Providing training through presentation of visual elements to address maladaptive behavior of users with skin pathologies

Abstract

To provide systems and methods for providing training via visual elements for presentation to address maladaptive behavior of users.SOLUTION: In a system 100, a session management service arranged in one or more server groups identifies a session defining a plurality of tasks for a user to be performed using at least one hand of the user holding a display to address a propensity for behavior associated with a condition of the user. The service provides a first indication to perform a first task using the at least one hand. The service provides, subsequent to the first task, a second indication to perform a second task using the at least one hand. The service provides, subsequent to the second task, a third indication to perform a third task using the at least one hand. The user is administered with an effective amount of a medication at least partially concurrently with the performance of the tasks.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 529,503, filed July 28, 2023 (entitled "Providing Training Through Presentation of Visual Elements to Address Maladaptive Behavior of Users with Skin Pathologies") and U.S. Provisional Patent Application No. 63 / 547,286, filed November 3, 2023 (entitled "Providing Training Through Presentation of Visual Elements to Address Maladaptive Behavior of Users with Skin Pathologies"), each of which is incorporated by reference in its entirety herein. [Background technology]

[0002] Skin diseases cause itching in the affected areas of the skin, causing the subject to reflexively scratch the affected areas. The urge to scratch the skin that is itchy due to skin diseases can be difficult for an individual to resist. Scratching these lesions in an attempt to relieve symptoms may provide temporary relief, but can also cause further skin problems and make the skin disease worse. This maladaptive behavior (e.g., scratching) can be bothersome to the individual experiencing the condition by interfering with the individual's normal activities. Scratching can also damage the skin. For example, scratching psoriatic lesions can worsen psoriasis or breach the skin barrier, allowing blood to flow. Further complications from scratching include skin infection, peeling skin, or skin discoloration.

[0003] In a medical approach, an individual may take medication to reduce the severity of the itch caused by the skin condition. There are also preventative medications to minimize the possibility that an individual will experience itch. These medications require a prescription and may be taken orally or topically. Topical and oral medications may be inconvenient or troublesome for an individual to administer continuously, especially when the individual is out in public or when the itch occurs on an exposed part of the individual's body. Sometimes, due to the location of the individual or the location of the skin condition, the individual may have to wait to administer the medication. Additionally, there may be cases where there is no prescription or no current medication for the skin condition. When itch is experienced for any period of time, it can cause extreme discomfort to the individual, increasing the individual's tendency to scratch maladaptively and becoming intolerant.

[0004] Additionally, therapeutic exercises to alleviate the effects of scratching may reduce the severity of maladaptive scratching. Certain behavioral therapies are effective in helping individuals reduce or eliminate the urge to scratch. Access to such behavioral therapies can be difficult to obtain, especially at the moment an individual feels the urge to scratch. Furthermore, without consistent adherence, the treatment will not prove useful to the individual. Finally, it is difficult to ascertain which treatment or combination of treatments will be most beneficial for an individual. Summary of the Invention [Problem to be solved by the invention]

[0005] To address these and other technical challenges, a service provides a set of interventions for digital therapy aimed at reducing a user's frequency, intensity, or tendency of maladaptive behaviors associated with skin conditions. The set of tasks combines inhibitory control training, habit reversal therapy (HRT), and urge surfing. Using a combination of these three tasks through a computing device (e.g., the user's smartphone) may increase the user's ability to control their maladaptive behaviors or urges in a synergistic manner. The tasks may include different actions performed by the user, such as through an end user device associated with the user. The purpose of each different task and its corresponding action is to resolve or reduce the frequency, intensity, or tendency of the subject's maladaptive behavior (e.g., reacting to skin itch). The service may identify and select tasks based on the sequential order of the tasks or based on a request initiated by the user through the user's device.

[0006] The combined use of Go / No-Go training, Habit Reversal Therapy (HRT) and urge surfing through a computing device (e.g., a smartphone) can enhance a user's ability to control maladaptive behaviors or urges in a synergistic manner. Controlling maladaptive urges can be an aspect of treating or resolving symptoms of skin diseases such as atopic dermatitis or psoriasis. Go / No-Go training primes the user for neuroplasticity by instructing the user to perform an action and then not to perform the action.

[0007] The combination of these interventions may lead to synergistic exposure by unexpectedly combining two opposing approaches: a top-down approach using habit reversal therapy and urge surfing, and a bottom-up approach using inhibitory control. The top-down approach may refer to deliberate, observable training by giving the user a set of conscious tools to decide how to engage in a reaction, rather than succumbing to the usual automatic reaction of succumbing to an urge. The bottom-up approach may refer to subconscious training that trains the user to unconsciously improve their ability to control their reaction to maladaptive behaviors. Furthermore, exposing the user to a combination of these interventions may improve or enhance the effectiveness of the medication the user is taking for a skin condition, as the user is less likely to engage in maladaptive behaviors (e.g., scratching).

[0008] The user adapts to pay less attention to or resist the maladaptive urge. Habit reversal therapy focuses on replacing maladaptive behaviors with observable adaptive behaviors by instructing the user to recognize that resisting the urge may cause it to disappear. HRT helps reduce undesirable repetitive behaviors by making the user aware of the cues of the onset of the maladaptive behavior and replacing the maladaptive behavior with another physically incompatible behavior. For example, instead of scratching a skin ailment, the HRT task or action may prompt the user to pinch their finger. The replacement of the maladaptive behavior with another preferred behavior may cause the user to feel anxious or anxious. In this case, the addition of urge surfing can alleviate the negative feelings that come from refraining from the maladaptive behavior. Urge surfing can motivate the user to resist the urge to perform the maladaptive behavior by playing games, visualizing calming scenarios, or through biofeedback such as pupil dilation or heart rate control.

[0009] Combining these therapies can significantly reduce the tendency to perform maladaptive behaviors. As an example, this combination can include a service that offers a game to the user through a mobile device. The user can control the game by placing their thumb on the mobile device and tilt the mobile device in the correct direction based on cues from the game. In this example, holding the phone is an incompatible behavior, so incorporating HRT shows an alternative behavior to prevent the user from scratching. To illustrate this example, during the game, a cue occurs that prompts the user to stop the primary task, such as tilting the phone, and instead rest for a period of time with their hand on the mobile device. This action would incorporate a go / no-go (GNG) therapy. Additionally, real-time biofeedback controls the game and its cues, helping the user practice mindfulness in the form of urge surfing. This combination of therapies offered by the service leads to a reduction in the fulfillment of maladaptive behaviors.

[0010] To provide these therapies, the service can select tasks and associated actions for the user to send to the end user device. The service can also time the delivery or presentation of the actions to the user so that the user does not need to actively access a digital therapeutic application on the device while suffering from an itch. The service can time the delivery or presentation of the actions to the user after the completion of a prior task. Additionally, as the service acquires additional data about the user, the service can select tasks and actions that are more targeted to the particular user and condition, and can store this data in the user's profile. The service can select the subsequent task based on at least the prior task, the completion of the prior task, an evaluation of the user's profile or the user's performance on the prior task, etc.

[0011] Since the application runs on the subject's mobile device or at least on a mobile device that is easily and reliably accessible to the subject, the application provides real-time support to the subject, for example, according to a predefined frequency (e.g., once a day). For example, upon receiving a request from the user to start a session, the application starts the session in real time, i.e., at least within a few milliseconds of receiving the request. Such rapid guidance cannot be achieved via a face-to-face visit, phone call, video conference, or text message between the user and a healthcare provider, such as a dermatologist. In this way, the application can provide and customize tasks for the user based on the user's performance. This increases the usefulness of each task, thereby minimizing overall bandwidth and data communication and creating an iteratively improving service for the user.

[0012] Furthermore, to retrain a skin disease patient's maladaptive scratching, the user can easily receive tasks relevant to the condition. This can reduce or eliminate the barrier for the user to physically access the device while combating maladaptive scratching. Selecting tasks to send to the user to address the subject's tendency to scratch can improve the quality of human computer interactions (HCI) between the user and the device. In addition, unnecessary consumption of computational resources (e.g., processing and memory) and network bandwidth of the service and user device can be reduced compared to sending ineffective messages, since the messages are more relevant to the user's condition. Furthermore, in the context of digital therapeutic applications, such personalized selection of tasks can deliver user-specific interventions to improve the subject's adherence to the treatment. As a result, not only can adherence to the treatment intervention be improved, but the subject's maladaptive behavior can also be improved. [Means for solving the problem]

[0013] Aspects of the present disclosure relate to systems and methods for providing training via visual elements to address maladaptive behaviors. The system may include a computing system having one or more processors coupled with a memory. The computing system may identify a session defining a set of tasks for a user to be performed using at least one hand of the user holding a display to address behavioral tendencies associated with the user's condition. The computing system may provide first instructions for performing a first task in the set of tasks using the at least one hand in a first portion of the session. The computing system may provide second instructions for performing a second task in the set of tasks using the at least one hand in a second portion of the session following the first task. The computing system may provide third instructions for performing a third task in the set of tasks using the at least one hand in a third portion of the session following the second task.

[0014] In some embodiments, the set of tasks may include one or more of: (i) a go / no-go task to prompt the user to perform or withhold an action; (ii) a habit reversal therapy task to prompt the user to perform a second action instead of performing a third action associated with the maladaptive behavior; and (iii) a duration in the tendency of the maladaptive behavior, an urge surfing task to prompt the user to perform a fourth task. In some embodiments, the computing system may provide a second instruction in response to completion of the first task, and providing the third instruction further includes providing the third instruction in response to completion of the second task. In some embodiments, at least one of the tasks may be to perform at least one of interacting or not interacting with a stimulus associated with the condition, and the stimulus includes at least one of text, image, or sound.

[0015] In some embodiments, the computing system may receive a request from a user indicating initiation of a behavior associated with the condition. In response to receiving the request, the computing system may initiate a session to address the behavioral tendency associated with the condition. In some embodiments, the computing system may receive sensory data identifying one or more physiological measurements of the user during performance of the first task. The computing system may modify the second task based on the one or more physiological measurements of the user identified in the sensory data. In some embodiments, the one or more physiological measurements may further include at least one of a breathing pattern, a pupil dilation, a heart rate, a skin conductance, or an oxygen saturation.

[0016] In some embodiments, the computing system may determine a score based on performance of the at least one task. The score may identify at least one of: (i) a degree of adherence of the user to the at least one task; or (ii) a likelihood of overcoming the maladaptive behavioral tendency. In some embodiments, the computing system may generate feedback to provide to the user based on performance of the at least one task. In some embodiments, the condition includes a skin condition corresponding to at least one of atopic dermatitis or psoriasis, and the user is taking a medication to address the skin condition in at least partial association with the session to address the maladaptive behavioral tendency of scratching.

[0017] Aspects of the present disclosure relate to a system and method for reducing the frequency or intensity of maladaptive behaviors associated with a skin condition in a user in need thereof. The computing system may obtain a first metric associated with the user prior to a plurality of time instances. The computing system may repeat the presentation of respective instructions for performing a task in a plurality of tasks using at least one hand to hold a display over each of the plurality of time instances. The computing system may obtain a second metric associated with the user after at least one of the plurality of time instances. If the second metric (i) increases by at least a first predetermined margin compared to the first metric, or (ii) decreases by at least a second predetermined margin compared to the first metric, a reduction in the frequency or intensity of maladaptive behaviors associated with a skin condition may occur in the user.

[0018] In some embodiments, the maladaptive behavior may include at least one of (i) continuous scratching of the user's affected epidermal tissue, (ii) intermittent scratching of the affected epidermal tissue, or (iii) a reflex response to pruritus of the affected epidermal tissue. In some embodiments, the skin condition may include at least one of (i) atopic dermatitis, (ii) contact dermatitis, (iii) psoriasis, (iv) urticaria, (v) prurigo nodularis, (vi) lichen planus, (vii) acne vulgaris, (viii) drug-induced rash, (ix) xerosis, or (x) uremia. In some embodiments, the skin condition may be caused by at least one of an infection, an allergy, or a genetic mutation.

[0019] In some embodiments, the reduction occurs when the second metric increases by a first predetermined threshold margin compared to the first metric, and the first metric and the second metric can be dermatology life quality index (DLQI) values. In some embodiments, the reduction occurs when the second metric decreases by a second predetermined threshold margin compared to the first metric, and the first metric and the second metric can be peak pruritus numerical rating scale (PP-NRS) values. In some embodiments, the reduction occurs when the second metric increases by a first predetermined threshold margin compared to the first metric, and the first metric and the second metric can be patient-reported outcomes measurements information systems (PROMIS) values.

[0020] In some embodiments, the reduction occurs when the second metric is decreased by a second predetermined threshold margin compared to the first metric, and the first metric and the second metric can be patient-oriented eczema measure (POEM) values. In some embodiments, the reduction occurs when the second metric is decreased by a second predetermined threshold margin compared to the first metric, and the first metric and the second metric can be psoriasis symptom inventory (PSI) values. In some embodiments, the reduction occurs when the second metric is decreased by a second predetermined threshold margin compared to the first metric, and the first metric and the second metric can be Sleep-Related Itch and Scratch Scale (SRISS) values. In some embodiments, the reduction occurs when the second metric is decreased compared to the first metric by a second predetermined threshold margin, and the first metric and the second metric may be Scratch Intensity and Impact Scale (SIIS) values. In some embodiments, the first metric and the second metric may be computerized cognitive assessment values.

[0021] In some embodiments, the user may be an adult diagnosed with a skin condition and associated with a first metric that meets a baseline threshold. In some embodiments, the first metric may be an itch numerical rating scale (NRS) at or below a baseline threshold of 4. In some embodiments, the user may be taking a medication to address the skin condition at least in part associated with the first time instance or the second plurality of time instances. In some embodiments, the medication may include at least one of capsaicin, diflorasone, diphenhydramine, doxepin, hydrocortisone, prednisone, prednicarbate, pimecrolimus, tetracaine, tacrolimus, terbinafine, or dexamethasone (zema lotion), among others.

[0022] In some embodiments, the plurality of tasks may include (i) a go / no-go task to prompt the user to perform or withhold a first action, (ii) a habit reversal therapy task to prompt the user to perform a second action instead of performing a third action associated with the maladaptive behavior, and (iii) a duration of the maladaptive behavior, an urge surfing task to perform the third action. In some embodiments, a task of one time instance of the plurality of time instances may be modified based on response data from the user while performing another task in a time instance prior to the time instance.

[0023] In some embodiments, a task of a time instance in the plurality of time instances may be modified based on a score determined performing another task of the plurality of tasks in a time instance preceding the first time instance. In some embodiments, a task of a time instance may be modified to change the order of performance, the length of time to complete the task, or the difficulty of performing the task. In some embodiments, a task of a time instance in the plurality of time instances may be independent of another task in a time instance preceding the first time instance. In some embodiments, the plurality of time instances ranges from two weeks to six months. In some embodiments, at least one of the first predetermined margin or the second predetermined margin may be based on a metric associated with a second user provided with a controlled therapy. In some embodiments, the user may belong to a treatment group and the second user may belong to a control group.

