic design features. In embodiments, “futuristic”design features may be characterized by the use of cutting-edge technologies, sustainable practices, and unconventional forms. In embodiments, futuristic design may encompass the use of unconventional geometrical designs, use of advanced materials for tactile stimulation, and the integration of smart biofeedback systems. In embodiments, the environment comprises futuristic walls. In embodiments, the environment comprises futuristic ceilings. In embodiments, the environment comprises futuristic floors. In embodiments, the environment comprises futuristic passageways between rooms. In embodiments, the environment comprises futuristic walkways. In embodiments, the environment comprises futuristic windows. In embodiments, the environment comprises futuristic decorative elements. In embodiments, the environment comprises futuristic interactive elements. In embodiments, the environment comprises futuristic audio visual elements. In embodiments, the environment comprises futuristic environmental control units.
[0268] In embodiments, the environment comprises adaptive design features. In embodiments, “adaptive” design features may be characterized by flexibility, modularity, and the general ability to respond to changing needs, conditions, or user requirements. In embodiments, adaptive design features comprise flexible floor plans, moveable and removable decorative, interactive, and furniture elements, integrated and customizable audio visual systems. In embodiments, the environment comprises adaptive walls. In embodiments, the environment comprises adaptive ceilings. In embodiments, the environment comprises adaptive floors. In embodiments, the environment comprises adaptive passageways between rooms. In embodiments, the environment comprises adaptive walkways. In embodiments, the environment comprises adaptive windows. In embodiments, the environment comprises adaptive decorative elements. In embodiments, the environment comprises adaptive interactive elements. In embodiments, the environment comprises adaptive audio visual elements. In embodiments, the environment comprises adaptive environmental control units.
[0269] In embodiments, a disclosed environment comprises one or more materials. In embodiments, the environment comprises natural materials. In embodiments, the environment comprises composite materials. In embodiments, the environment comprises synthetic materials.
[0270] In embodiments, the environment comprises material with visually and tangibly stimulating patterning. In embodiments, the environment comprises materials conducive to curvilinearity. In embodiments, the environment comprises materials that enhance sound. In embodiments, the environment comprises material that absorbs sound. In embodiments, the environment comprises materials on which light can be projected. In embodiments, the environment comprises transparent materials. In embodiments, the environment comprises sensory materials. In embodiments, the environment comprises materials that promote a sense of cocoon-like, protective intimacy. In embodiments, the environment comprises materials that utilize crisp whites and blues to create depth and spaciousness.
[0271] In embodiments, a disclosed environment comprises a room for the occupancy of one person. In embodiments, the room may be indoor. In embodiments, this room may be outdoor. In embodiments, the room may be designed to promote sensory stimulation. In embodiments, the sensory stimulation in this roommay involve discreet 3D projectors, aroma diffusion, and acoustic features. In embodiments, the room may be designed to promote stress reduction. In embodiments, the design features in the room that promote stress reduction comprises systems to interact with wearable health monitors to track progression of calmness. In embodiments, the design features in the room that promote stress reduction comprises interactive breathwork programs. In embodiments, the design features in the room that promote stress reduction comprises an audiovisual system, an ergonomic vibroacoustic lounger (Vibrolounger), or a combination thereof.
[0272] In embodiments, a disclosed environment may have a room for occupancy up to 10 people. In embodiments, the room may be indoor. In embodiments, the room may be outdoor. In embodiments, the room may incorporate biophilic design elements. In embodiments, the room comprises private alcoves. In embodiments, the room comprises tactile stimulus. In embodiments, the tactile stimulus in the room comprises kinetic sand. In embodiments, the tactile stimulus in the room comprises a cold-plunge pool. In embodiments, the tactile stimulus in the room comprises an infrared sauna. In embodiments, the room may be comprised of natural materials. In embodiments, the room may be comprised of synthetic materials designed to mimic natural materials.
[0273] In embodiments, a disclosed environment may have a room for occupancy of up to 15 people. In embodiments, the room may be indoor. In embodiments, the room may be outdoor. In embodiments, the room may be designed to facilitate group sessions. In embodiments, the room may be circular. In embodiments, the room may have a circular seating area to promote intimacy and connection. In embodiments, the room may contain an enclosed flame at the center to encourage openness and storytelling. In embodiments, the room comprises sensory floor tiles for comfort and slip-free grip. In embodiments, the room comprises a domed ceiling for 3D projection. In embodiments, the room comprises a domed ceiling to maximize acoustics.
[0274] In embodiments, a disclosed environment includes and / or interfaces with one or more computers or computing systems, which may include computing elements such as one or more of processing means such as a central processing unit (CPU) and a graphics processing unit (GPU), a permanent storage means (e.g., hard drive, solid-state drive), a temporary storage means (e.g., RAM), motherboard (e.g., input / output bus, means to connect components and external peripherals), a network card, a wireless transmitting and receiving means, and the like. Receiving and transmitting means may include Wi-Fi, Bluetooth®, near field communication (NFC), and others as will be readily appreciated by those in the art.
[0275] In some embodiments, the computing elements are all local (in the environment). In some embodiments, one or more of the computing elements are remote (e.g., a remote server, a remote storage device, or the like). In embodiments, only the minimum necessary computing elements are local, while the remaining computing elements are remote, e.g., external to the environment, or in another room or location.
[0276] Some embodiments of the disclosure include computer software and / or computer hardware / softwarecombinations configured to implement one or more methods or functions associated with the disclosure such as described herein. These embodiments may be in the form of modules implementing functionality in software and / or hardware software combinations. Embodiments also may take the form of a computer storage product with a computer-readable medium having computer code thereon for performing various computer-implemented operations, such as operations related to functionality described herein. The media and computer code may be those specially designed and constructed for the purposes of the disclosure, or they may be of the kind well-known and available to those of skill, or they may be a combination of both.
[0277] The steps or stages of a method, process, or algorithm described in connection with embodiments disclosed herein may be embodied directly in hardware, in a software module executed by a processor, or in a combination of both and / or other components. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, means, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the spirit or scope of this disclosure.
[0278] Thus, the various illustrative components, blocks, modules, means, and steps described in connection with the embodiments disclosed herein may be implemented or performed with a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. In some implementations, processors may be communication processors or other such processors specifically designed for implementing functionality in communication devices or other mobile or portable devices. A software module may reside in RAM memory, flash memory, ROM memory, EPROM or EEPROM memory, registers, hard drive, a SSD, a removable disk, a CD-ROM, or any other form of storage medium known in the art. An exemplary storage medium is coupled to the processor such that the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor. The processor and the storage medium may reside in an ASIC, which may reside in a user terminal. The processor and the storage medium also may reside as discrete components in a user terminal. Some embodiments of the invention may include computer software and / or computer hardware / software combinations configured to implement one or more methods or functionsassociated with the invention such as those described herein. These embodiments may be in the form of modules implementing functionality in software and / or hardware software combinations.
[0279] Embodiments may also take the form of a computer storage product with a computer-readable medium having computer code thereon for performing various computer-implemented operations, such as operations related to functionality as described herein. The media and computer code may be those specially designed and constructed for the purposes of the invention, or they may be of the kind well known and available to those having skill in the computer software arts, or they may be a combination of both. Examples of computer-readable media within the spirit and scope of the invention include solid-state drives (SSDs), magnetic media such as hard drives; optical media such as CD-ROMs, DVDs and holographic devices; magneto-optical media; and hardware devices that are specially configured to store and execute program code, such as programmable microcontrollers, ASICs, programmable logic devices (PLDs), and ROM and RAM devices. Examples of computer code may include machine code, such as produced by a compiler or other machine code generation mechanisms, scripting programs, PostScript programs, and / or other code or files containing higher-level code that are executed by a computer using an interpreter or other code execution mechanism. Computer code may be comprised of one or more modules executing a particular process or processes to provide useful results, and the modules may communicate with one another via means known or developed in the art. For example, some disclosed embodiments may be implemented using assembly language, Java, C, C#, C++, scripting languages, and / or other programming languages and software development tools as are known or developed in the art. Other embodiments may be implemented in hardwired circuitry in place of, or in combination with, machine-executable software instructions.
[0280] While the methods described and illustrated herein may include particular steps or stages, it should be apparent that other processes including fewer, more, or different stages than those described and shown are also within the spirit and scope of the invention. The methods and associated components, blocks, modules, means, and steps shown herein should therefore be understood as being provided for purposes of illustration, not limitation. It should be further understood that the specific order or hierarchy of steps or stages in the methods disclosed are only exemplary approaches. Based upon design preferences, the specific order or hierarchy of steps in the methods may be rearranged while remaining within the spirit and scope of the present disclosure.D. Additional Aspects and Features of Disclosed Environments
[0281] In addition to the aspects and features described elsewhere herein, disclosed bioadaptive environments may comprise one or more further aspects or features, such as any one or more of the below.
[0282] In some embodiments, a disclosed bioadaptive environment will have a means for ensuring safety and security. Ensuring safety and security refers to protecting the physical, psychological, and / or emotional state of one or more subjects in a disclosed environment from injury or harm, including from the danger or risk of injury or harm, whether from oneself, from another, or from the environment. “Protection” includes notonly the removal of the possibility of a harm, but also the reduction of potential for harm, such as a reduction in the danger of or risk of a harm. In embodiments, subjects are protected from physical injury or harm from oneself, from another, or from the environment. In embodiments, subjects are protected from psychological or emotional injury or harm from oneself, from another, or from the environment, such as from a negative or challenging psychedelic experience or “bad trip.” In embodiments, the subject protected from harm is a therapist, guide, facilitator, or the like, who for example is protected from the actions of a subject who ingested a psychedelic. In embodiments, the subject protected from harm is a subject who ingested a psychedelic, and who is protected from a therapist, guide, facilitator, or the like, such as protected from sexual or non-consensual touch. In embodiments, the subject protected from harm is a subject who ingested a psychedelic, and who is protected from one or more other subjects who ingested a psychedelic.
[0283] Numerous means for ensuring safety and security will be understood in view of this disclosure and the art to provide protection as described herein. In some embodiments, the means for ensuring safety and security is a means which is discreet, including a means which is not visible, or which is not readily or easily visible, in the environment. In some embodiments, the means for ensuring safety and security is a means which does not use traditional video recording or traditional video capture, such as closed-circuit television (CCTV). In some embodiments, the means for ensuring safety and security is a means which ensures the privacy of the subject, which maximizes the privacy of the subject, or which minimizes the intrusion of privacy of the subject. In some embodiments, the means for ensuring safety and security comprises the use of non-videographic means to determine the absolute or relative positions and / or movements of one or more subjects in the environment. In embodiments, the means for ensuring safety and security comprises a device that uses Wi-Fi signals to create a 3D rendering of the bodies of one or more subjects and their positions and movements, e.g., by the DensePose From WiFi methods described by Jiaqi Geng, Dong Huang, and Fernando De la Torre (The Human Sensing Lab, Carnegie Mellon Univ). In embodiments, the means for ensuring safety and security comprises a device that captures 3D human movement data to create a 3D rendering of the bodies of one or more subjects and their positions and movements, such as disclosed in US2023 / 0172536A1 , incorporated by reference. These and similar such means will discreetly monitor the movements of subjects within environments without the use of traditional video recording or CCTV, and in so doing will respect the privacy of the subjects while ensuring safety and security, such as from other subjects or from a therapist or other practitioner. In some embodiments, the safety and security of an subject is protected when they are alone with a therapist or other practitioner.
[0284] In embodiments, subject privacy is protected by the use of robust encryption methods to protect subject data, including when transmitted, received, stored, and processed, and including through encryption means on devices within the environment and by encryption means on a subject’s device, such as a subject’s device comprising a mobile application such as the TRAVLER app, when used in an environment.
[0285] In embodiments, the athletic floor will not only be able to produce sub frequencies (e.g., 40 Hz)beneath it, which can help to center and ground a subject during movement exercises. In embodiments, there also will be a top layer of padding to provide additional proprioceptive feedback and protection in case of fall. Through such embodiments, it will be readily appreciated the special attention paid to all the materials and surfaces within an environment, such as ergonomic handles, holds, and seats, which will encourage proper use, and safety during an altered state of consciousness, while encouraging tactical exploration.
[0286] In some embodiments, a discrete Wi-Fi monitoring system such as described, together with a wearable health monitor can both geolocate a subject within an environment, while also being monitored by one or more staff members outside, in particular embodiments, and also can receive alerts based on data received via our wearable. In preferred embodiments, beyond subject safety are also the privacy of a subject via these and other means such as the encryption protocols for data shared in an app or with practitioners.
[0287] In embodiments, LED panels and 3-D projectors are used to direct a subject towards safety in the event of an emergency. In embodiments, LED panels and 3-D projectors are used to guide a subject through breathwork or grounding exercises in the event of a dangerous psychological or physiological experience.
[0288] In some embodiments, a disclosed bioadaptive environment comprises a bathroom or powder room. In embodiments, a disclosed bioadaptive environment comprises a bathroom or powder room below a therapeutic bed. In embodiments, the EXPANDED Experience comprises a bathroom or powder room. In embodiments, the EXPANDED Experience comprises a bathroom or powder room below a therapeutic bed.
[0289] In some embodiments, a disclosed method comprises providing a subject with a gustatory stimulus. Examples of gustatory stimuli include sweet, salty, sour, bitter, umami, fatty, and spicy tastes. In some embodiments the gustatory stimulus is a food and / or beverage. In embodiments, a subject’s gustatory preferences (e.g., meaningful or favorable foods and tastes) are determined prior to a therapeutic experience (e.g., by the subject’s use of the TRAVLER app). In some embodiments, in response to biofeedback data (e.g., biofeedback data that suggests a subject is in distress), the environment provides the subject with a cue directing them to eat, or directs a guide to provide the subject with meaningful or preferable foods or tastes. In some embodiments, the consumption of a meaningful or preferable food or taste results in a desired therapeutic outcome or reduces the risk of an adverse psychological and / or physiological event.D. Methods for Enhancing a Therapeutic Experience
[0290] In another aspect are disclosed methods for enhancing a therapeutic experience comprising providing a subject with a therapeutic experience in a disclosed bioadaptive environment. In some embodiments, a disclosed method comprises providing a subject with psychotherapy in a disclosed environment.
