Systems and methods for providing intervention to address substance use disorders

Abstract

Systems and methods are provided herein for providing intervention to address a user's substance use disorder (SUD). The one or more processors may identify a profile including a plurality of substance use words, memory words, and neutral words for a user having a substance use disorder. The one or more processors may provide repetitive cycles of selection activities and visualization activities. The one or more processors may update the user's profile using the user's performance in the activity. The systems and methods provided herein may enhance the efficacy of a medicament administered by a user while addressing SUD.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the priority and benefit of U.S. Provisional Patent Application No. 63 / 626,465, filed on January 29, 2024, entitled "Managing Sessions to Provide Psychotherapeutic Components to Address User Conditions", and U.S. Non - Provisional Patent Application No. 18 / 951,081, filed on November 18, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to digital therapeutics, and more particularly to systems and methods for providing interventions to address substance use disorders. Background Art

[0004] Substance use disorder (SUD) is caused by the repeated, compulsive use of alcohol, drugs, or other such substances that lead to cognitive impairment, health risks, and disabilities. Common SUDs include alcohol use disorder (AUD), opioid use disorder (OUD), or drug use disorder, etc. This condition is caused by a variety of factors, such as biological and environmental factors. For example, specific factors that may lead to SUD include genetics, brain chemistry (such as changes in neurotransmitter levels like dopamine), mental health disorders (such as anxiety, depression, or attention - deficit / hyperactivity disorder (ADHD)), personality traits (such as impulsive behavior), coping mechanisms (such as a lack of effective coping strategies), or early exposure (such as during adolescence when the brain is still developing). Other factors that may lead to SUD include external influences, such as family (such as substance use in the family), peer pressure (such as peer - initiated substance use), availability (such as the accessibility of substances), socioeconomic status (such as poverty, unemployment), cultural norms (such as cultures that value alcohol), or media (such as media depictions of substance use), and so on.

[0005] SUD can affect an individual's physical and mental health, social well - being, and overall quality of life. People with SUD are more prone to various physical health complications. In addition, people with SUD are at a greater risk of developing mental disorders (such as cognitive impairment and emotional distress), and also have a higher risk of drug overdose. The overall quality of life of people with SUD is usually severely impaired.

[0006] At the neurological level, SUD causes changes in synaptic strength and connectivity, especially in the brain's reward circuits, which leads to the persistence of addictive behaviors. Specifically, SUD alters brain structure and function and causes neurotransmitter imbalances, which are crucial for cognition and overall brain function. In addition, individuals with SUD are at higher risk of developing neurological disorders (such as stroke, Parkinson's disease) and mental health disorders (such as depression, anxiety). For example, opioids bind to opioid receptors in the brain, reducing pain and causing a sense of euphoria. Specifically, developing a SUD such as OUD leads to impaired cognitive functions (such as executive function, memory) and changes in brain structure, especially in areas related to stress, decision-making, and behavior regulation.

[0007] SUD treatment can be used to stop and reduce the side effects of substance use. These treatments include face-to-face behavioral therapy, medication treatment, inpatient and outpatient treatment programs, drug withdrawal, or support groups, etc. However, due to treatment ineffectiveness and accessibility, it is very difficult to relieve SUD relapse. In particular, the motivation of individuals to adhere to treatment and the failure to address the underlying cognitive disorders that lead to substance use reduce the effectiveness of SUD treatment. For example, individuals who participate in inpatient rehabilitation may relapse once they transition back to their daily lives. Failing to consider both cognitive disorders and psychological factors (such as motivation) may lead to ineffective SUD treatment, ultimately resulting in little improvement in substance use disorders and potentially relapse. These treatments do not take into account the challenges related to maintaining an individual's commitment to abstaining from substance use and the cognitive impact of SUD on the individual. In addition, these treatments do not directly target the neural components that contribute to the persistence of maladaptive behaviors associated with SUD for rewiring or regulation. Summary of the Invention

[0008] This article presents systems and methods for providing digital therapeutics for the executive control systems of target users. The digital therapeutic applications described herein provide a unique combination of multi-component neuromodulation interventions aimed at cognitive deficits associated with substance use disorder (SUD). Specifically, this novel integrated approach first combines two training activities in an immersive challenge, targeting overlapping neural network substrates, which function to simultaneously train two sub-domains of executive control (e.g., inhibitory control and working memory), potentially mimicking a critical period-like state to enhance plasticity through a flexibility mechanism. The combined training paradigm adds a third training activity as a synergistic psychotherapy component, and by applying the third training to real-world-related activities, the plasticity induced by the first two activities can be utilized to help guide real-life behaviors related to the substance use disorder the user wants to target, thereby enhancing the clinical impact of these exercises.

[0009] By continuously and repeatedly performing these three training activities, especially in a combined training program, maximum benefits can be obtained. Over time, a user's habit-based drug use responses can be transformed into responses focused on achieving future goals. Thus, the first two training activities can exercise the user's "mental muscles" for impulse control and planning, while the third training activity applies the skills accumulated in the first two training activities to the real world. The combination of these three training modules has a synergistic effect in strengthening the user's impulse control against substance use disorders.

[0010] This integration represents a significant improvement over other intervention techniques that only focus on the cognitive or psychological components and do not address the integration of both, nor overcome the limitation of transferring the effects to real-world conditions. If there is an imbalance between an overactive impulse system and an underactive executive control system, the training activities disclosed herein can enhance the capabilities and efficiency of the executive control system, thereby improving functionality. The combination of the three training activities described herein targets overlapping neural network substrates within the prefrontal cortex, which are involved in decision-making and working memory functions and have the potential to optimize the brain's learning mechanisms.

[0011] Furthermore, the digital therapeutic application addresses the lack of personalized solutions that can effectively target the brain's decision-making and working memory functions. The application simultaneously incorporates activities for inhibitory control and working memory, while also integrating goal-related context to translate improvements in inhibitory control and working memory into real-world improvements. Based on the user's performance in the activities, the application increases the difficulty of the activities to further improve the individual's inhibitory control and working memory. The digital therapeutic application is capable of using information about the user to specifically tailor the intervention for SUD. The scores of the activity results indicate the user's performance and progress, and can be presented to the user to encourage compliance with the intervention program as they are able to see their progress. By continuously updating and challenging the user during the intervention, the digital therapeutic application ensures that the intervention remains effective and aligned with the evolving state of the user's executive control system.

[0012] Therefore, the digital therapeutic application addresses the lack of comprehensive cognitive and psychological treatment by providing digital interventions that can be dynamically adjusted according to an individual's responses to various activities. The application also provides a customized approach to treating SUD to meet the specific needs and physiological characteristics of each user. Through this integration of digital, cognitive, and psychological solutions, the treatment efficacy for SUD and related disorders is significantly enhanced, leading to better outcomes and overall patient care.

[0013] SUD poses numerous challenges to a patient's physical health, social well-being, and mental health. Patients with SUD are more prone to various physical health complications, including liver disease, lung disease, cardiovascular disease, nerve damage, human immunodeficiency virus (HIV), hepatitis B and C, sexually transmitted infections (STDs), malnutrition, sleep disorders, and an increased risk of overdose.

[0014] The digital therapeutic application described herein creates and maintains, for each user, a set of substance use words related to the user's SUD and a set of memory words unrelated to substance use (e.g., different from the set of substance use words).

[0015] In the first part, the user is instructed not to select substance use words or memory words that may be presented to the user, but only neutral words. This activity improves the function of the executive control system in the user's body by breaking the user's association with substance use (e.g., triggers). Over time, substance use words and memory words (i.e., words that the user should refrain from responding to) will appear less frequently than neutral words (i.e., words that the user should respond to), making the neutral words dominant (e.g., become natural). This also teaches the user to reduce their attention to substance use words. Additionally, since these words appear for a short time, the user can respond (or not respond), which encourages a high response rate to train inhibitory control and break any possible connection between the user and substance use words.

[0016] In the second part, the user is instructed to perform activities based on the visualization of future events. The future events may be related to the user's health, relationships, values, financial situation, enjoyment, charitable donations, sobriety, lifestyle, overcoming maladaptive behaviors related to the user's substance use, or other categories. Alternatively, the user can be instructed to create or identify goals to be achieved. Then the user is instructed to create cue words or images to remind the user of the future events in subsequent sessions.

[0017] In the third part, the user is instructed to perform an activity similar to the first part, specifically, not to select substance use words or memory words that appear on the screen, but to select neutral words. In the fourth part, a cue is shown to the user that contains the previously generated cue words or images so that the user can visualize the future events again. The cue can be a description or visual representation of the future event, or even a vision board that mimics a handwritten note on a sticky note or corkboard, showing information collected from multiple sessions (different future events) assembled into a design or screen. The user can choose to modify, delete, or create new cue words or images over time (e.g., as the goals change over time, or as the future events progress).

[0018] This sequence can be cycled and repeated multiple times over time: (1) the user is asked not to select the substance use words and / or memory words that appear on the screen, and then (2) the user is asked to visualize future events based on the previously generated cue words or images, including creating new future events and new cue words or images. In this way, the application can use various activities provided at different times to improve executive control, reduce the user's substance use, and mitigate relapse. These regular activities are tailored to the user to make progress by improving inhibitory control and working memory, while also leveraging the plasticity induced by improving executive control through visualizing future events. The application can integrate various technologies to target the brain function decline caused by substance use, while providing sustainable interventions to promote user compliance, and avoiding unnecessary time and money spent on ineffective traditional SUD treatments.

[0019] The application provides adaptive difficulty for the activities. As the user's proficiency and experience with the activities increase, the application continuously stimulates and challenges the user, thereby further enhancing the user's executive control. For example, over time, new memory words can be added to the list for the user to remember and reject responses. This may become increasingly difficult, such as adding more words each day. The application can also provide quizzes to test the user's memory of all the memory words and use the quiz results to determine whether to increase the number of memory words or keep the number the same. As another example, a score is created for the user based on the number or percentage of correct interactions with the substance use words, memory words, or both, the speed of the user's selection, or both. Once the score meets a threshold, the application can increase the difficulty, for example, by increasing the number of words in subsequent activities.

[0020] The digital therapeutic application described herein can reopen the window of adult plasticity, which is typically limited to childhood. This digital therapy can mimic the key principles of learning observed during the time periods when experiences shape traits and behavioral development (e.g., plasticity). For example, a first training activity with dominant responses, short response times, and specific cue words can create a challenging and salient learning environment for the user to quickly adapt and focus under such conditions. Additionally, the progressive difficulty element of the second training reflects how skills are naturally acquired during the developmentally sensitive periods (e.g., the plasticity period in childhood). The third training activity can utilize neuroplasticity, which is the basis for episodic memory formation throughout the user's life cycle. Combining the third training with the first and second trainings supports the neuroplasticity of the relevant brain regions and can enhance the clinical impact of the digital therapeutic application. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The foregoing and other objects, aspects, features, and advantages of the present disclosure will become more apparent and better understood by reference to the following description in conjunction with the accompanying drawings, in which:

[0022] Figure 1 Depicts a block diagram of a system for presenting an interactive session to address a user's substance use problem according to an exemplary embodiment.

[0023] Figure 2A And 2B Depicts a block diagram of a process for providing a session to a user to perform a substance use word activity according to an exemplary embodiment.

[0024] Figure 3A And 3B Depicts a block diagram of a process for providing a session to a user to perform a visualization activity according to an exemplary embodiment.

[0025] Figure 4A And 4B Depicts a block diagram of a process for providing a session to a user to perform a memory quiz activity according to an exemplary embodiment.

[0026] Figure 5 Depicts a flowchart of a visualization activity according to an exemplary embodiment.

[0027] Figure 6 Depicts a flowchart of a method for selecting an activity for a user to address a substance use problem according to an exemplary embodiment.

[0028] Figure 7 Shows an example research plan for a CT-102 mobile application engagement study.

[0029] Figure 8 Depicts a flowchart of a method for improving a user's substance use by administering digital therapy according to an exemplary embodiment.

[0030] Figure 9 Is a block diagram of a server system and a client computer system according to an exemplary embodiment. Detailed Description

[0031] To facilitate reading the following description of the various embodiments, the following listing of the parts of this specification and their respective content may be helpful:

[0032] Part A describes systems and methods for providing intervention instructions for a user's substance use disorder (SUD).

[0033] Part B describes systems and methods for improving a user's substance use by administering digital therapy.

[0034] Part C describes the networks and computing environments that may facilitate the implementation of the embodiments presented herein.

[0035] A. Systems and Methods for Providing Intervention Instructions for a User's SUD

[0036] Some aspects of the present disclosure are directed to systems and methods for selecting therapies that provide activity indications to address maladaptive behaviors related to a user's substance use. One or more processors may identify, for a user with a substance use disorder, a profile that includes a plurality of substance use words. One or more processors may present a plurality of memory words unrelated to substance use and an indication to memorize the plurality of memory words. One or more processors may provide an indication to perform an activity that avoids selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words. One or more processors may use the user's performance in the activity to update the user's profile. The activity of avoiding selecting one or more of the plurality of memory words may be performed concurrently with the activity of avoiding selecting one or more of the plurality of substance use words.

[0037] In multiple implementations, one or more processors may provide an indication to perform an activity that provides information about a future event. The future event may be related to at least one of the user's health, relationships, values, finances, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors related to substance use. One or more processors may provide an indication for the user to select a future event type prior to providing the indication to perform the activity, the future event type being selected from at least one of the user's health, relationships, values, finances, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors related to substance use. One or more processors may also provide an indication for the user to select a category of the future event prior to the indication to perform the activity. The category of the future event may be selected from the user's health, relationships, values, finances, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors related to substance use.

[0038] In multiple implementations, one or more processors may provide an indication to select a time range for a future event. The future event may occur within less than a month. The future event may occur within a time period of more than a month. One or more processors may instruct the user to generate one or more visual cues based on future event information provided by the user. The visual cue may be an image or text, including free text provided by the user. One or more processors may provide subsequent instructions to perform an activity that avoids selecting one or more of multiple memory words and / or one or more of multiple substance use words. The instruction may also include an instruction to perform an activity of selecting one or more neutral words that are not related to substance use and are different from the memory words. One or more processors may also provide a cue that includes a visual cue related to the future event information and provide an instruction to perform an activity related to the visual cue. The cue may be a timeline that identifies more than one visual cue. The timeline may be automatically updated based on the time marked to the visual cue. The activity may include a recorded voice or a text description.

[0039] In some aspects, the activity includes providing information about overcoming maladaptive behaviors related to substance use or providing information related to the user's health, relationships, values, finances, enjoyment, charitable donations, sobriety, or lifestyle. In some aspects, prior to providing an instruction to perform the activity, an instruction is provided for the user to select an activity selected from providing information about overcoming maladaptive behaviors related to substance use or providing information related to the user's health, relationships, values, finances, enjoyment, charitable donations, sobriety, or lifestyle. In some other aspects, prior to providing an instruction to perform the activity, an instruction is provided for the user to select a future event category.

[0040] In various implementations, one or more processors may provide subsequent instructions to perform an activity that avoids selecting one or more of multiple memory words and / or one or more of multiple substance use words. After performing the activity of avoiding selecting one or more of multiple memory words and presenting one or more of multiple substance use words, one or more processors may provide a cue related to the future event information. Prior to providing an instruction to perform the activity of avoiding selecting one or more of multiple memory words and one or more of multiple substance use words, one or more processors may also provide an instruction to perform an activity of avoiding selecting one or more of multiple substance use words. Similarly, the instruction may include an instruction to perform an activity of selecting one or more neutral words that are not related to substance use and are not one or more of the memory words.

[0041] In various implementations, one or more processors may provide instructions to perform an activity of selecting all memorization words from a plurality of words. One or more processors may provide instructions to perform an activity of selecting one or more memorization words from a plurality of words. One or more processors may determine a score that represents a percentage of correct interaction with the memorization words, and then one or more processors may select a plurality of words based on the score. In various implementations, correct interaction may refer to a user selecting a word (e.g., selecting, engaging, picking, touching, or contacting) or avoiding selecting a word (e.g., allowing the word to be displayed without picking, engaging, touching, or contacting the word on a display).