[0024] The above and other objects, aspects, features and advantages of the present disclosure will become more apparent and will be better understood by referring to the following description taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0025] [Figure 1] 1 illustrates a block diagram of a system for providing training via visual elements for presentation to address a user's maladaptive behavior according to an exemplary embodiment. [Diagram 2] 1 illustrates a block diagram of a process for identifying a session, receiving a request to initiate an action, and providing instructions for performing a task in a system for providing training according to an exemplary embodiment. [Diagram 3] 1 illustrates a block diagram of a process for evaluating user performance based on response data in a training delivery system according to an illustrative embodiment. [Figure 4]FIG. 1 illustrates a block diagram of a process for providing feedback to a user and determining tasks based on task performance in a system for providing training in accordance with an illustrative embodiment. [Figure 5A] 1 illustrates a flow diagram of a method for providing training via visual elements for presentation to address a user's maladaptive behavior according to an exemplary embodiment. [Figure 5B] 1 illustrates a flow diagram of a method for providing training via visual elements for presentation to address a user's maladaptive behavior according to an exemplary embodiment. [Figure 6] FIG. 1 illustrates a block diagram of an environment for presenting tasks on a device in a system for providing training via visual elements for presentation to address a user's maladaptive behavior according to an exemplary embodiment. [Figure 7A] 1 illustrates exemplary user interfaces of various types of interventions in a system for providing training to address maladaptive behaviors of a user with a skin condition, according to an exemplary embodiment. [Figure 7B] 1 illustrates exemplary user interfaces of various types of interventions in a system for providing training to address maladaptive behaviors of a user with a skin condition, according to an exemplary embodiment. [Figure 7C] 1 illustrates exemplary user interfaces of various types of interventions in a system for providing training to address maladaptive behaviors of a user with a skin condition, according to an exemplary embodiment. [Figure 8A] 1 illustrates a screenshot of an exemplary user interface for impulse surfing training in a system for providing training to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 8B] 1 illustrates a screenshot of an exemplary user interface for impulse surfing training in a system for providing training to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 9A]1 illustrates a screenshot of an exemplary user interface for impulse surfing training for a system for providing training via visual elements for presentation to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 9B] 1 illustrates a screenshot of an exemplary user interface for impulse surfing training for a system for providing training via visual elements for presentation to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 9C] 1 illustrates a screenshot of an exemplary user interface for impulse surfing training for a system for providing training via visual elements for presentation to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 10A] 1 illustrates a screenshot of an exemplary user interface of a go / no-go training for a system for providing training via visual elements for presentation to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 10B] 1 illustrates a screenshot of an exemplary user interface of a go / no-go training for a system for providing training via visual elements for presentation to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 11] 1 illustrates a screenshot of an exemplary user interface for Go / No-Go training in a system for providing training via visual elements for presentation to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 12] 1 illustrates screenshots of an exemplary user interface for Go / No-Go training in a system for providing training to address maladaptive behaviors of a user with a skin condition, according to an exemplary embodiment. [Figure 13]1 illustrates a screenshot of an exemplary user interface in a system for providing training to address maladaptive behaviors of a user with a skin condition, according to an exemplary embodiment. [Figure 14] 14A-14D show screenshots of an exemplary user interface of a go / no-go training in a system for providing training via visual elements for presentation to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 15] 15A-15D show screenshots of an exemplary user interface of a go / no-go training in a system for providing training via visual elements for presentation to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 16] 1 illustrates a screenshot of an exemplary user interface having options for various interventions in a system for providing training via visual elements for presentation to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 17] 17A-17M show screenshots of an exemplary user interface for encouraging impulse surfing training in a system for providing training via visual elements for presentation to address a user's maladaptive behavior, according to an exemplary embodiment. [Figure 18] 1 illustrates a flow diagram of a method for reducing the frequency or intensity of maladaptive behaviors associated with skin conditions, according to an exemplary embodiment. [Figure 19] FIG. 1 shows a timeline of study design to evaluate inhibitory control, habit reversal therapy, and compulsion surfing to interrupt scratching in subjects with skin diseases. [Figure 20] FIG. 2 is a block diagram of a server system and a client computer system in accordance with an exemplary embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] For purposes of reading the following description of the various embodiments, the following listing of sections of this specification and their respective contents may be helpful.

[0027] Section A describes systems and methods for providing training via visual presentations to address a user's maladaptive behavior.

[0028] Section B describes systems and methods for reducing the frequency or intensity of a user's maladaptive behaviors associated with a skin condition.

[0029] Section C describes network and computing environments useful for practicing the embodiments described herein.

[0030] A. Systems and methods for providing training via visual elements for presentation to address user's maladaptive behavior Referring now to FIG. 1, a block diagram of a system 100 for providing training via visual elements for presentation to address a user's maladaptive behavior is shown. In overview, the system 100 may include at least one session management service 105 and a set of user devices 110A-N (hereinafter generally referred to as user devices 110 or client devices 110) communicatively coupled to each other via at least one network 115. At least one user device 110 (e.g., a first user device 110A as shown) may include at least one sensor 120 and at least one application 125. The application 125 may include or provide at least one user interface 130 having one or more user interface (UI) elements 135A-N (hereinafter generally referred to as UI elements 135). The session management service 105 may include, among others, at least one session manager 140, a task selector 145, a measurement detector 150, or at least one performance evaluator 155. Session management service 105 may include or have access to at least one database 160. Database 160 may store, maintain, or otherwise include, among other things, one or more user profiles 165A-N (hereinafter generally referred to as user profiles 165) and one or more tasks 170A-N. The functionality of application 125 may be executed in part on session management service 105.

[0031] More specifically, the session management service 105 (sometimes referred to generally herein as a computing system or service) may be any computing device that includes one or more processors coupled with memory and software and is capable of performing various processes and tasks described herein. The session management service 105 may communicate with one or more user devices 110 and a database 160 via a network 115. The session management service 105 is located, distributed, or otherwise associated with at least one server group. A server group may 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 may be located, distributed, or otherwise associated with one or more client devices 110. Some components of the session management service 105 may be located in a server group and some may be located in a client device. For example, the session manager 140 may run or be located on the user device 110A, and the task selector 145 may run or be located on the server group.

[0032] Within the session management service 105, the session manager 140 may identify a session that defines a set of tasks 170 that a user performs via applications 125 on a respective user device 110. The task selector 145 may select at least one task 170 to provide to the user device 110 via the session manager 140. The task selector 145 may select a task 170 based on performance of a prior selected task. The measurement detector 150 may receive sensory data from the user via the user device 110 and may modify the task 170 or the selection of tasks 170 based on measurements included in the sensory data. The performance evaluator 155 may determine a score based on performance of one or more tasks 170 and provide feedback to the user via the applications 125 presented on the user device 110.

[0033] The user device 110 (sometimes referred to herein as an end-user computing device or client device) may be any computing device that includes one or more processors coupled with memory and software and is capable of performing the various processes and tasks described herein. The user device 110 may communicate with the session management service 105 and the database 160 via the network 115. The user device 110 may be a smartphone, other mobile phone, tablet computer, wearable computing device (e.g., smart watch, glasses), or laptop computer. The user device 110 may be used to access the application 125. In some embodiments, the application 125 may be downloaded (e.g., via a digital distribution platform) and installed on the user device 110. In some embodiments, the application 125 may be a web application having resources accessible via the network 115.

[0034] In some embodiments, the user device 110 may be coupled with at least one sensor 120. The sensor 120 may provide sensory data to the user device 110 or the session management service 105 regarding the user or the user's performance. The data may include biofeedback. The biofeedback may include various physical attributes of the user, such as the user's voice, heart rate, pupil dilation, breathing patterns, blood oxygen saturation, or response time, among others. The sensor 120 may sense, detect, or identify data related to the user or their performance. In some embodiments, the sensor 120 may include an audio sensor, such as a microphone (e.g., a piezoelectric microphone, a ribbon microphone, etc.) or a decibel meter. The audio sensor 120 may detect voice, heart rate, or other audio indications from the user. In some embodiments, the sensor 120 may include an imaging sensor, such as a camera or a video camera. The imaging sensor 120 may include a photodiode, an active pixel sensor, a charge-coupled device, or a quanta image sensor, among others. In some embodiments, the sensor 120 may include a timer. In some embodiments, the sensor 120 may include a light sensor, such as a photodiode, a photoresistor, or a phototransistor.

[0035] Further, the sensors 120 may include one or more pulse oximeters for detecting oxygen saturation in the user's blood. In some embodiments, the sensors 120 may detect a response time for a user to interact with the user device 110 based on a timer, an imaging sensor, or other sensors 120. In some embodiments, biofeedback may be captured by the sensors 120. For example, the imaging sensor 120 may detect the user's pupil dilation, and a heart rate sensor may detect changes in the user's pulse rate or heart rate. For example, a voice sensor may detect the user's breathing pattern. Data accumulated from the sensors 120 may be processed by the session management service 105 or the application 125.

[0036] The application 125 executing on the user device 110 may be a digital therapeutic application and may provide sessions (sometimes referred to herein as therapy sessions) to address maladaptive behavioral tendencies associated with the user's condition. The behaviors may include maladaptive scratching prompted by a condition such as a skin condition. The skin condition may cause other maladaptive behaviors such as picking, pinching, and rubbing the skin. The other behaviors may cause or be associated with the user's condition. The application 125 may be used to present tasks that prompt the user to take actions to reduce the frequency, intensity, or tendency to engage in behaviors associated with the user's condition. The tasks may be presented to the user as, among other things, detected measurements of the user received from the client device as a result of sending a request to initiate a session or scheduled times or durations.

[0037] A user of the application 125 may suffer from or be at risk for a skin condition, such as atopic dermatitis, contact dermatitis, psoriasis, urticaria, prurigo nodularis, lichen planus, acne vulgaris, drug-induced rash, xerosis, uremia, non-contact dermatitis (eczema), allergic reactions (such as exposure to plants, medicines, or other exposures), burns, rashes, scabies, hives, insect bites, and the like. The user may engage in maladaptive or other behaviors to attempt to reduce or alleviate the effects of the skin condition. For example, the user may scratch, pick, rub, or otherwise physically irritate the skin affected by the pathology. The user may simultaneously receive medication to address, at least in part, the pathology while providing a session through the application 125. The medication may be at least orally administered or topically applied. For example, the user may take or apply capsaicin, diflorasone, diphenhydramine, doxepin, hydrocortisone, prednisone, prednicarbate, pimecrolimus, tetracaine, tacrolimus, terbinafine, corticosteroids, vitamin D analogs, retinoids, calcineurin inhibitors, immunosuppressants, or antihistamines, etc. The medication may be in an effective amount (e.g., dosage or frequency) sufficient to produce a positive outcome or reduction in symptoms (e.g., a reduction in the tendency to itch or scratch). When taken at least partially concurrently with use of the application 125, the effectiveness of the medication may be improved or enhanced in terms of addressing the user's maladaptive behavior.

[0038] The skin conditions described herein can be treated using a variety of medications or treatment protocols depending on the particular skin condition. For example, treatments or treatment options include, but are not limited to, behavioral therapy, avoidance therapy, hormone replacement therapy (HRT), antibiotics, antihistamines, laser skin resurfacing, medicated creams, ointments or gels, moisturizers, oral medications, steroid tablets, creams or injections, surgical procedures, skin cleansers, and lifestyle changes.

[0039] Atopic dermatitis, also known as atopic eczema, refers to a non-contagious, long-lasting type of dermatitis. The causes of atopic dermatitis are thought to involve genetics, immune system dysfunction, and environmental exposure. Exposure to certain chemicals or irritants can worsen the symptoms of atopic dermatitis. Treatment of atopic dermatitis includes strengthening the skin barrier with moisturizing creams, anti-inflammatory corticosteroid creams, dietary therapy, phototherapy, calcineurin inhibitors, and antihistamines, among others.

[0040] Contact dermatitis refers to a type of non-contagious acute or chronic inflammation of the skin caused by chemical or physical substances. Symptoms of contact dermatitis include itchy or dry skin, rash, bumps, blisters, and swelling. Contact dermatitis occurs when long-term exposure to irritants directly damages the epidermal cells of the skin, activating an immune response, and resulting in an inflammatory skin reaction.

[0041] Psoriasis refers to a skin disease that causes a rash of itchy, scaly patches, most commonly occurring on the knees, elbows, trunk, and scalp. Psoriasis is a common chronic condition with no cure. It can be painful, disrupt sleep, and cause difficulty concentrating. The condition tends to flare up for weeks to months, then subside for a period of time. Common triggers for people with a genetic predisposition to psoriasis include infections, cuts, burns, and certain medications. The five main types of psoriasis are patchy, plaqueous, inverse, pustular, and erythrodermic. Various treatments include steroid creams, vitamin D3 creams, ultraviolet light, immunosuppressants such as methotrexate, and biologic therapies that target specific immune pathways.

[0042] Urticaria or hives are a type of acute skin rash consisting of red, raised, itchy bumps that may burn or sting. Hives often occur after an infection or as a result of an allergic reaction to medicines, insect bites, or foods. Other causes include emotional stress, hay fever, asthma, or extreme temperatures. Treatment includes allergen avoidance, antihistamines, corticosteroids, and leukotriene inhibitors. Immunosuppressants are used in severe cases over the long term.

[0043] Prurigo nodularis refers to a chronic skin disease characterized by itchy nodular lesions that typically appear on the trunk, arms, and legs. Prurigo nodularis is often associated with other skin conditions such as atopic dermatitis. Other known causes include autoimmune diseases, thyroid disease, lymphoma, and renal failure. Treatments include steroids, dupilumab, vitamins, cryosurgery, thalidomide, and UVB light.

[0044] Lichen planus is a chronic inflammatory and autoimmune disease that affects the skin, nails, hair and mucous membranes. It is characterized by polygonal, flat-topped, aggressive papules and plaques with fine, reticulated white scales thereon (Wickham's striae), and commonly affects the backs of the hands, flexed wrists and forearms, trunk, anterior legs and oral mucosa, and may include, among others, multiple, annular, linear, hypertrophic, atrophic, bullous, actinic, ulcerative, pigmented, follicular or inverse lesions.

[0045] Xerosis, also known as dry skin, refers to a common condition that affects the moisture and barrier function of the skin. Causes of dry skin include abnormalities in the barrier function of the stratum corneum of the skin. These abnormalities can be caused by dry climates, excessive heat, environmental or chemical irritants, burns, autoimmune diseases, and abrasions, among others.

[0046] Acne vulgaris refers to a chronic skin condition caused by the clogging of hair follicles along the skin surface.Acne can be classified as mild, moderate or severe to determine the appropriate treatment plan.Acne nodules or legions are usually polymorphous and take many forms, including open or closed comedones, papules, pustules or cysts, among others.