[0291] For any disclosed embodiment of an environment, it shall be understood that the present disclosure also encompasses using the environment in a method, such as a method for enhancing a therapeutic experience in a subject, a method of providing a subject with therapy (including, e.g., PAT), a method of treatment (e.g., of a medical condition), and the like, and numerous different examples of uses of thedisclosed bioadaptive environments are described herein, although it will be readily appreciated that such examples are non-limiting, and many other uses and embodiments will be understood from the teachings herein, and by combining elements, aspects, and features of different embodiments, according to ordinary skill and without undue experimentation. Hence, the disclosure of any embodiment of a disclosed environment will be understood to include all possible methods of using the embodiment of the environment.
[0292] In some embodiments, the method comprises subjecting the subject to a state of increased neuroplasticity or an altered state of consciousness in a disclosed environment. The altered state of consciousness may in embodiments result from the subject’s use of a psychoactive (e.g., psychedelic) substance (whether self-administered or as part of drug-assisted therapy), use of a compound that increases neuroplasticity (e.g., a neuroplastogen or psychoplastogen), meditation, hypnosis, breathwork, sound therapy, transcranial magnetic stimulation, movement therapy (including, e.g., yoga and dance therapy), as described in embodiments herein.
[0293] In some embodiments, the method comprises enhancing a psychedelic experience in a subject. In some embodiments, the method comprises providing a subject with psychedelic-assisted therapy in a disclosed environment. In some embodiments, the method comprises administering a psychedelic to a subject in a disclosed environment. In some embodiments, the subject self-administers a psychedelic in a disclosed environment.
[0294] In some embodiments, the method comprises guiding the subject through therapeutic breathwork in a disclosed environment. In some embodiments, the method comprises guiding the subject through meditation in a disclosed environment. In some embodiments, the method comprises guiding the subject through mindfulness practice in a disclosed environment. In some embodiments, the method comprises providing the subject with sound therapy in a disclosed environment. In some embodiments, the method comprises providing the subject with transcranial magnetic stimulation in a disclosed environment. In some embodiments, the method comprises providing the subject with movement therapy (e.g., dance, yoga) in a disclosed environment.
[0295] In some embodiments, a disclosed method comprises selecting a subject for undergoing therapeutic experience in a disclosed environment. In embodiments, a subject will participate in a therapeutic experience of a disclosed method if the subject meets certain specified inclusion criteria, does not meet certain specified exclusion criteria, does not meet any specified withdrawal criteria before or during the course of experience, and otherwise satisfies the requirements of the embodiment of the disclosure as claimed. In some embodiments, data collected from the subject’s use of a mobile application, software application, virtual journal (e.g., LOTIC Al™), remote therapy session, or virtual guide is used to determine whether a subject meets the specified inclusion, exclusion, and / or withdrawal criteria for a disclosed method. In some embodiments, data collected through a subject’s use of the mobile application TRAVLER™ is used to determine whether a subject meets the specified inclusion, exclusion, and / or withdrawal criteria.
[0296] In some embodiments, a disclosed method comprises collecting biofeedback data from the subject. In some embodiments, a disclosed method comprises modulating a stimulus in a disclosed environment. In some embodiments, a disclosed method comprises modulating a stimulus in a disclosed environment in response to subject biofeedback data.
[0297] In embodiments, a disclosed method comprises providing the subject with at least one or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof. In embodiments, a disclosed method comprises providing the subject with at least two or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof. In embodiments, a disclosed method comprises providing the subject with at least three or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof. In embodiments, a disclosed method comprises providing the subject with at least four or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof. In embodiments, a disclosed method comprises providing the subject with at least five or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof. In embodiments, a disclosed method comprises providing the subject with at least six or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof. In embodiments, a disclosed method comprises providing the subject with at least seven or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof. In embodiments, a disclosed method comprises providing the subject with at least eight or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof. In embodiments, a disclosed method comprises providing the subject with at least nine or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof. In embodiments, a disclosed method comprises providing the subject with at least 10 or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof. In embodiments, a disclosed method comprises providing the subject with greater than 10 of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof.
[0298] It will be understood that unless otherwise specified, the disclosure of a certain number of stimuli may comprise that number of the same category of stimuli (and no other category of stimuli). For example, in some embodiments, “at least x or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof’ may include x number of visual stimuli and no other category of stimuli.
[0299] In other embodiments, the disclosure of a certain number of stimuli may comprise that number in total of multiple categories of stimuli. Hence, in other embodiments, “at least x or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof’ may include x / 2 number of visual stimuli and x / 2 number of auditory stimuli. In yet other embodiments, “at least x or more ofa visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof” may include x / 3 number of visual stimuli, x / 3 number of auditory stimuli, and x / 3 number of tactile stimuli. In yet further embodiments, “at least x or more of a visual stimulus, an auditory stimulus, a tactile stimulus, an olfactory stimulus, and combinations thereof’ may include x / 4 number of visual stimuli, x / 4 number of auditory stimuli, x / 4 number of tactile stimuli, and x / 4 number of olfactory stimuli. Additional embodiments will be as readily appreciated by those of ordinary skill in the art.
[0300] In some embodiments, a disclosed method comprises providing the subject with at least one or more a visual stimulus and at least one or more of an auditory stimulus. In some embodiments, a disclosed method comprises providing the subject with at least one or more a visual stimulus and at least one or more of a tactile stimulus. In some embodiments, a disclosed method comprises providing the subject with at least one or more a visual stimulus and at least one or more of an olfactory stimulus.
[0301] In some embodiments, a disclosed method comprises providing the subject with at least one or more an auditory stimulus and at least one or more of an tactile stimulus. In some embodiments, a disclosed method comprises providing the subject with at least one or more an auditory stimulus and at least one or more of an olfactory stimulus.
[0302] In some embodiments, a disclosed method comprises providing the subject with at least one or more a tactile stimulus and at least one or more of an olfactory stimulus.
[0303] In embodiments, a disclosed method comprises providing the subject with at least one or more of a visual stimulus, at least one or more of an auditory stimulus, and at least one or more of a tactile stimulus.
[0304] In embodiments, a disclosed method comprises providing the subject with at least one or more of a visual stimulus, at least one or more of an auditory stimulus, and at least one or more of an olfactory stimulus.
[0305] In embodiments, a disclosed method comprises providing the subject with at least one or more of an auditory stimulus, at least one or more of a tactile stimulus, and at least one or more of an olfactory stimulus.
[0306] In embodiments, a disclosed method comprises providing the subject with at least one or more of a visual stimulus, at least one or more of an auditory stimulus, at least one or more of a tactile stimulus, and at least one or more of an olfactory stimulus.
[0307] In another aspect are disclosed methods for enhancing a psychedelic experience in a subject. In some embodiments, the method of enhancing a psychedelic comprises providing the subject with visual stimuli, auditory stimuli, tactile stimuli, and / or olfactory stimuli. In embodiments, enhancing the psychedelic experience improves a therapeutic outcome, such as when used for psychedelic-assisted therapy. In embodiments, enhancing the psychedelic experience reduces a negative outcome, such as when used for psychedelic-assisted therapy. In embodiments, the therapeutic outcome is improved as a result of one or more synergies or the overall synergism between the visual stimuli, auditory stimuli, tactile stimuli, and / or olfactory stimuli. In embodiments, a negative outcome is reduced as a result of one or more synergies or theoverall synergism between the visual stimuli, auditory stimuli, tactile stimuli, and olfactory stimuli.
[0308] In embodiments, a disclosed method comprises providing the subject with counseling and / or psychological support. In embodiments wherein a subject is provided with psychedelic-assisted therapy, counseling may include pre-dosing preparatory sessions, post-dosing integration sessions, observation during sessions (including using biofeedback data), and under some circumstances physical touch (e.g., “supportive touch,” such as holding a hand or placing a hand on the shoulder). i. Improving General Health and Wellbeing
[0309] In some embodiments, disclosed methods and environments are useful for improving general health and wellbeing in a subject. In some embodiments, the subject can be a person who suffers from a specific disease or disorder that negatively influences their quality of life. In some embodiments, the disease or disorder has been diagnosed by a medical professional. In other embodiments, the subject may individually and independently seek a therapeutic experience as a remedy for symptoms they are experiencing, whether or not these symptoms are associated with a specific, diagnosed medical condition. In other embodiments, the subject can also be a healthy person who does not suffer from such a disease or disorder (i.e., a person who does not experience symptoms associated with a diagnosed medical condition).
[0310] In some embodiments, improving the health and / or overall wellbeing of a subject refers to treating a healthy subject (a “healthy normal”; i.e., a disclosed environment or method can be used for the betterment of the well). In some embodiments, improving the health and / or overall wellbeing of a subject refers to treating a subject having a disease or disorder, such as a diagnosed disease or disorder, or a disease or disorder which is treated by the practice of a disclosed method.
[0311] In some embodiments, a disclosed environment or method is useful for improving the overall wellbeing of a subject. “Wellbeing” refers to a positive state of health or comfort, e.g., relative to a reference population. As used herein “mental wellbeing” refers to a positive mental state, relative to a reference population. For example, in a subject experiencing depression (whether or not medically diagnosed, or rising to the level of a clinical diagnosis), low self-esteem, addiction, compulsion, or anxiety may experience an improvement in mental wellbeing in response to therapy aimed at improving mood, self-esteem, addiction, compulsion, or anxiety, respectively. As used herein, “physical wellbeing” refers to one or more positive aspects of an subject's physical health. For example, an improvement of physical wellbeing includes alleviation of somatic symptoms associated with a psychological disorder, depression, addiction, compulsion, anxiety, or sexual dysfunction. Such symptoms include, for example, chronic pain, pain disorder, relational disorder, body dysmorphia, conversion (e.g., loss of bodily function due to anxiety), hysteria, neurological conditions without identifiable cause, or psychosomatic illness).
[0312] In some embodiments, the efficacy of a disclosed environment or method for improving the health and / or overall wellbeing of a subject is assessed by self-rated measures. Self-rated measures include but are not limited to the Quick Inventory for Depressive Symptomatology (QIDS-SR16), the trait scale of theState-Trait Anxiety Inventory (STAI-T), the Neuroticism scale from the Neuroticism-Extraversion-Openness Five-Factor Inventory (NEO-FFI), the World Health Organization-Five Well-Being Index (WHO-5), the Life Orientation Test-Revised (LOT-R; a measure of optimism), the Gratitude Questionnaire (GQ-6), and / or the Meaning in Life Questionnaire (MLQ) (Timmermann et al. Sci Rep. 2024; 14(1 ):3097). ii. Treating Medical Conditions, Diseases, and Disorders
[0313] In some aspects, disclosed environments and methods are useful in the treatment of a medical condition, disease, or disorder. In embodiments, “treating” or “treatment” refers to treating a medical condition, disease or disorder in a mammal, and preferably in a human, and includes causing a desired biological, psychological, or pharmacological effect, such as: (a) preventing a disorder from occurring in a subject who may be predisposed to the disorder but has not yet been diagnosed with it; (b) inhibiting a disorder, i.e., arresting its development; (c) relieving a disorder, i.e., causing regression thereof; (d) protecting from or relieving a symptom or pathology caused by or related to a disorder; (e) reducing, decreasing, inhibiting, ameliorating, or preventing the onset, severity, duration, progression, frequency or probability of one or more symptoms or pathologies associated with a disorder; and (f) preventing or inhibiting of a worsening or progression of symptoms or pathologies associated with a disorder or comorbid with a disorder. Other such measurements, benefits, and surrogate or clinical endpoints, alone or in combination, will be understood to one of skill based on the teachings herein and the knowledge in the art.
[0314] In some embodiments, a disclosed method comprises providing the subject psychotherapy, such as psychosocial or behavioral therapy, including any of (or adapted from any of) cognitive behavioral therapy (e.g., as described in Arch Gen Psychiatry 1999; 56:493-502), interpersonal therapy (e.g., as described in Psychol Addict Behav 2009; 23(1): 168-174), contingency management based therapy (e.g., as described in Psychol Addict Behav 2009; 23(1): 168-174; in J Consul Clin Psychol 2005; 73(2): 354-59; or in Case Reports in Psychiatry, Vol. 2012, Article ID 731638), motivational interviewing based therapy (e.g., as described in J Consul Clin Psychol 2001; 69(5): 858-62), meditation based therapy, such as transcendental meditation based therapy (e.g., as described in J Consul Clin Psychol 2000; 68(3): 515-52), or the therapeutic approach used by MAPS to treat subjects with PTSD (e.g., as in Mithoefer, M (2017). Manual for MDMA-Assisted Psychotherapy in the Treatment of Post-traumatic Stress Disorder).In other embodiments, psychotherapy is neither necessitated nor desired, or no specific type of psychotherapy is necessitated or desired, however any disclosed method may comprise providing the subject with one or more psychotherapy sessions. The flexibility to participate in specific therapies, as well as to choose between any such therapies (or to decide to forgo any specific therapy), while still receiving clinically significant therapeutic effects, is among the advantages of disclosed environments and methods. Furthermore, a subject can participate in numerous other therapeutically beneficial activities, where such participation follows or is in conjunction with disclosed methods, including breathing exercises, meditation and concentration practices, focusing on an object or mantra, listening to music, physical exercise, stretchingor bodywork, journaling, grounding techniques, positive self-talk, or engaging with a pet or animal, and it should be understood that such participation can occur with or without the participation or guidance of a therapist. In some embodiments, “psychotherapy” is specifically “psychedelic-assisted psychotherapy.” Psychedelic-assisted psychotherapy, broadly, includes a range of related approaches that involve at least one session where the subject ingests a psychedelic and is monitored, supported, or otherwise engaged by one or more trained mental health professionals while under the effects of the psychedelic (see, e.g., Schenberg EE. Front Pharmacol. 2018;9:323606). Protocols have been developed for the standardization of procedures which emphasize a high degree of care (see, e.g., Johnson et al. J Psychopharm. 2008;22(6): 603-20), such as the therapeutic approach used by MAPS to treat subjects with PTSD using MDMA (e.g., as described in Mithoefer et al. Treatment Manual: MDMA-Assisted Therapy for PTSD v8. 1 MAPS; 2017).
[0315] In some embodiments, the psychotherapy conducted with a disclosed method is conducted in widely spaced sessions. Sessions can be as frequently as weekly but are more often approximately monthly or less frequently. In most cases, a small number of sessions, on the order of one to three, is needed for a subject to experience significant clinical progress, as indicated, for example, by a reduction in the symptoms of the mental health disorder being treated. In some embodiments, psychotherapy comprises multiple sessions, during some of which a disclosed method is administered (“drug-assisted psychotherapy”); in others, the subject participates in psychosocial or behavioral therapy without concomitant administration of a drug.