[0042] In various implementations, one or more processors may determine a score indicating correct interaction, the speed of user selection, or both during an activity of selecting all memorization words from a plurality of words. In response to the score meeting a threshold, one or more processors may determine to increase the number of words for a subsequent activity of avoiding selecting one or more of the plurality of memorization words, an activity of avoiding selecting one or more of the plurality of memorization words, or an activity of selecting all memorization words from a plurality of words. One or more processors may display a score indicating at least one of the percentage of correct interaction, the speed of user selection, or both during one or more activities.

[0043] One or more processors may determine a score that represents correct interaction, the speed of user selection, or both during the performance of one or more activities, and then one or more processors may select a subsequent plurality of substance use words or a subsequent plurality of memorization words or both based on the score. The score may be determined by the number of correct interactions, the speed of user selection, or both during an activity of selecting all memorization words from a plurality of words. One or more processors may determine a score that represents correct interaction, the speed of user selection, or both during the performance of an activity of avoiding selecting one or more of the plurality of memorization words and / or a plurality of substance use words. One or more processors may determine to increase the number of words for a subsequent activity of avoiding selecting one or more of the plurality of memorization words and / or a plurality of substance use words in response to the score meeting a threshold.

[0044] One or more processors may generate one or more cue words or images based on future event information provided by a user, wherein the cue related to the future event information includes the one or more cue words or images.

[0045] In various implementations, one or more processors may provide instructions to perform activities that avoid selecting one or more of a plurality of substance use words and / or one or more of a plurality of memory words, and may also include providing instructions by one or more processors to perform activities that allow a user to select one or more of a plurality of neutral words that are not related to substance use and are different from the memory words. One or more processors may provide instructions to perform activities that avoid selecting one or more of a plurality of substance use words or memory words, including presenting one or more of the plurality of words for less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or equal to or greater than 10 seconds. One or more processors may provide instructions to the user to perform the activities at least once a day, at least once every 2 days, at least once every 5 days, or at least once a week. One or more activities may be performed within 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer. One or more processors may provide a prompt at least 1 day, 5 days, 1 week, or 1 month after providing instructions to perform activities that provide information about future events.

[0046] One or more processors may receive a request from a user that indicates the start of a behavior related to substance use, and in response to receiving the request, the one or more processors may initiate instructions for activities to address maladaptive behaviors related to the user's substance use. One or more processors may determine a time to provide instructions to perform activities that avoid selecting one or more of a plurality of memory words and / or one or more of a plurality of substance use words, wherein providing instructions by one or more processors to perform activities that avoid selecting one or more of a plurality of substance use words and / or one or more of a plurality of memory words also includes providing the instructions at the determined time.

[0047] In various implementations, an effective amount of a drug may be administered to the user, the drug including at least one of naloxone, naltrexone, nalmefene, samidorphan, nalorphine, levallorphan, naloxone, alvimopan, methylnaltrexone, naloxone, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine or a GLP-1 agonist. In various implementations, substance use includes at least one of alcohol use disorder (AUD), opioid use disorder (OUD), or drug abuse.

[0048] Another aspect of the present disclosure relates to a system including one or more processors for providing an indication of an activity to address maladaptive behavior related to a user's substance use. The one or more processors may identify, for a user with a substance use disorder, a profile including a plurality of substance use words. The one or more processors may present a plurality of memory words unrelated to substance use and an indication to memorize the plurality of memory words. The one or more processors may also provide an indication to perform an activity that avoids selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words. The one or more processors may use the user's performance in the activity to update the user's profile.

[0049] In various implementations, the one or more processors may provide an indication to perform an activity that provides information about a future event. The future event may be related to at least one of the user's health, relationships, values, finances, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behavior related to substance use. The one or more processors may provide an indication to the user to select a type of the future event before providing the indication to perform the activity, the type of the future event being selected from at least one of the user's health, relationships, values, finances, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behavior related to substance use. The one or more processors may also provide an indication to the user to select a category of the future event before the indication to perform the activity. The category of the future event may be selected from the user's health, relationships, values, finances, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behavior related to substance use.

[0050] In various implementations, the one or more processors may provide an indication to select a time range for the future event. The future event may occur within less than a month. The future event may occur over a period of more than one month. The one or more processors may instruct the user to generate one or more visual cues based on the future event information provided by the user. The visual cue may be an image or text, including free text provided by the user. The one or more processors may provide a subsequent indication to perform an activity that avoids selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words, and provide a cue including the visual cue related to the future event information and an indication to perform an activity related to the visual cue. The cue may be a timeline identifying the plurality of visual cues. The timeline may be automatically updated based on the time marked to the visual cue. The activity may include a recorded voice or a text description. The one or more processors may provide a cue related to the future event information after performing the activity of providing information. The activity of avoiding selecting one or more of the plurality of memory words may be performed simultaneously with the activity of avoiding selecting one or more of the plurality of substance use words.

[0051] In various implementations, one or more processors provide subsequent instructions to perform activities that avoid selecting one or more of a plurality of memory words and / or avoid selecting one or more of a plurality of substance use words. One or more processors may also provide subsequent instructions to perform activities that avoid selecting one or more of a plurality of memory words and / or one or more of a plurality of substance use words, and provide a hint related to future event information after performing the activity of avoiding selecting one or more of a plurality of memory words and presenting one or more of a plurality of substance use words. One or more processors may provide instructions to perform an activity of selecting all memory words from a plurality of words. One or more processors may provide instructions to perform an activity of selecting one or more memory words from a plurality of words. One or more processors may determine a score representing the percentage of correct interaction with memory words and select a plurality of memory words based on the score.

[0052] In various implementations, one or more processors may determine a score representing correct interaction, user selection speed, or both during the execution of one or more activities, and select subsequent pluralities of substance use words or subsequent pluralities of memory words, or both, based on the score. The score may be determined by the number of correct interactions, user selection speed, or both during the execution of the activity of selecting all memory words from a plurality of words. One or more processors may determine a score representing correct interaction, user selection speed, or both during the execution of the activity of avoiding selecting a plurality of memory words and / or a plurality of substance use words, and in response to the score meeting a threshold, determine to increase the number of words for subsequent activities of avoiding selecting a plurality of memory words and / or a plurality of substance use words. One or more processors may determine a score representing correct interaction, the speed of user selection, or both during the execution of the activity of selecting all memory words from a plurality of words, and in response to the score meeting a threshold, determine to increase the number of words for subsequent activities of avoiding selecting a plurality of memory words, avoiding selecting a plurality of substance use words, or selecting all memory words from a plurality of words.

[0053] In various implementations, one or more processors display a score that indicates the percentage of correct interactions during one or more activities, the speed of user selection, or at least one of the two. One or more processors may generate one or more cue words or images based on future event information provided by the user, where cues related to the future event information include the one or more cue words or images. Providing an indication to perform an activity that avoids selecting one or more of a plurality of substance use words and / or one or more of a plurality of memory words may further include one or more processors providing an indication to perform an activity that allows the user to select one or more of a plurality of neutral words that are not related to substance use and different from the memory words. Providing an indication to perform an activity that avoids selecting one or more of a plurality of substance use words or memory words may include presenting one or more of the plurality of words for less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or equal to or greater than 10 seconds.

[0054] In various implementations, an indication to perform an activity is provided to the user at least once a day, at least once every 2 days, at least once every 5 days, or at least once a week. An effective amount of a drug may be administered to the user, the drug including at least one of naloxone, naltrexone, nalmefene, samidorphan, naloxaphene, levallorphan, naloxone, alvimopan, methylnaltrexone, naloxicon, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, lofexidine, or a GLP-1 agonist. One or more processors may receive a request from the user that indicates the onset of a behavior related to substance use and, in response to receiving the request, initiate an indication of an activity to address the user's maladaptive behavior related to substance use. One or more processors may determine a time to provide an indication to perform an activity that avoids selecting one or more of a plurality of memory words and / or one or more of a plurality of substance use words, where providing an indication to perform an activity that avoids selecting one or more of a plurality of memory words and / or one or more of a plurality of substance use words further includes providing the indication at the determined time. One or more activities may be performed for 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer. Substance use may include at least one of alcohol use disorder (AUD), opioid use disorder (OUD), or drug abuse. A cue may be provided at least 1 day, 5 days, 1 week, or 1 month after providing an indication to perform an activity that provides information about a future event. One or more processors may provide an indication to avoid selecting one or more of a plurality of substance use words before providing an indication to perform an activity that avoids selecting one or more of a plurality of memory words and a plurality of substance use words.

[0055] Another aspect of the present disclosure relates to a method for treating or improving substance use disorder (SUD) in a user in need thereof. The method includes administering a treatment to the user that includes digital therapy. In some aspects, administering the digital therapy includes identifying, for a user with a substance use disorder, a profile that includes a plurality of substance use words. Administering the digital therapy includes presenting a plurality of memory words unrelated to substance use and instructions to memorize the plurality of memory words. In some aspects, administering the digital therapy includes providing instructions to perform an activity that avoids selecting one or more of the plurality of memory words and one or more of the plurality of substance use words.

[0056] In various implementations, administering the digital therapy includes providing instructions to perform an activity that provides information about a future event. The future event can relate to the user's health, relationships, values, finances, enjoyment, charitable contributions, sobriety, or lifestyle. The future event can be at least one day, one week, one month, one year, or more in the future. Administering the digital therapy can include, prior to the instructions to perform the activity, providing the user with instructions to select a category of future event. The category of future event can be selected from the user's health, relationships, values, finances, enjoyment, charitable contributions, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors related to substance use. In various implementations, administering the digital therapy includes providing instructions to select a time frame for the future event. The future event can occur in less than one month. The future event can occur in more than one month. Administering the digital therapy can include providing the user with instructions to generate one or more visual cues based on the future event information provided by the user. The visual cue can be an image or text, including free text provided by the user. Administering the digital therapy can include providing a cue that includes visual cues related to the future event information and instructions to perform an activity related to the visual cue. The cue can be a timeline that identifies a plurality of visual cues. The timeline can be automatically updated based on the time marked to the visual cue. The activity can include an audio recording or a text description.

[0057] Administering the digital therapy can include providing follow-up instructions to perform an activity that avoids selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words, and providing a cue that includes one or more visual cues related to the future event information and instructions to perform an activity related to the one or more visual cues. The cue can be a timeline that identifies more than one visual cue. The timeline can be automatically updated based on the time marked to the visual cue. The activity can include an audio recording or a text description.

[0058] In various implementations, administering digital therapy can include providing subsequent instructions to perform activities that avoid selecting one or more of multiple memory words and / or one or more of multiple substance use words. Administering digital therapy can include providing a prompt related to future event information after performing an activity that avoids selecting one or more of multiple memory words and presenting one or more of multiple substance use words. Administering digital therapy can include providing instructions to perform an activity that avoids selecting one or more of multiple substance use words prior to instructions to perform an activity that avoids selecting one or more of multiple memory words and one or more of multiple substance use words.

[0059] In various implementations, administering digital therapy can include providing instructions to perform an activity of selecting all memory words from multiple words. Administering digital therapy can include providing instructions to perform an activity of selecting one or more memory words from multiple words. Administering digital therapy can include determining a score representing the percentage of correct interactions with memory words, and then the digital therapy selects multiple memory words based on the score. In various implementations, administering digital therapy can include determining a score representing correct interactions, user selection speed, or both during the activity of selecting all memory words from multiple words. Administering digital therapy can include, in response to the score meeting a threshold, determining an increase in the number of words for a subsequent activity of avoiding selecting multiple memory words, an activity of avoiding selecting multiple memory words, or an activity of selecting all memory words from multiple words. Administering digital therapy can include displaying a score that indicates at least one of the percentage of correct interactions, the speed of user selection, or both during one or more activities.

[0060] Administering digital therapy can include determining a score representing correct interactions, user selection speed, or both during the performance of one or more activities, and then one or more processors select subsequent multiple substance use words or subsequent multiple memory words or both based on the score. The score can be determined by the number of correct interactions, user selection speed, or both during the activity of selecting all memory words from multiple words. Administering digital therapy can include determining a score representing correct interactions, user selection speed, or both during the activity of avoiding selecting multiple memory words and / or multiple substance use words. Administering digital therapy can include, in response to the score meeting a threshold, determining an increase in the number of words for a subsequent activity of avoiding selecting multiple memory words and / or multiple substance use words.

[0061] Administering digital therapy can include generating one or more prompt words or images based on future event information provided by the user, wherein the prompt related to the future event information includes one or more prompt words or images.

[0062] In various implementations, administering digital therapy can include providing instructions to perform activities that avoid selecting one or more of a plurality of substance use words and / or one or more of a plurality of memory words, and can also include providing, via digital therapy, instructions to a user to perform activities that select one or more of a plurality of neutral words that are unrelated to substance use and different from the memory words. Administering digital therapy can include providing instructions to perform activities that avoid selecting one or more of a plurality of substance use words or memory words, which includes presenting one or more of the plurality of words for less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or equal to or greater than 10 seconds. Instructions to perform the activities can be provided to the user by one or more processors at least once a day, at least once every 2 days, at least once every 5 days, or at least once a week. One or more of the activities can be performed for 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer. A cue can be provided by one or more processors at least 1 day, 5 days, 1 week, or 1 month after providing instructions to perform an activity instruction that provides information about a future event.

[0063] Administering digital therapy can include receiving a request from a user that indicates the onset of a behavior related to substance use, and in response to receiving the request, initiating, by digital therapy, instructions for an activity to address maladaptive behaviors related to the user's substance use. Administering digital therapy can include determining a time for providing instructions to perform an activity instruction that avoids selecting one or more of a plurality of memory words and / or one or more of a plurality of substance use words, wherein providing, by digital therapy, instructions to perform an activity that avoids selecting one or more of a plurality of substance use words and / or one or more of a plurality of memory words also includes providing the instructions at the determined time.

[0064] In various implementations, an effective amount of a drug can be administered to a user, the drug including at least one of naloxone, naltrexone, nalmefene, samidorphan, nalorphine, levallorphan, naloxone, alvimopan, methylnaltrexone, naloxone, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine or a GLP-1 agonist. In various implementations, substance use includes at least one of alcohol use disorder (AUD), opioid use disorder (OUD), or drug abuse.

[0065] In various implementations, when a user experiences a decrease in the Obsessive Compulsive Drug Use Scale (OCDUS) metric after receiving digital therapy, the user's SUD is improved. When a user experiences an improvement in the Drug Abstinence Self-Efficacy Scale (DASES) metric after receiving digital therapy, the user's SUD can be improved. When a user experiences an improvement in the Modified Visual Analogue Scale (MVAS) rating for craving after receiving digital therapy, the user's SUD can be improved. When a user experiences a self-reported reduction in substance use after receiving digital therapy, the user's SUD can be improved. When a user experiences an improvement in the Opioid Substitution Treatment Quality of Life (OSTQOL) scale after receiving digital therapy, the user's SUD can be improved. The user can be in at least partial substance use treatment that is concurrent with receiving digital therapy. A medication prescription for substance use can be prescribed to the user. After receiving digital therapy, the user's substance use is reduced. When a user shows improvement in at least one of the Recovery Empowerment Scale, Perceived Stress Scale, OSTQOL, MVAS, or self-reported total substance use through the timeline follow-back (TLFB) procedure after receiving digital therapy, the user's SUD can be improved. Digital therapy can be administered at least daily, every two days, or weekly. Digital therapy can be administered for at least one week, one month, or three months. Administering digital therapy can include using the user's performance in activities to update the user's profile.

[0066] 1. Overview

[0067] Now refer to Figure 1, which shows a block diagram of a system 100 for presenting an interactive session to address maladaptive behaviors related to a user's substance use. Generally, the system 100 can include at least one session management service 105 and a set of user devices 110A-N (collectively referred to hereinafter as user devices 110), which are communicatively coupled to each other via at least one network 115. At least one user device 110 (e.g., the first user device 110A as shown) can include at least one application 125. The application 125 can include or provide at least one user interface 130, which has one or more user interface (UI) elements 135A-N (collectively referred to hereinafter as UI elements 135). The session management service 105 can at least include a session processor 140, a word generator 145, an activity selector 150, a response processor 155, a performance evaluator 160, a feedback generator 165, etc. The word generator 145 can include words provided in a database or words selected from a specific glossary of indicative terms. In some aspects, the user can input relevant words related to the user's specific substance use. In other aspects, the user can rate the relevance of words from a list of potential words provided by the word generator 145. In another aspect, eye-tracking or biometric technology can be measured by the user device to determine which words are most prominent to the user for inclusion in the database to be selected by the word generator. In another aspect, the word generator 145 can generate new words in real time, possibly using a generative AI machine learning model, without using pre-generated words or requiring a database to store these words.