[0047] Uremia refers to a condition in which there is a high concentration of urea in the blood. Urea is one of the main components of urine. It can be defined as a condition in which there is an excess in the blood of end products of amino acid and protein metabolism, such as urea and creatinine, which would normally be excreted in urine. Uremia is generally caused by reduced renal function or renal failure. Symptoms of uremia include dry skin, itching, calcinosis, and uremic frost, among others.

[0048] Non-contact dermatitis refers to a skin condition that does not involve direct contact with a substance. Examples of non-contact dermatitis include cradle cap, atopic dermatitis, dermatitis herpetiformis, and other forms of inflammatory skin disease that do not involve direct contact with a substance.

[0049] The application 125 may include, present, or otherwise provide a user interface 130 including one or more UI elements 135 to a user of the user device 110 according to a configuration on the application 125. The UI elements 135 may correspond to visual components of the user interface 130 such as command buttons, text boxes, checkboxes, radio buttons, menu items, and sliders, among others. In some embodiments, the application 125 may be a digital therapeutic application and may provide sessions (sometimes referred to herein as therapy sessions) via the user interface 130 that address maladaptive scratching tendencies.

[0050] The application 125 can receive instructions to present tasks 170 to the user. The tasks 170 can be or include stimuli or actions presented to the user in text, as images, as videos, audibly, or as other presentations, and can include instructions for the user to perform actions to reduce or alleviate the desire or tendency to engage in maladaptive behaviors. The tasks 170 can include interacting or not interacting with the user device 110. For example, the tasks 170 can include tapping the user interface 130 or not tapping the user interface 130 for a duration. The tasks 170 can include instructions for the user to reduce the severity of the condition. For example, the messages can include instructions aimed at increasing the user's calmness or mental stamina. The tasks 170 can include an interactive interface for engaging the user through the user interface 130 in one or more therapies designed to reduce the tendency to engage in maladaptive behaviors. For example, the user can play a game on the user device 110 presented by the application 125 that incorporates one or more therapies to address the behavior.

[0051] Treatments for reducing the tendency of skin disease-related behaviors may include inhibitory control training, habit reversal therapy, or urge surfing paradigms. Inhibitory control training includes tasks such as the GNG task, where the user is prompted by a task 170 to perform an action for a period of time and then refrains from performing the action for a period of time. HRT may refer to a therapy that instructs the user to replace a maladaptive behavior with a permissible behavior. In some implementations, the permissible behavior may be physically incompatible with the maladaptive behavior, thereby preventing the user from engaging in the maladaptive behavior while performing the permissible behavior. Urge surfing may refer to a therapy that distracts or assists the user to persevere through resisting the tendency to engage in the maladaptive behavior, such as through an application 125 running on the user device 110.

[0052] The database 160 may store and maintain various resources and data related to the session management service 105 and the applications 125. The database 160 may include a database management system (DBMS) for organizing and arranging the data maintained thereon. The database 160 may communicate with the session management service 105 and one or more user devices 110 via the network 115. While performing various operations, the session management service 105 and the applications 125 may access the database 160 to retrieve identified data therefrom. The session management service 105 and the applications 125 may also write data to the database 160 from the performance of such operations.

[0053] Such operations may include maintaining a user profile 165 (sometimes referred to herein as a subject profile). The user profile 165 may include information regarding the user's condition, as described herein. For example, the user profile 165 may include information related to the severity of the condition, the occurrence of the condition (such as itching caused by a skin condition), medications or treatments the user is taking for the condition, the duration of the condition, etc. The user profile 165 is updated on a schedule, periodically (e.g., daily, weekly), in response to changes in user information (e.g., entered by the user via the user interface 130 or learned from the user device 110), or in response to a clinician (e.g., a doctor or nurse) addressing the user's condition, among other things.

[0054] The user profile 165 can store and maintain information related to users of the application 125 through the user device 110. Each user profile 165 can be associated with or correspond to a respective audience or user of the application 125. The user profile 165 can include or store information of each session performed by the user. The session information can include various parameters or tasks 170 of previous sessions performed by the user, which can be initially null. The user profile 165 can enable streamlined communication to the user by presenting the user with tasks that are most likely to help the user address a condition or reduce the tendency to engage in maladaptive behaviors, based at least on the user profile 165. This directed approach can reduce the need for multiple communications with the user, thereby reducing bandwidth and increasing the benefits of user-computer interaction.

[0055] In some embodiments, the user profile 165 may identify or include information regarding the treatment plan implemented by the user, such as the type of treatment (e.g., therapy, medication, or psychotherapy), duration (e.g., day, week, or year), and frequency (e.g., daily, weekly, quarterly, yearly), among others. The user profile 165 includes data collected by the sensors 120, such as the user's heart rate, breathing patterns, or pupil dilation. The user profile 165 may be stored and maintained in the database 160 using one or more files (e.g., extensible markup language (XML), comma-separated values ​​(CSV) delimited text files, or structured query language (SQL) files). The user profile 165 may be iteratively updated as the user provides responses and performs tasks 170. For example, the performance evaluator 155 may update the user profile 165 based on the user's completion of tasks 170.

[0056] Further, the identification of the tasks 170 may be stored and maintained on the database 160. For example, the database 160 may maintain the tasks 170 using one or more data structures or files (e.g., an Extensible Markup Language (XML), a Comma Separated Values ​​(CSV) delimited text file, or a Structured Query Language (SQL) file). Each of the tasks 170 may prompt the user via the application 125 to perform an action 220 via the application 125. For example, the application 125 may receive instructions presenting an activity to be performed as part of the task 170. The task 170 may provide behavioral therapy including cognitive behavioral therapy, habit reversal therapy, biofeedback, and relaxation therapy, which are also useful for reducing the tendency to engage in maladaptive behaviors. The task 170 may be presented as a game, activity, or action performed by the user via the user interface 130. For example, the task 170 may prompt the user to make a fist with their hand, prompt them to interact with the user interface 130, or instruct them to refrain from performing an action via the user interface 130 or their own body.

[0057] In response to the presentation of instructions prompting the user to perform a specified task 170, the user can use the application 125 to record the performance or completion of the task 170. Examples of the tasks 170 can include breathing exercises, mind-body exercises, or hand exercises, among others. The tasks 170 can include GNG tasks and HRT tasks, urge surfing tasks, or combinations thereof, among others. The tasks 170 can be text-based, image-based, or video-based, among other presentation methods. The tasks 170 can be presented to the user via a user interface 130 executing on the application 125. Each task 170 can identify or include information that is presented via the user interface 130 of the application 125. For example, the task 170 information can include a reminder to perform the task 170 for a session, or a reminder to take an action to mitigate a behavior. The tasks 170 can be delivered periodically, such as daily, weekly, or monthly, among others. The tasks 170 can be delivered according to a schedule or in response to receiving instructions from the user. The tasks 170 may be derived from a library of pre-generated psychotherapy activities or actions and / or a library of pre-generated engagement messages. The tasks 170 may include reminders for the subject to take medication, engage in an activity, or perform other actions that may reduce the tendency to scratch maladaptively, among other actions. The tasks 170 may be personalized based on the user's activity, adherence, or performance related to the plan. For example, the tasks 170 may be personalized based on information in the user profile 165 or based on other tasks 170 in which the user has engaged.

[0058] 2, a block diagram of a process 200 for identifying a session, receiving a request to initiate an action, and providing instructions to perform a task in the system 100 for providing training to address a user's maladaptive behavior is shown. The process 200 may include or correspond to operations performed in the system 100 for presenting a user interface to a user with a skin condition. Under the process 200, the session manager 140 executing on the session management service 105 may access the database 160 to search, retrieve, or otherwise identify a user profile 165 of a user 210 (sometimes referred to herein as a subject, patient, or person) of the application 125 on the user device 110. The user profile 165 may identify or define, among other things, information related to the user 210, the instance of the application 125 on the user device 110, and the user device 110. For example, the user profile 165 may identify that the user 210 has a certain tendency to engage in maladaptive scratching. The user profile 165 may identify, among other things, that the user 210 is taking medication to address a skin condition or other condition and the frequency of maladaptive behaviors in the user 210 .

[0059] Identification of the user profile 165 allows the session manager 140 to determine or identify a session of the user 210 to address the behavioral tendencies. The session may correspond to, include, or define a set of tasks 170 performed by the user 210 via the application 125. Each task 170 may be performed by the user 210 using at least one of the user's 210 hands. The tasks 170 may define, specify, or otherwise specify at least actions 220A-N (hereinafter actions 220) and at least one duration 225 for each action 220. The actions 220 may be, for example, clasping the user's 210 hands, using the hands to tap or otherwise interact with the user interface 130 via UI elements 135, performing tapping motions with the user's 210 hands, among other actions involving one or more hands of the user 210. The actions 220 may involve activities that do not involve the user's hands. For example, actions 220 may include focusing on a spot on the screen of the user device 110, performing a breathing exercise, or tapping the user's 210 foot, among others. Each task 170 can also have a set duration 225, ranging anywhere from a few seconds (e.g., 40 seconds) to a few minutes (e.g., 3 minutes) to a few hours (e.g., 3 hours). Each task can include one or more actions 220 that are performed as part of that task.

[0060] The task 170 may specify a set of different actions 220 for different types of tasks. Each task 170 may correspond to a different therapy, such as HRT, GNG, urge surfing, etc. The task 170 may include one or more actions that correspond to the therapy associated with the task 170. For example, if the task 170 is a GNG task, the action 220 may include a first action 220A for the user to press the screen of the user interface 130 for a first duration 225. The first duration 225 may be any range of time for the GNG task, such as 5-10 minutes. In this example, the user may be prompted by the application 125 to press the screen of the user interface 130 for 7 minutes, after which the application 125 may present a second action 225B. The second action 225B may include prompting the user to stop pressing the screen for the second duration 225.

[0061] Continuing, if the task 170 is an HRT task, the action 220 may include prompting the user to understand that resisting the urge (e.g., the maladaptive behavior of scratching) leads to the urge dissipating, and instructing the user to perform an acceptable behavior that is different from the maladaptive behavior. For example, the first action 220A may alert the user to a cue that indicates the onset of the maladaptive behavior, such as a tingling sensation on the skin, an increased heart rate, or other indication. The second action 220B of the HRT task 170 may prompt the user to clench a fist, focus on a spot on the user interface 130, or pinch the user's fingers for a duration 225. In some embodiments, the duration 225 may be between 2-3 minutes for an HRT task. If the task 170 is an urge surfing task, the task 170 may include actions related to managing the tendency to perform the maladaptive behavior and tolerating discomfort resulting from resisting the tendency. A first action 220A of the urge surfing task may be playing a game associated with the application 125, watching a video associated with the application, or controlling an application based on information detected by the sensor 120, for a duration 225 of the maladaptive behavior tendency. The duration 225 may be between 2 and 5 minutes for the urge surfing task.

[0062] The user profile 165 may include information about a prior session, such as previous tasks 170 performed by the user 210 in response to a previous instruction 215, a request 205 by the user 210 to start a session, performances related to tasks 170 already performed by the user 210, taking of medication by the user 210 to address the user's condition or information detected by the sensor 120, among others. The user profile 165 may also identify or include information about recorded performances of maladaptive behaviors, such as occurrences of tendencies to perform maladaptive behaviors, occurrences of performing maladaptive behaviors, duration of prior occurrences, and taking of medication, among others. The user profile 165 may initially lack information about prior sessions and may build information as the user 210 performs tasks 170 via the application 125. The user profile 165 may be used to select tasks 170 to provide to the user 210 via the application 125 in a session.

[0063] The session manager 140 can initiate a session in response to receiving a request 205 from a user 210 via an application 125. The user 210 can provide a request 205 to initiate a session via the user interface 130 for fulfillment through the application 125. The request 205 can include information related to the initiation of a user's condition. The request 205 can include, among other things, an identification of the user 210 or user profile 165, symptoms related to the user's 210 condition, attributes related to the condition such as the time of the request 205, the severity of the trend, etc. The application 125 running on the user device 110 can generate the request 205 to send to the session management service 105 in response to the user 210 interacting with the application 125. In some embodiments, the session manager 140 can initiate a session in response to, among other things, a scheduled session time, detection by a sensor 120, based on the user 210 taking a prescribed medication to address the condition, etc.

[0064] For a session, the task selector 145 can identify or select tasks 170 to provide to the user 210 via the application 125. The selection of tasks 170 can be based on, among other things, the completion of a previous task 170, based on information in the user profile 165, or based on the severity of the tendency to perform maladaptive behaviors. In some embodiments, the session manager 140 can select a set of tasks 170 to provide to the user 210. For example, the session manager 140 can select a first task (e.g., go / no go), a second task (e.g., HRT), and a third task (e.g., urge surfing). The task selector 145 can select tasks 170 based on the user profile 165. The user profile 165 can include historical information related to the user's condition, such as occurrence or type of symptoms, time of symptom occurrence, strength of tendency to perform maladaptive behaviors, demographic information, prescription information, location information, etc. For example, the task selector 145 can select tasks 170 that have historically improved the user's tendency to perform maladaptive behaviors.

[0065] In some embodiments, the task selector 145 may select the task 170 based on a predefined schedule of tasks. For example, the task selector 145 may select the task 170 for a GNG therapy task according to a predefined schedule of tasks. In this illustrative example, the task selector 145 may select a subsequent task based on a subsequent task of the predefined schedule. For example, the predefined schedule of tasks 170 may include a first task corresponding to GNG therapy, a second task corresponding to HRT therapy, or a third task corresponding to urge surfing therapy. In some embodiments, the task selector 145 may select the task 170 based on a set of rules. The rules may be configured to provide a task 170 or a set of tasks 170 to target an underlying cause of a condition or skin condition of the user 210 or to alleviate the condition in a systematic, objective, and therapeutically effective manner. The rules may be based on the completion time of the task 170, the user profile 165, the performance of the task 170, or other attributes of the system 100.

[0066] Upon selection, the session manager 140 may provide, transmit, or otherwise communicate a task 170 or instruction 215 to the user device 110. In some embodiments, the session manager 140 may transmit instructions to present the task 170 via the user interface 130 for the application 125 on the user device 110. The instructions may include, for example, specifications on which UI elements 135 should be used and may specify content to be displayed on the UI elements 135 of the user interface 130. The instructions may further specify or include the task 170. The instructions may be code, data packets, or controls for presenting the task 170 to the user 210 via the application 125 executing on the user device 110. The instructions may include processing instructions for displaying the task 170 on the application 125. The instructions may also include instructions for the user 210 to execute in association with his or her session. For example, the instructions may display a message instructing the user to take a medication associated with his or her session. The instructions include a task 170 that specifies or includes at least one stimulus associated with a condition. The stimulus may include text, images, or sounds presented by the user device 110 via the application 125. For example, the stimulus may include the presentation of an image instructing the user 210 to interact with the application 125 via a user interface 130, such as those described in FIGS.