[0316] In some embodiments, disclosed methods with or without standardized psychological treatment or support, which refers to any accepted modality of standard psychotherapy or counseling sessions, whether once a week, twice a week, or as needed; whether in person or virtual (e.g., over telemedicine or by means of a web program or mobile app); and whether with a human therapist or a virtual or Al “therapist.” As used herein, “therapist” refers to a person who treats a subject using the disclosed methods, whether that person is a psychiatrist, clinical psychologist, clinical therapist, registered therapist, psychotherapist, or other trained clinician, counselor, facilitator, or guide, although it will be understood that certain requirements will be appropriate to certain aspects of the drug-assisted therapy (e.g., prescribing, dispensing, or administering a drug, offering psychotherapeutic support). In embodiments, a “person” includes an Al or virtual therapist.
[0317] In some embodiments, wherein a psychoactive substance (e.g., a psychedelic) is administered to a subject, a disclosed environment allows for said administration to occur without or with reduced risk of side effects that would require guide supervision, and therefore allow for treatment utilizing the disclosed methods without the need for such supervision, and / or additionally without the requirement of adjunctive psychotherapy (although it also may be provided in certain embodiments herein).
[0318] In some instances, certain personalized approaches (i.e., “personalized” or “precision” medicine) may be utilized, based on individual characteristics or individual genetic variation. The term “genetic variation” refers to a change in a gene sequence relative to a reference sequence (e.g., a commonly-found and / or wild-type sequence). Genetic variation may be recombination events or mutations such assubstitution / deletion / insertion events like point and splice site mutations.
[0319] In embodiments, disclosed methods and environments are used to treat a central nervous system (CNS) disorder. Broadly, CNS disorders include diseases of the nervous system (e.g., movement disorders, neurodegenerative disorders) as well as mental, behavioral, and neurodevelopmental disorders, such as those in the DSM-5, Merck Manual, ICD-11 , or other such diagnostic resources known to one of skill.1 . Mental, Behavioral, or Neurodevelopmental Disorders
[0320] In embodiments, disclosed methods and environments are useful for treating a mental, behavioral, or neurodevelopmental disorder. In embodiments, the subject has a mental, behavioral, or neurodevelopmental disorder, and the method treats said mental, behavioral, or neurodevelopmental disorder. In embodiments, disclosed methods provide beneficial therapeutic effects for the treatment of a mental, behavioral, or neurodevelopmental disorder.
[0321] The ICD-11 , which is incorporated by reference herein in its entirety, defines “mental, behavioral, or neurodevelopmental disorders” as syndromes characterized by clinically significant disturbance in a subject's cognition, emotional regulation, or behavior that reflects a dysfunction in the psychological, biological, or developmental processes that underlie mental and behavioral functioning. Such disorders include, but are not limited to, neurodevelopmental disorders, schizophrenia or other primary psychotic disorders, catatonia, mood disorders, anxiety or fear-related disorders, obsessive-compulsive or related disorders, disorders specifically associated with stress, dissociative disorders, feeding (or eating) disorders, elimination disorders, disorders of bodily distress or bodily experience, disorders due to substance use or addictive behaviors, impulse control disorders, disruptive behavior or dissocial disorders, personality disorders (and related traits), paraphilic disorders, factitious disorders, neurocognitive disorders, mental or behavioral disorders associated with pregnancy, childbirth or the puerperium, sleep-wake disorders, sexual dysfunctions, and gender incongruence.
[0322] A mental, behavioral, or neurodevelopmental disorder where otherwise undefined, will be understood to refer to the disorder as defined in the ICD-11. Within the category of mental, behavioral, or neurodevelopmental disorders, the term mental disorder (or “mental health disorder”) generally refers to a disease condition that involves negative changes in emotion, mood, thinking, and / or behavior. In general, mental health disorders are characterized by clinically significant disturbances in a subject's cognition, emotion, behavior, or a combination thereof, resulting in impaired functioning, distress, or increased risk of suffering. Although the terms “mental disorder” and “mental health disorder,” as well as terms that define specific diseases and disorders, generally shall refer to the criteria in the ICD-11 , or a subject with a diagnosis based thereon, it will be appreciated that disclosed methods are equally applicable to subjects having an equivalent underlying disorder, whether that disorder is diagnosed based on the criteria in ICD-11 , ICD-10, DSM-5, or DSM-IV (each of which is incorporated by reference herein in its entirety) whether the diagnosis is based on other clinically acceptable criteria, or whether the subject has not yet had a formalclinical diagnosis.
[0323] In embodiments, a disclosed method is useful in preventing a mental health disorder. In embodiments, the subject is not diagnosed with a mental health disorder, and the method prevents a mental health disorder.
[0324] In embodiments, measures of therapeutic efficacy include reports by a subject or an observer. In embodiments, measures of therapeutic efficacy include responses to a questionnaire. Non-limiting representative examples of applicable measures of symptom improvement include the Generalized Anxiety Disorder Scale-7 (GAD-7), Montgomery-Asberg Depression Rating Scale (MADRS), Global Assessment of Functioning (GAF) Scale, Clinical Global Impression (CGI), Substance Abuse Questionnaire (SAQ), Mini International Neuropsychiatric Interview 5 (MINI 5), Columbia Suicide Severity Rating Scale (C-SSRS), Patient Health Questionnaire (PHQ-9), Pittsburgh Sleep Quality Index (PSQI), Interpersonal Reactivity Index (IRI), Short Form (36) Health Survey (SF-36), Self-Compassion Scale (SCS), Trauma History Questionnaire (THQ), Beck Depression Index (BDI), and related subject- or observer-reported measures.
[0325] In embodiments, the mental health disorder is a mood disorder, anxiety disorder, psychotic disorder, personality disorder, eating disorder, or substance use disorder.
[0326] In embodiments, disclosed methods and environments are useful for treating a mood disorder. In embodiments, the subject has a mood disorder, and the method treats said mood disorder. In embodiments, disclosed methods provide beneficial therapeutic effects for the treatment of a mood disorder. A “mood disorder” refers to a class of mental disorders that alter emotional state. These can result in persistent or intense sadness, elation, and / or anger. Negative impacts may result from these disorders such as impairments in health, sleep, social functioning, problems at school or work, financial issues, or control over substance use. As defined in the ICD-11, mood disorders are categorized according to the specific type(s) of mood episodes, and their pattern over time. The primary types of mood episodes are depressive episodes, manic episodes, mixed episodes, and hypomanic episodes. Mood disorders are often separated into two categories: “bipolar and related disorders” and “depressive disorders” characterized by elements of depression and mania. These exist on a continuum and can exist alone or in combination with varying levels of duration and intensity. These disorders may involve various etiologies, including but not limited to, differing patterns of neurotransmitter abnormalities, genetic predisposition, trauma, abuse, and psychosocial stressors. In some embodiments, the mood disorder is a bipolar or related disorder (e.g., bipolar type I disorder, bipolar type II disorder, cyclothymic disorder), a depressive disorder, or a substance-induced mood disorder. In some embodiments, the mood disorder is a depressive disorder. In embodiments, the depressive disorder is single-episode depressive disorder, major depressive episode disorder, persistent depressive disorder (formally known as dysthymia), disruptive mood dysregulation disorder, melancholic depression, atypical depression, premenstrual dysphoric disorder, postpartum depression, substance / medication-induced depressive disorder, depressive disorder due to another medical condition, seasonal affective disorder,mixed depressive and anxiety disorder, or an unspecified depressive disorder. In embodiments, the mood disorder is selected from the group consisting of major depressive disorder, persistent depressive disorder, postpartum depression, premenstrual dysphoric disorder, seasonal affective disorder, psychotic depression, disruptive mood dysregulation substance / medication-induced depressive disorder, post-traumatic stress disorder, panic disorder, acute stress disorder, or depressive disorder due to another medical condition. In embodiments, the mood disorder is a depressive disorder (e.g., major depression, melancholic depression, atypical depression, or dysthymia). The depressive disorder may be associated with one or more prodromal symptoms selected from the group consisting of depressed mood, decreased appetite, weight loss, increased appetite, weight gain, initial insomnia, middle insomnia, early waking, hypersomnia, decreased energy, decreased interest or pleasure, self-blame, decreased concentration, indecision, suicidality, psychomotor agitation, psychomotor retardation, crying more frequently, inability to cry, hopelessness, worrying / brooding, decreased self-esteem, irritability, dependency, self-pity, somatic complaints, decreased effectiveness, helplessness, and decreased initiation of voluntary responses. The depressive disorder can be associated with a diagnosis with a terminal illness, a life-threatening illness, or cancer.
[0327] In embodiments, disclosed methods and environments are useful for treating an anxiety disorder. In embodiments, the subject has an anxiety disorder, and the method treats said mood disorder. In embodiments, disclosed methods provide beneficial therapeutic effects for the treatment of an anxiety disorder. An “anxiety disorder” refers to a class of mental disorders that induce excessive or abnormal fear, dread, or worry. Negative impacts may result from these disorders, results such as impairments in health, social functioning, problems at school or work, financial issues, or control over substance use. These disorders may involve various etiologies, including but not limited to, differing patterns of neurotransmitter abnormalities, genetic predisposition, substance use, trauma, abuse, and psychosocial stressors. In embodiments, the anxiety disorder is selected from the group consisting of post-traumatic stress disorder, major depressive disorder, panic disorder, specific phobia, social phobia, obsessive-compulsive disorder, acute stress disorder, or generalized anxiety disorder, generalized anxiety disorder (GAD), panic disorder, social anxiety, acute stress disorder (ASD), and obsessive compulsive disorder (OCD).
[0328] In some embodiments, disclosed methods are used to treat an obsessive-compulsive or related disorder. In general, these disorders are characterized by repetitive thoughts and behaviors, such as cognitive phenomena (obsessions, intrusive thoughts and preoccupations). In some embodiments, the disorder is characterized by a compulsive need to accumulate possessions and distress related to discarding them (i.e., hoarding disorder). In some embodiments, the disorder is body-focused and can be characterized by recurrent and habitual actions (e.g., a tic disorder, such as Tourette's Syndrome, trichotillomania, nail-biting, temporomandibular disorder, thumb-sucking, repetitive oral-digital, lip-biting, fingernail biting, eye-rubbing, skin-picking, or a chronic motor tic disorder). In some embodiments, the disorder is obsessive-compulsive disorder, body dysmorphic disorder, olfactory reference disorder, hypochondriasis,hoarding disorder, a body-focused repetitive behavior disorder, or a substance-induced obsessive-compulsive disorder.
[0329] In some embodiments, disclosed methods and environments are useful for treating a disorder associated with stress. In some embodiments, the disorder associated with stress has an identifiable stressor that is a causal factor, like exposure to a stressful or traumatic event, or a series of such events or adverse experiences. Stressors may be within the normal range of life experiences (e.g., divorce, socioeconomic problems), or from a threatening or traumatizing experience. In general, the nature and duration of the symptoms that arise in response to the stressor can distinguish the disorder from everyday stress. In embodiments, disclosed methods are used to treat post-traumatic stress disorder, complex post-traumatic stress disorder, prolonged grief disorder, adjustment disorder, reactive attachment disorder, or disinhibited social engagement disorder.
[0330] In some embodiments, disclosed methods and environments are useful for treating a dissociative disorder. Dissociative disorders can be characterized by involuntary disruption or discontinuity in the normal integration of one or more of the following: identity, sensations, perceptions, affects, thoughts, memories, control over body movements, or behavior. In some subjects, dissociative disorder symptoms can be severe, and may result in impairment in personal, social, educational, occupational or other areas of functioning. In some embodiments, disclosed methods are used to treat dissociative neurological symptom disorder, dissociative amnesia (including amnesia with dissociative fugue and without dissociative fugue), trance disorder, possession trance disorder, dissociative identity disorder, partial dissociative identity disorder, or depersonalization- derealization disorder.
[0331] In some embodiments, disclosed methods and environments are useful for treating a psychotic disorder. In embodiments, disclosed methods are administered to a subject having a psychotic disorder, thereby treating said psychotic disorder. In embodiments, disclosed methods, when administered to a subject, provide beneficial therapeutic effects for the treatment of a psychotic disorder. A “psychotic disorder” refers to a class of mental disorders that are characterized by significant impairments in reality and alterations in behavior manifest in positive symptoms like persistent delusions, persistent hallucinations, disorganized thinking and speech, grossly disorganized behavior, as well as experience of negative symptoms such as blunted or flat affect and avolition and psychomotor disturbances involve distortions in cognition or reasoning. A psychotic disorder may impair judgment, emotional regulation, communication, mood, or behavior. Negative impacts may result from these disorders such as impairments in health, social functioning, problems at school or work, financial issues, or control over substance use. These disorders may involve various etiologies, including but not limited to genetic predisposition, developmental disorders, trauma, abuse, or psychosocial stressors. In embodiments, the psychotic disorder is selected from the group consisting of schizophrenia (e.g., paranoid, disorganized, catatonic, undifferentiated, or residual type), schizophreniform disorder, schizoaffective disorder (e.g., delusional type or the depressive type), delusionaldisorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, personality disorder of the paranoid type, or personality disorder of the schizoid type.
[0332] In some embodiments, disclosed methods and environments are useful for treating catatonia. In some embodiments, “catatonia” refers to a category of syndromes characterized by the co-occurrence of several symptoms of decreased, increased, or abnormal psychomotor activity. In some embodiments, the catatonia is associated with another mental disorder. In some embodiments, the catatonia is induced by substances or medications.