[0068] The session management service 105 can include or have access to at least one database 170. The database 170 can store, maintain, or otherwise include one or more user profiles 175A-N (collectively referred to hereinafter as user profiles 175). Generally, the user devices 110 and the session management service 105 can be part of a computing system to provide the application 125.

[0069] More specifically, the session management service 105 (sometimes collectively referred to as the service herein) can be any computing device including one or more processors coupled to a memory and software and capable of performing the various processes and activities described herein. The session management service 105 can communicate with one or more user devices 110 and the database 170 via the network 115. The session management service 105 can be located, positioned, or otherwise associated with at least one server group. The server group can correspond to a data center, a branch office, or a site where one or more servers corresponding to the session management service 105 are located. The session management service 105 can be located, positioned, or otherwise associated with one or more user devices 110. Some components of the session management service 105 can be located within the server group, while some components can be located within the client device. For example, the session management service 105 can run or be located on the user device 110, while the activity selector 150 can run or be located on the server group.

[0070] In the session management service 105, the session processor 140 can initiate a session for a user via the application 125. The word generator 145 can generate words for session indication from the database 170. The activity selector 150 can select an activity for the user for indication. The response processor 155 can receive the user's response to the indication and the activity. The performance evaluator 160 can evaluate the user's performance based on the response. The feedback generator 165 can provide feedback to the user via the application 125 based on the results of the performance evaluator 160.

[0071] The user device 110 (sometimes referred to as the end-user computing device or the client device herein) can be any computing device including one or more processors coupled to a memory and software and capable of performing the various processes and activities described herein. The user device 110 can communicate with the session management service 105 and the database 170 via the network 115. The user device 110 can be a smart phone, other mobile phone, tablet computer, wearable device (e.g., smart watch, glasses), or laptop computer. The user device 110 can be used to access the application 125. In some embodiments, the application 125 can be downloaded and installed on the user device 110 (e.g., via a digital distribution platform). In some embodiments, the application 125 can be a web application having resources accessible via the network 115.

[0072] The application 125 executed on the user device 110 can be a digital therapy application and can provide sessions (sometimes referred to herein as therapy sessions) to address substance use disorder (SUD). The users of the application 125 may be diagnosed with SUD or at risk of SUD. For example, a user may use a certain substance more frequently and in larger amounts, resulting in health problems (such as breathing problems) or withdrawal symptoms. The causes of SUD may include genetic, behavioral, environmental, physiological, and psychological factors. For example, individuals with a family history of SUD may have an increased sensitivity to substances and a higher risk of addiction. In another example, socioeconomic conditions such as financial difficulties and poverty may lead to the use of substances as a coping mechanism.

[0073] Examples of SUD include opioid use disorder, alcohol use disorder, narcotic use disorder, etc. SUD may lead to physical health, mental health, social and economic, and other problems. The impacts on physical health may include, for example, heart diseases (such as hypertension, arrhythmia, or cardiomyopathy), decreased lung function, lung injury, brain injury (such as neurotoxicity), or immunosuppression. Such a condition may impede or hinder interpersonal relationships, such as facing social stigma, and may result in economic losses such as unemployment.

[0074] The application 125 can be used to provide sessions to reduce the user's substance use. The sessions can be presented to the user as a result of the user's input information (such as substance use, lifestyle, work schedule). The sessions can include various activities aimed at reducing substance use, such as inhibitory control training, working memory training, and thinking about future events. The sessions can include any number of activities in any order, and the sessions can be generated based on the information input by the user. By providing digital therapy (such as intervention) to the user through the application 125, the adverse effects of SUD can be addressed.

[0075] The user can at least partially receive treatment to address the condition or the side effects of the condition while at least partially receiving the intervention provided by the application 125. For example, the user may be receiving treatment for SUD. The user may at least partially receive treatment and any number of sessions or any combination thereof. The treatment can include taking medications. The medications can be administered at least orally, intravenously, or topically. For example, the medications can include SUD treatment medications (such as naloxone, naltrexone, nalmefene, samidorphan, naloxapine, levallorphan, naloxone, alvimopan, methylnaltrexone, naloxicon, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, lofexidine, or GLP-1 agonists), etc. The application 125 can enhance the efficacy of the medications the user is taking to address the condition. The treatment can include cognitive behavioral therapy (CBT), contingency management, psychotherapy, recovery programs, or support groups, etc.

[0076] Application 125 may include, present, or otherwise provide to a user of user device 110 a user interface 130 that includes one or more UI elements 135, according to a configuration on application 125. UI elements 135 may correspond to visual components of user interface 130, such as command buttons, text boxes, check boxes, radio buttons, menu items, and sliders, among others. In some embodiments, application 125 may be a digital therapy application and may provide one or more sessions (sometimes referred to herein as therapy sessions) via user interface 130 to address a user's substance use disorder.

[0077] Database 170 may store and maintain various resources and data related to session management service 105 and application 125. Database 170 may include a database management system (DBMS) to arrange and organize the data maintained thereon. Database 170 may communicate with session management service 105 and one or more user devices 110 via network 115. When running various operations, session management service 105 and application 125 may access database 170 to retrieve identified data therefrom. Session management service 105 and application 125 may also write data to database 170 by running such operations.

[0078] Such operations may include maintaining user profiles 175 (sometimes referred to herein as subject profiles). User profiles 175 may include information related to a user's condition (e.g., SUD) as described herein. For example, user profiles 175 may include information related to the severity of the condition, the occurrence of the condition (e.g., the occurrence of symptoms related to the condition), medications or treatments the user has taken for the condition, and / or the duration of the condition, among others. User profiles 175 may be updated in response to a schedule, periodically (e.g., daily, weekly), in response to changes in user information (e.g., user input via user interface 130 or learned from user device 110), or in response to a clinician (e.g., doctor or nurse) addressing the user's condition.

[0079] User profiles 175 may store and maintain information related to a user of application 125 via user device 110. Each user profile 175 may be associated with or correspond to a respective user of application 125. User profiles 175 may contain or store information for each session executed by the user. Information for a session may include various parameters, actions, images, prompts, or selections or actions from previous sessions executed by the user and may initially be empty. User profiles 175 may enable simplified communication with the user by presenting to the user sessions that are most likely to help the user address their SUD problem, based at least on user profile 175. This targeted approach may reduce the need for multiple communications with the user, thereby reducing bandwidth and increasing the benefit of user-computer interaction.

[0080] In some embodiments, the user profile 175 may identify or include information about the treatment regimen taken by the user, such as the type of treatment (e.g., therapy, medication, or psychotherapy), duration (e.g., days, weeks, or years), and frequency (e.g., daily, weekly, quarterly, annually), etc. The user profile 175 may be stored and maintained in the database 170 using one or more files (e.g., Extensible Markup Language (XML), comma-separated values (CSV) delimited text files, or Structured Query Language (SQL) files). When the user provides responses, makes selections, and performs session-related actions, the user profile 175 may be iteratively updated. The user profile 175 may also be updated based on the words generated by the word generator 145 and the activities performed by the user selected by the activity selector 150. For example, the user profile 175 may be updated using the responses received by the response processor 155.

[0081] The database 170 may store substance use words 180A-N (collectively referred to as substance use words 180 hereinafter). The substance use words 180 may be words related to substance use. For example, the substance use words 180 may include needle, drug, or opioid, etc. The user profile 175 may include substance use words 180 based on information related to the user. The database 170 may also store memory words 185A-N (collectively referred to as memory words 185 hereinafter). The memory words 185 include words unrelated to substance use. For example, the memory words 185 may include dog, whale, ball, apple, or computer, etc. The database 170 may store neutral words.

[0082] 2. Select an activity

[0083] Now refer to Figure 2A -B, which shows a block diagram of a process 200 that provides a session for the user 210 to perform an activity by the system 100. The process 200 may include or correspond to operations performed by the system 100 to receive and process data provided by the user 210. From Figure 2ABeginning, under process 200, word generator 145 can generate words from database 170 for use in the activity selected by activity selector 150. This session combines the substance use word activity and the memory word activity into a single selection activity, which means that either the substance use word can be shown to the user or the memory word can be shown to the user. Combining the substance use word and memory word activities can target overlapping neural network substrates, which function to train two sub-domains of executive control (e.g., inhibitory control and working memory) simultaneously, thus preparing the prefrontal cortex and limbic regions of the brain for plastic changes by simulating critical brain development time periods. Activities involving substance use words and memory words can keep user 210 focused and induce plasticity in the brain. For example, the instructions to user 210 can include messages guiding user 210 to avoid simultaneously selecting memory word 185 and / or substance use word 180 in the same activity (but not necessarily on the same screen). In this case, a screen with memory words can be presented to the user, and then a subsequent screen with substance use words can be presented to the user, and the user will receive the correct score by not selecting either screen. The instructions can also include guiding user 210 to select one or more of a set of neutral words. This set of neutral words has nothing to do with substance use and is different from the memory word 185 used in the instructions. For example, user 210 can refuse to interact (e.g., select) with user interface 130 when memory word 185 or substance use word 180 is presented, but can select neutral words in order to receive the correct score.

[0084] The selection activity trains user 210 to strengthen inhibitory control and break the stimulus-action pattern (e.g., trigger factors) that leads user 210 to drug use. The substance use word activity can break the association between user 210 and drugs and allow the formation of new stimulus-action associations. The substance use word activity can also prepare the prefrontal cortex and limbic regions of the brain for plastic changes.

[0085] Activity selector 150 can combine the substance use word activity and the memory word activity as a single activity for selection. However, activity selector 150 can select the substance use word activity as the single activity for the user to perform, which means that only the substance use word will be shown to the user and not the memory word. For example, this can occur to introduce the treatment to the user or to ease the user into the subsequent combined substance use word and memory word activity. Similarly, activity selector 150 can select the memory word activity as the single activity for the user to perform, which means that only the memory word will be shown to the user and not the substance use word. In response to activity selector 150 selecting this selection activity, session processor 140 generates instruction 215. Instruction 215 can include substance use word 180 and memory word 185 generated by word generator 145. Instruction 215 can include messages to perform the substance use word and memory word activities and avoid selecting one or more of substance use word 180 and / or memory word 190.

[0086] In some aspects, a single activity or session can include multiple rounds that include multiple trials. Each trial can include the display of a single word. For example, the first trial can include the display of a substance use word, the second trial can then display a memory word, and the third trial can then display a neutral word. However, in some embodiments, a single trial can include multiple words, which can include multiple substance use words, multiple memory words, and / or multiple neutral words. The activity can include 1 - 20 rounds, 2 - 10 rounds, or 3 - 5 rounds per session. The activity can include 10 - 200 trials, 20 - 150 trials, 50 - 100 trials, or 70 - 80 trials per round. The number of trials per round or the number of rounds per session depends on the amount of time given for the trials, rounds, or session and the particular user, e.g., 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or more per round, as the time taken by each user for a trial, round, and / or session may vary.

[0087] To generate substance use words, the session processor 140 can first identify the user's SUD based on the user profile 175. The user profile 175 can include a set of substance use words 180 based on the user's SUD. Before generating the indication 215, the word generator 145 can identify words based on at least one of the user profile 175 or past sessions stored in the database 170. For example, the user profile 145 can contain the user's past and / or current conditions, which can be used to determine the intervention. While generating the indication 215, an effective amount of a drug can be administered to the user to counteract the SUD, including at least one of naloxone, naltrexone, nalmefene, thiamifensine, nalorphine, levallorphan, naloxone, alvimopan, methylnaltrexone, naloxicon, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, or lofexidine or a glp - 1 agonist. The word generator 145 can also generate words based on the drugs the user is taking.

[0088] To generate memory words, the word generator 145 can select memory words 185 associated with the user profile 175. The indication 215 can present the memory words 185 to the user 210. The memory words 185 can be unrelated to substance use. The indication 215 can include a message to remember the memory words 185.

[0089] To generate neutral words, the word generator 145 can select neutral words based on factors such as the user profile 175, words unrelated to substance use, and / or words different from the memory words 185.

[0090] 3. Visualization Activity

[0091] Now refer to Figure 3A and3B , a block diagram of a process 300 for providing a session to a user 210 to perform a visualization activity through the system 100 is shown. After completing the selection activity as described above, the process 300 can provide a session for the user to perform a visualization activity. The process 300 can include or correspond to operations performed by the system 100 to receive and process data provided by the user 210. Starting from Figure 3A , under the process 300, the activity selector 150 can select a visualization activity, and the session processor 140 can generate a visualization indication 505 for the user 210 to perform the visualization activity. The visualization activity can provide target-related context to the user 210 to leverage the improvement of the user 210 in performing control functions in the selection activity. The visualization activity can translate the improvement of the selection activity into real-world context and can facilitate maintaining and updating the association of the user 210 with, for example, the substance use term 185.

[0092] In response to the activity selector 150 selecting a visualization activity, the session processor 140 can generate a visualization indication 305. The visualization indication 305 can instruct the user 210 to perform the visualization activity, including asking the user to provide information 310 about a future event. The visualization indication 305 can be a textual or audio description of the activity. The visualization indication 305 can be generated, sent, and received in the same manner as other indications described herein. The future event can be related to health, relationships, values, finances, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors related to the substance use of the user 210. The future event can generally be positive, such as a birthday, celebration, wedding, graduation, goal, or purpose, etc. The future event can be at least one day, one week, one month, one year, or longer in the future. The future event can be less than 1 week, 1 day, 12 hours, or 1 hour. The visualization indication 305 can present a UI element 135 to the user 210 to input event information 310, such as the time when the future event may occur. For example, the user 210 can input an upcoming future event as a graduation and the graduation date. Then the event information 310 can be stored in the database 170.

[0093] In some embodiments, before the session processor 140 generates the visualization indication 305, the session processor 140 may provide an indication to the user 210 to select a type of future event, the type of future event being selected from at least one of the user's health, relationships, values, finances, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors related to substance use. In some embodiments, the session processor 140 may provide an indication to the user 210 to select a category of future events. The category may be selected from at least one of the user's health, relationships, values, finances, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors related to substance use. Future events may be labeled by category. In some embodiments, the session processor 140 provides an indication to perform visualization activities based on the category after the user 210 has performed a certain number of visualization activities. In various implementations, the visualization indication 405 may include a request to select a time range for the future event. The future event may occur in less than a month or more than a month. Future events may be labeled with a time range. In some embodiments, the session processor 140 provides an indication to perform visualization activities based on the time range after the user 210 has performed a certain number of visualization activities.

[0094] After performing the visualization activities, the session processor 140 may generate a prompt 330 related to the event information 310. The prompt 330 may be used in a subsequent session to enable the user to visualize the future event from a previous session. The prompt 330 may encourage the user 210 and remind the user 210 of the cognitive gains obtained through the system 100. The session processor 140 may provide the prompt 330 to the user at least 1 day, 5 days, 1 week, or 1 month after providing the visualization indication 305 to the user 210, particularly after a subsequent session in which the user performs a selection activity.

[0095] The prompt 330 may include one or more cue words or images based on the event information 310 provided by the user to remind the user 210 of the upcoming future event. For example, in response to event information 310 including graduation information, the prompt may include the word "graduation" or "graduation cap and gown" or an image of a graduation cap and gown. The user 210 may also input one or more self-generated cue words or images through the UI element 130, and these cue words and images may be recorded. In some embodiments, the session processor 140 may instruct the user 210 to generate one or more visual cues based on the future event information provided by the user. In some embodiments, the session processor 140 may provide one or more visual cues for the user 210 to select and store the visual cues selected by the user 210.

[0096] The prompt 330 can be a timeline that identifies more than one visual prompt. For example, the prompt 330 can include an image of a birthday cake with the words "within one month" indicating a family member's birthday, and an image of an airplane with the words "within two months" indicating a trip to visit a friend. The timeline can be automatically updated based on the time marked to the visual prompt. For example, the session processor 140 can request that the user 210 time-stamp the selected visual prompt and generate a timeline based on the visual prompt and the current time.