[0067] In some embodiments, the session manager 140 may calculate, specify, or otherwise determine the time to transmit or present the indication 215 via the user interface 130 of the application 125. In some embodiments, the session manager 140 may maintain a timer that counts the time that has elapsed since the presentation of a previous indication 215. The timer may count, among other things, the time that has elapsed since the receipt of a read of the indication 215, from the transmission communicated from the application 125 as part of a transfer protocol, or from the communication of the indication 215 from the session management service 105. In some embodiments, the session manager 140 may maintain a timer that counts the time that has elapsed since the performance of a previous task. Using the timer, the session manager 140 may determine whether the elapsed time exceeds a threshold. The threshold may delineate, specify, or define an amount of time to provide the indication 215 for presentation. If the elapsed time exceeds the threshold, the session manager 140 may transmit the indication 215. Conversely, if the time counted by the timer does not exceed the threshold, the session manager 140 may refrain from transmitting the indication 215 and continue to update the time.

[0068] In some embodiments, session manager 140 may provide instructions 215 according to a schedule. The schedule may identify or specify the time at which instructions 215 are presented or communicated. For example, the schedule may specify presentation of instructions hourly, daily, or weekly. The schedule may be defined according to a prescription drug schedule or may be defined based on historical data of the user, such as included in user profile 165. When the time matches the schedule, session manager 140 may provide instructions 215 for display on user interface 130.

[0069] Upon receiving the instructions 215, the application 125 on the user device 110 may render, display, or otherwise present the instructions 215. The instructions 215 may be presented via one or more UI elements 135 of a user interface 130 of the application 125 on the user device 110. The presentation of the UI elements 135 may follow a task 170 provided to the user 210 via the application 125. The user 210 may perform the task 170 by interacting with the application 125 executing on the user device 110. The user 210 may perform one or more actions 220 of the task 170 for a duration 225. Performing the task 170 may include performing an interaction or non-interaction with a stimulus. Interacting with the stimulus may include, among others, speaking to or making another sound at the user device 110, pressing or tapping one or more of the UI elements 135, rotating or otherwise manipulating the user device 110, etc. Non-interaction with the stimuli includes not tapping or pressing the UI 130 or a portion of the UI 130 or not holding the user device 110 in a specified position. If the user 210 does not complete the task, the session manager 140 may send subsequent prompts 215 prompting the user 210 to complete the task or the session manager 140 may abort the task 170 upon the lapse of a threshold period of time. Completion of the task 170 may cause the application 125 to communicate completion of the task 170 from the user device 110.

[0070] In some embodiments, the application 125 may render, display, or otherwise present the instructions 215 independent of the session management service 105. The application 125 may share or have the same functionality as the session manager 140, as described above. For example, the application 125 may maintain a timer to track the time elapsed since the previous presentation of the instructions 215. The application 125 may compare the elapsed time to a time limit for the instructions 215. If the elapsed time exceeds the time limit, the application 125 may determine to present the instructions 215. The application 125 may also use a schedule to determine when to present the instructions 215. The application 125 may present the instructions 215 for display through the user interface 130 on the user device 110. The instructions 215 may include a response mechanism, such as a UI element 135, to provide information related to the status of the user 210 as well as to indicate acceptance or rejection of the task 170.

[0071] 3, a block diagram of a process 300 for evaluating a user's performance based on response data in a system 100 for providing training to address a user's maladaptive behavior is shown. The process 300 can include or correspond to an operation of configuring visual elements for a presentation to address a user's maladaptive behavior. Under the process 300, in overview, a measurement detector 150 on a session management service 105 can search, identify, or otherwise receive response data 310 from an application 165 running on a user device 110. In some embodiments, the measurement detector 150 may receive the response data 310 periodically, as a result of the lapse of a threshold time, by querying the user device 110 for the response data 310, among other things, if the response data 310 is outside the range of response data for the user profile 165. For example, the measurement detector 150 may receive the response data 310 every minute, every hour, or according to a schedule of data transmission. The measurement detector 150 may query the response data 310 after the lapse of a threshold time. For example, the measurement detector 150 may receive response data 310 when a user performs a task 170 for longer than a threshold time.

[0072] The response data 310 may include or identify user interactions by the user 210 with the task 170. The response data 310 may include a time of task completion. For example, the response data 310 may include that the user spent 4 minutes on a first task and 7 minutes on a second task. The response data 310 may include a total time of session completion and may also include a start time of the session and a completion time of the session. The response data 310 may identify UI elements interacted with during the duration 225 of the task 170. For example, the response data 310 may include a list of buttons, toggles, or other UI elements selected by the user 210 at a particular time during the performance of the task 170. The response data 310 may include other information such as the location of the user 210 while performing the session, such as geolocation, IP address, GPS location, triangulation with cellular towers, etc. The response data 310 may include measurements 305. The measurements 305 may include measurements of time, location, or user data, among others.

[0073] In some embodiments, the response data 310 may be sensory data and may identify a measurement 305 of the user 210. The measurement 305 may be or relate to a physiological measurement 305 of the user. The measurement 305 may be collected by a sensor 120 of the user device 110. The sensor 120 may include a sensor that detects biological or physiological information, as described herein. The physiological measurement 305 may be or include a measurement related to the body of the user 210. For example, the physiological measurements 305 may be breathing patterns (e.g., the sequence of inhalation and exhalation lengths), pupil dilation (e.g., change in the diameter of the user's pupils), heart rate (e.g., beats per minute or heart rate acceleration), blood oxygen levels (e.g., oxygen saturation in the user 210), blinking patterns (e.g., the rate at which the user's eyes blink), moisture levels (e.g., of the user's skin or breath), skin conductance of the user 210, activity level of the user 210 (e.g., number of steps per day or other indication of activity), user weight, user height, user concentration level (e.g., how well the user 210 can see the user device 110 or engage in a task 170 or the user's skin conductance), etc. The measurement detector 150 may store these measurements 305 and other response data 310 in the database 160.

[0074] Using the response data 310, the performance evaluator 155 can calculate, generate, or otherwise evaluate the performance or score 315 of the user 210 based on the measurements 305 or the response data 310. The score 315 can identify, among other things, the reaction time or correctness of the user 210 in performing the task 170, the degree of compliance of the user 210 with the task 170, or the likelihood of overcoming a tendency for maladaptive behavior, etc. For example, the performance evaluator 155 can determine from the response data 310 that the user 210 has not performed one or more actions 220 of the task 170 or that the user 210 has not performed an action 220 of the task 170 within a threshold time (e.g., a reaction time).

[0075] The degree of adherence of the user 210 to the task 170 may be based on the user's 210 response time to the actions 220 of the task 170 being greater than or less than a threshold time. For example, if the user 210 takes too long to complete the task 170, the user 210 may not be fully engaged or adherent to the task 170. The degree of adherence of the user 210 may be based on responses provided by the user via the UI elements 135 while performing the task 170. For example, if the user 210 presses a button presented by the application 125 during the task 170 at an incorrect time or at a time not instructed to press the button, the degree of adherence of the user 210 may be low. Conversely, if the user 210 completes the task 170 within the threshold time and performs a threshold number of actions 220 in accordance with the task 170, the degree of adherence of the user 210 may be high.

[0076] The performance evaluator 155 can calculate, generate, or otherwise determine a score 315 associated with the likelihood of overcoming the behavioral tendency. The likelihood of overcoming the behavioral tendency can refer to, include, or relate to the probability that the user 210 will no longer engage in the maladaptive behavior. For example, if the user 210 successfully resists the tendency every time the tendency occurs, the user 210 can be said to have a 100% rate of overcoming the behavioral tendency. The likelihood of overcoming the behavioral tendency can include a threshold number of occurrences of the tendency. For example, the performance evaluator 155 may not determine the likelihood until a threshold occurrence of the tendency occurs or a threshold number of tasks 170 are performed by the user 210. The performance evaluator 155 may determine the likelihood of overcoming the behavioral tendency based on at least the selection of UI elements 135 during the session, the user profile 165, the time of the session, the time of the tasks 170, the time of the actions 220, etc. In this example, the performance evaluator 155 can generate a score associated with the user 210's performance with respect to at least one of the tasks 170.

[0077] Referring now to FIG. 4, a block diagram of a process 400 for providing feedback to a user and determining a task based on the performance of one or more tasks in the system 100 for providing training to address a user's maladaptive behavior is shown. The process 400 may include or correspond to operations performed in the processes 100, 200, or 300. Under the process 400, the task selector 145 may identify or select a task 170' that the session manager 140 selects to provide via the application 125. In some embodiments, the task 170' may be for a portion of a session subsequent to the portion in which the task 170 was performed. For example, the task 170' may be performed in a second or third portion of a session while the task 170 was performed in a first portion of the session. In some embodiments, the task 170' may be for another session different from the session in which the task 170 was performed. The selection of the task 170' may be based on a previous task 170, a user profile 165, a measurement 305, a score 315, or a requirement 205. The task selector 145 may select a successor task 170' to a task 170 depending on the user's 210 performance in a preceding task 170. For example, the task selector 145 may select the urge surfing task 170' over the GNG task if the user's measurements 305 indicate an increased heart rate.

[0078] In some embodiments, the task selector 145 may modify the selection of the task 170' based on the measurements 305. The measurements 305 may indicate a physical, emotional, or other state of the user 210 related to the physiology of the user 210. For example, an increase in the user's 210 heart rate may indicate that the user 210 is feeling anxious or stressed related to an urge to scratch the affected skin. In this example, the task selector 145 may select the task 170' corresponding to an urge surfing task to address the user's concerns. Based on these physiological measurements 305, the task selector 145 may select the task 170'. In some embodiments, the task selector 145 may modify the parameters of the task 170' according to the physiological measurements 305.

[0079] In some embodiments, the task selector 145 may identify or select a task 170' based on a time measurement of the measurement 305. In some embodiments, the task selector 145 may select a task 170' based on a measured reaction time during the task 170. For example, the task selector 145 may select a task 170' having a longer duration 225' such that the reaction time measured during performance of the task 170 is longer. The task selector 145 may modify the action 220', duration 225', or other parameters of the task 170' based on the measurement 305. For example, the task selector 145 may select an action 220' of the task 170' corresponding to a shorter duration 225' if the measurement 305 indicates that the user 210 has an increased tendency to engage in maladaptive behavior and the measurement 305 indicates that the user 210 performed the preceding task 170 in less than a threshold time.

[0080] The task selector 145 can identify or select a task 170' based on a score 315. In some embodiments, the task selector 145 can select a task 170' based on a score 315 corresponding to a reaction time or correctness. For example, the task selector 145 may select a task 170' having a longer duration 225' than the task 170 if the score corresponding to the reaction time is below a threshold level. The task selector 145 may select a task 170' to include a greater number of actions 220' or a lesser number of actions 220' if the score corresponding to the correctness of the predecessor task 170 is below a threshold. In some embodiments, the task selector 145 may select a task 170' based on a reaction time and the correctness of the predecessor task or any predecessor tasks.

[0081] The task selector 145 may select a task 170' based on the user's 210 adherence. For example, the task selector 145 may select a task 170' that corresponds to the user's adherence to a previous task 170. The task selector 145 may select a task of a different therapy type than the previous task 170 if the user's 210 adherence to the task 170 is low. Conversely, the task selector 145 may select the same therapy type for the task 170' if the user 210 showed low adherence to that type of therapy in the previous task 170. The task selector 145 may determine to select or modify the task 170' using any combination of the tasks 170, the user profile 165, the measurements 305, or the scores 315. For example, the task selector 145 may use the user's 210 heart rate in combination with the user's correctness score 315 to determine which of the tasks 170 to provide to the user 210 via the application 125 running on the user device 110.

[0082] In some embodiments, task selection may select task 170' in response to completion of task 170. For example, session manager 140 may search for, identify, or otherwise receive the completion of task 170 from user device 110. Upon receipt, session manager 140 may process or analyze the completion to determine, extract, or identify information related to user 210, a tendency to perform maladaptive behaviors, task 170, or a condition or other information related to task 170. Upon receiving the completion of the first task 170, session manager 140 may provide a second task 170'.

[0083] With the selection of the task 170', the session manager 140 may transmit, provide, or otherwise communicate at least one instruction 215'. The communication of the instruction 215' may be similar to the communication of the instruction 215 discussed in the process 200. The instruction 215' may be instructions for presenting the task 170 via the user interface 130 for the application 125 on the user device 110. The instructions may include, for example, specifications on which UI element 135 should be used and may specify content to be displayed on the UI element 135 of the user interface 130. The instructions may further specify or include the task 170'. The instructions may be code, data packets, or control for presenting the task 170 to the user 210 via the application 125 executing on the user device 110. The instructions may include the task 170 specifying or including at least one stimulus associated with the state. The stimulus may include text, images, or sounds presented by the user device 110 via the application 125. For example, the stimulus may include the presentation of an image instructing the user 210 to interact with the application 125 via the user interface 130, such as those illustrated in FIGS.

[0084] Upon receiving the instruction 215', the application 125 on the user device 110 can render, display, or otherwise present the instruction 215'. The instruction 215' can be presented via one or more UI elements 135 of the user interface 130 of the application 125 on the user device 110. The presentation of the UI elements 135 can be according to a task 170' provided to the user 210 via the application 125. The user 210 can perform the task 170' by interacting with the application 125 executing on the user device 110. The user 210 can perform one or more actions 220 of the task 170' for a duration 225. Performing the task 170' can include performing an interaction or non-interaction with a stimulus. Interacting with the stimulus can include, among other things, speaking or making another sound to the user device 110, pressing or tapping one or more of the UI elements 135, rotating or otherwise manipulating the user device 110. Non-interaction with the stimuli includes not tapping or pressing the UI 130 or a portion of the UI 130, or holding the user device 110 in a specified position. If the user 210 does not complete the task, the session manager 140 may send subsequent prompts 215' prompting the user 210 to complete the task, or the session manager 140 may abort the task 170' upon the lapse of a threshold period of time. Completion of the task 170' may cause the application 125 to communicate completion of the task 170' from the user device 110.

[0085] In some embodiments, the session manager 140 may generate, output, or otherwise generate feedback for the user 210 to receive via the user interface 130. The session manager 140 may generate the feedback based on at least the user 210's performance of the task 170, the user profile 165, the request 205, the measurement 305, or the score 315. The feedback may include text, video, or audio for presentation to the user 210 via the application 125 displayed through the user interface 130. The feedback may include, among other things, a presentation of the score 315, a string or phrase, or audio or haptic feedback. The feedback may display a message such as a motivational message, a suggestion to improve performance, a congratulatory message, a comforting message, or the like. The feedback may include a presentation of the score 315. The session manager 140 may generate the feedback based on the measurement 305. In some embodiments, the session manager 140 may generate the feedback during the user 210's performance of the task 170.

[0086] Once generated, the session manager 140 can transmit, communicate, or otherwise present the feedback for presentation via the application 125 during performance of the task 170 or after completion of the task 170. For example, the measurement 305 may indicate an increase in the skin conductance of the user 210 during performance of the task 170, which may indicate an increase in the user 210's focus on the task 170. The session manager 140 can then generate feedback corresponding to the increase in skin conductance, such as a motivational message for display on the user interface 130. Similarly, the measurement 305 may indicate an increase in the heart rate of the user 210, which may indicate an increase in the user 210's stress or anxiety. The session manager 140 can then present calming feedback, such as a relax message, on the user interface 130.