[0333] In some embodiments, disclosed methods and environments are useful for treating a personality disorder. In embodiments, disclosed methods are administered to a subject having a personality disorder, thereby treating said personality disorder. In embodiments, disclosed methods, when administered to a subject, provide beneficial therapeutic effects for the treatment of a personality disorder. Personality disorders may be generally characterized by long-term, all encompassing thought patterns related to others or in perceiving one’s identity, self-worth, accuracy of self-view, and self-discretion that is manifest in patterns of cognition, emotional experience, emotional expression, and maladaptive behavior. The thoughts and behaviors are considered unhealthy and inflexible. A “personality disorder” refers to a class of mental disorders that involve long-term, all-encompassing thought patterns and behaviors relating to others. The thoughts and behaviors are considered unhealthy and inflexible. They result in serious problems with work and socializing, increasing the difficulty of handling common stress and problems. These patterns create distress and impair ability to function. In some embodiments, disclosed methods are used to treat a mild, moderate, or severe personality disorder. In some embodiments, disclosed methods are used to treat a prominent personality trait or patterns (e.g., negative affectivity, detachment, dissociality, disinhibition, anankastia, borderline pattern). These disorders may involve various etiologies, including but not limited to, genetic predisposition, trauma, abuse, reactivity, and other psychosocial pressures. In embodiments, the personality disorder is selected from the group consisting of antisocial personality disorder, avoidant personality disorder, borderline personality disorder, dependent personality disorder, histrionic personality disorder, masochistic or sadistic behavior, narcissistic personality disorder, obsessive-compulsive personality disorder, paranoid personality disorder, psychopathy, sociopathy, schizoid personality disorder, or schizotypal personality disorder.paranoia, schizophrenia, antisocial disorders, borderline personality disorder, histrionic disorder, narcissism, psychopathy, masochistic, or sadistic behavior.
[0334] In some embodiments, disclosed methods and environments are useful for treating a feeding or eating disorder. In embodiments, disclosed methods are administered to a subject having a feeding or eating disorder, thereby treating said eating disorder. In embodiments, disclosed methods, when administered to a subject, provide beneficial therapeutic effects for the treatment of an eating disorder. Feeding or eating disorders generally involve abnormal eating or feeding behaviors or a preoccupation with thoughtsconcerning eating or feeding behaviors that are not explained by another health condition, and are not developmentally appropriate or culturally sanctioned. These disorders can involve preoccupation with food as well as body weight and shape concerns. A “feeding or eating disorder” refers to a class of disorders involving severe problems with thoughts concerning food and eating behaviors. It may jeopardize health by leading an individual to eat far more or far less than necessary. These disorders may involve various etiologies, including but not limited to, comorbid mood disorder, low self-esteem, childhood sexual abuse, trauma, and psychosocial pressures. In embodiments, the eating disorder is selected from the group consisting of binge eating, anorexia nervosa (including anorexia with significantly low body weight, anorexia with dangerously low body weight, or anorexia in recovery with normal body weight), bulimia nervosa or avoidant / restrictive food intake disorder, pica, or rumination-regurgitation disorder.
[0335] In some embodiments, disclosed methods and environments are useful for treating an elimination disorder. Elimination disorders include, for example, the repeated voiding of urine into clothes or bed, and the repeated passage of feces in inappropriate places once the individual has reached a developmental age when continence is ordinarily expected. In embodiments, disclosed methods are used to treat enuresis (including nocturnal enuresis, diurnal enuresis, and nocturnal and diurnal enuresis) or encopresis (including both with encopresis constipation or overflow incontinence, and encopresis without constipation or overflow incontinence).
[0336] In some embodiments, disclosed methods and environments are useful for treating a disorder of bodily distress or bodily experience. Disorders of bodily stress typically involve bodily symptoms that the subject finds distressing and to which the subject devotes excessive attention. Bodily integrity dysphoria typically involves a disturbance in the person’s experience of the body manifested by persistent discomfort or intense feelings of body configuration. In some embodiments, disclosed methods are used to treat a bodily distress disorder (including mild, moderate, and severe bodily distress disorder) or body integrity dysphoria.
[0337] In some embodiments, disclosed methods and environments are useful for treating a substance use disorder. In embodiments, disclosed methods are administered to a subject having a substance use disorder, thereby treating said substance use disorder. In embodiments, disclosed methods, when administered to a subject, provide beneficial therapeutic effects for the treatment of a substance use disorder. A “substance use disorder” refers to a class of mental disorders with neurological impacts on behavior, often leading to an inability to control intake of a substance, either legal or illicit. Uncontrolled consumption of a substance may lead to harmful consequences despite a desire to cease consumption of the substance. The result may be impairments in health, social functioning, problems at school or work, financial issues, or control over substance use. These disorders may involve various etiologies, including but not limited to, cultural / social environment, personality, abuse, trauma, genetic predisposition, and psychosocial pressures.
[0338] In some embodiments, the substance use disorder is selected from alcohol use disorder, cannabis use disorder, caffeine use disorder, phencyclidine use disorder, inhalants use disorder, opioids use disorder,sedatives use disorder, hypnotics use disorder, anxiolytics use disorder, stimulants use disorder, and tobacco use disorder. In some embodiments, the substance use disorder is alcohol use disorder. In some embodiments, the substance use disorder is cannabis use disorder. In some embodiments, the substance use disorder is caffeine use disorder. In some embodiments, the substance use disorder is phencyclidine use disorder. In some embodiments, the substance use disorder is inhalant use disorder. In some embodiments, the substance use disorder is opioids use disorder. In some embodiments, the substance use disorder is sedatives use disorder. In some embodiments, the substance use disorder is hypnotics use disorder. In some embodiments, the substance use disorder is anxiolytics use disorder. In some embodiments, the substance use disorder is stimulants use disorder. In some embodiments, the substance use disorder is tobacco use disorder. In some embodiments, the substance use disorder is alcohol use disorder, wherein said alcohol use disorder is selected from alcohol abuse, alcohol dependence, and alcoholism. In some embodiments, the disorder is associated with another addictive behavior (e.g., gambling disorders, gaming disorder). In some embodiments, a substance use disorder can be screened using a Screening to Brief Intervention (S2BI), Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), Brief Screener for Alcohol, Tobacco, and other Drugs (BSTAD), Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS), the Opioid Risk Tool - OLID (ORT-OUD) Chart, Drug Abuse Screen Test (DAST-10), and Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS).
[0339] In some embodiments, disclosed methods and environments are useful for treating other addictions, including food addiction, eating disorder, binge eating disorder, pathological gambling, pathological use of electronic devices, pathological use of electronic video games, pathological use of electronic communication devices, pathological use of cellular telephones, addiction to pornography, sex addiction, obsessive-compulsive disorder, impulse control disorder, compulsive spending, intermittent explosive disorder, kleptomania, pyromania, trichotillomania, compulsive over-exercising, and compulsive overworking.
[0340] In some embodiments, disclosed methods and environments are useful for treating an impulse control disorder. In general, impulse control disorders are characterized by the repeated failure to resist an impulse, drive, or urge to perform an act that is rewarding to the subject despite negative long-term consequences, such as harm to the subject or a significant impairment in important areas of the subject’s functioning. In some embodiments, impulse control behaviors include fire-setting, stealing, inappropriate sexual behavior, and explosive outbursts. In some embodiments, disclosed methods are used to treat pyromania, kleptomania, compulsive sexual behavior disorder, or intermittent explosive disorder.
[0341] In some embodiments, disclosed methods and environments are useful for treating a disruptive behavior disorder or a dissocial disorder. Such disorders may be broadly characterized by persistent behavior problems that range from persistently defiant, disobedient, provocative or spiteful behaviors to behaviors that violate the rights of others or norms, rules, or laws. In some embodiments, disclosed methods are used to treat oppositional defiant disorder (including oppositional defiant disorder with chronicirritability-anger and oppositional defiant disorder without chronic irritability-anger) or conduct-dissocial disorder (including childhood-onset conduct-dissocial disorder and adolescent-onset conduct-dissocial disorder).
[0342] In some embodiments, disclosed methods and environments are useful for treating a paraphilic disorder. Paraphilic disorders can be characterized by persistent and intense patterns of atypical sexual arousal, the focus of which involves others whose age or status renders them unwilling or unable to consent. In some embodiments, disclosed methods are is used to treat exhibitionistic disorder, voyeuristic disorder, pedophilic disorder, coercive sexual sadism disorder, frotteuristic disorder, other paraphilic disorders involving non-consenting individuals, or paraphilic disorders involving solitary behavior or consenting individuals.
[0343] In some embodiments, disclosed methods and environments are useful for treating a factitious disorder. In general, factitious disorders may be characterized by intentionally feigning, falsifying, inducing or aggravating medical, psychological, or behavior signs and symptoms or injury to oneself or another person. Subjects with factitious disorders may seek treatment or otherwise present themselves or another person as ill, injured, or impaired. In embodiments, disclosed methods are used to treat factitious disorder imposed on self or a factitious disorder imposed on another.
[0344] In some embodiments, disclosed methods and environments are useful for treating a neurocognitive disorder. Neurocognitive disorders may be characterized by primary clinical defects in cognitive functioning that are acquired (rather than developmental), and therefore the subject experiences a decline from a previously attained level of functioning. In some embodiments, disclosed methods are used to treat delirium. In some embodiments, the delirium is associated with another disease or disorder. In some embodiments, the delirium is associated with a psychoactive substance (including medications and illicit or illegal substances). In some embodiments, disclosed methods are used to treat mild neurocognitive disorder. In some embodiments, disclosed methods are used to treat an amnestic disorder. In some embodiments, the amnestic disorder is associated with another disease or disorder. In some embodiments, the delirium is associated with a psychoactive substance (including medications and illicit or illegal substances). In some embodiments, disclosed methods are used to treat dementia. In some embodiments, the dementia is associated with Alzheimer’s disease, Parkinson’s disease, cerebrovascular disease, Lewy body disease, a psychoactive substance (including medications and illicit or illegal substances). In some embodiments, disclosed methods are used to treat a behavioral or psychological disturbance associated with dementia. In some embodiments, dementia is assessed using a Functional Activities Questionnaire (FAQ), Ascertain Dementia 8 (AD8), Mini-Cog, Mini-Mental State Exam (MMSE), the Montreal Cognitive Assessment (MoCA), and the Neuropsychiatric Inventory Questionnaire (NPI-Q).
[0345] In some embodiments, disclosed methods and environments are useful for treating a mental or behavioral disorder associated with pregnancy, childbirth, or the puerperium. In some embodiments, thesyndrome associated with pregnancy or the puerperium involves significant mental and behavioral features, including a depressive symptom. In some embodiments, the disorder includes psychotic symptoms. In some embodiments, disclosed methods are used to treat mental or behavioral disorders associated with pregnancy, childbirth or the puerperium, with psychotic symptoms. In embodiments, disclosed methods are used to treat mental or behavioral disorders associated with pregnancy, childbirth or the puerperium, without psychotic symptoms.
[0346] In some embodiments, disclosed methods and environments are useful for treating a sleep-wake disorder. In general, sleep-wake disorders are associated with difficulty initiating or maintaining sleep (e.g., insomnia), excessive sleepiness (e.g., hypersomnolence disorders), respiratory disturbance during sleep (e.g., sleep-related breathing disorders (SRBDs), such as obstructive sleep apnea (OSA), central sleep apnea (CSA), sleep-related hypoventilation disorders, sleep-related hypoxemia disorder, snoring, catathrenia, Cheyne-Stokes breathing, and sleep-disordered breathing), disorders of the sleep-wake schedule (e.g., circadian rhythm sleep-wake disorders), abnormal movements during sleep, or problematic behavioral or psychological events that occur while falling asleep, during sleep, or upon arousal from sleep (e.g., parasomnia disorders). In some embodiments, disclosed methods are used to treat an insomnia disorder, a hypersomnolence disorder, a sleep-related breathing disorder, a circadian rhythm sleep-wake disorder, or a parasomnia disorder.
[0347] In some embodiments, disclosed methods and environments are useful for treating sexual dysfunction. Sexual dysfunctions can be defined as syndromes wherein a subject may have difficulty experiencing personally satisfying, non-coercive sexual activities. In some embodiments, disclosed methods are used to treat hypoactive sexual desire dysfunction, sexual arousal dysfunction, orgasmic dysfunction, ejaculatory dysfunction, or sexual dysfunction associated with pelvic organ prolapse.
[0348] In some embodiments, disclosed methods and environments are useful for treating a psychological disorder that includes a repetitive body-focused behavior (e.g., a tic disorder, such as Tourette's Syndrome, trichotillomania, nail-biting, temporomandibular disorder, thumb-sucking, repetitive oral-digital, lip-biting, fingernail biting, eye-rubbing, skin-picking, or a chronic motor tic disorder).
[0349] In some embodiments, disclosed methods and environments are useful for treating a psychosomatic symptom or a somatic symptom (e.g., chronic pain, anxiety disproportionate to severity of physical complaints, pain disorder, body dysmorphia, conversion, hysteria, neurological conditions without identifiable cause, or psychosomatic illness).2. Neurodegenerative Disorders
[0350] In some embodiments, disclosed methods and environments are useful for treating a neurodegenerative disorder. In some embodiments the disclosed methods provide beneficial therapeutic effects for the treatment of a neurodegenerative disorder.
[0351] The term “neurodegenerative disorder” refers to a class of progressive, chronic, and debilitatingconditions characterized by the gradual loss of structure and function of neurons within the central nervous system (CNS) or peripheral nervous system (PNS). These disorders involve the degeneration, impairment, or death of neuronal cells, leading to a decline in cognitive, motor, and / or sensory abilities.
[0352] Neurodegenerative disorders can be classified according to primary clinical features, e.g., dementia, parkinsonism, or motor neuron disease, anatomic distribution of neurodegeneration, e.g., frontotemporal degenerations, extrapyramidal disorders, or spinocerebellar degenerations, or principal molecular abnormality (Dugger B, Dickson DW. Pathology of Neurodegenerative Diseases. Cold Spring Harbor Perspectives in Biology. 2017:9(7);a028035). These disorders may involve various etiologies, including but not limited to, presence of pathogenic proteins, age, environmental stressors, and genetic predisposition (Armstrong R. Folia Neuropathologica. 2020:58(2);93-112).
[0353] In some embodiments, the neurodegenerative disorder is selected from the group consisting of Alzheimer’s disease, amyotrophic lateral sclerosis or Charcot’s disease, chronic traumatic encephalopathy, corticobasal degeneration, dementias including vascular dementia, frontotemporal dementia, lewy body dementia, Huntington’s disease, Lytico-Bodig disease, mild cognitive impairment, multiple sclerosis, a motor neuron disease, neuromyelitis optica spectrum disorder, Parkinson’s disease or Parkinsonisms, prion diseases, progressive supranuclear palsy, posterior cortical atrophy, and traumatic brain injury.