[0097] In some embodiments, the session processor 140 can send a request to the user to input information to generate the prompt 330. For example, the session processor 140 can request that the user provide a text reminder (e.g., a cue word), a date and / or time range of a future event, and a category of the future event and / or the prompt 330. For example, the prompt 330 can be categorized as at least one of the user's health, relationships, values, finances, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors related to substance use.

[0098] In some embodiments, the session processor 140 stores the prompt 330 after generating it. The session processor 140 can store the prompt 330 after each visualization activity. A collection of the prompts 330 can be displayed on the user device 110 so that the user 210 can visualize various future events at once. For example, the collection of the prompts 330 can be displayed as a future vision board on the user device 110.

[0099] Further reference Figure 3A - 3B After process 200 and / or process 300, the prompt 330 can be provided to the user. For example, the session processor 140 can provide an instruction to the user 210 to perform an activity that avoids selecting one or more memory words 185 and / or one or more substance use words 180. After performing the selection activity, the session processor 140 can send the prompt 330 to the user device 110 for presentation to the user 210. The prompt 330 can include one or more visual prompts. The one or more visual prompts can be a description of a future event or an image description of a future event. The prompt can be in other formats, such as audio. The prompt 330 can enhance the brain plasticity caused by the activity and strengthen the changes within the brain executive control system.

[0100] In accordance with the prompt 330, the session processor 140 can generate a follow-up activity for the user 210 to perform. The follow-up activity can be related to the visual prompt. The follow-up activity can include an audio / video recording or a text description. The audio / video recording or the text description can be related to the visual prompt. The application 125 can record the interaction 315 between the user 210 and the activity.

[0101] In some embodiments, the prompt 330 is provided after performing a selection activity. In some embodiments, the prompt 330 is provided before performing a selection activity. In some embodiments, the prompt 330 is provided during the performance of a selection activity. As another example, a visualization activity can be provided to the user 210 first, the prompt 330 is provided, and then the user is instructed to perform a selection activity. In some aspects, the user can be instructed to perform a selection activity, followed by an instruction to perform a visualization activity, followed by a subsequent instruction to perform a selection activity, and then the prompt 330.

[0102] 4. Repeat the cycle of selection activity and visualization activity

[0103] To obtain the greatest benefit, the session processor 140 can initiate a selection activity, followed by a visualization activity that stores a prompt, followed by a subsequent selection activity, and then a subsequent visualization activity that includes displaying the prompt to the user, and this cycle can be repeated multiple times over a period of 1 - 24 hours, 1 - 7 days, 1 - 4 weeks, 1 - 12 months, or more than one year.

[0104] In other embodiments, these three activities can be performed in multiple orders, multiple times, and multiple combinations based on the user profile 175. Each of these activities can be performed at multiple frequencies and / or multiple times (in seconds, minutes, etc.).

[0105] For example, during a given week, the user 210 can be provided with substance use word and memory word instructions on a certain number of days of the week to perform a combined selection activity. This activity can be performed a certain number of times according to the user profile 175. Visualization instructions 305 can be provided to the user 210 on a certain number of days that also deliver the substance use word and memory word instructions. The visualization activity can be performed a certain number of times according to the user profile 175. On the days when the user 210 is provided with substance use word and memory word instructions, the prompt 330 can be provided to the user 210 before, during, or after performing the substance use word and memory word activity.

[0106] To implement this cycle, the activity selector 150 can select a selection activity or a visualization activity for the user 210 to perform. The activity selector 150 can also select the length of time for performing the activity, such as 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes, or longer. The time at which the session processor 140 sends the session can be at least once a day, at least once every 2 days, at least once every 5 days, or at least once a week.

[0107] The sessions generated by the session management service 105 described herein can reopen the plasticity window of adults, which is typically limited to childhood. For example, the activity selector 150 that alternates between substance use words and memory words activities can reopen this window. The session processor 140 can mimic the key principles of learning observed during the period when experience shapes traits and behavioral development (e.g., plasticity) by providing various activities and words for the session. For example, a substance use word activity with an advantageous response, short response time, and indication of a specific word as indicated by the session processor 140 and / or the feedback generator 165 can create a challenging and prominent learning environment for the user to quickly adapt and focus under such conditions.

[0108] 5. Memory Test

[0109] Now referring to Figure 4A and 4B FIGs. [FIG numbers not provided in the original, so left as is], a block diagram of a process 400 for providing a session to a user 210 by the system 100 to perform a memory test activity is shown, which is provided after the activity selection. The process 400 can include or correspond to operations performed by the system 100 to receive and process data provided by the user 210. Starting from Figure 4A in the process 400, the activity selector 150 can select a memory test, and the session processor 140 can create, write, or otherwise generate a memory test indication 405 based on the words. The memory test indication 405 that guides the user 210 to perform the memory test activity can reinforce the knowledge learned from the selected activity. For example, the selected activity can include a subset of the memory words 185, while the memory test activity includes all the memory words 185.

[0110] The session processor 130 can generate a memory test indication 405 in response to the activity selector 150 selecting a memory test activity for the user 210 to perform. The memory test indication 405 can include a message to perform the memory test activity by interacting (e.g., selecting) with all the memory words 185 in a set of words. The set of words can include the memory words 185 and neutral words. The set of neutral words is different from the memory words 185 or the substance use words 180 and is not related to substance use. For example, the memory words 185 can be presented together with the neutral words, and the memory test indication 405 can instruct the user 210 to select only the memory words 185. In some embodiments, the memory test indication 405 can instruct the user 210 to select one or more memory words 185. For example, the memory test activity may not include all the memory words 185. The memory test indication 405 can also include a subset of the memory words 185 for the user 210 to select. The memory test indication 405 can be generated, sent, and received in the same manner as the other indications described herein.

[0111] Moving on to Figure 4B, after receiving the memory test instruction 405, the application 125 on the user device 110 can display, render, or otherwise present the memory test instruction 405 through the user interface 130. Then, the application 125 can prompt or guide the user 210 to provide a response 415 to the memory test instruction 405, such as performing a memory test activity. The response 415 can be provided by the user 210 performing an interaction 410 with the UI element 135 on the user interface 130 that displays the memory word 185 and the neutral word. In response to the memory word 185 appearing on the screen, the user 210 can select the memory word 185 that can be included in the interaction 410. The interaction 410 can be recorded by the application 125 and sent as the response 415. The interaction 410 can also record the interaction of the user 210 with the neutral word. The interaction 410 can be recorded, received, and determined in the same manner as other interactions described herein.

[0112] In response to the response score 420 meeting the threshold, the feedback generator 165 can increase the number of words for subsequent activities. The feedback generator 165 can instruct the word generator 135 to generate more memory words 185' for subsequent activities. The memory words 185' can include the memory words 185 or can be different from the memory words 185 used in the previous session.

[0113] 6. Example

[0114] In one example, the user interface can be presented through an application. The user interface can be an indication of which activity the user is instructed to perform. The user interface can provide the user with an indication of the activity. The user interface provides memory words for the user to memorize and avoid selecting.

[0115] The user interface can provide an indication to the user to remember the mnemonic words and avoid selecting mnemonic words during the selection activity. The mnemonic words can be provided on the screen of the user interface together with the indication to avoid selecting mnemonic words. The user interface can provide an indication to avoid selecting substance use words. The user interface can provide an indication to avoid selecting both substance use words and mnemonic words. The user interface can present one of the substance use words or mnemonic words in an area of the user interface. After the user interacts with the substance use word or mnemonic word, the user interface can remove the substance use word or mnemonic word and then present a subsequent mnemonic word or substance use word in an area of the screen different from the previous mnemonic word or substance use word. In some aspects, the substance use words are presented before the mnemonic words. In some aspects, the mnemonic words are presented before the substance use words. In some aspects, neutral words unrelated to substance use are presented to the user interface in the same or a different area from the previous substance use or mnemonic words. The substance use words, mnemonic words, or neutral words can be presented on the user interface for a period of time and then removed before presenting subsequent words. Alternatively, the substance use words, mnemonic words, and / or neutral words can be presented on the user interface on a single screen. The period of time for presenting the mnemonic words, substance use words, or neutral words can be less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or equal to or greater than 10 seconds. The user interface can indicate to the user that the activity is completed. The user interface can display a score to the user based on the user's performance during the activity.

[0116] In one example, a user interface for a memory quiz activity can present a set of words including mnemonic words for the user to select. The user interface can present the mnemonic words together with a set of neutral words and present an indication for the user to select the mnemonic words. In some aspects, the user interface can include an indication to avoid selecting the neutral words. The mnemonic words can be displayed for a period of time. The mnemonic words and the neutral words can be displayed together on a single screen. The period of time for presenting the mnemonic words can be less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or equal to or greater than 10 seconds. The user interface can display a score to the user based on the results of the interaction and the results of the activity.

[0117] In some examples, after performing activities such as a memory quiz activity and / or a substance use word and mnemonic word activity, a user interface indicating the activity score can be presented to the user. The user interface can present an explanation of the basis for the score to the user, including the percentage, quantity, and / or time of correct interactions and / or selections. The user interface can display the score to the user along with metrics related to the score, such as accuracy, selection time, the quantity and / or percentage of correct interactions and / or selections. The user interface can also indicate the challenge or difficulty of the activity and how they may affect the user's score. In some embodiments, the user interface provides areas for improvement to the user, including activities in which the user can improve performance. The user interface can indicate incorrect interactions and / or selected words.

[0118] Figure 5 A flowchart showing a visualized activity according to an exemplary embodiment is presented. The user interface in this setup 500 can be part of an application and is presented through the user interface 130. The user interface 505 can be the home page (e.g., the starting page) where the user begins the visualized activity. The user interface 510 can introduce the visualized activity and any subsequent activities (e.g., a selection activity). The user interface 515 can display the visualized activity for the user to execute. The user interface 520 can be the end screen of the visualized activity and / or subsequent activities.

[0119] In some examples, the user interface can present the visualized activity and indicate to the user which activity they are instructed to perform. The user interface can present an indication for the user to participate in the visualized activity. The user interface can provide an indication for the user to imagine a future event. The user interface can provide an indication for the user to input information about the future event. The user interface can present specific questions about the future event to the user, such as the time of the event, the location of the event, the attendees of the event, or how the user feels after completing the event, etc. The user interface can present questions or requests to the user to input information about the event, such as a description or an image of the event.

[0120] In another example of the user interface for the visualized activity, the user interface can provide the user with options for the time range of the future event of the visualized activity (e.g., one day, one week, one month, or more than one year, etc.). The user interface can provide the user with options to select the theme or category of the future event (i.e.: health, relationships, values, finance, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle) and an indication to visualize the events related to that category. In some aspects, the user interface can provide the user with options to select upcoming challenges in the user's life and an indication of how the user intends to handle the future event or challenge. The user interface can provide options to select the time range of the future event or challenge. For example, the user interface can provide options for a specific time range for the future event or challenge (e.g., one day, one week, one month, or more than one year, etc.).

[0121] In one example, the user interface can include an input for the user to create a prompt for the visualized activity, which can include reminders or images related to the future event and the date of the future event. The user interface can ask the user to select a category (i.e.: health, relationships, values, finance, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle). The user interface can include an indication for the user to input information related to the future event (such as a description or an image of the event).

[0122] In some examples, the user interface may include an input for the user to create a prompt and / or reminder related to a future event. The prompt may be text, an image, or audio-based content. The user interface may include an input or indication for the user to provide an event reminder and a description or image related to the event. The user interface may request the user to input the time of the future event.

[0123] When the user provides an input related to the prompt, the user interface may indicate to the user that a new prompt has been created. The user interface may display a future board and notify the user that the prompt has been added to the user's future board. The prompt may be provided on a timeline on the user's future board, indicating the date or time of the event (e.g., one day, one week, one month, or more than one year, etc.). The user interface may be a screen indicating the completion of a visualization activity and / or a start screen of a subsequent activity (e.g., a substance use word activity).

[0124] In one example, the user interface may present the future board after the user performs a visualization activity. The user interface may present a future board with multiple prompts entered by the user. The user interface may present the future board after the user performs other selection activities and / or visualization activities. The future board may be sorted by the time range in which the future event occurs (e.g., one day, one week, one month, or more than one year, etc.) and / or the category of the prompt (i.e.: health, relationships, values, finance, enjoyment, charitable donations, sobriety, small progress, achievements, future gratitude, challenges, lifestyle). The prompts may be provided along the timeline and presented in chronological order, or presented within a group of prompts that will occur within a similar time range (e.g., one day, one week, one month, or more than one year, etc.). Prompts related to the visualization activity may be removed from the future board or moved to a separate location or group after the future event is completed or passed. The user interface may include an indication to interact with one or more prompts displayed on the future board, including an indication that the future event has been completed or has passed. The prompt may be text, audio, or visually-based content related to the future event.

[0125] 9. Process

[0126] Reference Figures 1 to 4B , the indication 215 may adopt various formats related to the application 125. In some embodiments, the indication 215 may be displayed, rendered, or otherwise presented to the user 210 through the user interface 130 of the application 125. In some embodiments, the indication 215 may include a Short Message Service (SMS) (e.g., a text message) or a Multimedia Message Service (MMS) (e.g., an audio message, a video message). For example, the indication 215 may include a link to open the application 125, guiding the user to perform an activity.

[0127] Interaction 220 may include actions such as physically operating the user device 110, activating a UI element 135, or viewing a substance use word 180 or a memory word 185 or a neutral word 190. Interaction 220 may include actions of moving, tapping, swiping, shaking up and down, rocking, tilting, or orienting the user device 110 towards a side of the user device 110. A side of the user device 110 may refer to a boundary created by the user interface 130 associated with the user device 110, such as a side of a rectangular screen.

[0128] Interaction 220 may include actions such as touching, pressing, or otherwise activating a UI element 135 of the user interface 130 associated with at least one of the substance use word 180, the memory word 185, or the neutral word 190. For example, the user 210 may provide one or more interactions 220 through an application 125 running on the user device 110 by activating one or more of the UI elements 135 described herein. The user 210 may provide the interaction 220 by pressing a button associated with the application 125 and displayed via the user interface 130. In some embodiments, one or more first UI elements 135A may be associated with the substance use word 180, and one or more second UI elements 135B may be associated with the memory word 185, and one or more third UI elements 190 may be associated with the neutral word 190. In some embodiments, the interaction 220 may include the user avoiding selecting or activating one or more UI elements 135 during a period of time when the substance use word 180, the memory word 185, or the neutral word 190 is presented on the user interface 135 during a selection activity. The period of time during which these words are presented and the user avoids selecting these words may be 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or equal to or greater than 10 seconds.

[0129] Application 125 can monitor at least one interaction 220 with a substance use word 180, a memory word 185, and / or a neutral word 190. Application 125 can monitor during a session in response to the presentation of a substance use word 180, a memory word 185, and / or a neutral word 190 or in response to receiving an interaction 220. Application 125 can monitor the receipt of an interaction 220. Application 125 can monitor an interaction 220 through a user interface 130 or through sensors associated with a user device 110, etc. Application 125 can receive multiple interactions 220 during a session. For example, application 125 can monitor a series of interactions 220 provided by user 210 during a session. Application 125 can monitor and record information related to the received interaction 220. For example, application 125 can monitor and record the time of interaction 220, the duration of interaction 220, the sequence of interaction 220, the substance use word 180 and / or memory word 185 and / or neutral word 190 associated with interaction 220, and / or the latency time between the presentation of the substance use word 180, memory word 185, neutral word 190 and the selection of these words, etc.

[0130] When user 210 provides an interaction 220, application 125 can generate at least one response 225. Response 225 can identify the interaction 220. Response 225 can include information about the interaction 220, such as the duration of interaction 220, the time of interaction 220, the substance use word 180 and / or memory word 185 and / or neutral word 190 associated with interaction 220, and / or the latency time between the presentation of the substance use word 180 and / or memory word 185 and / or neutral word 190 and the selection of these words, etc. Application 125 can generate a response 225 for transmission to session management service 105. Response 225 can be in a format readable by session management service 105, for example, an electronic file readable by the session management service or a data packet readable by session management service 105, etc.