[0087] Session manager 140 may present score 315 in conjunction with the feedback or separately from the feedback. For example, session manager 140 may present score 315 as part of the feedback, or at a time different from the presentation of the feedback, or may not present score 315 at all. Session manager 140 may communicate feedback via instructions 215' or as a separate communication. Session manager 140 may communicate feedback as part of a follow-on task 170'. For example, session manager 140 may include in instructions 215' the next task 170' and feedback regarding the performance of the preceding task 170. Through this means, user 210 may be aware of progress in addressing tendencies to engage in maladaptive behaviors.

[0088] The session management service 105 may repeat the above-described functions (e.g., processes 200, 300, and 400) over multiple sessions. The number of sessions may span a set number of days, weeks, or years, or may have no clear end point. By repeatedly selecting the tasks 170 based on at least the measurements 305, the user profile 165, or the scores 315, the user 210 may be able to receive content that helps mitigate the tendency to engage in maladaptive behaviors. This may overcome the difficulties the user 210 faces in accessing such care, even when suffering from a condition that may otherwise inhibit the user from seeking treatment or even physically accessing the user device 110. Furthermore, the quality of human-computer interaction (HCI) between the user 210 and the user device 110 may be improved from performing the tasks 170 when presented through the user interface 130 of the application 125.

[0089] Because the task 170 is more relevant to the user's condition (e.g., a skin condition), the user 210 may be more likely to engage with such a task 170 when presented via the user device 110. This may reduce unnecessary consumption of the service and the computational resources (e.g., processing and memory) of the user device 110, and may reduce network bandwidth usage compared to sending an otherwise ineffective or irrelevant task 170. Furthermore, in the context of digital therapeutic applications, personalized selection of the task 170 may deliver user-specific interventions to improve the subject's adherence to the treatment. This may result in not only higher adherence to the treatment intervention, but also potential improvement of the user's condition or tendency to engage in maladaptive behaviors.

[0090] 5A and 5B, a method 500 for providing training via visual elements for presentation to address a user's maladaptive behavior is shown. Each figure shows operations performed by a client and operations performed by a service. The method 500 can be implemented or performed using any of the components detailed herein, such as the session management service 105 and the user device 110. Starting with FIG. 5A, under the method 500, a service (e.g., the session management service 105) may identify a session (505). The service may provide a first instruction (e.g., the instruction 215) for a first task (e.g., the task 170) to a client (e.g., the user device 110) (510). The client may present the first instruction for the first task (515). Once the first task is completed, the service may determine whether there is any response information (520). Upon receiving the response information, the service may modify a second task (e.g., the task 170') (525). The service may provide second instructions (e.g., instructions 215') for the second task (530). The client may perform the second task (535). The service may determine a score associated with the performance of the one or more tasks (540). The service may provide feedback to the client (545). The client may receive the feedback (550), such as via a user interface.

[0091] 5B, upon completion of the second task, the service may determine whether there is response information (555). Upon receipt of the response information, the service may modify (560) a third task (e.g., task 170'). The service may provide (565) third instructions (e.g., instructions 215') for the third task. The client may submit (570) the third instructions for the third task. The service may determine (575) a score associated with the performance of the one or more tasks. The service may provide (580) feedback to the client. The client may receive the feedback (585), such as via a user interface.

[0092] 6, a sample system 600 is shown that provides a task on a device 605 for a system for providing training via visual elements for presenting to address a user's maladaptive behavior. The system can include a client device 605 (e.g., user device 110), a left hand 610A, and a right hand 610B. The client device 605 can include an application 125 and a sensor 120 installed thereon. In some embodiments, the client device 605 is similar to the user device 110 and can perform the application 125. The application 125 can be presented on a user interface or display of the client device 605. In some embodiments, the application 125 can be presented on the user device 605 as a game, image, video, or interactive application 125. One or two of the hands 610 can be used to interact with the device 605 to perform one or more of the tasks 170. The device 605 can include one or more user elements, such as UI elements 135, to accept input by the hand 610. The hand 610 may press the screen of the client device 605 to input, may manipulate or rotate the client device 605 to register the movement of the client device 605 (through detection by an accelerometer, gyroscope, or other sensor of the sensors 120), or the hand 610 may simply hold the client device 605.

[0093] The application operates on the subject's mobile device or at least on a mobile device that is easily and reliably accessible to the subject, so that, for example, according to a predefined frequency (e.g., once a day), the application provides real-time support to the subject. For example, upon receiving a request from the user to start a session, the application starts the session in real time, i.e., at least within a few milliseconds of receiving the request. Such rapid guidance cannot be achieved via a face-to-face visit, phone call, video conference, or text message between the user and a healthcare provider such as a dermatologist. In this way, the application can provide and customize tasks for the user based on the user's performance. This increases the usefulness of each task, thus minimizing overall bandwidth and data communication and creating an iteratively improving service for the user.

[0094] 7A-7C show screenshots of exemplary user interfaces 700-725 of a system for providing training through visual elements for presenting to address a user's maladaptive behavior. FIG. 7A shows a GNG therapy task operated through an application on a client device. The client device displays a user interface 700 to "move" (e.g., interact with the client device). The client device displays a user interface 705 to "itch" (e.g., not interact with the client device). The GNG task motivates the user to interact with the device as in the user interface 700 when the words displayed on the screen are not related to the maladaptive behavior. Next, the GNG task shows that the user does not interact with the client device when the user interface 705 displays words related to the maladaptive behavior. FIG. 7B shows an exemplary HRT task including steps 720. In a first display 710, a first step 720A and a second step 720B are shown. In a second display 715, a third step 720C and a fourth step 720D are shown. Steps 720 on displays 710 and 715 show an HRT task that includes a lesson in performing a manipulation with the user's hands to perform a function that is physically incompatible with the maladaptive behavior. Figure 7C shows the GNG task interface. Display 725 shows the task action of tapping the circle as fast as possible. Display 730 shows the task action of withholding a response when the phone vibrates or provides haptic feedback.

[0095] Next, Figures 8A-8B show screenshots of an exemplary set of user interfaces (800-815) for a system that provides training via visual elements to present to address a user's maladaptive behavior. Figure 8A shows an Impulse Surfing task. A first user interface 800 shows a series of balls falling in response to a user providing an initial tap on the user interface 800. A second user interface 805 shows a user's thumb interacting with a ball on the user interface 805 by pressing the user interface 805. Figure 8B shows an Impulse Surfing task including a first user interface 810 and a second user interface 815. The first user interface 810 prompts the user to place their thumb on the user interface 810. The second user interface 815 displays a shape emanating from the position of the user's thumb.

[0096] Next, Fig. 9A-9C show screenshots of an exemplary set of user interfaces (900-945) of a system for providing training through visual elements for presenting to address a user's maladaptive behavior. Fig. 9A shows a GNG task including a first user interface 900, a second user interface 905, and a third user interface 910 for a user to perform according to the GNG task. The first user interface 900 shows words related to maladaptive behavior, and the user refrains from interacting with the words. The second user interface 905 shows words that are not related to maladaptive behavior or words that have positive associations. During the second user interface 905, the user may perform an action to catch positive or neutral words. In the third user interface 910, words related to maladaptive behavior are displayed for the user to ignore. Fig. 9B shows a GNG task including a first user interface 915, a second user interface 920, a third user interface 925, and a fourth user interface 930. During this GNG task, the user is to catch positive or neutral words that are not related to maladaptive behavior or skin disease. Conversely, the user is to ignore words that are related to maladaptive behavior or skin disease. Figure 9C shows the GNG task including user interfaces 935-960 in which the user interacts with the neutral or positive words, for example, by "shooting."

[0097] 10A-10B next show screenshots of exemplary user interfaces (1005-1025) of a system for providing training via visual elements for presenting to address a user's maladaptive behavior. FIG. 10A shows a GNG task including a first user interface 1005 and a second user interface 1010. The GNG task may include a user tapping on a positive or neutral word, causing words related to maladaptive behavior or skin disease to fall down. FIG. 10B shows a GNG task including a first user interface 1015, a second user interface 1020, and a third user interface 1025. In the GNG task of this embodiment, a user may interact with (e.g., "pop") a bubble containing a positive or neutral word.

[0098] Referring now to FIG. 11, a screenshot of an exemplary task 1105 of a system for providing training via visual elements for presenting to address a user's maladaptive behavior is shown. The exemplary task 1105 may be accomplished by the application 125 via the user device 110. A user may interact with the task 1105 through a user interface, such as the user interface 130. The task 1105 may be a GNG task and may include a user moving a ball to either side of the user interface depending on whether a displayed word is relevant or neutral with respect to a maladaptive behavior or a skin condition. Referring now to FIG. 12, a screenshot of an exemplary task including user interfaces 1205-1215 of a system for providing training via visual elements for addressing a user's maladaptive behavior is shown. The exemplary task may be a GNG task and may include a user interacting with the user interfaces 1205-1215 by tapping on the screen if a displayed word is positive or neutral. Referring now to FIG. 13, a screenshot of an exemplary task including user interfaces 1305-1315 of a system for providing training via visual elements for addressing a user's maladaptive behavior is shown. An example task may be a GNG task and may involve a user interacting with user interfaces 1305-1315 when displayed words are positive or neutral.

[0099] 14A-D, screen shots of exemplary user interfaces 1400-1415 of a go / no-go training in a system for providing training are shown. User interface 1400 may prompt a user to prepare for the start of a go / no-go training. User interface 1405 may instruct the user to hold a button having a neutral word (e.g., "hike") related to skin disease following user interface 1400. User interface 1410 may be displayed following user interface 1405 and may indicate to the user that a go / no-go task is about to be completed. User interface 1415 may be displayed following user interface 1410 and may notify the user of the completion of the task.

[0100] 15A-D next show screenshots of exemplary user interfaces 1500-1515 for Go / No-Go training in a system for providing training. User interface 1500 may indicate that all rounds (or sessions) have been completed by the user on a particular day. User interface 1505 may be a start screen for a Go / No-Go training task. User interface 1510 may indicate a total number of rounds available for the user to perform. User interface 1515 may indicate that one of a total number of three available rounds has been performed by the user on a particular day.

[0101] Referring now to FIG. 16, a screenshot of an exemplary user interface 1600 with options for various interventions in a system for providing training is shown. The user interface 1600 may include a set of user interface elements corresponding to available types of training, such as a complex task, a go / no-go task, a habit reversal therapy task, and an urge surfing task. A user of the application may select one of the user interface elements to request the provision of the corresponding task. Referring now to FIG. 17A-M, 17A-M show screenshots of exemplary user interfaces 1700-1760 for urge surfing training in a system for providing training. The user interfaces 1700-1760 may be rendered following selection of the urge surfing training option in the user interface 1600. The user interfaces 1700-1760 may show morphing of a blob to facilitate the user to visualize and draw attention away from a maladaptive behavior (e.g., scratching) through the duration of the urge to perform such behavior.

[0102] B. Methods for reducing the frequency or intensity of maladaptive behaviors associated with skin conditions in users in need thereof Referring now to FIG. 18, a flow diagram of a method for reducing the frequency or intensity of maladaptive behaviors associated with skin conditions in a user in need thereof is shown. The method 1800 may be performed by any component or actor described herein, such as the session management service 105, the user device 110, or the user 210, among others. The method 2000 may be used in combination with any function or action described in Section A or Section B herein. In general terms, the method 1800 may include obtaining a baseline metric (1805). The method 1800 may include selecting a task (1810). The method 1800 may include presenting instructions to perform the task (1815). The method 1800 may include obtaining a session metric (1820). The method 1800 may include determining whether to continue (1825). The method 1800 may include determining whether the session metric is an improvement over the baseline metric (1830). Method 1800 may include determining that a reduction is indicated if the session metric is determined to be improved over the baseline metric (1835). Method 1800 may include determining that a reduction is not indicated if the session metric is determined to be not improved over the baseline metric (1840).

[0103] In further detail, the method 1800 may include retrieving, identifying, or otherwise obtaining a baseline metric (1805). The baseline metric may be associated with a user (e.g., user 210) suffering from or diagnosed with a skin condition. The skin condition may include, for example, one or more of atopic dermatitis, contact dermatitis, psoriasis, urticaria, prurigo nodularis, lichen planus, acne vulgaris, drug-induced rash, xerosis, uremia, or non-contact dermatitis (eczema), among others. The skin condition may be caused by infection (e.g., due to a disease such as chickenpox), allergy (e.g., to a plant, animal, drug, or other exposure), or genetic mutation, among others. The maladaptive behavior associated with the skin condition may include, for example, at least one of the user's continuous scratching of the affected epidermal tissue, intermittent scratching of the affected epidermal tissue, or a reflexive response to pruritus on the affected epidermal tissue.

[0104] A baseline measurement may be obtained (e.g., by a computing device) prior to performing any time instance or session in which a task is performed by a user via a digital therapeutic application (e.g., application 125 described herein or a research app). The baseline measurement may indicate the user's status with respect to the severity of the skin condition and associated maladaptive behaviors relative to the user's daily routine and activities. The baseline metric may include, for example, a Dermatology Life Quality Index (DLQI) value, a Peak Pruritus Numeric Rating Scale (PP-NRS) value, a Patient-Reported Outcome Measurement Information System (PROMIS) value, a Patient-Oriented Eczema Measurement (POEM) value, a Psoriasis Symptom Inventory (PSI) value, an Eczema Area and Severity Index (EASI), a digital EASI (EASI-dig), a Scoring in Atopic Dermatitis (SCORAD), a Patient-Oriented SCORAD (PO-SCORAD), a Psoriasis Area and Severity Index (PASI) or a Self-Administered PASI (SA-PASI) or a computerized cognitive assessment value, etc. Prior to performance of any task, the user may have an initial baseline metric that meets a baseline threshold. The threshold may delineate, define, or identify a value of an initial metric at which a user is identified as suitable or eligible to perform a task via the digital therapeutic application. The initial metric may be, for example, an Itch Numeric Rating Scale (NRS) and the baseline threshold may be a value of 4 or less.

[0105] The user may be of any demographic or characteristic, such as age (e.g., adult (18 years or older) or late adolescent (between 18 and 24 years old)) or gender (e.g., male, female, or non-binary), among others. In at least part association with the time instance or session in which the user performs the task, the user may be taking a medication to address a pathology. For example, the medication may include capsaicin, diflorasone, diphenhydramine, doxepin, hydrocortisone, prednisone, prednicarbate, pimecrolimus, tetracaine, tacrolimus, terbinafine, corticosteroids, vitamin D analogs, retinoids, calcineurin inhibitors, immunosuppressants, or antihistamines, and the like. The medication may be in an effective amount (e.g., dosage or frequency), which may be sufficient to provide a positive outcome or reduction in symptoms (e.g., reduced itching or tendency to scratch). The effectiveness of the medication in terms of addressing the user's maladaptive behavior may be improved or enhanced by association with a task performed via the digital therapeutic application.