[0354] In some embodiments, disclosed methods and environments are useful for the treatment of neurodegenerative disorders (e.g., Alzheimer’s, Parkinson’s, Huntington’s). In some embodiments, a disclosed method or environment is useful for treating Alzheimer’s disease. In some embodiments, a disclosed method or environment is useful for treating posterior cortical atrophy. In some embodiments, a disclosed method or environment is useful for treating Alzheimer’s disease with comorbid posterior cortical atrophy. In some embodiments, a disclosed method or environment is useful for treating posterior cortical atrophy associated with or caused by Alzheimer’s disease.3. Pain Disorders
[0355] In embodiments, disclosed methods are used to treat a pain disorder. In embodiments, disclosed methods are therapeutically administered to a subject having a pain disorder. In some methods herein, the disclosed methods, when used therapeutically, provide beneficial effects for the treatment of a pain disorder. In some embodiments the pain disorder is treated by the disclosed methods in combination with the disclosed methods and psychotherapy, drug-assisted psychotherapy (Chiteni A., Cureus 2021 :13(10)), drug administration without psychotherapy, or other treatment for improving psychological or mental health.
[0356] A “pain disorder” refers to conditions characterized by the experience of persistent or recurrent physical or psychological pain, either localized or widespread, that significantly impairs an individual's daily functioning and quality of life. These disorders may involve various etiologies, including but not limited to nociceptive, neuropathic, psychogenic, idiopathic or radicular origins. In embodiments, a method is used to treat neuropathic pain. In embodiments, a method is used to treat psychogenic pain. In embodiments, amethod is used to treat idiopathic pain. In embodiments, methods are used to treat radicular pain.
[0357] Pain disorders may manifest as acute or chronic pain, and can affect different parts of the body, such as musculoskeletal, neurological, gastrointestinal, or visceral systems. Pain can be expressed as, but is not limited to, post-herpetic pain, trigeminal pain, occipital pain, or pudendal pain. In embodiments, a disclosed method is used to treat pain associated with chemotherapy (e.g., chemotherapy associated neuropathy). In embodiments, a disclosed method is used to treat arthritis, back pain, central pain, chronic fatigue syndrome, cluster headaches, migraine headaches, phantom limb pain, complex regional pain syndrome, compression mononeuropathy, diabetic neuropathy, fibromyalgia, focal neuropathy, herniated disc pain, or sciatica.
[0358] In some embodiments, pain is assessed using the Pain, Enjoyment, and General Activity Scale (PEG), the Numeric Rating Scale (NRS), the Visual Analog Scale (VAS), Behavioral Pain Scale (BPS), and the Faces Pain Scale-Revised (FPS-R).E. Therapeutic Effects of Disclosed Environments and Methods
[0359] In some aspects are disclosed methods for enhancing a therapeutic experience comprising providing a subject with a therapeutic experience in a disclosed bioadaptive environment, including providing the subject with psychotherapy in the disclosed environment. In some embodiments, providing a subject with a therapeutic experience in a disclosed embodiment results in a therapeutic effect.
[0360] A therapeutic effect, according to disclosed embodiments, can comprise, e.g., an improvement in the subject’s general health and wellbeing, and / or an improvement of one or more symptoms of a medical condition. For example, in some embodiments a therapeutic effect relates to improved health and wellbeing, and includes any one or more of enhanced well-being, greater prosocial behavior, and an increased sense of connectedness to nature and all things. In some embodiments, the therapeutic effect is an improvement of the subject’s skill(s), such as ability for creative problem solving. In some embodiments, wherein the subject has a disease or disorder (whether or not such condition is formally diagnosed, or is diagnosable), the therapeutic effect is a reduction in one or more symptoms of the disease or disorder, such as a mental, behavioral, neurodevelopmental, neurodegenerative, or pain disorder, or another medical condition.
[0361] In general, “therapeutic effect” or “therapeutic efficacy” means the responses(s) in a subject after their therapeutic experience that are judged to be desirable and beneficial. In embodiments, the term “therapeutic effect” refers to a measurable effect during a therapeutic experience; alternatively or additionally, “therapeutic effect” refers to a measurable effect after a therapeutic experience. In embodiments, there is a measurable effect during a therapeutic experience and which is maintained after the end of the experience, and which may be durable for a period of days, weeks, months, or years. A therapeutic effect may be measured and compared to baseline, which may be the time before the therapeutic experience, such as measured before starting the therapeutic experience, or measured at some time before starting the therapeutic experience (e.g., during an onboarding session or a preparation session). As an example, a depression score may be measured by a questionnaire or obtained from biomarkers or a digital phenotypebefore the therapeutic experience, and then measured or or obtained during the experience and / or after the experience, including at time points that are days, weeks, months, or years after the experience, such as 1 week, 2 weeks, 3 weeks, 1 month, 3 months, 6 months, 9 months, 1 year, 1.5 years, 2 years, and the like.
[0362] Therapeutic effects may differ, depending on various factors, such as: the disorder to be treated, improvement in health or wellbeing sought, whether a subject experiences a state of increased neuroplasticity or an altered state of consciousness during their therapeutic experience, and whether a substance (e.g., a psychoactive substance, psychedelic, psychoplastogen, etc.) is administered to induce a state of increased neuroplasticity or an altered state of consciousness in a subject; but would be readily understood by those of ordinary skill.
[0363] Measures of therapeutic effect includes any outcome measure, endpoint, effect measure, or measure of effect within clinical or medical practice or research that is used to assess the effect, whether positive or negative, of an intervention or treatment, whether subject-reported (e.g., questionnaires), based on other subject data (e.g., direct subject monitoring or biofeedback data), gathered through laboratory tests such as blood work, urine samples, etc., through medical examination by a doctor or other medical professional, or by digital tools or means, e.g., electronic tools such as online tools, smartphones, wireless devices, biosensors, or health apps.
[0364] In embodiments, a therapeutic effect is measured using one or more assessments. “Assessment” refers to any means or method used with a subject, whether before, during, after, or unrelated in time to a specific therapeutic experience, to measure, estimate, or evaluate a nature, ability, symptom, disorder, or other characteristic of the subject, whether qualitatively or quantitatively, and whether performed by a guide or facilitator (e.g., an interview), by the subject themself (e.g., a self-reported questionnaire), by a third-party or by a computer, including a device (e.g., a medical sensor or biosensor, a mobile application (e.g., TRAVLER), a watch or fitness tracker, or a “wearable”), and whether graded by a human decision-maker, an artificial intelligence, machine learning, or computer algorithm, or by other means for processing subject data (e.g., biofeedback data).
[0365] One of skill will appreciate that useful questionnaires and assessments may include those in use by mental health professionals (e.g., the Hamilton Rating Scale for Depression (HAM-D); the Mini International Neuropsychiatric Interview 5 (MINI 5) (see, e.g., Sheehan et al. J of Clinical Psychiatry. 1998; 59(Supp. 20): 22-33); the Columbia Suicide Severity Rating Scale (C-SSRS) (see, e.g., Mundt et al. J of Clinical Psychiatry. 2013; 74(9): 887-93); the Patient Health Questionnaire (PHQ-9) (see, e.g., Kroenke et al. J Gen Intern Med. 2001 ;16(9)); the Generalized Anxiety Disorder 7 (GAD-7) (see, e.g., Spitzer et al. Arch Intern Med. 2006; 166(10): 1092-97); and the like).
[0366] An assessment may be computer-assisted, and other computer-assisted assessments may be performed besides the assessments above. The term “computer-assisted” in “computer-assisted assessment” means an assessment comprising the use of electronic tools such as online tools,smartphones, tablets, wireless devices, or apps (e.g., TRAVLER). In embodiments, one or more computer-assisted assessments may be used, optionally together with one or more digital biomarkers, to provide data to construct a digital phenotype. In some embodiments, a computer-assisted assessment may comprise, involve, or be used in combination with a biofeedback system and / or other forms of subject monitoring. In some embodiments, the digital biomarkers or the digital phenotype may comprise, involve, or be used in combination with a biofeedback system and / or other forms of subject monitoring. In some embodiments, a computer-assisted assessment comprises, involves, or is used in combination with visual stimuli. In some embodiments, a computer-assisted assessment comprises, involves, or is used in combination with auditory stimuli. In some embodiments, a computer-assisted assessment comprises, involves, or is used in combination with tactile stimuli. In some embodiments, a computer-assisted assessment comprises, involves, or is used in combination with olfactory stimuli.
[0367] A computer-assisted assessment also may include the use of an electronic psychiatric notes system. For example, in the context of therapy (e.g., PAT), relevant clinical information can be recorded by a therapist interacting face-to-face with an subject, and may also include the use of computer systems where the therapist and subject interact virtually (either synchronously or asynchronously), as well as where a subject only interacts with a computer (“computer” broadly meaning any electronic tool suitable for such purposes, including desktop, laptop, and notebook computers; tablets, smartphones, and other mobile devices; watches, fitness trackers, and personal electronic devices; and the like).
[0368] In some aspects, disclosed methods and environments provide beneficial therapeutic effects and / or improve the therapeutic efficacy of psychedelic-assisted therapy or other forms of psychotherapy.1 . Improving Health and Wellbeing
[0369] In embodiments, the therapeutic effect comprises an improvement in a subject’s general health and wellbeing. In some embodiments, the therapeutic effect comprises an increase of the subject’s relaxation, tranquility, emotional stability, subjective feeling of having a calm and centered state of mind.
[0370] In embodiments, relaxation is increased by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or greater than 100%, up to and including a feeling of complete and total relaxation. The increase of relaxation may be assessed using a patient questionnaire, an assessment, one or more physiological or digital biomarkers, or one or more other methods described herein or known to one in the art.
[0371] In embodiments, tranquility is increased by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or greater than 100%, up to and including a feeling of complete and total tranquility. The increase of tranquility may be assessed using a patient questionnaire, an assessment, one or more physiological or digital biomarkers, or one or more othermethods described herein or known to one in the art.
[0372] In embodiments, emotional stability is increased by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or greater than 100%, up to and including a feeling of complete and total emotional stability. The increase of emotional stability may be assessed using a patient questionnaire, an assessment, one or more physiological or digital biomarkers, or one or more other methods described herein or known to one in the art.
[0373] In embodiments, the subjective feeling of having a calm and centered state of mind is increased by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or up to 100%, including a feeling of a completely calm and centered state of mind. The subjective feeling of having a calm and centered state of mind may be assessed using a subject questionnaire or an assessment. In embodiments, a calm and centered state of mind also may be determined by measuring one or more physiological or digital biomarkers, or one or more other methods described herein or known to one in the art.
[0374] In embodiments, the therapeutic effect comprises a reduction of the subject’s tension. In embodiments, tension is reduced by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or up to 100%, including a total elimination of tension. The reduction of tension may be assessed using a subject questionnaire, an assessment, one or more physiological or digital biomarkers, or one or more other methods described herein or known in the art.
[0375] In embodiments, the therapeutic effect comprises a reduction of the subject’s stress. In embodiments, stress is reduced by about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, or up to 100%, including a total elimination of stress. The reduction of stress may be assessed using a subject questionnaire, an assessment, one or more physiological or digital biomarkers, or one or more other methods described herein or known to one in the art.
[0376] In some embodiments, the therapeutic effect is measured by an increase in the score of any of the Mystical, Positive Mood, Transcendence of Time and Space, and Ineffability subscales of the 30-item revised Mystical Experience Questionnaire (MEQ30). The MEQ30 is considered to be an efficient measure of individual mystical experiences, and may be positively predictive of persisting change in attitudes, behavior, and well-being attributed to psychedelic experiences (Barrett et al. J Psychopharmacol. 2015;29(11):1182— 1190).
[0377] In embodiments, a subject participating in a disclosed method has a score on the Mystical subscaleof at least 10, at least 15, at least 20, at least 25, at least 30, at least 35, at least 40, at least 45, at least 50, at least 55, at least 60, at least 65, at least 70, or 75. In embodiments, a subject participating in a disclosed method has a score on the Mystical subscale of at least 40, at least 45, at least 50, at least 55, at least 60, at least 65, at least 70, or greater than 70. In embodiments, a subject participating in a disclosed method has a score on the Mystical subscale of at least 50. In embodiments, a subject participating in a disclosed method has a score on the Mystical subscale of at least 55. In embodiments, a subject participating in a disclosed method has a score on the Mystical subscale of at least 60. In embodiments, a subject participating in a disclosed method has a score on the Mystical subscale of at least 65. In embodiments, a subject participating in a disclosed method has a score on the Mystical subscale of at least 70. In embodiments, a subject participating in a disclosed method has a score on the Mystical subscale of 75.
[0378] In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 10, at least 15, at least 20, at least 25, or 30. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 20, at least 21 , at least 22, at least 23, at least 24, at least 25, at least 26, at least 27, at least 28, at least 29, or 30. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 20. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 21. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 22. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 23. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 24. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 25. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 26. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 27. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 28. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of at least 29. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale of 30.
[0379] In embodiments, a subject participating in a disclosed method has a score on the Transcendence of Time and Space subscale of at least 5, at least 10, at least 15, at least 20, at least 25, or greater than 25. In embodiments, a subject participating in a disclosed method has a score on the Transcendence of Time and Space subscale of at least 15, at least 20, at least 25, or greater than 25. In embodiments, a subject participating in a disclosed method has a score on the Transcendence of Time and Space subscale of at least 15. In embodiments, a subject participating in a disclosed method has a score on the Transcendence of Time and Space subscale of at least 20. In embodiments, a subject participating in a disclosed method has a score on the Transcendence of Time and Space subscale of at least 25. In embodiments, a subjectparticipating in a disclosed method has a score on the Transcendence of Time and Space subscale of 30.
[0380] In embodiments, a subject participating in a disclosed method has a score on the Ineffability subscale of at least 5, at least 6, at least 7, at least 8, at least 9, at least 10, at least 11 , at least 12, at least 13, at least 14, or 15. In embodiments, a subject participating in a disclosed method has a score on the Ineffability subscale of at least 9, at least 10, at least 11 , at least 12, at least 13, at least 14, or 15. In embodiments, a subject participating in a disclosed method has a score on the Ineffability subscale of at least 9. In embodiments, a subject participating in a disclosed method has a score on the Ineffability subscale of at least 10. In embodiments, a subject participating in a disclosed method has a score on the Ineffability subscale of at least 11. In embodiments, a subject participating in a disclosed method has a score on the Ineffability subscale of at least 12. In embodiments, a subject participating in a disclosed method has a score on the Ineffability subscale of at least 13. In embodiments, a subject participating in a disclosed method has a score on the Ineffability subscale of at least 14. In embodiments, a subject participating in a disclosed method has a score on the Ineffability subscale of 15.