[0131] Response processor 155 can receive, identify, or otherwise detect a response 225 for identifying an interaction 220. Response processor 115 can receive a response 225 from application 125. Response processor 155 can receive a response 225 at a predetermined time interval or when an interaction 220 occurs during a session. Response processor 155 can query or ping application 125 to obtain a response 225. Response processor 155 can receive multiple responses 225 over a period of time. For example, response processor 140 can receive a first response 225 indicating a first interaction 220 and a second response 225 indicating a second interaction 220.

[0132] The response processor 155 may store the response 225 including the interaction 220 in the database 170. The response processor 155 may store information related to the response 225, including the time of the response 225, the actions related to the interaction 220, the user profile 175 related to the response 225, and the substance use words 180 and / or memory words 185 and / or neutral words 190 related to the response 225, etc. The response 225 may include or identify the interaction 220 of the user 210 with the substance use words 180 and / or memory words 185 and / or neutral words 190. The response 225 may include the activity completion time or the number of activities completed. For example, the response 225 may include that the user has completed a certain number of activities or spent a certain number of minutes performing actions associated with presenting the substance use words 180 and / or memory words 185 and / or neutral words 190. The response 225 may include the total number of trials or rounds to complete a session, the total time to complete a session, and may also include the start time and the completion time of the session. The response 225 may include the UI elements 135 interacted with during the presentation of the substance use words 180 and / or memory words 185 and / or neutral words 190. For example, the response 225 may include a list of buttons, controls, or other UI elements 135 selected by the user 210 at a specified time during the presentation of the substance use words 180 and / or memory words 185 and / or neutral words 190. The response 225 may include other information, such as the location of the user 210 when performing the session, such as geographical location, IP address, GPS location, or triangulation of cell towers, etc. The response 225 may include measurement values, such as time, location, or measurement values of user data, etc.

[0133] The performance evaluator 160 may calculate, generate, or otherwise determine a response score 230 associated with the response 225 based on the interaction 220 with the substance use words 180 and / or memory words 185 and / or neutral words 190. The response score 230 may indicate the level of correctness or conversely the level of error associated with the response 225. A high response score 230 may be associated with a high level of correctness in selecting neutral words 190 and / or avoiding selecting substance use words 180 and / or memory words 185. A low response score 230 may be associated with a low level of correctness (e.g., a high level of error). For example, a low response score 230 may indicate that the user 210 has selected the substance use words 180 and / or memory words 185.

[0134] When determining the response score 230, the performance evaluator 160 may evaluate the response 225 based on the interaction 220. The performance evaluator 160 may determine the response score 230 based on the percentage of correct interactions with the memory word 185 and / or the substance use word 180 and / or the neutral word 190. The percentage of correct interactions may be based on, for example, the number or rate at which the user 210 interacts with the memory word 185 and / or the substance use word 180 and / or the neutral word 190 based on the interaction 220. For example, the performance evaluator 160 may be based on the number of interactions with the substance use word 180, the number of rejection selections for the substance use word 180, the number of interactions with the memory word 185, the number of rejection selections for the memory word 185, the number of interactions with the neutral word 190, and / or the number of rejection selections for the neutral word 190.

[0135] In some embodiments, the response score 230 is determined based on correct interactions during the interaction 220, the speed of user selections, or both. Correct interactions indicate the number, rate, or percentage, etc., at which the user 210 correctly interacts with the neutral word 190 and avoids selecting the substance use word 180 and the memory word 185. The application 125 may record the speed between interactions, which may be used to calculate the response score 230. For example, the time between the memory word 185 appearing on the user interface 130 and the user 210 incorrectly interacting with the memory word 185 may be used to calculate the response score 230. The response score 230 may also be displayed on the user interface 130, indicating at least one of the percentage of correct interactions during the interaction 220, the speed of user selections, or both.

[0136] The feedback generator 165 may also generate, output, or otherwise produce feedback that the user 210 receives through the application 125 running on the user interface 130. The feedback generator 165 may generate feedback based at least on the response score 230, the user profile 175, the response 225, or the presentation of the historical substance use word 180 and the memory word 185 and the neutral word 190. The feedback may include text, video, or audio to be presented to the user 210 through the application 125 displayed on the user interface 130. The feedback may include the presentation of the response score 230. The feedback may display messages such as motivational messages, suggestions for improving performance, congratulatory messages, comforting messages, etc. In some embodiments, the feedback generator 165 may generate feedback during a session executed by the user 210. The feedback may include the response score 230 to be displayed on the user interface 1430, including at least one of the percentage of correct interactions during the interaction 220, the speed of user selections, or both.

[0137] Based on the response score 230, the feedback generator 165 can generate and select subsequent substance use words 180’, memory words 185’, and neutral words 190 for subsequent conversations. The subsequent substance use words 180’, memory words 185’, and neutral words 190 can be associated with the user profile 175 and used for subsequent activities. The feedback generator 165 can also update the user profile 175 based on the response score 230. The interaction 220 can be recorded in the user profile 175, and the session processor 140 can generate subsequent activities and words based on at least one of the response score 230 and the interaction 220. The update to the user profile 175 can reflect the progress and performance of the user 210 and can indicate to the session management service 105 to increase or decrease the difficulty of subsequent instructions.

[0138] In some embodiments, the feedback generator 165 can also determine, based on the response score 230, whether to increase the number of substance use words and / or memory words and / or neutral words in the subsequent activities of the session management service 105 (e.g., increase the difficulty). For example, in response to the response score 230 meeting a threshold, the feedback generator 165 can update the user profile 175 to include the response score 230 in response to receiving the response score 230 from the performance evaluator 160. The feedback generator 165 can determine whether the response score 230 meets the threshold. Then, the user profile 175 can instruct the session handler 140 to increase the number of memory words in the subsequent session. The feedback generator 165 can also display the response score 230 on the user device 110.

[0139] Based on the response score 230, the feedback generator 165 can direct the session processor 140 to generate an indication for subsequent sessions to perform activities that avoid selecting memory words 185’ and / or avoid selecting substance use words 180’. The memory words 185’ can include the memory words 185 or can be different from the memory words 185 used in the previous session. The words generated by the word generator 145 for subsequent sessions can be determined by the response scores of the first session, the second session, etc., especially the response scores of memory tests. The feedback generator 165 can also update the user profile 175 based on the response score 230. The feedback generator 165 can store the response score 230 in the user profile 175 and then it can be used for subsequent sessions initiated by the session management service 105. The feedback generator 165 can also increase the number of words for the user 210 to memorize in subsequent sessions. For example, the number of words in the memory words 185’ can be greater than the number of words in the memory words 185 to increase the difficulty of the memory word activity in subsequent sessions. The feedback generator 165 can also decrease the number of words for the user 210 to memorize in subsequent sessions to reduce the difficulty of the activities in subsequent sessions.

[0140] The progressive difficulty elements determined by the performance evaluator 160 and the feedback generator 165 for mnemonic word training reflect how skills are naturally acquired during the developmental sensitive period (e.g., the plastic period in childhood). For example, the word generator 145 can increase the number of words generated in response to the score generated by the performance evaluator 160. The visualization activities selected by the activity selector 150 and generated by the session processor 140 can utilize neuroplasticity, which is the basis for episodic memory formation throughout the user's life cycle. The session processor 140 that combines visualization with substance use words and mnemonic words supports the neuroplasticity of the relevant brain regions and can enhance the clinical impact of digital therapeutic applications. For example, the session processor 140 can generate sessions according to the instructions of the activity selector 150. Then, the session processor 140 can provide the words generated by the word generator 145 for the sessions selected by the activity selector to support neuroplasticity.

[0141] Figure 6FIG. 600 is a flowchart showing a method for providing activities to a user to address a substance use disorder according to an exemplary embodiment. The method 600 may be performed by any component of the system 100, such as the session management service 105, the user device 110, or the user 210, etc. Under the method 600, one or more processors may identify a profile (605). The profile may be the profile of the user 210 and may identify the user 210's specific substance use disorder and previous treatments. One or more processors may select an activity based on the profile (610). The activity may be based on the user 210's substance use disorder. One or more processors may present a substance use word indication to the user 210 (615). The substance use word indication may include a substance use word and an indication not to select the substance use word. One or more processors may receive a response to the substance use word indication (620). The response may include the user 210's interaction with the substance use word, a memory word, and / or a neutral word. One or more processors may present a memory word indication (625). The memory word indication may request the user 210 to interact with the memory word presented to the user 210. Then, one or more processors may receive a response to the memory word indication (630). The response may include the user 210's interaction with the memory word, the substance use word, and / or a neutral word. One or more processors may provide a visual indication to the user 210 (635). The visual indication may prompt the user 210 to think about a future event that will occur to the user 210. Then, one or more processors may receive event information (640). The event information may be related to the future event and may be input by the user 210. One or more processors may provide a prompt for the event (645). The prompt may be based on the event information and may be provided after, before, or during the execution of an activity (e.g., a selection activity). Then, one or more processors may receive a response based on the prompt (650). One or more processors may present a subsequent substance use word indication and / or a memory word indication to the user, and then present a subsequent visual indication including a prompt, and this cycle may be repeated one or more times over a period of 1-24 hours, 1-7 days, 1-4 weeks, 1-12 months, or more than one year. The response may be based on the user's performance in receiving the prompt. Then, one or more processors may update the profile based on the response (655). The response may include a score based on the user 210's performance.

[0142] 11. Dynamic content delivery

[0143] In some implementations, the system may include dynamic content delivery that transmits requests to the user device.

[0144] For example, the activity selector 150 can select an activity based on the best time to send the activity to the user 210. The activity selector 150 is configured to select an activity and instruct the session processor 140 to send an indication 215 with "Just-in-time-intervention" (JITI) to reinforce the training provided by the activity. For example, the activity selector 150 can select an activity and the time to send a session to the user 210 based on the user profile 175 and past sessions stored in the database 170. The activity selector 150 can also select the duration of time to perform the activity based on the user profile 175 and past sessions stored in the database 170.

[0145] In some embodiments, the activity selector 150 can select and / or initiate an activity based on user physiological changes measured by wearable technology. For example, in response to biometrics indicating an increased risk of substance use measured by the user's wearable technology (e.g., smartwatch, smartphone), the application 125 can initiate a session 210 to address maladaptive behaviors related to substance use. The activity selector 150 can select an activity based on the biometrics provided by the wearable technology. Thus, the application 125 and the activity selector 150 can adjust the timing and type of indications and activities based on user physiological changes measured by the wearable technology to provide personalized interventions and activity plans to address substance use issues.

[0146] In some embodiments, the session processor 140 can provide an indication in response to receiving a request from the user 210 indicating the start of a behavior related to substance use. For example, the user 210 may feel an urge to use a substance and provide a request to initiate a session to the session management service 105. The session processor 140 can then initiate an activity indication to address the maladaptive behaviors of the user 210 related to substance use. These activities can include, for example, selecting activities and visualization activities to reinforce the learning of the user 210 in past sessions. The session can be provided in a timely manner and in accordance with the request of the user 210.

[0147] In some embodiments, the session processor 140 provides a session within a predetermined time period. Based on the user profile 175, the session management service 105 can determine the activity schedule of the user 210. For example, the session management service 105 can set a selected activity to be sent at a first time and then set a visualization activity to be sent one day later. The schedule can be adjusted based on the response received from the user 210 for interacting with the activity. The session processor 140 can also determine the time to provide an indication to the user 210.

[0148] In some embodiments, the session processor 140 provides sessions based on JITI. For example, the session processor 140 can provide a session to the user 210 at a determined time based on the user profile 175, the response score of the user 210, and the request of the user 210. The session processor 140 can determine the optimal time to provide a session to the user 210. For example, the session processor 140 can determine a time of day when the likelihood of a response is greater than at other times, which is determined by the user's previous activities. Then, the session processor 140 can determine to always provide a session to the user 210 at the time of day when the likelihood of a response is greater.

[0149] B. Systems and Methods for Improving User Substance Use Through Digital Therapeutics Management

[0150] Figure 8 A flowchart of a method 800 for improving user substance use is depicted. The method 800 can be performed by any component of the system 100, such as the session management service 105, the user device 110, or the user 210, etc. Under the method 800, one or more processors can administer a digital therapeutic to the user (805). The digital therapeutic can be directed at addressing the user's substance use problem. One or more processors can provide an instruction to the user (810). The instruction can direct the user to perform an activity. One or more processors can receive a response (815). The response can be based on the user's performance during the activity. One or more processors can determine a score (820). The score can be based on the response. One or more processors identify an activity based on the score (825). The score can indicate a subsequent activity provided by one or more processors to the user. One or more processors can decide whether to continue the digital therapeutic (830). This can be based on the effectiveness of the intervention or the length of the intervention, etc. One or more processors can determine whether session metrics show better improvement than baseline metrics (835). The method 800 can include determining that improvement is shown when it is determined that the session metrics are better than the baseline metrics (840). The method 800 can include determining that no improvement is shown when it is determined that the session metrics are not better than the baseline metrics (845).

[0151] More specifically, the method 800 can include administering a digital therapeutic to the user. The digital therapeutic can be associated with a user having SUD (e.g., the user 210). SUD can be the result of, for example, genetics, brain chemistry (e.g., changes in neurotransmitter levels, such as dopamine), mental health disorders (e.g., anxiety, depression, or attention deficit hyperactivity disorder (ADHD)), personality traits (e.g., impulsive behavior), coping mechanisms (e.g., lack of effective coping strategies), or early exposure (e.g., during adolescence when the brain is still developing). The effects of SUD on the user can include physical health effects (e.g., cardiovascular disease, lung disease, etc.) and mental health effects (e.g., depression, anxiety, etc.).

[0152] The user can have any demographics or characteristics, such as age (e.g., adult (over 18 years old) or late adolescence (between 18 - 24 years old)) or gender (e.g., male, female, or non - binary), etc. At least partially concurrent with the time instance or session in which the user performs an activity, the user may be taking a drug to address a pathology. For example, the drug can include naloxone, naltrexone, nalmefene, samidorphan, nalorphine, levallorphan, naropine, alvimopan, methylnaltrexone, naloxicon, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, lofexidine, or a GLP - 1 agonist, etc. The drug can have an effective amount (e.g., dose or frequency) that is sufficient to produce a positive outcome or alleviate symptoms (e.g., weight loss). The efficacy of the drug in addressing the user's SUD can be improved or enhanced by being concurrent with the interventions performed and monitored via the digital therapeutic application.

[0153] In some embodiments, a user of the digital therapeutic application can be exposed to or obtain a session for the user to perform via the digital therapeutic application (e.g., application 125 or the research application described herein). As discussed herein, the session can include a repeating cycle of the selection activity and the visualization activity described herein. A second group can include another group of users as a control group. The users in the second group can be exposed to or obtain a control therapy (sometimes referred to herein as a placebo or standard treatment).

[0154] The control therapy can exclude activities designed to address SUD and performed via the digital therapeutic application. In some embodiments, the control therapy can include an intervention performed via an application on a computing device that is inert with respect to SUD or related symptoms. In some embodiments, the control therapy can include an inert version of the intervention that has no association with SUD. The inert version of the intervention may lack the generation of an appropriate intervention for each user.

[0155] In some embodiments, the control therapy can include a care - as - usual (CAU) treatment protocol. The CAU treatment protocol may lack the digital therapeutic application described herein. For example, the CAU treatment protocol can have the user receive SUD drug treatment as scheduled (e.g., one to three times a day), and can include an SUD assessment in person or via a web application to evaluate symptoms. Baseline metrics (e.g., metrics prior to the intervention) can be obtained from the users in the treatment group and the control group (e.g., those receiving the inert version or CAU) (e.g., via a computing device).

[0156] Method 800 may include providing an indication (710) to a user. The indication may be related to at least one of a selection activity and a visualization activity or a combination thereof. For example, repeating an indication of a substance use word and / or a memory word and / or a neutral word, and an indication of information about a future event. The user may also be prescribed a medication for substance use. The user may use Method 800 to at least partially treat substance use.

[0157] Method 800 may include receiving a response (815). The response may be an interaction of the user with the activity. For example, the response may include an interaction of the user with a word displayed on a user device, an instance where the user rejects a selection of a word, and an instance where the user provides information about a future event.