[0106] In some embodiments, a study to test the effectiveness of a digital therapeutic application may have at least two groups. The first group may include a set of users (e.g., including users) for a treatment group. The first group of users may be exposed to or provided with tasks for the users to perform via a digital therapeutic application (e.g., application 125 described herein or a study app). As discussed herein, the tasks may include, for example, a go-no-go task, an HRT task, and an urge surfing task, or any combination thereof. The second group may include another set of users for a control group. The second group of users may be exposed to or provided with a control therapy (sometimes referred to herein as a placebo or standard of care).

[0107] The controlled therapy may exclude tasks that are intended to address the skin condition and are performed via a digital therapeutic application. In some embodiments, the controlled therapy may include tasks that are performed via an application on a computing device that is inactive with respect to the skin condition or related symptoms. The tasks may include any tasks other than go / no-go training, HRT, and urge surfing tasks as described herein for the digital therapeutic application. In some embodiments, the controlled therapy may include an inactive version of go / no-go training that presents a go stimulus to the user without association with the skin condition. The inactive version of go / no-go training may lack a no-go stimulus. The controlled therapy application may also lack HRT and urge surfing tasks.

[0108] In some embodiments, the controlled therapy may include an inactive version of HRT in which the user is presented with prompts to perform tasks unrelated to the skin condition. For example, an inactive version of HRT may prompt the user to perform a breathing or running exercise without any prompts regarding scratching or reflexive actions in response to an itch. In some embodiments, the controlled therapy may include an inactive version of urge surfing. For example, an inactive version of urge surfing may lack messages to the user regarding the skin condition. The controlled therapy may include other forms of cognitive behavioral therapy.

[0109] In some embodiments, the control therapy may include a care-as-usual (CAU) treatment plan. The CAU treatment plan may be devoid of the digital therapeutic application described herein. For example, the CAU treatment plan may have the user receive medication for a skin condition on a scheduled basis (e.g., 1-3 times per day) and may include an assessment of the skin condition conducted directly or via a web application to assess symptoms. Baseline metrics may be obtained (e.g., via a computing device) from users in both the treatment and control groups (e.g., receiving an inactive version or CAU).

[0110] The method 1800 may include identifying or selecting a task from a set of tasks (1810). A task may be selected (e.g., by a computing device) from the set of tasks for a time instance or a portion of a session at a particular time instance. The set of tasks may be for the user to perform an action with a display of the computing device to reduce, mitigate, or otherwise decrease the frequency or intensity of a maladaptive behavior associated with a skin condition (e.g., scratching skin affected by eczema) on the part of the user. The set of tasks from which the task is selected may include, for example, a go / no-go task prompting the user to perform or withhold a first action, a habit reversal therapy task prompting the user to perform a first action instead of performing a second action associated with the maladaptive behavior, a duration of the maladaptive behavior, an urge surfing task prompting the user to perform a third action, and the like. The task may be selected using a number of factors, as detailed in Section A herein.

[0111] The method 1800 may include providing or presenting instructions for performing the selected task (1815). A digital therapeutic application executing on the computing device may display, render, or otherwise present instructions for performing a one-handed or two-handed task to hold the display in a specified manner. The instructions may be presented via one or more user interface elements presented through a graphical user interface of the digital therapeutic application. The instructions may instruct the user to perform the task for a set period of time during the session. For example, a go-no-go task may be 5-10 minutes, an HRT task may be 2-3 minutes, and an urge surfing task may be 2-5 minutes.

[0112] The method 1800 may include retrieving, identifying, or otherwise obtaining a session metric (1820). The session metric may be associated with a user (e.g., user 210) with respect to a skin condition or associated maladaptive behavior. The session metric may be obtained (e.g., by a computing device) after performing at least one of the time instances or sessions in which a task is to be performed by the user via the digital therapeutic application. The baseline measurement may indicate the user's status with respect to the severity of the skin condition and associated maladaptive behavior to the user's daily routine and activities as a result of the performance of the task. Session metrics may include, for example, Dermatology Life Quality Index (DLQI) values, Peak Pruritus Numeric Rating Scale (PP-NRS) values, Patient-Reported Outcome Measurement Information System (PROMIS) values, Patient-Oriented Eczema Measurement (POEM) values, Psoriasis Symptom Inventory (PSI) values, Scratch Intensity and Impact Scale (SIIS) values, Sleep-Related Itch and Scratch Scale values, Eczema Area and Severity Index (EASI) values, Digital EASI (EASI-dig) values, Scoring of Atopic Dermatitis (SCORAD) values, Patient-Oriented SCORAD (PO-SCORAD) values, Psoriasis Area and Severity Index (PASI) values, or Self-Administered PASI (SA-PASI) values, computerized cognitive assessment values, etc. Session metrics may be the same types of measurements as baseline metrics. Session metrics may be obtained from users in both treatment and control groups.

[0113] Method 1800 may include identifying or determining whether to continue (1825). The determination may be based on a set length of the test (e.g., days, weeks, or years), a set number of time instances to perform one or more tasks, or a set number of tasks to be provided to the user. For example, the set number of time instances may range between two weeks and six months relative to obtaining the baseline metrics. Once the amount of time since obtaining the baseline metrics exceeds the set length, it may be determined to stop providing additional tasks.

[0114] In contrast, if the amount of time since obtaining the baseline metric does not exceed the set length, the decision may be to continue providing additional tasks and repeat from (1810). Selection or modification of a task for the next time instance or session may be based on performance of the task in a previous time instance or session. In some embodiments, the next task may be modified based on response data from the user while performing the task in a previous time instance or session. In some embodiments, the next task may be modified based on a score determined from performance of the task in a previous time instance or session. The tasks may be modified, for example, by order of performance (e.g., relative to other tasks), the length of time to complete the task, and the difficulty of performing the task. Selection or modification of a task for the next time instance or session may be independent of performance of the task in a previous time instance or session.

[0115] The method 1800 may include identifying or determining whether the session metric is an improvement over a baseline metric (1830). The improvement may correspond to a reduction in the frequency or intensity of maladaptive behaviors associated with the skin condition. The improvement may be indicated when the session metric increases by a first predetermined margin compared to the baseline metric or when the session metric decreases by a second predetermined margin compared to the baseline metric. The margin may identify or define a difference in value between the baseline and the session metric for determining that the user exhibits a reduction in the frequency or intensity of maladaptive behaviors associated with the skin condition. Whether the improvement is indicated by an increase or a decrease may depend on the type of metric used to measure the user with respect to the skin condition or the associated maladaptive behavior. The margin may also depend on the type of metric used. The margin may depend on the type of metric used and may generally correspond to a difference in values ​​that indicate a noticeable difference by a clinician or user with respect to the skin condition or the maladaptive behavior, or may indicate a statistically significant result in the difference in values ​​between the baseline and the session metric.

[0116] In some embodiments, at least one of the first predetermined margin or the second predetermined margin may be calculated, generated, or otherwise determined (e.g., by a computing device). The first predetermined margin or the second predetermined margin may be based on baseline and session metrics obtained from a treatment group or a control group of users. The margin may correspond to a statistically significant difference between the change in baseline and session metrics in the treatment group and the change in baseline and session metrics in a control group (e.g., receiving a control therapy). The difference may be based on any number of statistical tests, such as a t-test, a z-test, a chi-square test, etc.

[0117] The method 1800 may include determining 1835 that a reduction is indicated when the session metric is determined to be improved over the baseline metric by a first predetermined margin. In some embodiments, a reduction may occur when the session DLQI metric increases by a first predetermined threshold margin compared to the baseline DLQI metric. In some embodiments, a reduction may occur when the session PP-NRS metric decreases by a first predetermined threshold margin compared to the baseline PP-NRS metric. In some embodiments, a reduction may occur when the session PROMIS metric increases by a first predetermined threshold margin compared to the baseline PROMIS metric. In some embodiments, a reduction may occur when the session POEM metric decreases by a first predetermined threshold margin compared to the baseline POEM metric. In some embodiments, a reduction may occur when the session PSI metric decreases by a first predetermined threshold margin compared to the baseline PSI metric.

[0118] In some embodiments, a reduction may occur when a session EASI metric (or EASI-dig) is decreased by a first predetermined threshold margin compared to a baseline EASI metric (or EASI-dig). In some embodiments, a reduction may occur when a session SCORAD metric is decreased by a first predetermined threshold margin compared to a baseline SCORAD metric. In some embodiments, a reduction may occur when a session PO-SCORAD metric is decreased by a first predetermined threshold margin compared to a baseline PO-SCORAD metric. In some embodiments, a reduction may occur when a session SA-PASI metric is decreased by a first predetermined threshold margin compared to a baseline SA-PASI metric. In some embodiments, a reduction may occur when a session computer cognitive assessment metric is decreased by a first predetermined threshold margin compared to a baseline computer cognitive assessment metric.

[0119] The method 1800 may include determining that a reduction is not indicated if it is determined that the session metric has not improved by a second predetermined margin compared to the baseline metric (1840). In some embodiments, a reduction may not occur when the session DLQI metric has not increased by a first predetermined threshold margin compared to the baseline DLQI metric. In some embodiments, a reduction may not occur when the session PP-NRS metric has not decreased by a first predetermined threshold margin compared to the baseline PP-NRS metric. In some embodiments, a reduction may not occur when the session PROMIS metric has not increased by a first predetermined threshold margin compared to the baseline PROMIS metric. In some embodiments, a reduction may not occur when the session POEM metric has not decreased by a first predetermined threshold margin compared to the baseline POEM metric. In some embodiments, a reduction may not occur when the session PSI metric has not decreased by a first predetermined threshold margin compared to the baseline PSI metric.

[0120] In some embodiments, no reduction may occur if the session EASI metric (or EASI-dig) does not decrease by a first predefined threshold margin compared to the baseline EASI metric (or EASI-dig). In some embodiments, no reduction may occur if the session SCORAD metric does not decrease by a first predefined threshold margin compared to the baseline SCORAD metric. In some embodiments, no reduction may occur if the session PO-SCORAD metric does not decrease by a first predefined threshold margin compared to the baseline PO-SCORAD metric. In some embodiments, no reduction may occur if the session SA-PASI metric does not decrease by a first predefined threshold margin compared to the baseline SA-PASI metric. In some embodiments, no reduction may occur if the session computer cognitive assessment metric does not decrease by a first predefined threshold margin compared to the baseline computer cognitive assessment metric.

[0121] (Protocol, a randomized controlled exploratory basket study evaluating inhibitory control, habit reversal therapy, and compulsion surfing to interrupt scratching in atopic dermatitis and psoriasis)

[0122] 1. Protocol Summary overview

[0123] The CT-100 (e.g., application 125) is a platform that provides interactive software-based therapeutic components that may be used as part of a multi-modal treatment in future software-based digital therapeutics. One class of components in the CT-100 is the Digital Neural Activation and Modulation (DiNaMo™) components. The DiNaMo components target key neural systems (including, but not limited to, systems related to sensation, perception, emotion, pain, attention, cognitive control, social and self-processing) to optimally improve patient health.

[0124] DiNaMo, a combination of inhibitory control, habit reversal therapy (HRT), and urge surfing, aims to control urges (e.g., scratching) through a combination of bottom-up and top-down approaches. Go / No-Go (GNG) training (inhibitory control tasks) helps individuals implicitly train inhibitory control skills so that they can resist urges when they come. HRT interrupts these habitual activities by offering physically incompatible alternative actions to prevent engagement in the unwanted behavior. Finally, urge surfing helps train individuals to feel pleasure in experiencing the urge without succumbing by acknowledging this unpleasant sensation and recognizing that it will eventually pass, even if they do not engage in the desired behavior.

[0125] The aim of the proposed study is to evaluate the initial effects of DiNaMo components (research application [App]) on measures of unwanted behavior intensity and related outcomes (inhibitory control and general quality of life [QoL]) in various conditions such as atopic dermatitis and psoriasis. Results from this study may be used as components of future prescription digital therapeutics (PDT).

[0126] the purpose

[0127] Evaluate trends in changes in the intensity of unwanted behaviors and related outcomes (inhibitory control and general QoL) measured by indication-specific measures, QoL measures, and computerized cognitive assessment of inhibitory control compared with the digital control arm.Feasibility and acceptability of a home-based digital treatment combining GNG, HRT, and urge surfing training will be measured by engagement with the study app, user experience questionnaires, and qualitative interviews.

[0128] To assess the safety of the study app.To investigate the feasibility and acceptability of a home-based digital treatment combining GNG, HRT and urge-surfing training as measured by study app engagement, user experience questionnaires and qualitative interviews.

[0129] Evaluation criteria

[0130] Exploratory Endpoints Change from baseline to end of study in the Peak Pruritus Numeric Rating Scale (PP-NRS) or other measure of itch behavior. Change from baseline to the end of the study in the Scratch Intensity and Impact Scale (SIIS) or other measures of scratching behavior. - Change from baseline to end of study in the Sleep-Related Itch and Scratch Scale (SRISS). -Change from baseline to end of study in Dermatology Life Quality Index (DLQI). · Change in indication-specific measures from baseline to end of study. Change from baseline to end of study in QoL symptoms assessed using the PROMIS®-29+2 Profile v2.1 (PROMIS-29+2 Preference [PROPr]) scale. Change in computerized cognitive assessment from baseline to end of study. Your experience with the study app, measured by metrics such as daily app usage and daily time spent in the app. Experience of using the study app, as assessed by a user experience questionnaire and optional qualitative interviews after the study app treatment period. The percentage of participants who showed improvement at the end of the study as measured by Global Rating of Change (GRC) scores.

[0131] Safety Endpoints Frequency and severity of adverse events (Aes), serious Aes and study discontinuations due to Aes. -The frequency and severity of Aes associated with symptom exacerbations related to the indication.

[0132] Study design

[0133] Referring now to FIG. 19, a timeline of the study design to evaluate inhibitory control, habit reversal therapy, and urge surfing to interrupt scratching in atopic dermatitis and psoriasis is shown.

[0134] Screening Period (Days -28 to -1): Participants will be screened for up to 14 days, including electronic informed consent. Assessments during this period will be performed according to the Schedule of Activities and Assessments (SoA) (e.g., in-person or remote). Screening and baseline visits may occur on the same day.

[0135] Baseline Virtual Visit (Day 0): Eligible participants will be contacted for a baseline visit to review and confirm eligibility and perform identity verification. Participants will be deemed eligible to participate in the study if they meet all entry criteria and have no exclusion criteria based on investigator assessment. Eligible participants will be randomized during the Day 0 virtual study visit. Participants will be randomized 1:1 within instructions (e.g., study app:digital control app or study app:CAU). Participants randomized to the study app treatment group will download and activate the app on their personal primary iPhone or Android smartphone.