[0381] In some embodiments, the score of any of the Mystical, Positive Mood, Transcendence of Time and Space, and Ineffability subscales for a subject participating in a disclosed method is at least 50% of the maximum possible score. In some embodiments, the score of any of the Mystical, Positive Mood, Transcendence of Time and Space, and Ineffability subscales for a subject participating in a disclosed method is at least 55% of the maximum possible score. In some embodiments, the score of any of the Mystical, Positive Mood, Transcendence of Time and Space, and Ineffability subscales for a subject participating in a disclosed method is at least 60% of the maximum possible score. In some embodiments, the score of any of the Mystical, Positive Mood, Transcendence of Time and Space, and Ineffability subscales for a subject participating in a disclosed method is at least 75% of the maximum possible score. In some embodiments, the score of all of the Mystical, Positive Mood, Transcendence of Time and Space, and Ineffability subscales for a subject participating in a disclosed method is at least 60% of the maximum possible score. In some embodiments, the score of any of the Mystical, Positive Mood, Transcendence of Time and Space, and Ineffability subscales for a subject participating in a disclosed method is at least 75% of the maximum possible score.
[0382] In embodiments, a subject participating in a disclosed method scores at least 60% of the maximum score in all MEQ30 dimensions (e.g., Mysticism, Positive Mood, Transcendence, and Ineffability), indicating a “mystical-type experience.” In embodiments, a subject participating in a disclosed method scores at least 65% of the maximum score in all MEQ30 dimensions (e.g., Mysticism, Positive Mood, Transcendence, and Ineffability), indicating a “mystical-type experience.” In embodiments, a subject participating in a disclosed method scores at least 70% of the maximum score in all MEQ30 dimensions (e.g., Mysticism, Positive Mood, Transcendence, and Ineffability), indicating a “mystical-type experience.” In embodiments, a subject participating in a disclosed method scores at least 75% of the maximum score in all MEQ30 dimensions(e.g., Mysticism, Positive Mood, Transcendence, and Ineffability), indicating a “mystical-type experience.” In embodiments, a subject participating in a disclosed method scores at least 80% of the maximum score in all MEQ30 dimensions (e.g., Mysticism, Positive Mood, Transcendence, and Ineffability), indicating a “mystical-type experience.”
[0383] In some embodiments, the therapeutic effect is measured by a decrease in the score of any of the Fear, Grief, Physical Distress, Insanity, Isolation, Death, and Paranoia subscales of the Challenging Experience Questionnaire (CEQ). The CEQ is a validated research tool used to evaluate acute adverse psychological reactions that occur during a psychedelic experience (Barrett et al. J Psychopharmacol. 2016;30(12):1279— 1295).
[0384] In embodiments, a subject participating in a disclosed method has a score on any of the Fear, Grief, Physical Distress, Insanity, Isolation, Death, and Paranoia subscales that is less than 30%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1 % of the maximum score for the subscale. In embodiments, a subject participating in a disclosed method has a score on any of the Fear, Grief, Physical Distress, Insanity, Isolation, Death, and Paranoia subscales that is less than 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1% of the maximum score for the subscale. In embodiments, a subject participating in a disclosed method has a score on all of the Fear, Grief, Physical Distress, Insanity, Isolation, Death, and Paranoia subscales that is less than 30%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1% of the maximum score for the subscale. In embodiments, a subject participating in a disclosed method has a score on all of the Fear, Grief, Physical Distress, Insanity, Isolation, Death, and Paranoia subscales that is less than 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1 % of the maximum score for the subscale.
[0385] In embodiments, a subject participating in a disclosed method has a score on the CEQ Fear subscale of less than 10% of the maximum value for the subscale. In embodiments, a subject participating in a disclosed method has a score on the CEQ Grief subscale of less than 10% of the maximum value for the subscale. In embodiments, a subject participating in a disclosed method has a score on the CEQ Physical Distress subscale of less than 10% of the maximum value for the subscale. In embodiments, a subject participating in a disclosed method has a score on the CEQ Insanity subscale of less than 10% of the maximum value for the subscale. In embodiments, a subject participating in a disclosed method has a score on the CEQ Isolation subscale of less than 10% of the maximum value for the subscale. In embodiments, a subject participating in a disclosed method has a score on the CEQ Death subscale of less than 10% of the maximum value for the subscale. In embodiments, a subject participating in a disclosed method has a score on the CEQ Paranoia subscale of less than 10% of the maximum value for the subscale.
[0386] In embodiments, a subject participating in a disclosed method has a score on the CEQ Fear subscale of less than 6, less than 5, less than 4, less than 3, less than 2, or less than 1. In embodiments, a subject participating in a disclosed method has a score on the Fear subscale of less than 3, less than 2, or less than 1 .
[0387] In embodiments, a subject participating in a disclosed method has a score on the CEQ Grief subscale of less than 13, less than 12, less than 10, less than 9, less than 8, less than 7, less than 6, less than 5, less than 4, less than 3, less than 2, or less than 1. In embodiments, a subject participating in a disclosed method has a score on the Grief subscale of less than 6, less than 5, less than 4, less than 3, less than 2, or less than 1 .
[0388] In embodiments, a subject participating in a disclosed method has a score on the CEQ Physical Distress subscale of less than 6, less than 5, less than 4, less than 3, less than 2, or less than 1. In embodiments, a subject participating in a disclosed method has a score on the Physical Distress subscale of less than 2 or less than 1 .
[0389] In embodiments, a subject participating in a disclosed method has a score on the CEQ Insanity subscale of less than 4, less than 3, less than 2, or less than 1. In embodiments, a subject participating in a disclosed method has a score on the Insanity subscale of less than 3, less than 2, or less than 1 .
[0390] In embodiments, a subject participating in a disclosed method has a score on the CEQ Isolation subscale of less than 5, less than 4, less than 3, less than 2, or less than 1. In embodiments, a subject participating in a disclosed method has a score on the Isolation subscale of less than 2 or less than 1 .
[0391] In embodiments, a subject participating in a disclosed method has a score on the CEQ Death subscale of less than 3, less than 2, or less than 1. In embodiments, a subject participating in a disclosed method has a score on the Death subscale of less than 2 or less than 1.
[0392] In embodiments, a subject participating in a disclosed method has a score on the CEQ Paranoia subscale of less than 3, less than 2, or less than 1. In embodiments, a subject participating in a disclosed method has a score on the Paranoia subscale of less than 2 or less than 1 .
[0393] In some embodiments, an individual participating in a disclosed method has an increased score on the MEQ30 Mysticism subscale compared to a comparable subject not participating in a disclosed method. In embodiments, a subject participating in a disclosed method has a score on the Mysticism subscale that is at least 1 point, 5 points, 10 points, 15 points, 20 points, 25 points, 30 points, 35 points, 40 points, 45 points, or 50 points higher than the score of a comparable subject not participating in a disclosed method.
[0394] In embodiments, a subject participating in a disclosed method has an increased score on the MEQ30 Positive Mood subscale compared to a comparable subject not participating in a disclosed method. In embodiments, a subject participating in a disclosed method has a score on the Positive Mood subscale that is at least 1 point, 5 points, 10 points, 15 points, or 20 points points higher than the score of a comparable subject not participating in a disclosed method.
[0395] In embodiments, a subject participating in a disclosed method has an increased score on the MEQ30 Transcendence subscale compared to a comparable subject not participating in a disclosed method. In embodiments, a subject participating in a disclosed method has a score on the Transcendence subscale that is at least 1 point, 5 points, 10 points, 15 points, or 20 points higher than the score of a comparablesubject not participating in a disclosed method.
[0396] In embodiments, a subject participating in a disclosed method has an increased score on the MEQ30 Ineffability subscale compared to a comparable subject not participating in a disclosed method. In embodiments, a subject participating in a disclosed method has a score on the Ineffability subscale that is at least 1 point, 2 points, 3 points, 4 points, 5 points, 6 points, 7 points, 8 points, 9 points, or 10 points higher than the score of a comparable subject not participating in a disclosed method.
[0397] In embodiments, a subject participating in a disclosed method has a decreased score on the CEQ Fear subscale compared to a comparable subject not participating in a disclosed method. In embodiments, a subject participating in a disclosed method has a score on the Fear subscale that is 1 point, 2 points, 3 points, 4 points, or more than 4 points lower than the score of a comparable subject not participating in a disclosed method.
[0398] In embodiments, a subject participating in a disclosed method has a decreased score on the CEQ Grief subscale compared to a comparable subject not participating in a disclosed method. In embodiments, a subject participating in a disclosed method has a score on the Grief subscale that is 1 point, 2 points, 3 points, 4 points, 5 points, 6 points, 7 points, 8 points, 9 points, 10 points, 11 points, or more than 11 points lower than the score of a comparable subject not participating in a disclosed method.
[0399] In embodiments, a subject participating in a disclosed method has a decreased score on the CEQ Physical Distress subscale compared to a comparable subject not participating in a disclosed method. In embodiments, a subject participating in a disclosed method has a score on the Physical Distress subscale that is 1 point, 2 points, 3 points, 4 points, or more than 4 points lower than the score of a comparable subject not participating in a disclosed method.
[0400] In embodiments, a subject participating in a disclosed method has a decreased score on the CEQ Insanity subscale compared to a comparable subject not participating in a disclosed method. In embodiments, a subject participating in a disclosed method has a score on the Insanity subscale that is 1 point, 2 points, 3 points, or more than 3 points lower than the score of a comparable subject not participating in a disclosed method.
[0401] In embodiments, a subject participating in a disclosed method has a decreased score on the CEQ Isolation subscale compared to a comparable subject not participating in a disclosed method. In embodiments, a subject participating in a disclosed method has a score on the Isolation subscale that is 1 point, 2 points, 3 points, 4 points, or more than 4 points lower than the score of a comparable subject not participating in a disclosed method.
[0402] In embodiments, a subject participating in a disclosed method has a decreased score on the CEQ Death subscale compared to a comparable subject not participating in a disclosed method. In embodiments, a subject participating in a disclosed method has a score on the Death subscale that is 1 point, 2 points, or more than 2 points lower than the score of a comparable subject not participating in a disclosed method.
[0403] In embodiments, a subject participating in a disclosed method has a decreased score on the CEQ Paranoia subscale compared to a comparable subject not participating in a disclosed method. In embodiments, a subject participating in a disclosed method has a score on the Paranoia subscale that is 1 point, 2 points, or more than 2 points lower than the score of a comparable subject not participating in a disclosed method.2. Improving Outcomes in Treating Medical Conditions, Diseases, and Disorders
[0404] In embodiments, a therapeutic effect resulting from a subject having an enhanced therapeutic experience in a disclosed environment or according to a disclosed method improves one or more outcomes in the treatment of a medical condition.
[0405] In embodiments, a therapeutic effect is assessed using an outcome measure. In some embodiments, an “outcome measure” refers to clinical data, such as any of physiological measures, patient-centered outcome measures (PCOMs), behavioral factor measures, and other such measures as will be readily known to one of skill.
[0406] In embodiments, the outcome measure is a physiological measure. In embodiments, the outcome measure is a measure of one or more physical (e.g., physiological, anatomical, biochemical, neurological, metabolic, and the like) responses of a subject in response to a treatment. In embodiments, the outcome measure is a PCOM. In embodiments, the PCOM is an assessment of the subject’s beliefs, opinions and needs in relation to therapy (e.g., subject-reported negative or positive effects they attribute to a treatment). In embodiments, the outcome measure is a behavioral factor measure, e.g., a measure of one or more behaviors, such as specific behaviors or behavioral patterns indicative of a medical condition.
[0407] In embodiments, a therapeutic effect is assessed by monitoring or self-monitoring of a subject.
[0408] In embodiments, wherein a subject is treated for a mental health disorder, a therapeutic effect is assessed by measuring a change (e.g., reduction) in the severity or frequency of symptoms of the mental health disorder. In embodiments, a therapeutic effect is assessed by comparing the severity or frequency of one or more of a subject’s symptoms to their baseline severity or frequency of that symptom, for a period of time after the subject’s therapeutic experience (e.g., 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, or longer than 3 months). In embodiments, the severity or frequency one or more symptoms is reduced by at least about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 100% compared to the subject’s baseline severity or frequency of that symptom.
[0409] In embodiments, a reduction in at least one symptom of the mental health disorder is a reduction in one or more symptoms of the mental health disorder, such as two symptoms of the mental health disorder, three symptoms of the mental health disorder, four symptoms of the mental health disorder, five symptoms of the mental health disorder, or greater than five symptoms of the mental health disorder. In embodiments, the subject’s number of symptoms are compared to their baseline number of symptoms, for a period of time after the subject’s therapeutic experience (e.g., 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months,or longer than 3 months). In embodiments, the number of symptoms is decreased by at least about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 100% compared to the subject’s baseline number of symptoms.
[0410] In embodiments, wherein a subject is treated for a neurodegenerative disorder, a therapeutic effect is assessed by measuring a change (e.g., reduction) in the severity or frequency of symptoms of the neurodegenerative disorder. In embodiments, a therapeutic effect is assessed by comparing the severity or frequency of one or more of a subject’s symptoms to their baseline severity or frequency of that symptom, for a period of time after the subject’s therapeutic experience (e.g., 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, or longer than 3 months). In embodiments, the severity or frequency one or more symptoms is reduced by at least about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 100% compared to the subject’s baseline severity or frequency of that symptom.
[0411] In embodiments, a reduction in at least one symptom of the neurodegenerative disorder is a reduction in one or more symptoms of the neurodegenerative disorder, such as two symptoms of the neurodegenerative disorder, three symptoms of the neurodegenerative disorder, four symptoms of the neurodegenerative disorder, five symptoms of the neurodegenerative disorder, or greater than five symptoms of the neurodegenerative disorder. In embodiments, the subject’s number of symptoms are compared to their baseline number of symptoms, for a period of time after the subject’s therapeutic experience (e.g., 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, or longer than 3 months). In embodiments, the number of symptoms is decreased by at least about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 100% compared to the subject’s baseline number of symptoms.
[0412] In embodiments, wherein a subject is treated for a substance use disorder, a therapeutic effect is assessed by measuring a change (e.g., reduction) in the severity or frequency of symptoms of the substance use disorder. In embodiments, a therapeutic effect is assessed by comparing the severity or frequency of one or more of a subject’s symptoms to their baseline severity or frequency of that symptom, for a period of time after the subject’s therapeutic experience (e.g., 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, or longer than 3 months). In embodiments, the severity or frequency one or more symptoms is reduced by at least about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 100% compared to the subject’s baseline severity or frequency of that symptom.