[0158] Method 800 may include determining a score (820) based on the response. The score may be based on the number of correct interactions, the percentage of correct interactions, the selection speed, or any combination thereof. A correct interaction indicates the number of times the user correctly selects or avoids selecting a word. For example, for a selection activity, a correct interaction may be the user selecting a neutral word, avoiding selecting a substance use word, and / or avoiding selecting a memory word. As another example, for a memory quiz, a correct interaction may be the user selecting a memory word and avoiding selecting a neutral word. The selection speed may indicate the time between when a word appears on the user device and when the user selects the word.

[0159] Method 800 may include identifying an activity (825) based on the score. The score may indicate the performance and progress of the user. The score may meet a threshold and indicate an increase in the number of words and / or an increase in the difficulty of subsequent activities. The score may also indicate the type of activity to be provided to the user, such as a selection activity or a visualization activity.

[0160] A baseline measurement may be obtained (e.g., by a computing device) before the user performs any activity of an intervention via a digital therapeutic application (e.g., Application 125 or a research application described herein). The baseline measurement may indicate the user's condition in terms of SUD severity. Baseline metrics may include, for example, substance use frequency, Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis, Obsessive Compulsive Drug Use Scale (OCDUS) metric, Drug Abstinence Self-Efficacy Scale (DASES) metric, Modified Visual Analogue Scale (MVAS) rating, self-reported substance use, Opioid Substitution Treatment Quality of Life (OSTQOL) scale, Recovery Empowerment Scale, Perceived Stress Scale, impact on daily functioning, tolerance, withdrawal, or duration of use, etc. Before performing the intervention, the user may have an initial baseline metric that meets a baseline threshold. The threshold may depict, define, or identify the value of the initial metric according to which the user is determined to be suitable or eligible to perform activities via the digital therapeutic application. The initial metric may be, for example, a DSM-5 that meets 4 or more criteria.

[0161] Session metrics can be associated with a user (e.g., user 210) relative to a SUD. Session metrics can be obtained after at least one time instance or session in which the user performs an activity via a digital therapeutic application (e.g., via a computing device). Baseline measurements can indicate the user's condition in terms of SUD severity and the associated impact on the user's daily life and activities due to the implementation of the intervention. Session metrics can include, for example, substance use frequency, Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnoses, Obsessive Compulsive Drug Use Scale (OCDUS) metrics, Drug Abstinence Self-Efficacy Scale (DASES) metrics, Modified Visual Analogue Scale (MVAS) scores, self-reported substance use, Opioid Substitution Treatment Quality of Life (OSTQOL) scale, Recovery Empowerment Scale, Perceived Stress Scale, impact on daily functioning, tolerance, withdrawal, or duration of use, etc. Session metrics can be of the same type of measurement as baseline metrics. Session metrics can be obtained from users in both treatment and control groups.

[0162] Method 800 can include identifying or determining whether to continue (830). The determination can be based on a set length of the trial (e.g., days, weeks, or years), a set number of time instances in which one or more activities are performed, a set amount of time in which the activities are performed, or a set number of activities to be provided to the user. For example, the set number of time instances can be between 1 week and 6 months relative to obtaining baseline metrics. For example, digital therapy can be performed at least daily, every other day, every 3 days, or weekly. When the amount of time elapsed since obtaining baseline metrics exceeds the set length, it can be determined to stop providing additional activities.

[0163] Conversely, when the amount of time elapsed since obtaining baseline metrics does not exceed the set length, it can be determined to continue providing additional interventions and repeat from (805). The selection or modification of the indication for the next time instance or session can be based on the activity performance in the previous time instance or session. In some embodiments, the next indication can be modified based on response data when the user performs an activity in the previous time instance or session. In some embodiments, the next indication can be modified based on a score determined according to the activity performance in the previous time instance or session. The indication can be modified, for example, according to the execution order (e.g., relative to other interventions), the length of time to complete the intervention, and the difficulty of performing the intervention, etc. The selection or modification of the indication for the next time instance or session can be independent of the execution of the intervention in the previous time instance or session.

[0164] Method 800 may include identifying or determining whether a session metric has improved compared to a baseline metric (835). The improvement may correspond to a reduction in substance use or the intensity of side effects related to SUD. Improvement may be indicated when the session metric increases by a first predetermined magnitude compared to the baseline metric, or when the session metric decreases by a second predetermined magnitude compared to the baseline metric. The magnitude may identify or define the difference in values between the baseline metric and the session metric to determine a reduction in the intensity of side effects related to SUD displayed by the user. Whether improvement is indicated by an increase or a decrease may depend on the type of metric used to measure the user's metrics relative to SUD. The magnitude may also depend on the type of metric used and may generally correspond to a difference in values that shows a significant difference relative to SUD, or a statistically significant result showing the difference in values between the baseline metric and the session metric.

[0165] In some embodiments, at least one of the first predetermined magnitude or the second predetermined magnitude may be calculated, generated, or otherwise determined (e.g., by a computing device). The first predetermined magnitude or the second predetermined magnitude may be based on baseline and session metrics obtained from users in a treatment group or a control group. The magnitude may correspond to the difference between the changes in the baseline and session metrics in the treatment group and the changes in the baseline and session metrics in a control group (e.g., receiving a control treatment) that is statistically significant. The difference may be based on any number of statistical tests, such as a t-test, a z-test, a chi-square test, etc.

[0166] Method 800 may include determining to indicate improvement (840) when it is determined that the session metric has improved compared to the baseline metric. In some embodiments, when the DSM-5 metric decreases by a first predetermined magnitude from the baseline DSM-5 metric, improvement may be determined (e.g., by a computing system or a clinician examining the user). In some embodiments, when the session OSTQOL metric decreases by a second predetermined magnitude from the baseline OSTQOL metric, improvement may be determined. In some embodiments, when the session dropout metric decreases by a second predetermined magnitude from the baseline dropout metric, improvement may be determined. In some embodiments, when the session percentage impact on daily life metric decreases by a first predetermined magnitude from the baseline percentage impact on daily life metric, improvement may be determined. After administering a digital treatment, the user's substance use may decrease.

[0167] Method 800 may include determining that no improvement is shown (845) when it is determined that the session metrics are not an improvement over the baseline metrics. In some embodiments, when the DSM-5 metrics do not decrease by a first predetermined amount from the baseline DSM-5 metrics, it may be determined (e.g., by a computing system or a clinician examining the user) that no improvement has occurred. In some embodiments, when the session OSTQOL metrics do not decline by a second predetermined amount from the baseline OSTQOL metrics, it may be determined that no improvement has occurred. In some embodiments, when the session dropout metrics do not decrease by a second predetermined amount from the baseline dropout metrics, it may be determined that no improvement has occurred. In some embodiments, when the session percentage impact on daily life metrics do not decrease by a first predetermined amount from the baseline percentage impact on daily life metrics, it may be determined that no improvement has occurred.

[0168] Example 1: Efficacy of Cognitive Activities in Digital Therapeutics for SUD

[0169] In one example, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), the CT-102 mobile application (e.g., Application 125) was provided to individuals self-reporting a diagnosis of moderate to severe opioid use disorder (OUD). The DSM-5 includes a series of criteria and identifies individuals with moderate to severe OUD. An individual meets 4 - 5 criteria for moderate OUD and 6 or more criteria for severe OUD. The treatment duration was approximately 2 - 52 weeks. This study was a single-group study aimed at examining the feasibility and acceptability of a simplified version of the CT-102 application for participants 18 years of age and older with OUD. The single group had at least 20 participants.

[0170] Based on an expected early termination (ET) rate of 33%, at least 20 participants were recruited to achieve at least 10 completers. This estimate was based on an approximation and reflected an ET of 50% determined in randomized controlled trials with treatment durations of 2 to 52 weeks. There was a subcohort of approximately 5 - 10 participants in the group who voluntarily agreed to participate in a designated user experience research (UXR) survey and interview.

[0171] Users will participate in the activities disclosed herein, including activity selection, visualization activities, and memory tests. Users will be evaluated based on multiple clinical endpoints provided below.

[0172] Screening phase: All participants were required to undergo screening for up to 7 days. The evaluations during this period were conducted according to the Schedule of Activities and Assessments (SoA). According to the researchers' evaluations, if a participant met all inclusion criteria and did not meet any exclusion criteria, they were considered eligible. Screening and baseline visits could be conducted on the same day.

[0173] Baseline Visit: At the end of the screening phase, eligible participants were enrolled. Baseline assessments were conducted according to the SoA. Participants downloaded and activated the Study APP (e.g., abbreviated as CT-102) on their personal primary iPhone or Android smartphone. Participants were instructed to access and use the Study APP daily.

[0174] Engagement Phase: Participants interacted with the Study APP daily and completed activities as instructed by the Study APP. During the engagement phase, participants underwent approximately 2 oral fluid drug tests per week. These tests were conducted to support the treatment mechanism provided by the Study APP and were not considered study endpoints. Oral fluid drug tests included twice-weekly remotely administered point-of-care tests and once-weekly remotely provided additional oral fluid samples for confirmatory laboratory testing (transmitted by mail). Participants received the assessments described in the SoA. Approximately 6 participants received a virtual interview at the end of Week 2 (Days 9 to 15). Approximately 10 participants participated in the weekly user engagement survey.

[0175] Follow-up Phase: At the end of the engagement, participants will undergo a one-week post-treatment follow-up. Participants will receive the assessments described in the SoA. Participants who opt-in to the UXR will participate in the final UXR interview.

[0176] Primary Endpoints:

[0177] ● Degree of Engagement

[0178] o Number of days of app engagement during the engagement phase

[0179] o Number of courses completed during the engagement phase

[0180] o Number of DiNaMo™ sessions completed during the engagement phase

[0181] ● Therapeutic Alliance

[0182] o Change in the Mobile Agnew Relation Measure (mARM) during the engagement phase

[0183] ● Change in Cognitive Function as Measured by the Mobile Agnew Relation Measure (mARM) during the Engagement Phase

[0184] o Change in the delay discounting metric derived from the Financial Choice Questionnaire during the engagement phase

[0185] o Change in the drug demand metric derived from the Hypothetical Purchase Task during the engagement phase

[0186] o Change in objective working memory function as measured by the Digit Span Task during the engagement phase

[0187] o Changes in subjective working memory function measured by the metamemory questionnaire during the engagement phase

[0188] o Changes in subjective inhibitory control measured by the Barratt Impulsiveness Scale (BIS-11) during the engagement phase

[0189] o Maximum working memory challenge conditions achieved by DiNaMo during the engagement phase

[0190] o Active working memory challenge conditions in DiNaMo during the engagement phase

[0191] o Maximum response latency challenge conditions achieved by DiNaMo during the engagement phase

[0192] o Active response latency challenge conditions in DiNaMo during the engagement phase

[0193] ● Application usability and perception

[0194] o Changes in the patient global impression (PGI-C single item) during the engagement phase

[0195] ● Opioid use and craving management

[0196] o Changes in the Obsessive Compulsive Drug Use Scale [OCDUS] during the engagement phase

[0197] o Changes in drug withdrawal self-efficacy (Drug Abstinence Self-Efficacy Scale [DASES]) during the engagement phase

[0198] o Changes in the modified visual analogue scale (MVAS) craving scores during the engagement phase

[0199] ● Participant feedback

[0200] o Customer satisfaction (CSAT) (single item) during the engagement phase

[0201] o Digital Intervention Barriers Scale (DIBS-7) during the engagement phase

[0202] ● Changes in the Recovery Empowerment Scale during the engagement phase

[0203] Changes in the Perceived Stress Scale during the engagement phase

[0204] Exploratory endpoints:

[0205] • Changes in self-reported opioid use using the Timeline Followback (TLFB) procedure during the engagement phase

[0206] • Changes in the total amount of substance use self-reported using the TLFB procedure during the participation phase

[0207] • Changes in the Recovery Empowerment Scale during the participation phase

[0208] • Changes in the Perceived Stress Scale during the participation phase

[0209] • Changes in the Opioid Substitution Treatment Quality of Life (OSTQOL) during the participation phase

[0210] The correlations between user engagement metrics, perceived treatment outcomes (PGI-C), user satisfaction (CSAT), and treatment-related changes in OCDUS, DASES, MVAS, delay discounting (Financial Choice Questionnaire), cognitive measures (BIS-11, metamemory questionnaire, digit span) and the TLFB activities and the Schedule of Assessments (SoA). A study of adults (aged 18 and above) with substance use-related disorders using the CT-102 mobile application can follow the study protocol 700 as Figure 7 shown

[0211] Screening phase

[0212] ● All participants are required to enter a 7-day screening phase to determine their eligibility. Assessments during this period are conducted according to the Schedule of Activities and Assessments (SoA).

[0213] ● If all required assessments are completed according to the protocol, participants can complete the screening and baseline visit on the same day.

[0214] Baseline visit (Day 1)

[0215] ● At the end of the screening phase, eligible participants will be enrolled.

[0216] ● Participants will also undergo the baseline assessment as described in the Schedule of Activities and Assessments.

[0217] ● Site staff assist eligible participants in downloading and installing the StudyApp onto their personal primary smartphones. The StudyApp can be activated using a unique activation code.

[0218] ● Participants are required to visit and use the StudyApp daily.

[0219] ● If all required assessments are completed according to the protocol, participants will complete the screening and baseline visit on the same day.

[0220] Participation phase

[0221] ● Participants interact with the StudyApp daily and complete activities as instructed by the StudyApp.

[0222] ● During the participation phase, participants will undergo oral fluid drug testing approximately twice a week. These tests are conducted to support the treatment mechanism provided by the StudyApp and are not considered research endpoints. Oral fluid drug testing includes twice-weekly remotely administered point-of-care tests and once-weekly remotely provided additional oral fluid samples for confirmatory laboratory testing (sent by mail).

[0223] ● Participants will undergo the assessments described in the SoA

[0224] ● Approximately 6 participants will receive a virtual interview at the end of the second week

[0225] ● Approximately 10 participants will participate in the user engagement survey each week

[0226] Follow-up phase (1 week)

[0227] ● At the end of participation, participants will receive post-treatment follow-up. Participants will undergo the assessments described in the SoA

[0228] ● Participants who opt into the UXR portion will participate in a final UXR interview

[0229] At least 20 participants were enrolled in this study. Approximately 10 sites will participate in the study

[0230] Research evaluation

[0231] Monetary Choice Questionnaire

[0232] The Monetary Choice Questionnaire (MCQ) is a self-report assessment tool used to evaluate delay discounting behavior, which measures the tendency for rewards to devalue as the delay to receipt of the reward increases. Through a series of 27 hypothetical decision prompts, participants choose between a smaller immediate reward and a larger delayed reward. An individual's discount rate for future rewards indicates their preference for immediate gratification and delayed gains, providing insights into the decision-making processes related to financial decisions, impulsivity, and health behaviors. This delay discount rate can be calculated based on MCQ responses

[0233] Hypothetical Purchase Task

[0234] The Hypothetical Purchase Task (HPT) is a tool used to measure the hypothetical drug demand for opioids and other substances. In the HPT, participants report the quantity of drugs they would purchase at nine increasing prices. This method helps researchers create demand curves and evaluate drug demand behavior. Research has found correlations between these demand measurements and clinical variables such as substance use and treatment outcomes, including predicting future opioid use in patients with OUD.

[0235] Barratt Impulsivity Scale (BIS-11)

[0236] The BIS-11 is designed to evaluate impulse control in the areas of attention (e.g., difficulty concentrating), motor (e.g., automatic driving), and planning-related (e.g., failure to plan ahead). It aims to improve upon previous versions of the BIS. The BIS-11 has previously demonstrated treatment-related changes in the responses of patients with OUD to psychological interventions.

[0237] It ranks 30 items using a 4-point scale (1 = never / rarely, 2 = occasionally, 3 = often, 4 = almost always / always). The BIS-11 has 3 subscales:

[0238] The attentional impulsivity subscale evaluates concentration, intrusive thoughts, and racing thoughts.

[0239] The motor impulsivity subscale evaluates the tendency towards impulsive behavior and lifestyle consistency.

[0240] The non-planning impulsivity subscale evaluates careful thinking and planning and the enjoyment of challenging mental activities.

[0241] Drug Abstinence Self-Efficacy Scale (DASES)

[0242] The DASES is a 20-item self-report survey that measures an individual's confidence in their ability to abstain from drugs in specific situations. The DASES is a psychometrically validated adaptation of the Alcohol Abstinence Self-Efficacy Scale.