[0136] Intervention Period (Days 1-28-84): Study app group participants are instructed to access and perform the tasks daily, for example, 10-120 minutes per day, 3-10 times per day, 3-7 days per week, for 4-12 weeks. In some embodiments, participants are instructed to access and perform the tasks daily for a period of 2-28 weeks, 2-20 weeks, 2-15 weeks, 2-12 weeks, 2-10 weeks, or 2-8 weeks. Control group participants receive a digital control app and perform the tasks for approximately 1-10 minutes per day, 3-7 days per week, for 4-12 weeks. Both groups are assessed every 2-6 weeks during the 4-12 week intervention period. At the end of the treatment period, the study app is disabled and study app group participants complete a user experience questionnaire.

[0137] Follow-up period (up to 1-24 weeks): A portion of participants will be invited to complete an optional qualitative interview up to 7 days after the end of treatment. Participants will not perform any activities within their respective apps.

[0138] Anticipated Number of Participants: At least 15-200 participants per instruction, and at least 30-400 participants in total.

[0139] Research participation criteria

[0140] Entry Criteria: Participants are eligible to participate in this study if they meet all of the following criteria: 1. Participants are fluent in written and spoken English and are able to read, understand, and sign the informed consent form (ICF). 2. You are a resident of the United States. 3. Be 18 years of age or older. 4. Itch NRS ≥ 4 during baseline. 5. Meet indication-specific entry criteria as reported by study participant with appropriate clinical documentation (documentation will be provided to the study team upon request). 6. Have a valid email address and are willing and able to receive and reply to email messages. 7. You will have access to the Internet for the duration of the study. 8. Willing and able to comply with study protocols and evaluations. 9. During the duration of the study, participants are solely using an iPhone with iPhone operating system (OS) 14 or later or an Android smartphone with OS 10 or later. 10. Willing and able to receive Short Message Service (SMS) text messages and notifications via smartphone.

[0141] Exclusion Criteria: Participants were not eligible to participate in the study if they met any of the following criteria: 1. Pregnant or planning to become pregnant. 2. Have visual, dexterity, or cognitive impairments severe enough that they cannot use app-based reaction time-based activities, as determined by the researcher. 3. Have a severe psychiatric disorder with a psychiatric history (e.g., schizophrenia, bipolar disorder or severe personality disorder). 4. History of psychiatric hospitalization within the past 6 months. 5. Participated in any research study (including studies on psychotherapy, mindfulness, cognitive training, or drug treatment) in the past 3 months. 6.Disease-specific medications were ordered or changed within 30 days prior to study participation. 7. Self-reported substance use disorder within the past year. 8. You are currently experiencing a skin infection. They plan to introduce new treatments (including psychotherapy, mindfulness, cognitive training, and pharmacological treatments) during the 9.7- to 39-week study period. 10. Plan to change current pharmacological or psychological treatment plan during the 7-39 week study period.

[0142] Eligible study app group participants will download and install the study app onto their smartphone at the baseline visit (Day 0).

[0143] Treatment plan: Study app: 4-12 weeks (10-120 minutes per day, 3-10 times per day, 3-7 days per week)

[0144] Study Duration: Study participation will last approximately 7 to 39 weeks: Screening period: up to 2 weeks Intervention period: 4-12 weeks Follow-up: up to 1-24 weeks

[0145] Sample size

[0146] There will be at least 60-120 participants per instruction, and 120-240 participants total. This sample size should be sufficient to measure effect sizes with relative precision. However, this study is exploratory in nature and can be used to estimate effect sizes.

[0147] statistical analysis

[0148] Changes from baseline will be summarized using descriptive statistics. Changes from baseline to end of study in PROMIS-29+2 subscales, computerized cognitive assessment and DLQI, PP-NRS or other itch measures, and SIIS or other scratch measures and SRISS will be analyzed using analysis-of-covariance (ANCOVA) models to estimate differences between the two treatment arms. The model includes change from baseline as the dependent variable and treatment arm, instructions, and baseline value as covariates in the model. 95% confidence intervals (CIs) and two-sided p-values ​​for the null hypothesis of no difference between the two arms will be provided. Least-squares means for the treatment effects will be provided. Additionally, least-squares means, 95% CIs, and p-values ​​for the null hypothesis of no change from baseline will be provided for each treatment arm.

[0149] For indication-specific measures such as Patient-Oriented Eczema Measure (POEM), Psoriasis Symptom Inventory (PSI), Eczema Area and Severity Index (EASI), Digital EASI (EASI-dig), Scoring for Atopic Dermatitis (SCORAD), Patient-Oriented SCORAD (PO-SCORAD), Psoriasis Area and Severity Index (PASI) or Self-Administered PASI (SA-PASI), change from baseline to end of study in each treatment arm and 95% CI and two-sided p-value for the null hypothesis of no difference between treatment arms are provided. CIs and p-values ​​are based on two sample t-distribution. 95% CI for change from baseline to end of study in each arm and two-sided p-value for the null hypothesis of no change from baseline are provided using one sample (pre-post) t-distribution.

[0150] Activity and evaluation schedule

[0151] Descriptive statistics are used for user experience, engagement and safety parameters.

[0152] [Table 1] Abbreviations: AE = adverse events, DLQI = Dermatology Life Quality Index, EOS = end of study, ET = early termination, GRC = global assessment of change; ID = Identifier, NA = Not Applicable, PHQ-8 (Patient Health Questionnaire Depression Scale) = Patient Health Questionnaire Depression Scale, PP-NRS = Peak Pruritus Numeric Rating Scale, PROMIS®-29 = Patient-Reported Outcomes Measurement Information System-Profile v2.1, PROPr = PROMIS-29+2 Preferences, SAE = Serious Adverse Events, SIIS = Scratch Intensity and Impact Scale, SRISS = Thread-Related Itch and Scratch Scale a Remote visits will be managed via video conferencing platforms where appropriate. dAfter completing the intervention period, each app will be disabled on days 28-84. After days 28-84 or upon withdrawal from the study, participants will no longer be able to access the content provided by the app.

[0153] 2. Introduction

[0154] Rationale for the study

[0155] The CT-100 is a platform that delivers interactive software-based therapeutic components that may be used as part of a multi-modal treatment in future software-based digital therapeutics. One class of components in the CT-100 is the Digital Neural Activation and Modulation (DiNaMo) components. The DiNaMo components target key neural systems (including but not limited to systems related to sensation, perception, emotion, pain, attention, cognitive control, and social and self-processing) to optimally improve a patient's cognitive and mental health.

[0156] DiNaMo, a combination of inhibitory control, habit reversal therapy (HRT) and urge surfing, aims to control urges (e.g. scratching) through a combination of bottom-up and top-down approaches. Go / No-Go (GNG) training (inhibitory control tasks) helps individuals implicitly train inhibitory control skills to help them resist urges when they come. HRT interrupts these habitual activities by offering physically incompatible alternative actions to prevent engagement in the unwanted behavior. Finally, urge surfing helps train individuals to get used to experiencing urges without giving in by acknowledging this unpleasant sensation and recognizing that it will eventually pass, even if they do not engage in the desired behavior.

[0157] The aim of the proposed study is to evaluate the initial effects of DiNaMo components (research applications [Apps]) on measures of the strength of unwanted behaviors and related outcomes (inhibitory control and general quality of life [QOL]) in various conditions such as atopic dermatitis and psoriasis. Results from this study could be used as components for future digital therapeutics.

[0158] task

[0159] Inhibitory control: Inhibitory control refers to an individual's ability to withhold responses based on impulses and habitual behavior. Inhibitory control can be assessed with a variety of cognitive tasks, one of the most common being the GNG task. In this task, there are two stimuli: a go, which prompts the individual to respond, and a no-go, which prompts the individual to withhold their response. The go stimulus appears more frequently, building the response into a habitual action, thereby making the no-go condition more difficult.

[0160] Habit Reversal Therapy: HRT helps to reduce unwanted repetitive behaviors. The first step is to become aware of the cues that indicate the onset of the behavior you want to stop, and the second step is to replace that behavior with another, physically incompatible behavior.

[0161] Impulse surfing: Impulse surfing is a technique for managing unwanted habits, urges or behaviors. The person learns to tolerate the discomfort caused by the urge not to act, in the same way that a surfer is taught to ride a wave.

[0162] Application (CT-100-D-003DiNaMo component)

[0163] The CT-100-D-003DiNaMo component (e.g., application 125) combines inhibitory control training, HRT, and urge surfing using the GNG paradigm. GNG is hypothesized to promote plastic changes in the brain. These changes can be carried over to subsequent HRT lessons, teaching alternative behaviors in the face of an itch, and urge surfing teaching control over the worries that may arise when an itch cannot be scratched.

[0164] The training consists of regular and challenging exercise. In this study, the treatment plan of daily 15-minute sessions divided into GNG training, HRT and urge surfing will be carried out over a period of 4 to 12 weeks, which is comparable in total task time and treatment duration compared to previous studies in the literature.

[0165] The control group will use a digital control app. The digital control app is designed as an inactive version of the GNG training. Participants will only be presented with neutral "go" stimuli, without any disease-related "no-go" stimuli, and will not be mentioned about these components of the task. HRT and urge surfing will not be included in the control application.

[0166] Controlled care as usual: A care as usual (CAU) control group will only complete assessments and will not use the study app. There may or may not be a CAU control group in this study.

[0167] 3. Purpose and Endpoints

[0168] The objectives of the study are as follows:

[0169] To assess trends in the study app intervention group compared with the digital control app arm for change in the intensity of undesirable behaviors and related outcomes (inhibitory control and general QoL) as measured by indication-specific measures, QoL measures, and computerized cognitive assessment of inhibitory control.

[0170] The feasibility and acceptability of a home-based digital treatment combining GNG, HRT and urge-surfing training will be measured through engagement with the study app, user experience questionnaires and qualitative interviews.

[0171] This study was exploratory in nature and did not evaluate specific statistical endpoints. Study endpoints are presented in Table 1.

[0172] [Table 2]

[0173] 4. Study Design

[0174] Overall Design

[0175] Referring to Figure 19, this is a randomized hypothetical study evaluating the study app compared to a digital control app (or CAU) in participants with atopic dermatitis and psoriasis. The study consists of a screening period of up to 2 weeks, an intervention period of -12 weeks, and a follow-up period of 1 to 24 weeks. Participants who meet the eligibility criteria will be randomized on study day 0 (baseline visit).

[0176] Screening Period (Days -14 to 0): Participants will be screened for up to 14 days, including electronic informed consent. Assessments during this period will be performed remotely according to the Schedule of Activities and Assessments (SoA). Based on the investigator's assessment, participants will be considered eligible if they meet all entry criteria and have no exclusion criteria. Screening and baseline visits may take place on the same day.

[0177] Baseline Virtual Visit (Day 0): Eligible participants will be contacted for a baseline visit to confirm eligibility and perform identity verification. Based on investigator assessment, participants will be considered eligible to participate in the study if they meet all inclusion criteria and have no exclusion criteria.

[0178] Eligible participants will be randomized during a virtual study visit on Day 0. Participants will be randomized 1:1 (study app: control) within instructions. Participants randomized to the study app treatment group will download and activate the app on their primary iPhone or Android smartphone.

[0179] Intervention period (Days 1-28): Study app group participants will be instructed to access the study app and perform tasks as instructed daily for a maximum of 10-60 minutes per day, 3-7 days per week, for 4-12 weeks. Assessments will be conducted according to a Schedule of Activities and Assessments (SoA). Control group participants will receive the digital control app (or CAU). During the 12-week intervention period, both groups will be assessed every 2-6 weeks.

[0180] At the end of the treatment period, the study app will be disabled and study app group participants will complete a user experience survey.

[0181] Follow-up period (up to 1–24 weeks): Participants complete follow-up assessments according to the SoA. A portion of participants is invited to complete an optional qualitative interview. Participants do not perform any activities within the study app (see section 6.2).

[0182] Rationale for study design

[0183] The study is designed to assess the initial effects of the study app on the intensity of undesirable behaviors and related outcomes. Participants will be assessed based on validated standard participant-assessed outcomes. Participants' engagement with the study app will be assessed based on participant usage data captured within the study app. Participants will also be assessed for safety throughout the duration of the study. The scales and assessments are described below.

[0184] Definition of end of research

[0185] The end of the study is defined as the last contact or last attempted contact date of the last participant who completed or discontinued the study. In this study, participants who completed the assessments on days 28 to 84 (+3) (at the end of the study) are defined as study completers.

[0186] 5. Study subjects

[0187] Participants will be assigned a unique participant identifier (ID) upon signing the Informed Consent Form (ICF) at screening. Prospective approval of protocol deviations from recruitment and enrollment criteria, also known as protocol waivers or exemptions, will not be permitted.

[0188] Entry Criteria

[0189] Participants were eligible to participate in the study if they met all of the following criteria: 1. Be fluent in written and spoken English and be able to read, understand, and sign the ICF. 2. You are a resident of the United States. 3. Be 18 years of age or older. 4. Baseline itch numeric rating scale (NRS) score of 4 or higher. 5. Meet indication-specific entry criteria reported by study participant with sufficient clinical documentation (documentation will be provided to the study team upon request). 6. Have a valid email address and are willing and able to receive and respond to email messages. 7. You will have access to the Internet for the duration of the study. 8. Willing and able to comply with study protocols and evaluations. 9. During the duration of the study, participants are solely using an iPhone with iPhone operating system (OS) 14 or later or an Android smartphone with OS 10 or later. 10. Willing and able to receive Short Message Service (SMS) text messages and notifications on a smartphone.

[0190] Exclusion criteria

[0191] Participants were ineligible to participate in the study if they met any of the following criteria: 1. Pregnant or planning to become pregnant. 2. Have visual, dexterity, or cognitive impairments severe enough, in the opinion of the investigator, to prevent use of app-based reaction time-based activities. 3. Have a severe mental disorder with a history of psychiatric illness (e.g., schizophrenia, bipolar disorder, or severe personality disorder). 4. Have been hospitalized in a psychiatric hospital within the past 6 months. 5. Participated in any research study (including studies on psychotherapy, mindfulness, cognitive training, and drug treatment) in the past 3 months. 6.Disease-specific medications have been prescribed or changed within 30 days prior to study participation. 7. Self-reported substance use disorder within the past year. 8. You are currently experiencing a skin infection. They plan to introduce new treatments (including psychotherapy, mindfulness, cognitive training, and research into pharmacological treatments) during the 9.7- to 39-week study period. 10. Plan to change current pharmacological or psychological treatment plan during the 7-39 week study period.

[0192] Lifestyle Considerations: Participants will need to have access to a smartphone on a daily basis for the duration of the study.

[0193] 6. Research intervention

[0194] Study App: The study intervention being evaluated is the digital mobile application (e.g., Application 125), which is a CT-100 DiNaMo component. Participants randomized to this group will download and install the study app on their smartphone at the baseline visit (Day 0) and will use the study app daily for DiNaMo training during the -12-week intervention period.

[0195] Digital control: Participants randomized to the digital control group will download and install the digital control app onto their smartphone at the baseline visit (day 0) and will use the digital control app daily during the 4- to 12-week intervention period. Certain participants will be randomized to the CAU control group and will only complete study assessments during the 4-week intervention period.