[0413] In embodiments, a reduction in at least one symptom of the substance use disorder is a reduction in one or more symptoms of the substance use disorder, such as two symptoms of the substance use disorder, three symptoms of the substance use disorder, four symptoms of the substance use disorder, five symptoms of the substance use disorder, or greater than five symptoms of the substance use disorder. In embodiments, the subject’s number of symptoms are compared to their baseline number of symptoms, for a period of time after the subject’s therapeutic experience (e.g., 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, or longer than 3 months). In embodiments, the number of symptoms is decreased by at least about10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 100% compared to the subject’s baseline number of symptoms.
[0414] In embodiments, wherein a subject is treated for an alcohol use disorder, a therapeutic effect is assessed by measuring a change (e.g., reduction) in the severity or frequency of symptoms of the alcohol use disorder. In embodiments, a therapeutic effect is assessed by comparing the severity or frequency of one or more of a subject’s symptoms to their baseline severity or frequency of that symptom, for a period of time after the subject’s therapeutic experience (e.g., 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, or longer than 3 months). In embodiments, the severity or frequency one or more symptoms is reduced by at least about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 100% compared to the subject’s baseline severity or frequency of that symptom.
[0415] In embodiments, a reduction in at least one symptom of the alcohol use disorder is a reduction in one or more symptoms of the alcohol use disorder, such as two symptoms of the alcohol use disorder, three symptoms of the alcohol use disorder, four symptoms of the alcohol use disorder, five symptoms of the alcohol use disorder, or greater than five symptoms of the alcohol use disorder. In embodiments, the subject’s number of symptoms are compared to their baseline number of symptoms, for a period of time after the subject’s therapeutic experience (e.g., 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, or longer than 3 months). In embodiments, the number of symptoms is decreased by at least about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 100% compared to the subject’s baseline number of symptoms.
[0416] In embodiments, wherein a subject is treated for an Alzheimer's disease, a therapeutic effect is assessed by measuring a change (e.g., reduction) in the severity or frequency of symptoms of the neurodegenerative disorder. In embodiments, a therapeutic effect is assessed by comparing the severity or frequency of one or more of a subject’s symptoms to their baseline severity or frequency of that symptom, for a period of time after the subject’s therapeutic experience (e.g., 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, or longer than 3 months). In embodiments, the severity or frequency one or more symptoms is reduced by at least about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 100% compared to the subject’s baseline severity or frequency of that symptom.
[0417] In embodiments, a reduction in at least one symptom of the Alzheimer's disease is a reduction in one or more symptoms of the Alzheimer's disease, such as two symptoms of the Alzheimer's disease, three symptoms of the Alzheimer's disease, four symptoms of the Alzheimer's disease, five symptoms of the Alzheimer's disease, or greater than five symptoms of the Alzheimer's disease. In embodiments, the subject’s number of symptoms are compared to their baseline number of symptoms, for a period of time after the subject’s therapeutic experience (e.g., 1 day, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, or longer than 3 months). In embodiments, the number of symptoms is decreased by at least about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or 100% compared to the subject’sbaseline number of symptoms.
[0418] In some embodiments, a therapeutic effect in treating a subject with Alzheimer’s disease is assessed using one or more of the recommended assessments for the diagnosis of Alzheimer’s disease. The diagnosis of Alzheimer’s disease may involve a comprehensive approach to gather information and conduct various tests. Without being limited by theory, and simply by way of example, healthcare professionals typically begin by interviewing the person experiencing symptoms as well as their family members or friends, asking questions about their overall health, medication use, diet, past medical history, daily activities, and changes in behavior and personality. They then proceed to perform tests assessing memory, problem-solving skills, attention, counting abilities, and language proficiency. Screening tools like the GPCOG, designed for primary care settings and available in multiple languages, can be utilized to evaluate cognitive impairment. Another commonly used test is the Mini-Cog, a brief 3-minute assessment that includes a memory recall task and a scored clock-drawing test. If necessary, additional diagnostic assessments may be recommended based on the results. These can include ordering standard medical tests such as blood and urine analyses to identify other potential causes, conducting a psychiatric evaluation to assess mental health conditions like depression, collecting cerebrospinal fluid (CSF) via a spinal tap to measure Alzheimer's-associated proteins, and performing brain scans like CT, MRI, or PET to support an Alzheimer's diagnosis or exclude alternative causes of symptoms, (see, e.g., Alireza. Med Clin North Am. 2019;103(2):263-293).
[0419] In embodiments, disclosed methods provide a therapeutic effect in treating a mood disorder (e.g., bipolar and related disorders, depressive disorders). In embodiments, the therapeutic effect comprises a reduction in symptoms related to the mood disorder.
[0420] In embodiments, disclosed methods provide a therapeutic effect in treating an anxiety disorder (e.g., post-traumatic stress disorder, generalized anxiety disorder, obsessive compulsive disorder). In embodiments, the therapeutic effect comprises a reduction in symptoms related to the anxiety disorder.
[0421] In embodiments, disclosed methods provide a therapeutic effect in treating a psychotic disorder (e.g., schizophrenia, schizophreniform disorder, schizoaffective disorder). In embodiments, the therapeutic effect comprises a reduction in symptoms related to the psychotic disorder.
[0422] In embodiments, disclosed methods provide a therapeutic effect in treating a personality disorder (e.g., paranoia, schizophrenia, antisocial disorders, borderline personality disorder). In embodiments, the therapeutic effect comprises a reduction in symptoms related to the personality disorder.
[0423] In embodiments, disclosed methods provide a therapeutic effect in treating an eating disorder (e.g., binge eating, anorexia nervosa, bulimia nervosa or avoidant / restrictive food intake disorder). In embodiments, the therapeutic effect comprises a reduction in symptoms related to the eating disorder.
[0424] In embodiments, disclosed methods provide a therapeutic effect in treating a substance use disorder (e.g., alcohol use disorder, cannabis use disorder, caffeine use disorder, phencyclidine use disorder). Inembodiments, the therapeutic effect comprises a reduction in symptoms related to the substance use disorder.
[0425] In embodiments, disclosed methods provide a therapeutic effect in treating addiction (e.g., food addiction,, pathological gambling, pathological use of electronic devices). In embodiments, the therapeutic effect comprises a reduction in symptoms related to the addiction.
[0426] In embodiments, disclosed methods provide a therapeutic effect in treating a psychological disorder (e.g., a tic disorder, such as Tourette's Syndrome, trichotillomania, nail-biting). In embodiments, the therapeutic effect comprises a reduction in symptoms related to the psychological disorder.
[0427] In embodiments, disclosed methods provide a therapeutic effect in treating a neurodegenerative disorder (e.g., Alzheimer’s, Parkinson’s, Huntington’s). In embodiments, the therapeutic effect comprises a reduction in symptoms related to the neurodegenerative disorder.
[0428] It will also be readily appreciated that each such exemplary embodiment below in Examples 1-11 comprises numerous variations which also may be referred to as embodiments.F. Exemplary Embodiments of the DisclosureExample 1 : Bioadaptive Environment Room Layout
[0429] A bioadaptive environment according to one embodiment of the disclosure is shown in FIG. 1, and is indicated generally by 100. In its various embodiments, environment 100 comprises multiple connected environments 200, 300, and 400 (each of which also may be referred to as “sub-environments,” where the environment is partially or fully within a larger environment, for additional clarity and to avoid confusion) which accommodate variable occupancy and provide alternate sensory and therapeutic experiences.
[0430] According to the embodiment of FIG. 1, the environment comprises a bioadaptive (sub-)environment for one subject 200 (FIG. 2), which is an example of what can be referred to as a “Solo Sensory Pod” and which in some embodiments also may be styled by Applicant as a “Solo SENSATION POD™.”
[0431] According to the embodiment of FIG. 1, the environment further comprises a bioadaptive (sub-)environment for up to 15 people 300 (FIG. 3), which is an example of what can be referred to as a “Tribal Experience Pod” and which in embodiments also may be styled as a “TRIBAL EXPERIENCE™.”
[0432] According to the embodiment of FIG. 1, the environment further comprises a bioadaptive (sub-)environment for up to 10 people 400 (FIG. 4), which is an example of what can be referred to as a “Nature Experience Pod” and which in embodiments also may be styled as a “NATURE EXPERIENCE™.”Example 2: Bioadaptive Solo SENSATION POD™ Environment
[0433] A bioadaptive environment according to one embodiment of the disclosure is shown in FIG. 2, and is indicated generally by 200. In this example, (sub-)environment 200 is comprised within another environment, such as that depicted in FIG. 1. However, in other embodiments environment 200 is provided as a standalone environment. In this example, this environment serves as a “home base” for a subject to experience in private or to return to after exploring the broader environment of FIG. 1. This environment is anexample of what can be referred to as a “Solo Sensory Pod” and which in some embodiments also may be styled by Applicant as a “Solo SENSATION POD™ ”
[0434] Environment 200 comprises a control hub 204 that the subject uses to modulate the choreographed sensory stimuli in the environment.
[0435] Specifically, the environment comprises various means for providing the subject with visual stimuli, which are controlled by the control hub, including discreet 3D projectors to transform static textures into a spectacle of light, color, and immersive environments from majestic mountain tops to starry desert skies, and reactive LEDs to provide adjustable ambient lighting and that synchronize with the music.
[0436] Environment 200 further comprises various means for providing the subject with auditory stimuli, which are also controlled by the control hub. The auditory stimuli includes music, which begins playing as a pre-programmed soundtrack of soundscapes and songs (e.g., selected by a guide; in response to subject preferences determined in real time or in advance, for instance by the subject’s use of a mobile application, such as a mobile application styled by Applicant as TRAVLER™; or in response to biofeedback data, such as elsewhere described herein). As the subject undergoes the therapeutic experience, the subject uses the control hub to change the music according to their preferences. The auditory stimuli further includes verbal cues that guide the subject through an interactive breathwork routine (which minimizes the subject’s stress by leading the subject through programmed somatic exercises), meditation routine, and / or mindfulness routine, according to subject preferences, guide input, and / or biofeedback data.
[0437] Environment 200 further comprises various means for providing the subject with olfactory stimuli, which are also controlled by the control hub. The olfactory stimuli in this example includes aroma diffusion (e.g., an aroma diffuser 206 for dispersing scents and essential oils into the air), which excites the subject’s senses, calms their nerves and synchronizes with the visual and auditory stimuli to immerse the subject in the therapeutic experience.
[0438] Environment 200 further comprises various means for providing the subject with tactile stimuli, which are also controlled by the control hub. In particular, the environment comprises an ergonomic chair 208 (which can also be a bench) that contains haptic panels that vibrate to provide the subject with therapeutic gamma stimulation. Another means for providing tactile stimuli in this environment is the floor 202, which comprises haptic floor panels that also vibrate to provide the subject with therapeutic gamma stimulation.
[0439] Environment 200 further comprises additional means for receiving and processing biofeedback data from the subject, such as: one or more receiving means for receiving biofeedback data from one or more wearable biofeedback devices worn by the subject; and one or more processing means that process the biofeedback data to modify and personalize one or more stimuli for the specific subject. For example, environment 200 may receive subject biofeedback data (e.g., movement, blood oxygen, or heart rate data) collected from a wearable smart watch, process the biofeedback data using a specialized machine learning model, and adapt the stimuli to a subject’s physiological state.
[0440] Furthermore, environment 200 may provide a subject with a personalized therapeutic experience by modifying the presented stimuli according to data collected through the TRAVLER™ application. For example, the environment may provide the subject with a calming visual stimuli, such as natural landscapes, that the subject had previously identified as a preferable form of visual stimuli through the TRAVLER™ application, in response to biofeedback data (e.g., restlessness) that indicates the subject is in need of relaxation. The environment may also respond to biofeedback data indicating a subject’s restlessness by presenting the subject with a calming sequence. At various stages throughout the therapeutic experience, the environment may also provide an individual subject with auditory reminders of intentions and goals that the subject had previously recorded using the TRAVLER™ application .Example 3: Bioadaptive TRIBAL EXPERIENCE™ Environment
[0441] A bioadaptive environment according to another embodiment of the disclosure is shown in FIG. 3, and is indicated generally by 300. In this example, the environment comprises a room for the occupancy of about 15 subjects, which is an example of what can be referred to as a “Tribal Experience Pod,” and which in some embodiments also may be styled by Applicant as a “TRIBAL EXPERIENCE™.” In this example, environment 300 is comprised within another environment, such as that depicted in FIG. 1. However, in other embodiments environment 300 is provided as a standalone environment.
[0442] In some embodiments, environment 300 comprises the same means for visual, auditory, olfactory, and tactile stimulation as described in Example 2. In other embodiments, environment 300 comprises the same such means, but with modifications thereto as needed to adapt the physical dimensions of any one or more of such means to be suitable for simultaneous use by more than one subject, as would be understood by one of skill in view of the teachings herein and the general knowledge in the art. For example, instead of the ergonomic chair 208, in one embodiment the environment comprises a curved bench 308 upon which up to about 15 subjects can comfortably relax. The circular seating fosters a sense of intimacy and connection between subjects, further enhancing their shared therapeutic experience. As another example, environment 300 comprises multiple aroma diffusers to disperse sufficient quantities of scents and essential oils into the larger interior volume of the environment, one of which is shown as aroma diffuser 306.
[0443] Additionally, the environment comprises multiple points of entry and exit, one of which is shown as an entrance 302, through which the subjects enter this environment during their therapeutic experiences according to their preferences.
[0444] In the center of the environment is a fire display 304, which in this example comprises a holographic flame created by a 3D holographic projector. In other embodiments, the fire display comprises a gas flame within a glass enclosure. The fire display has the appearance of a campfire, which evokes ideas of ancestral rites of passage, and facilitates group therapy and community-building by encouraging subjects to engage in storytelling and interact socially.
[0445] Like the environment described in Example 2, the floor 310 of environment 300 comprises tiles inaddition to providing tactile stimulation (e.g., therapeutic gamma stimulation) offer comfort and slip-free grip to facilitate movement therapy (e.g., yoga).
[0446] Environment 300 further comprises a dome ceiling that acts as a surface for 3D projection and reflects sound created by the environment’s means for providing auditory stimulation to result in the subjects experiencing full surround sound.