[0243] Customer Satisfaction (CSAT) single item

[0244] The CSAT is a single-item rating of a customer's satisfaction with a product or service. This survey is deliberately designed to be simple and easy to understand, encouraging users to participate and provide honest feedback. Participants are asked to rate their satisfaction on a 5-point scale, where 1 represents "very dissatisfied" and 5 represents "very satisfied". This format allows for a direct quantitative evaluation of customer satisfaction, providing valuable insights into the effectiveness and user-friendliness of digital interactions or interventions.

[0245] Meta-Memory Questionnaire (MMQ)

[0246] The Meta-Memory Questionnaire (MMQ; also known as the Multifactorial Memory Questionnaire) is a self-report tool designed to evaluate three subjective dimensions of memory: overall satisfaction with memory (MMQ-Satisfaction), perception of daily memory ability (MMQ-Ability), and use of memory strategies and aids (MMQ-Strategy). The MMQ focuses on clinically relevant aspects of memory, including memory-related emotions, and avoids items unrelated to daily functioning. The questionnaire consists of 57 self-report items and takes approximately 10 minutes to complete. The MMQ has been determined to have excellent psychometric properties and also shows responsiveness to brief cognitive training interventions in clinical populations.

[0247] Digital Intervention Barriers Scale (DIBS-7)

[0248] DIBS-7 identifies a 10-item unidimensional scale that covers barriers commonly faced in digital mental health interventions. DIBS-7 has demonstrated strong criterion-related validity, with its mean score strongly correlated with established variables related to digital mental health intervention (DMHI) engagement, including treatment expectations, engagement behavior indicators, and satisfaction. These associations are stronger than those with user characteristics related to engagement, indicating its broad applicability across different user groups. DIBS-7 further shows a significant moderation of treatment response, highlighting the relevance of DIBS-7 in assessing factors that influence the effectiveness of DMHIs.

[0249] Mobile Agnew Relationship Measure (mARM)

[0250] mARM is a validated patient-rated scale that evaluates the DWA of using mobile health interventions to treat mental health conditions. It is adapted from the well-validated Agnew Relationship Measure and consists of 25 items that are rated on a 7-item scale ranging from "strongly disagree" to "strongly agree".

[0251] System Usability Scale (SUS)

[0252] The System Usability Scale (SUS) is a widely used scale for quantifying the usability of many software and hardware products. SUS scores are expressed as a percentage and range from 0 to 100. A perfect score of 100% indicates perfect usability and an excellent user experience.

[0253] Patient Global Impression of Change (PGI-C)

[0254] The Patient Global Impression of Change (PGI-C) is a self-reported 7-point scale used to describe the patient's rating of overall improvement. The PGI-C has been validated against well-established measures of pain intensity, pain interference with daily life, and treatment effectiveness in many other episodic diseases. Importantly, change relative to baseline, rather than relative to the last visit, is evaluated.

[0255] Obsessive Compulsive Drug Use Scale (OCDUS)

[0256] The Obsessive Compulsive Drug Use Scale (OCDUS) measures three factors: thoughts about substances and interference, desire and control, and resistance to thoughts and intentions.

[0257] Self-reported substance use via Timeline Followback (TLFB)

[0258] The TLFB retrospectively collects data on substance use for each day during the reporting period, providing detailed information about use patterns. The TLFB was originally developed to assess self-reported alcohol use (Sobell & Sobell, 1992), but the procedure has since been adapted to support the assessment of other substance use, including opioids, and has been validated for this purpose.

[0259] Recovery Empowerment Scale

[0260] The Recovery Empowerment Scale (RES) is a self-report tool consisting of 20 items designed to evaluate the empowerment of individuals in recovery from substance use disorders. Seven of the items were adapted from the Women's Recovery Empowerment Scale. The RES assesses four dimensions of empowerment: emotional, cognitive, behavioral, and relational. Specifically, it includes four emotional empowerment items, four cognitive empowerment items, three behavioral empowerment items, and nine relational empowerment items. Respondents rate the items on a seven-point Likert scale ranging from "almost never" to "almost always", with higher scores indicating greater empowerment. The scale is applicable to both men and women and provides a comprehensive and reliable measure of empowerment for diverse populations.

[0261] Perceived Stress Scale

[0262] The Perceived Stress Scale consists of 14 items and is used to measure to what extent situations in a person's life are appraised as stressful. The scale also includes some direct questions about the current stress level.

[0263] Brief Trauma Questionnaire (BTQ)

[0264] The BTQ is a 10-item self-report questionnaire designed to assess trauma exposure according to the DSM-IV. However, due to the difficulty in accurately evaluating subjective responses, it specifically includes only life-threatening and severe injuries.

[0265] The BTQ was originally created to assess trauma exposure according to the DSM-IV guidelines. Due to the difficulty in accurately measuring Criterion A.2 (subjective response) in a brief self-report format, it only focuses on Criterion A.1 (life threat / severe injury). Since Criterion A.2 has been removed from the PTSD diagnostic criteria in the DSM-5, the BTQ now provides a comprehensive assessment of Criterion A.

[0266] Opioid Substitution Treatment Quality of Life Scale (OSTQOL)

[0267] The Opioid Substitution Treatment Quality of Life Scale (OSTQOL) is a specialized tool developed to evaluate the quality of life (QOL) of patients receiving opioid substitution treatment (OST). The scale was developed through a rigorous process of focus group discussions with OST patients to identify key QOL themes. The final scale consists of 38 items covering 6 subscales, covering all aspects of QOL, some of which are particularly relevant to patients with OUD: personal development, psychological distress, social connection, substance well-being, satisfaction with opioid substitution treatment, and experiences of stigma and discrimination. This tool has shown good internal consistency reliability, strong convergent and discriminant validity, and good treatment responsiveness in large-scale trials in the OUD patient population. The OSTQOL is a multidimensional tool designed to minimize the burden on respondents and administrators while providing a comprehensive assessment of the QOL of OST patients.

[0268] Modified Visual Analogue Scale (MVAS)

[0269] The modified VAS for craving is a two-dimensional representation used to evaluate the intensity and frequency of craving (expressed as the percentage of time during the day that craving experiences occur). Different from the standard VAS (which usually consists of a single line marked with endpoints representing "no pain" and "the worst pain imaginable"), the MVAS includes additional markers or descriptors on the scale, enabling participants to more accurately represent their pain levels by differentiating between mild, moderate, and severe pain. Using the MVAS can reduce ambiguity and improve the reliability of pain assessment.

[0270] Columbia-Suicide Severity Rating Scale (C-SSRS)

[0271] The Columbia-Suicide Severity Rating Scale (C-SSRS) is a scale for assessing suicidal thoughts and behaviors. It assesses the degree of an individual's suicidal thoughts, ranging from "wanting to die" to "active suicidal ideation with specific plans, intentions, and behaviors". This assessment includes a baseline assessment and a post-baseline assessment. The former assesses whether there have been any suicide events and suicidal thoughts in the participant's lifetime, and the latter focuses on suicidal tendencies since the last trial visit.

[0272] UXR interviews

[0273] Some participants will participate in video-conference-based qualitative user interviews with members of the Click Therapeutics product development team. Approximately 6 participants will participate in UXR interviews in Week 2 (Days 9 to 15), and 10 participants will participate in the final visit interviews. These interviews will collect more information about the users' experience of using the application, such as their favorite application features, the usability of the features, challenges related to the intervention, or any other feedback on regular interaction with the application.

[0274] User Engagement Survey

[0275] A User Engagement Survey will be developed to understand the participants' experience of the study application during the engagement phase. The questionnaire will ask questions related to perceived fun, challenges, and related user experiences. Participants will fill out these questionnaires electronically once a week. It will take approximately 10 minutes to complete the questionnaire.

[0276] Example 2: Clinical Evaluation of the Safety and Efficacy of a Digital Therapeutics Application

[0277] This study evaluated the efficacy and safety of CT-102 as an adjunctive therapy in participants 18 years of age and older with OUD who were being treated with US FDA-approved medications for OUD (MOUD). The treatment interval was 2 - 52 weeks. The digital therapeutics application was evaluated as an adjunctive treatment for OUD. Users will participate in the activities disclosed herein, including selection activities, visualization activities, and memory tests. Users will be evaluated based on multiple clinical endpoints provided below.

[0278] Users of CT-102 will evaluate the statistically significant differences in the primary and secondary clinical endpoints described herein according to one or more controls. One or more controls include a control group not participating in the CT-102 group, users not participating in one or more selection activities, visualization activities, or memory test activities. Evaluate the changes in the primary and secondary clinical endpoints of the CT-102 group and the control group relative to the baseline, and evaluate the clinically significant change values of the CT-102 group compared with the control group.

[0279] Study objective: The purpose of this study is to evaluate the efficacy and safety of CT-102 as adjuvant therapy in OUD patients aged 18 and above receiving MOUD during the treatment interval.

[0280] Primary endpoint: Biochemically verified opioid abstinence, defined as ≥80% negative samples during the evaluation period.

[0281] Secondary endpoints:

[0282] ● Changes in self-reported non-opioid use during the participation phase (timeline follow-back procedure)

[0283] ● Changes in self-reported opioid use during the participation phase (timeline follow-back procedure)

[0284] ● Changes in the Recent Overdose Experience Scale (RODES) during the participation phase

[0285] ● Changes in the Personal Opioid Overdose Risk Survey (PORS) during the participation phase

[0286] ● Changes in the Opioid Substitution Therapy Quality of Life (OSTQOL) during the participation phase

[0287] ● Changes in the Short Form Health Survey (SF-36) during the participation phase

[0288] ● Changes in the Obsessive Compulsive Drug Use Scale (OCDUS) during the participation phase

[0289] ● Changes in the Drug Abstinence Self-Efficacy Scale (DASES) during the participation phase

[0290] ● Changes in biochemically verified non-opioid use during the participation phase

[0291] ● Changes in the MOUD retention rate reported by study participants during the participation phase, with sufficient clinical records provided to the study team upon request

[0292] ● Overall improvement evaluated by the Patient Global Impression of Change (PGI-C) during the participation phase

[0293] ● During the engagement phase, the durability of efficacy is measured by biochemically verified opioid withdrawal from over-the-counter opioids.

[0294] Exploratory endpoints:

[0295] ● The engagement of participants with the investigational digital therapy is measured by key engagement metrics.

[0296] ● The durability of efficacy is measured by self-report of opioid use (timeline follow-back procedure) during and / or after the engagement phase.

[0297] ● The durability of efficacy is measured by self-report of non-opioid use (timeline follow-back procedure) during and / or after the engagement phase.

[0298] Safety endpoints:

[0299] ● The frequency and severity of AEs, serious AEs, and study termination due to AEs

[0300] ● The incidence of suicidal behavior and suicidal ideation, assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS).

[0301] Study design: This is a multicenter, randomized, double-blind, digital-controlled study designed to evaluate the efficacy and safety of CT-102 as an adjunct to MOUD for OUD in patients 18 years of age and older.

[0302] Screening phase:

[0303] • All participants enter a 14-day screening phase to determine eligibility.

[0304] • During the screening phase, participants complete various tasks in the onboarding software module to confirm their digital literacy and interest in the study.

[0305] • Assessments during this period are based on the Schedule of Activities and Assessments (SoA).

[0306] Run-in phase: Participants then undergo a 28-day run-in phase designed to establish a baseline of use.

[0307] Baseline visit: After completion of the 28-day run-in phase, the study team ensures that participants continue to meet all inclusion criteria and have no exclusion criteria. Participants are randomly assigned to CT-102 or digital control on Day 1.

[0308] Treatment phase:

[0309] • Participants follow the protocol treatment tasks for up to 365 days.

[0310] • Participants interact with the Study APP daily and complete tasks as instructed by the Study APP.

[0311] • During the treatment phase, participants undergo oral fluid drug testing approximately twice a week. Between treatment phases, if more than 16 out of 20 samples are negative responders during this period, they are considered drug abstinent.

[0312] • Oral fluid drug testing includes twice-weekly remotely administered point-of-care testing and twice-weekly additional remotely collected oral fluid samples for confirmatory laboratory testing (transmitted by mail).

[0313] • The results of the biological samples can also be cross-referenced with self-reported opioid use, which is evaluated via a timeline follow-back procedure.

[0314] Follow-up phase: After completion of the designated treatment, participants will be monitored for up to 12 weeks and undergo post-treatment follow-up. Participants will receive the evaluations described in the SoA.

[0315] Statistical analysis: Assess the equivalence of treatment conditions with respect to key baseline variables. This involves comparing treatment conditions at the baseline levels of demographic and potential treatment moderators (such as gender and age). According to the intention-to-treat principle, all randomized participants are included in the analysis. The null hypothesis for the primary endpoint is that there is no difference in success rates between the two groups, and the alternative hypothesis is that the success rates between the two groups are different. A proportion test is used to evaluate this hypothesis. The main objective is to obtain a stable estimate of the effect size and adjust the sample size to show a statistically significant difference in the primary endpoint between the treatment groups.

[0316] C. Network and Computing Environment

[0317] The various operations described herein can be implemented on a computer system. Figure 9 A simplified block diagram of a representative server system 900, client computing system 914, and network 926 that can be used to implement some embodiments of the present disclosure is shown. In various embodiments, the server system 900 or a similar system can implement the services or servers or portions thereof described herein. The client computing system 914 or a similar system can implement the clients described herein. The system 900 described herein can be similar to the server system 900. The server system 900 can have a modular design that incorporates multiple modules 902 (such as blades in a blade server embodiment); although two modules 902 are shown, any number of modules can be provided. Each module 902 can include a processing unit 904 and local memory 906.

[0318] The processing unit 904 may include a single processor (which may have one or more cores) or multiple processors. In some embodiments, the processing unit 904 may include a general-purpose main processor and one or more dedicated coprocessors, such as a graphics processor, a digital signal processor, etc. In some embodiments, some or all of the processing unit 904 may be implemented using custom circuitry (such as an application-specific integrated circuit (ASIC) or a field-programmable gate array (FPGA)). In some embodiments, such integrated circuits execute instructions stored on the circuit itself. In other embodiments, the processing unit 904 may execute instructions stored in the local memory 906. Any type of processor in any combination may be included in the processing unit 904.

[0319] The local memory 906 may include volatile storage media (e.g., DRAM, SRAM, SDRAM, etc.) or non-volatile storage media (e.g., magnetic or optical disks, flash memory, etc.). The storage media included in the local memory 906 may be fixed, removable, or upgradeable as needed. The local memory 906 may be physically or logically divided into various sub-units, such as system memory, read-only memory (ROM), and permanent storage devices. The system memory may be a read-write memory device or a volatile read-write memory, such as dynamic random access memory. The system memory may store some or all of the instructions and data required by the processing unit 904 during operation. The ROM may store static data and instructions required by the processing unit 904. The permanent storage device may be a non-volatile read-write memory device that can store instructions and data even when the module 902 is powered off. The term "storage media" as used herein includes any medium that can store data indefinitely (subject to being overwritten, electrical interference, power loss, etc.), but does not include carrier waves and transient electronic signals propagated through wireless or wired connections.

[0320] In some embodiments, the local memory 906 may store one or more software programs executed by the processing unit 904, such as an operating system or a program implementing various server functions, such as the functions of the system 900 or any other system described herein, or the functions of any other server associated with the system 900 or any other system described herein.

[0321] "Software" generally refers to a sequence of instructions that, when executed by a processing unit 904, causes the server system 900 (or a portion thereof) to perform various operations, thereby defining one or more specific machine implementations for executing and performing the operations of the software program. The instructions can be stored as firmware residing in read-only memory or as program code stored in a non-volatile storage medium, which can be read into volatile working memory for execution by the processing unit 904. The software can be implemented as a single program or as a collection of separate programs or program modules that interact as needed. From the local storage 906 (or non-local storage described below), the processing unit 904 can retrieve program instructions to be executed and data to be processed from the local storage 906 (or non-local storage described below) to perform the various operations described above.

[0322] In some server systems 900, multiple modules 902 can be interconnected via a bus or other interconnect 908, thereby forming a local area network that supports communication between the modules 902 and other components of the server system 900. The interconnect 908 can be implemented using various technologies, including server racks, hubs, routers, etc.