[0447] Subjects in environment 300 may wear Radio Frequency Identification (RFID) bracelets that provide subjects with personalized messages during their therapeutic experiences. Environment 300 further comprises various means for receiving and processing biofeedback data from the subject(s), such as: one or more receiving means for receiving biofeedback data from one or more wearable biofeedback devices worn by the subject (e.g., RFID bracelet); and one or more processing means that process the biofeedback data to modify and personalize one or more stimuli for the specific subject. Environment 300 further comprises additional means for receiving and processing biofeedback data from the subject(s), such as: one or more receiving means for receiving biofeedback data from one or more wearable biofeedback devices worn by the subject(s); and one or more processing means that process the biofeedback data to modify and personalize one or more stimuli for the specific subject(s).
[0448] Furthermore, environment 300 may provide a subject with a personalized therapeutic experience by modifying the presented stimuli according to data collected through the RFID bracelet. For example, the environment may provide the subject with cues to begin or instruction to perform a guided movement therapy (e.g., led by a virtual guide) in response to received biofeedback data indicating that a subject had transitioned from the Vibrolounger to the movement area of the environment. The environment may further personalize the movement therapy experience by modifying complementary visual, auditory, or olfactory stimuli, in response to received biofeedback data (e.g., respiratory rate), to ensure the subject maintains a favorable physiological and emotional state over the course of the experience.Example 4: Bioadaptive NATURE EXPERIENCE™ Environment
[0449] A bioadaptive environment according to another embodiment of the disclosure is shown in FIG. 3, and is indicated generally by 400. In this example, the environment comprises a room for the occupancy of about 10 subjects, which is an example of what can be referred to as a “Nature Experience Pod,” and which in some embodiments also may be styled by Applicant as a “NATURE EXPERIENCE™.” In this example, environment 400 is comprised within another environment, such as that depicted in FIG. 1. However, in other embodiments environment 400 is provided as a standalone environment.
[0450] Environment 400 comprises biophilic design themes, interactive art, and cozy conversation nooks to e...
Claims
CLAIMSThe invention claimed is:1 . A method for enhancing a therapeutic experience of a human subject in a bioadaptive environment, comprising: a. providing to the subject, at a first presentation time point, using at least one stimulus means: i. a first visual stimulus; ii. a first auditory stimulus; ill. a first tactile stimulus; and iv. a first olfactory stimulus; b. receiving, with at least one receiving means: i. an identification input from the subject; ii. an intention input from the subject; ill. a first biofeedback input from the subject at a first biofeedback time point; and iv. a second biofeedback input from the subject at a second biofeedback time point; c. producing, with at least one processing means: i. a personalization score, from the identification input and the intention input; and ii. a biofeedback score, from the first biofeedback input and the second biofeedback input; d. further producing, with at least one processing means: i. a bioadaptive visual score, from the personalization score and the biofeedback score; ii. a bioadaptive auditory score, from the personalization score and the biofeedback score; ill. a bioadaptive tactile score, from the personalization score and the biofeedback score; and iv. a bioadaptive olfactory score, from the personalization score and the biofeedback score; e. transmitting, with at least one transmitting means, the bioadaptive visual score, the bioadaptive auditory score, the bioadaptive tactile score, and the bioadaptive olfactory score; and f. providing to the subject, at a second presentation time point, using at least one stimulus means: i. a second visual stimulus, wherein the second visual stimulus is updated based on the bioadaptive visual score; ii. a second auditory stimulus, wherein the second auditory stimulus is updated based on the bioadaptive auditory score; ill. a second tactile stimulus, wherein the second tactile stimulus is updated based on the bioadaptive tactile score; and iv. a second olfactory stimulus, wherein the second olfactory stimulus is updated based on the bioadaptive olfactory score; wherein the bioadaptive environment is a bounded physical environment sized to hold at least one subject.
2. The method of claim 1 , wherein the visual stimulus comprises lights, patterns, or geometric shapes.
3. The method of claim 1 , wherein the audio stimulus comprises any one or more of soundscapes, songs, music, narration, sub-frequencies, and ambient sounds4. The method of claim 1 , wherein the tactile stimulus comprises any one or more of an undulating surface, a vibrating surface, a moist surface, a heated surface, and a textured surface.
5. The method of claim 1 , wherein the olfactory stimulus comprises an aroma.
6. The method of claim 1 , wherein the gustatory stimulus comprises a food, a beverage, or a taste that is any one or more of sweet, salty, sour, bitter, umami, fatty, and spicy.
7. The method of claim 1 , wherein at least two of the visual stimulus, the auditory stimulus, and the tactile stimulus, comprise a stimulus at a frequency of about 40 Hz.
8. The method of claim 7, wherein the stimulus at a frequency of about 40 Hz provides gamma stimulation or gamma entrainment.
9. The method of claim 1 , wherein the biofeedback input is the provided by a Neurable Smart Headphone device, a functional Near Infrared Spectroscopy (fNIRS) device, a Low Intensity Focused Ultrasound (LIFU), a Mindware Technologies device, an Open-LIFU 2.0, an Open-Motion 3.0, a compression garment, a watch, a wrist strap, a chest strap, a ring, a belt, a shoe, a insole, glasses, a patch, a wrist bracelet, an ankle bracelet, a non-compression garment, a headband, a neckband, a hat, a smartwatch, a fitness tracker, a heart rate monitor, an ECG monitor, a blood pressure monitor, a smart ring, smart glasses, a bioharness, smart clothing, smart socks, smart shoes, smart earbuds, a respiration monitor, a smart belt, a body temperature monitor, a smart bracelet, a stress monitor, a hydration monitor, a smart patch, a mood ring, smart clothing, a wearable EMG sensor, a smart headband, a smart neckband, smart headphones, or a wearable brain sensing headband.
10. The method of claim 1 , further comprising: a. providing to the subject, at a first presentation time point, a first gustatory stimulus; b. further producing, with at least one processing means, a bioadaptive gustatory score, from the personalization score and the biofeedback score; and c. providing to the subject, at a second presentation time point, a second gustatory stimulus, wherein the second gustatory stimulus is updated based on the bioadaptive gustatory score.11 . The method of claim 1 , wherein the gustatory stimulus comprises a food, a beverage, or a taste that is any one or more of sweet, salty, sour, bitter, umami, fatty, and spicy.
12. The method of claim 1 , wherein the therapeutic experience is a state of increased neuroplasticity.
13. The method of claim 1 , wherein the therapeutic experience is an altered state of consciousness.
14. The method of claim 1 , wherein the therapeutic experience is a non-pharmacological intervention.
15. The method of claim 14, wherein the non-pharmacological intervention is any of breathwork, meditation, sound therapy, transcranial magnetic stimulation (TMS), movement therapy, physical rehabilitation exercises, dance therapy, yoga, hypnosis, art therapy, gamma stimulation, vibration therapy, and a calming protocol.
16. The method of claim 1 , wherein the therapeutic experience is a pharmacological intervention.
17. The method of claim 16, wherein the pharmacological intervention comprises the administration of a psychoactive substance, a psychedelic, an entactogen, a dissociative, a psychoplastogen, a neuroplastogen, or a neuroplasticity-inducing agent.
18. The method of claim 16, wherein the pharmacological intervention comprises the administration of any of psilocybin, lysergic acid diethylamide (LSD), 5-methoxy-di methyltryptamine (5-MeO-DMT), N,N-dimethyltryptamine (DMT), ayahuasca, pharmahuasca, 2,5-dimethoxy-4-bromophenethylamine (2C-B), mescaline, 3,4-methylenedioxymethamphetamine (MDMA), methylone, ketamine, esketamine, a single enantiomer thereof, a non-racemic mixture thereof, a pharmaceutically-acceptable salt thereof, and any combination thereof.
19. The method of claim 16, wherein the pharmacological intervention comprises the administration of a psychedelic.
20. The method of claim 19, wherein the psychedelic is psilocybin or LSD.
21. The method of claim 16, wherein the pharmacological intervention further comprises psychedelic-assisted therapy (PAT), psychological support, or monitoring.
22. The method of claim 1 , wherein the method further comprises increasing feelings of wellbeing.
23. The method of claim 1 , wherein the method further comprises reducing feelings of stress.
24. The method of claim 1 , wherein the method further comprises treating a medical condition.
25. The method of claim 24, wherein the medical condition is a mental health disorder.
26. The method of claim 25, wherein the mental health disorder is selected any of post-traumatic stress disorder (PTSD), adjustment disorder, affective disorder, a depressive disorder, atypical depression,postpartum depression, catatonic depression, a depressive disorder due to a medical condition, premenstrual dysphoric disorder, seasonal affective disorder, dysthymia, an anxiety disorder, a phobia disorder, a binge disorder, body dysmorphic disorder, alcohol or drug abuse or dependence disorders, a substance use disorder, substance-induced mood disorder, a mood disorder related to another health condition, a disruptive behavior disorder, an eating disorder, an impulse control disorder, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), a personality disorder, an attachment disorder, and a dissociative disorder.
27. The method of claim 26, wherein the substance use disorder is any of alcohol use disorder, nicotine dependency, opioid use disorder, sedative, hypnotic, or anxiolytic use disorder, stimulant use disorder, and tobacco use disorder.
28. The method of claim 24, wherein the medical condition is a neurodegenerative disorder.
29. The method of claim 28, wherein the neurodegenerative disorder is any of multiple sclerosis, Parkinson’s disease, dementia, Alzheimer’s disease, Huntington’s disease, amyotrophic lateral sclerosis (ALS), and motor neuron disease.
30. The method of claim 28, wherein the neurodegenerative disorder is Alzheimer’s disease.
31. The method of claim 30, wherein the Alzheimer’s disease is posterior cortical atrophy (PCA) or Benson's syndrome.
32. The method of claim 28, wherein the neurodegenerative disorder is caused by or associated with traumatic brain injury (TBI) or mild traumatic brain injury (mTBI).
33. The method of claim 24, wherein the medical condition is pain or a pain disorder.
34. The method of claim 1, wherein the environment is sized to hold between 1-10 people, between 10-15 people, or greater than 15 people.
35. A bioadaptive environment for enhancing a therapeutic experience of a human subject, comprising: a. at least one receiving means, adapted to receive: i. an identification input from the subject; ii. an intention input from the subject; ill. a first biofeedback input from the subject at a first biofeedback time point; and iv. a second biofeedback input from the subject at a second biofeedback time point; b. at least one processing means, adapted to produce: i. a personalization score, from the identification input and the intention input; and ii. a biofeedback score, from the first biofeedback input and the second biofeedback input;c. at least one processing means, adapted to further produce: i. a bioadaptive visual score, from the personalization score and the biofeedback score; ii. a bioadaptive auditory score, from the personalization score and the biofeedback score; ill. a bioadaptive tactile score, from the personalization score and the biofeedback score; and iv. a bioadaptive olfactory score, from the personalization score and the biofeedback score; d. at least one transmitting means, adapted to transmit the bioadaptive visual score, the bioadaptive auditory score, the bioadaptive tactile score, and the bioadaptive olfactory score; e. a means for providing a visual stimulus, adapted to receive the bioadaptive visual score; f. a means for providing an auditory stimulus, adapted to receive the bioadaptive auditory score; g. a means for providing a tactile stimulus, adapted to receive the bioadaptive tactile score; h. a means for providing an olfactory stimulus, adapted to receive the bioadaptive olfactory score; i. wherein each of the means for providing a visual stimulus, the means for providing an auditory stimulus, the means for providing a tactile stimulus, and the means for providing an olfactory stimulus are adapted to update the stimulus in response to the bioadaptive score; and wherein the bioadaptive environment is a bounded physical environment sized to hold at least one subject.
36. The bioadaptive environment of claim 35, wherein the means for providing the visual stimulus comprises a lighting system or a display system.
37. The bioadaptive environment of claim 35, wherein the means for providing the auditory stimulus comprises audio equipment for providing audio content.
38. The bioadaptive environment of claim 35, wherein the means for providing the auditory stimulus comprises a vibroacoustic lounger or means for providing vibroacoustic therapy (VAT).
39. The bioadaptive environment of claim 35, wherein the means for providing the tactile stimulus comprises a tactile material, tactile seating, or a vibroacoustic lounger.
40. The bioadaptive environment of claim 35, wherein the means for providing the olfactory stimulus comprises an aroma diffuser.41 . The bioadaptive environment of claim 35, wherein the biofeedback input is provided by a Neurable Smart Headphone device, a functional Near Infrared Spectroscopy (fNIRS) device, a Low Intensity Focused Ultrasound (LIFU), a Mindware Technologies device, an Open-LIFU 2.0, an Open-Motion 3.0, a compression garment, a watch, a wrist strap, a chest strap, a ring, a belt, a shoe, a insole, glasses, a patch, a wrist bracelet, an ankle bracelet, a non-compression garment, a headband, a neckband, a hat, a smartwatch, a fitness tracker, a heart rate monitor, an ECG monitor, a bloodpressure monitor, a smart ring, smart glasses, a bioharness, smart clothing, smart socks, smart shoes, smart earbuds, a respiration monitor, a smart belt, a body temperature monitor, a smart bracelet, a stress monitor, a hydration monitor, a smart patch, a mood ring, smart clothing, a wearable EMG sensor, a smart headband, a smart neckband, smart headphones, or a wearable brain sensing headband.
42. The bioadaptive environment of claim 35, further comprising: a. at least one processing means, adapted to further produce a bioadaptive gustatory score, from the personalization score and the biofeedback score; b. at least one transmitting means, adapted to transmit the bioadaptive gustatory score; and c. a means for providing a gustatory stimulus, adapted to receive the bioadaptive gustatory score; wherein the means for providing a gustatory stimulus is adapted to update the gustatory stimulus in response to the bioadaptive gustatory score;43. The bioadaptive environment of claim 42, wherein the means for providing the gustatory stimulus comprises a food dispenser, a beverage dispenser, or a dispenser for a comestible item or simulation thereof.
44. The bioadaptive environment of claim 35, wherein the environment further comprises one or more design features.
45. The bioadaptive environment of claim 35, wherein the design features are any one or more of curvilinear design features, biophilic design features, modern design features, futuristic design features, and adaptive design features.
46. The bioadaptive environment of claim 35, wherein the environment is sized to hold between 1 -10 people, between 10-15 people, or greater than 15 people.