[0323] A wide area network (WAN) interface 910 can provide data communication capabilities between a local area network (e.g., via the interconnect 908) and a network 926 (e.g., the Internet). Other technologies can be used to communicatively couple the server system to the network 926, including wired (e.g., Ethernet, IEEE 802.3 standard) or wireless technologies (e.g., Wi-Fi, IEEE 802.11 standard).

[0324] In some embodiments, the local memory 906 is intended to provide working memory for the processing unit 904, providing rapid access to programs or data to be processed while reducing traffic on the interconnect 908. Storage of large amounts of data can be provided on the local area network via one or more mass storage subsystems 912 that can be connected to the interconnect 908. The mass storage subsystems 912 can be based on magnetic, optical, semiconductor, or other data storage media. Direct attached storage, storage area networks, network attached storage, etc. can be used. Any data storage or other data collections generated, used, or maintained by a service or server described herein can be stored in the mass storage subsystems 912. In some embodiments, additional data storage resources (possibly with increased latency) can be accessed via the WAN interface 910.

[0325] The server system 900 can operate in response to requests received through the WAN interface 910. For example, one of the modules 902 can implement a supervision function and allocate discrete activities to other modules 902 in response to received requests. Work allocation techniques can be used. When processing a request, the result can be returned to the requester through the WAN interface 910. Such operations can generally be automated. Additionally, in some embodiments, the WAN interface 910 can connect multiple server systems 900 to each other, thereby providing a scalable system capable of managing a large number of activities. Other techniques for managing server systems and server farms (collections of collaborating server systems) can be used, including dynamic resource allocation and reallocation.

[0326] The server system 900 can interact with various user-owned or user-operated devices via a wide area network, such as the Internet. Figure 9 An example of a user-operated device is shown, namely the client computing system 914. The client computing system 914 can be implemented as, for example, a consumer device such as a smartphone, other mobile phone, tablet, wearable computing device (such as a smartwatch, glasses), desktop computer, laptop computer, etc.

[0327] For example, the client computing system 914 can communicate through the WAN interface 910. The client computing system 914 can include computer components such as a processing unit 916, a storage device 918, a network interface 920, a user input device 922, and a user output device 924. The client computing system 914 can be a computing device implemented in various forms, such as a desktop computer, laptop computer, tablet, smartphone, other mobile computing device, wearable computing device, etc.

[0328] The processing unit 916 and the storage device 918 can be similar to the above-mentioned processing unit 904 and local storage 906. Suitable devices can be selected according to the requirements of the client computing system 914. For example, the client computing system 914 can be implemented as a "thin" client with limited processing power or a high-performance computing device. The client computing system 914 can be equipped with program code executable by the processing unit 916 to implement various interactions with the server system 900.

[0329] The network interface 920 can provide a connection to a network 926, such as a wide area network (e.g., the Internet), to which the WAN interface 910 of the server system 900 is also connected. In various embodiments, the network interface 920 can include a wired interface (e.g., Ethernet) or a wireless interface that implements various RF data communication standards (e.g., Wi-Fi, Bluetooth, or cellular data network standards (e.g., 3G, 4G, LTE, etc.)).

[0330] The user input device 922 can include any device (or devices) through which a user can provide signals to the client computing system 914; the client computing system 914 can interpret the signals as indicating a specific user request or information. In various embodiments, the user input device 922 can include any one or all of a keyboard, touchpad, touch screen, mouse or other pointing device, trackball, click wheel, dial, button, switch, keypad, microphone, etc.

[0331] The user output device 924 can include any device to which the client computing system 914 can provide information. For example, the user output device 924 can include a display image that is generated by or transmitted to the client computing system 914 for display. The display can incorporate various image generation technologies, such as liquid crystal displays (LCDs), light emitting diode (LED) displays (including organic light emitting diodes (OLEDs)), projection systems, cathode ray tubes (CRTs), etc., as well as support electronics (e.g., digital-to-analog or analog-to-digital converters, signal processors, etc.). Some embodiments can include devices that function as both input and output devices, such as touch screens. In some embodiments, other user output devices 924 can be provided in addition to or in place of the display. Examples include indicator lights, speakers, tactile "display" devices, printers, etc.

[0332] Some embodiments include electronic components, such as microprocessors, memories, and storage, which store computer program instructions on a computer-readable storage medium. Many of the features described in this specification can be implemented as processes that are specified as a set of program instructions encoded on a computer-readable storage medium. When these program instructions are executed by one or more processing units, they cause the processing units to perform the various operations indicated in the program instructions. Examples of program instructions or computer code include machine code, such as that generated by a compiler, and files that include higher-level code that is executed by a computer, electronic component, or microprocessor using an interpreter. Through appropriate programming, the processing units 904 and 916 can provide various functions for the server system 900 and the client computing system 914, including any functions performed by the server or client described herein or other functions.

[0333] It should be understood that the server system 900 and the client computing system 914 are exemplary, and there may be variations and modifications. Computer systems related to embodiments of the present disclosure may have other functions not specifically described herein. Additionally, although the server system 900 and the client computing system 914 are described with reference to specific blocks, it should be understood that these blocks are defined for convenience of description and are not intended to imply a specific physical arrangement of components. For example, different blocks may or may not be located in the same facility, the same server rack, or the same motherboard. Moreover, the blocks do not have to correspond to physically distinct components. The blocks can be configured to perform various operations, such as by programming a processor or providing appropriate control circuitry, and various blocks may or may not be reconfigured depending on how the initial configuration is obtained. Embodiments of the present disclosure can be implemented in various devices, including electronic devices implemented using any combination of circuitry and software.

[0334] Although the present disclosure has been described with respect to specific embodiments, those skilled in the art will recognize that numerous modifications can be made. Embodiments of the present disclosure can be implemented using a variety of computer systems and communication technologies, including but not limited to the specific examples described herein. Embodiments of the present disclosure can be implemented using any combination of dedicated components or programmable processors or other programmable devices. The various processes described herein can be implemented on the same processor or different processors in any combination. When a component is described as being configured to perform some operation, such a configuration can be implemented, for example, by designing electronic circuitry to perform the operation, by programming a programmable electronic circuit (such as a microprocessor) to perform the operation, or any combination thereof. Additionally, although the above embodiments may refer to specific hardware and software components, those skilled in the art will recognize that different combinations of hardware or software components can also be used, and specific operations described as being implemented in hardware can also be implemented in software, and vice versa.

[0335] A computer program incorporating various features of the present disclosure can be encoded and stored on various computer-readable storage media; suitable media include magnetic disks or tapes, optical storage media (such as compact discs (CDs) or digital versatile discs (DVDs), flash memory, and other non-transitory media). A computer-readable medium encoded with program code can be packaged together with a compatible electronic device, or the program code can be provided separately from the electronic device (e.g., downloaded via the Internet or as a separately packaged computer-readable storage medium).

[0336] Therefore, although the present disclosure has been described with respect to specific embodiments, it should be understood that the present disclosure is intended to cover all modifications and equivalents within the scope of the following claims.

Claims

1. A method for treating or ameliorating substance use disorder (SUD) in a user in need thereof, comprising: Administering to the user a treatment comprising a digital therapeutic comprising: identifying profiles that include multiple substance use words for users with substance use disorders; presenting a plurality of mnemonics unrelated to substance use and instructions to memorize the plurality of mnemonics; and Instructions are provided to perform an activity that refrains from selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words.

2. The method according to claim 1, wherein Administering the digital therapeutic further includes: Provides instructions to perform activities that provide information about future events.

3. The method according to claim 2, wherein: The future event is related to at least one of the user's health, relationships, values, finances, enjoyment, charitable contributions, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors related to substance use.

4. The method according to claim 3, wherein Administering the digital therapeutic further includes: Prior to providing instructions to perform the activity, providing instructions for the user to select a future event type selected from at least one of the user's health, relationships, values, finances, enjoyment, charitable contributions, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors related to substance use.

5. The method according to claim 2, wherein: Administering the digital therapeutic further includes: An indication is provided prior to the instruction to perform the activity for the user to select a category for the future event.

6. The method according to claim 5, wherein: Categories of future events were selected from the user's health, relationships, values, finances, enjoyment, charitable contributions, sobriety, small progress, achievements, future gratitude, challenges, lifestyle, or overcoming maladaptive behaviors related to substance use.

7. The method according to claim 2, wherein, Administering the digital therapeutic further includes: Provides an indication of the time frame for selecting a future event.

8. The method according to claim 7, wherein, Future events can occur in less than a month.

9. The method according to claim 7, wherein, Future events can occur over a period of more than one month.

10. The method according to claim 2, wherein Administering the digital therapeutic further includes: Based on the future event information provided by the user, the user is instructed to generate one or more visual cues.

11. The method according to claim 10, wherein: The one or more visual cues are images or text, including free text provided by a user.

12. The method according to any one of claims 1 to 11, wherein, Administering the digital therapeutic further includes: providing subsequent instructions to perform an activity that avoids selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; and A prompt is provided that includes one or more visual cues associated with future event information and instructions to perform an activity associated with the one or more visual cues.

13. The method according to claim 12, wherein: The cue is a timeline that identifies more than one visual cue.

14. The method according to claim 12, wherein The timeline automatically updates based on the time marked to the visual cue.

15. The method according to claim 12, wherein, The activity may include an audio recording or a text description.

16. The method according to any one of claims 4 to 15, wherein, Administering the digital therapeutic further includes: Provides prompts with information about future events after performing an activity that provides information.

17. The method according to any one of claims 1 to 16, wherein, The activity of refraining from selecting one or more of the plurality of memory words is performed simultaneously with the activity of refraining from selecting one or more of the plurality of substance use words.

18. The method according to any one of claims 1 to 17, wherein Administering the digital therapeutic further includes: Subsequent instructions are provided to perform activities of refraining from selecting one or more of the plurality of memory words and / or refraining from selecting one or more of the plurality of substance use words.

19. The method according to any one of claims 16 to 18, wherein, Administering the digital therapeutic further includes: providing subsequent instructions to perform an activity that avoids selecting one or more of the plurality of memory words and / or one or more of the plurality of substance use words; and After performing the activity of avoiding selecting one or more of the plurality of memory words and presenting one or more of the plurality of substance use words, a prompt related to information about the future event is provided.

20. The method according to any one of claims 1 to 19, wherein Administering the digital therapeutic further includes: Provide instructions to perform the activity of selecting all memory words from a plurality of words.

21. The method according to any one of claims 1 to 20, wherein, Administering the digital therapeutic further includes: Instructions are provided to perform an activity of selecting one or more memory words from a plurality of words.

22. The method according to claim 20 or 21, wherein Administering the digital therapeutic further includes: determining a score representing the percentage of correct interactions with the memory word; and A plurality of memory words are selected according to the scores.

23. The method according to any one of claims 1 to 22, wherein, Administering the digital therapeutic further includes: determining a score representing correct interaction, selection speed, or both during performance of one or more activities; and The subsequent multiple substance use words or the subsequent multiple memory words, or both, were selected based on the scores.

24. The method according to claim 23, wherein, The score is determined by correct interactions, selection speed, or both during the performance of the activity of selecting all memorized words from a plurality of words.

25. The method according to any one of claims 1 to 24, wherein, Administering the digital therapeutic further includes: determining scores representing correct interaction, selection speed, or both during performance of the activity to avoid selecting multiple memory words and / or multiple substance use words; and In response to the score satisfying the threshold, a determination is made to increase the number of words for a subsequent activity to avoid selecting the plurality of memory words and / or the plurality of substance use words.

26. The method according to any one of claims 20 to 23, wherein, Administering the digital therapeutic further includes: determining a score representing correct interaction, selection speed, or both during performance of the activity of selecting all memorized words from a plurality of words; and In response to the score satisfying the threshold, it is determined to increase the number of words for a subsequent activity of avoiding selecting a plurality of memory words, an activity of avoiding selecting a plurality of substance use words, or an activity of selecting all memory words from a plurality of words.

27. The method according to any one of claims 22 to 26, wherein Administering the digital therapeutic further includes: A score is displayed that represents a percentage of correct interactions, a selection speed, or at least one of both during one or more activities.

28. The method according to any one of claims 2 to 27, further comprising: generating one or more prompt words or images based on future event information provided by the user; as well as The prompt related to the future event information includes one or more prompt words or images.

29. The method according to any one of claims 1 to 28, wherein Providing instructions to perform an activity of avoiding selecting one or more of the plurality of substance use words and / or one or more of the plurality of memory words also includes providing instructions to the user to perform an activity of selecting one or more of the plurality of neutral words that are not related to substance use and that are different from the memory words.

30. The method according to any one of claims 1 to 29, wherein Providing instructions to perform an activity that avoids selecting one or more of the plurality of substance use words or memory words includes presenting one or more of the plurality of words for less than 1 second, less than 2 seconds, less than 3 seconds, 5 seconds, or equal to or greater than 10 seconds.

31. The method according to any one of claims 1 to 30, wherein Instructions to perform the activity are provided to the user at least once a day, at least once every 2 days, at least once every 5 days, or at least once a week.

32. The method according to any one of claims 1 to 31, wherein Administering to the user an effective amount of a drug, the drug comprising at least one of naloxone, naltrexone, nalmefene, samidorphan, nalorphine, levallorphan, naloxone, alvimopan, methylnaltrexone, naloxipam, acamprosate, disulfiram, topiramate, gabapentin, methadone, buprenorphine, lofexidine or a GLP-1 agonist.

33. The method according to any one of claims 1 to 32, wherein Administering the digital therapy further comprises: Receiving a request from the user that indicates the onset of a behavior related to substance use; and In response to receiving the request, initiating an indication of an activity to address maladaptive behavior related to the user's substance use.

34. The method according to any one of claims 1 to 33, wherein Administering the digital therapy further comprises: Determining a time to provide an indication to perform an activity that avoids selecting one or more of a plurality of memory words and / or a plurality of substance use words, and wherein providing an indication to perform an activity that avoids selecting one or more of a plurality of substance use words and / or a plurality of memory words further comprises providing the indication at the determined time.

35. The method according to any one of claims 1 to 34, wherein, One or more activities are performed over a period of 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes, 10 minutes or longer.

36. The method according to any one of claims 1 to 35, wherein The substance use comprises at least one of alcohol use disorder (AUD), opioid use disorder (OUD) or drug abuse.

37. The method according to any one of claims 1-36, wherein, The prompt is provided at least 1 day, 5 days, 1 week or 1 month after providing an indication to perform an activity that provides information about a future event.

38. The method according to any one of claims 1 to 37, wherein When the user experiences a decrease in the Obsessive Compulsive Drug Use Scale (OCDUS) metric after administering the digital therapy, the user's SUD is improved.

39. The method according to any one of claims 1 to 38, wherein, When the user experiences an improvement in the Drug Abstinence Self-Efficacy Scale (DASES) metric after administering the digital therapy, the user's SUD is improved.

40. The method according to any one of claims 1 to 39, wherein When the user experiences an improvement in the Modified Visual Analogue Scale (MVAS) rating for craving after administering the digital therapy, the user's SUD is improved.

41. The method according to any one of claims 1 to 40, wherein, When the user experiences a reduction in self-reported substance use after administering the digital therapy, the user's SUD is improved.

42. The method according to any one of claims 1 to 41, wherein When the user experiences an improvement in the Opioid Substitution Treatment Quality of Life (OSTQOL) scale after administering the digital therapy, the user's SUD is improved.

43. The method according to any one of claims 1 to 42, wherein, The user is in at least partial substance use treatment that is concurrent with administering the digital therapy.

44. The method according to any one of claims 1 to 43, wherein The user is prescribed a drug for substance use.

45. The method according to any one of claims 1 to 44, wherein, After administering the digital therapy, the user's substance use is reduced.

46. The method according to any one of claims 1 to 45, wherein, When the user, after administering the digital therapy, shows improvement in at least one of the Recovery Empowerment Scale, Perceived Stress Scale, OSTQOL, MVAS or self-reported total substance use by the Timeline Followback (TLFB) procedure, the user's SUD is improved.

47. The method according to any one of claims 1 to 46, wherein, The digital therapy is administered at least daily, every two days or weekly.

48. The method according to claim 47, wherein, The digital therapy is administered for at least one week, one month or three months.

49. The method according to any one of claims 1 to 48, further comprising: Using the user's performance in the activity to update the user's profile.

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