[0196] App Download and Activation: During the baseline visit, study personnel will assist randomized participants with downloading, installing, and activating their app. Installation and activation instructions are provided in CT-100-D-003 Study App Site Instructions. Only participants enrolled in the study may activate the app.

[0197] App Disabling and Uninstallation: After completion of the intervention period (day X), the study app will be disabled and will no longer be available to participants. Site personnel will inform participants who complete the study or terminate early to uninstall the study app.

[0198] Measures to minimise bias, randomisation: Participants in each indication during the study will be randomised in a 1:1 ratio to either the investigational app or the digital control app. To reduce participants' expectations, trial participants will be blinded to the active hypothesis; i.e., eligible participants will be informed by trial site staff that a) they will be randomised to one of two digital treatments during the trial, and b) the aim of the trial is to compare the effectiveness of these two digital treatments, which may or may not improve symptoms related to the indication. No reference should be made to participants to the "Digital Control App" or the "Control App" - both interventions should be referred to only as the investigational app

[0199] Adherence to study intervention: Participants will be instructed to use each app (study app or digitally controlled app) according to the app's instructions. Adherence to this plan will not be defined in this study; however, engagement levels with the apps will be measured.

[0200] Protocol Deviations: Note that visits outside of the time window are not considered protocol deviations unless the site demonstrates an effort to remind participants of their upcoming appointments or takes corrective action to change participant behavior.

[0201] Concomitant Medications: Participants will continue prescribed treatment while enrolled in the study. Participants will self-report any changes in concomitant medications through the end of the follow-up period.

[0202] 7. Study Assessment and Procedures

[0203] Study evaluations and procedures, including their timing, are summarized in the SoA. Strict adherence to study design requirements, including those specified in the SoA, is mandatory and necessary for the conduct of the study. No waivers or exceptions to the protocol will be permitted. Every effort should be made to ensure that evaluations and procedures required in the protocol are completed as described. Study and safety evaluations are described below.

[0204] Study Evaluation: This study will use the following evaluation scales for the periods provided in the SoA.

[0205] Screening Survey: The screening survey is a non-validated survey describing the DiNaMo daily exercise and asking participants to reflect on their motivation and willingness to continue the app-delivered tracking and / or exercise for approximately 10-60 minutes daily for 4-12 weeks. The survey also includes questions regarding demographics, medical history, medications, eligibility criteria, and pregnancy status. This survey is completed by participants.

[0206] Patient Health Questionnaire Depression Scale: The Patient Health Questionnaire Depression Scale (PHQ-8) is an 8-item self-report measure to establish the diagnosis of mood disorders and to assess the severity of mood symptoms. The scale is completed electronically by participants.

[0207] Computerized Performance Measures: Computerized cognitive performance assessments measure inhibitory control. This / these cognitive assessments will be administered at the Baseline and ET / EOS visits.

[0208] Itch Numeric Rating Scale: Peak Pruritus NRS (PP-NRS) is a patient-reported outcome that assesses the severity of itch with a single item. Participants rate their "worst" itch in the past 24 hours on a scale of 0 to 10, with 10 being the "worst itch imaginable." Itch may also be measured through a diary tracking mechanism or an itch perception questionnaire.

[0209] Scratching Intensity and Impact Scale: The Scratching Intensity and Impact Scale (SIIS) is a 13-item questionnaire using a 5-point Likert-type measure ranging from 0 (never) to 4 (always). Scratching can also be measured by wearable sensors that detect scratching, diary tracking mechanisms, and a scratching pleasure scale.

[0210] Sleep-Related Itch and Scratch Scale: The Sleep-Related Itch and Scratch Scale (SRISS) is a 16-item questionnaire using a 5-point Likert-type scale ranging from 0 (never) to 4 (always) to assess the impact of itch and scratching over the past 7 days on various aspects of sleep.

[0211] Dermatology Life Quality Index: The Dermatology Life Quality Index (DLQI) is a simple and practical questionnaire that assesses the impact of skin diseases and their treatment on participants' QoL.

[0212] PROMIS®-29+2 Profile v2.1: PROMIS-29 is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS-29 is a short paper assessment that includes four items from each of the seven PROMIS domains (mood, physical functioning, pain interference, depressive symptoms, fatigue, sleep disturbance, and ability to engage in social roles and activities), one pain intensity questionnaire (NRS 0-10), and two cognitive function questionnaires. PROMIS-29 is universal (i.e., it can assess a patient's health regardless of disease or condition) rather than disease specific, and is intended for adults (ages 18 and older). Scores are produced for all seven domains. The domains are assessed in the past 7 days. PROMIS-29 has been widely administered and validated in a variety of populations and settings. This electronic questionnaire is completed by the participant. Completion takes approximately 7 minutes. PROMIS29+2 also allows for the calculation of the PROMIS Preference (PROPr) score. This allows the calculation of a single QoL summary score using the PROMIS subscales, on a scale of 0 (death) to 1 (perfect health).

[0213] User Experience Survey (and optional qualitative interview): The user experience survey is a survey designed to understand participants' experience of the study app during the intervention phase. The survey asks questions related to perceived enjoyment, challenges, and related user experiences and does not include questions related to clinical outcomes. The survey will be completed electronically by participants. It will take approximately 7 minutes to complete.

[0214] Additionally, a subset of participants may be involved in qualitative telephone or video conference-based user interviews to gather additional information about users' experiences with the app, such as preferred app features, ease of use of features, challenges associated with the intervention, or other feedback gained from regular interactions with the app.

[0215] Global Rating of Change: The Global Rating of Change (GRC) is a self-reported, single-item, 10-point Likert scale used to assess participants' rating of their overall improvement with instructions following the study intervention. This item will be completed electronically by participants.

[0216] Patient-Oriented Eczema Measure (POEM): The POEM is a seven-item self-assessment measurement tool that captures the variability and chronicity of atopic eczema and provides a global assessment of patient symptoms.

[0217] Psoriasis Symptom Inventory (PSI): The PSI is an eight-item patient-reported outcome measure to assess the severity of psoriasis vulgaris symptoms. Each item is scored on a five-point scale.

[0218] Eczema Area and Severity Index (EASI): EASI is a physician-assessed tool that estimates the severity of atopic dermatitis. Disease severity is assessed by rating the severity of each of four symptoms (erythema, induration, excoriation and lichenification) on a scale of 0 to 3 (none to severe) for four areas (head / neck, upper extremities, trunk and lower extremities). This value is multiplied by the approximate affected area score, which ranges from 1 (less than 10%) to 6 (more than 90%), and then by a scale factor that takes into account the proportionate size of each area. The sum of the four provides an overall score of disease severity. Digital EASI uses digital images to automatically and digitally assess and approximate the EASI score without the need for a physician summary.

[0219] Scoring Atopic Dermatitis (SCORAD) is a physician-assessed tool that estimates the severity of atopic dermatitis. Sites affected by the disease are shaded on the body to show an approximation of the affected areas. The intensity of each area is rated on a scale of 0 (none) to 3 (severe). The severity sign is a comprehensive assessment that takes into account redness, swelling, oozing, scratching, lichenification and dryness. Finally, subjective symptoms are assessed, with itching and drowsiness calculated on a 10-point scale ranging from 0 (no itching / drowsiness) to 10 (the worst imaginable). The final score is affected areas / 5+7*(sum of all severity scores) / 2+(sum of subjective symptom scores). The patient-oriented SCORAD (PO-SCORAD) is a patient-reported version of the same tool.

[0220] The Psoriasis Area and Severity Index (PASI) is a physician-assessed tool that estimates the severity of psoriatic disease. Disease severity is assessed by rating the severity of each of three symptoms (redness, thickness and scaling) in four areas (head / neck, upper limbs, trunk and lower limbs) on a scale of 0 to 4 (no symptoms to very severe). These severity scores are summed for each area and multiplied by a scale factor that takes into account the proportion of the size of each area. This value is multiplied by the approximate affected area score, which ranges from 0 (none) to 6 (90-100%). Finally, these four area scores are summed to obtain the final PASI score. The self-administered PASI (SAPASI) or patient-directed PASI (PO-PASI) are patient-reported versions of the same tool.

[0221] 8.Statistical considerations

[0222] The Statistical Analysis Plan (SAP) will be finalized prior to database lock and will include a more technical and detailed description of the statistical analysis described in this section.

[0223] Determining sample size

[0224] Approximately 60–120 participants will be randomized to each instruction in the study in a 1:1 (study app:digital control app or CAU) ratio, resulting in a total of 120–240 participants. This sample size should be sufficient to measure the effect size relatively precisely. However, this study is exploratory in nature and will be used to estimate the effect size.

[0225] Analysis Set

[0226] For the purposes of the analysis, we define the following analysis set: [Table 3]

[0227] General Considerations

[0228] Descriptive statistics include n, mean and standard deviation, median, and minimum and maximum for continuous variables. For categorical variables, Ns and percentages are reported. Tabulations will be by treatment arm unless otherwise specified.

[0229] 95% confidence intervals (Cis) and statistical tests will be performed for several efficacy endpoints and will be detailed as part of the description of the planned analyses for each endpoint.

[0230] Data collection methods are programmed to minimize missing data (e.g., a response is required to proceed to the next assessment question). SAP addresses the handling of incomplete surveys where domains or totals exist. If a complete survey or visit is missing, no imputation is performed and only observed data is included in the analysis.

[0231] Disciplinary Actions for Participants

[0232] This analysis will be performed on the enrolled analysis set. The number of participants who enrolled, failed screening, were randomized, and completed the study will be presented. The number of subjects in each analysis set will be presented by treatment arm within the indications.

[0233] Demographics and baseline characteristics

[0234] To assess comparability of the two arms at baseline, demographic and baseline characteristic data will be summarized by treatment group within each indication and by treatment overall. These summaries will be presented for the modified intention-to-treat (mITT) set. If there is a difference of 5 or more in the total number of participants between the mITT and safety, intention-to-treat and per-protocol analysis sets, summaries will be presented for these sets.

[0235] Exploratory endpoint analysis

[0236] The SAP will detail the derivation of endpoints, especially for questionnaires with multiple domains. Analyses of these endpoints will be performed by treatment arm using the mITT set. Analyses will also be repeated in the per-protocol set. Absolute values, changes from baseline to midweek (if applicable), and changes to end of study will be summarized using descriptive statistics.

[0237] Changes from baseline to end of study in PROMIS-29+2 subscales and PROPr, computerized cognitive assessment measures, and DLQI and PP-NRS are analyzed using an analysis of covariance model to estimate the differences between the two treatment arms. The model has change from baseline as the dependent variable and includes treatment arm, instructions and baseline value as covariates in the model. 95%CI and two-sided p-values ​​for the null hypothesis of no difference between the two arms are provided. Least squares means of the treatment effect are provided. Additionally, for each treatment arm, least squares means, 95%Cis and p-values ​​for the null hypothesis of no change from baseline are provided.

[0238] For Patient-Oriented Eczema Measures (POEM) and Psoriasis Symptom Inventory (PSI) or other indication-specific measures, 95% CIs and two-sided p-values ​​for the change from baseline to end of study in each treatment arm and the null hypothesis of no difference between treatment arms are provided. CIs and p-values ​​are based on two sample t-distributions. 95% CIs for the change from baseline to end of study in each arm and two-sided p-values ​​for the null hypothesis of no change from baseline are provided using one sample (pre-post) t-distributions.

[0239] For measures assessed at baseline, every 2-6 weeks, and end of study, the mITT set will be used to generate mean (standard error) graphs of change from baseline over time by treatment arm and indication. Descriptive statistics will be used for user experience, engagement, and safety parameters.

[0240] Example 1: Use of CT-100-D-003DiNaMo in digital therapeutics targeting maladaptive behaviors associated with common skin conditions

[0241] In one embodiment, the CT-100-D-003 DiNaMo application (also referred to herein as the application) (e.g., application 125) is administered to an individual with a skin condition. The individual with the skin condition is selected based on having an Itch Numeric Rating Scale (NRS) of ≧4. Treatment is for 2-28 weeks according to the protocol. Patients receiving treatment are expected to show improvement in symptoms associated with at least one instruction as measured by computerized compliance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS, among others. The improvement in symptoms associated with at least one instruction in individuals receiving the application is expected to be statistically significant compared to any improvement in symptoms associated with the corresponding instruction observed in individuals receiving digital control or CAU.

[0242] Example 2: Use of CT-100-D-003DiNaMo in digital therapeutics targeting maladaptive behaviors associated with atopic dermatitis

[0243] In one embodiment, the CT-100-D-003DiNaMo application (also referred to herein as the application) (e.g., application 125) is administered to an individual with a skin condition. The individual with the skin condition is selected based on having an Itch Numeric Rating Scale (NRS) of ≧4, specifically diagnosed with or at risk for atopic dermatitis. Treatment is for 2-28 weeks according to a protocol. Treated individuals are expected to show improvement in at least one instruction-related symptom as measured by computerized compliance measures, such as PP-NRS, SIIS, SRISS, DLQI, PROMIS, POEM, SCORAD, PO-SCORAD, among others. The improvement in at least one instruction-related symptom in individuals receiving the application is expected to be statistically significant compared to any improvement in the corresponding instruction-related symptom observed in individuals receiving digital control or CAU.

[0244] Example 3: Use of CT-100-D-003DiNaMo in digital therapeutics targeting maladaptive behaviors associated with psoriasis

[0245] In one embodiment, the CT-100-D-003DiNaMo application (also referred to herein as the application) (e.g., application 125) is administered to an individual with a skin condition. The individual with the skin condition is selected based on having an Itch Numeric Rating Scale (NRS) of ≧4, specifically diagnosed with or at risk for psoriasis. Treatment is for 2-28 weeks according to the protocol. The individual receiving the treatment is expected to show improvement in at least one instruction-related symptom as measured by, among other things, computerized compliance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS, PSI, or PASI. The improvement in at least one instruction-related symptom in the individual receiving the application is expected to be statistically significant compared to any improvement in the corresponding instruction-related symptom observed in the individual receiving the digital control or CAU.

[0246] Example 4: Use of CT-100-D-003DiNaMo in digital therapeutics targeting maladaptive behaviors associated with contact dermatitis

[0247] In one embodiment, the CT-100-D-003DiNaMo application (also referred to herein as the application) (e.g., application 125) is administered to an individual with a skin condition. The individual with the skin condition is selected based on having an Itch Numeric Rating Scale (NRS) of ≧4, and specifically diagnosed with or at risk for contact dermatitis. Treatment is for 2-28 weeks according to the protocol. Treated individuals are expected to show improvement in at least one instruction-related symptom as measured by computerized compliance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS, among others. The improvement in at least one instruction-related symptom in individuals receiving the application is expected to be statistically significant compared to any improvement in the corresponding instruction-related symptom observed in individuals receiving digital control or CAU.

[0248] Example 5: Use of CT-100-D-003DiNaMo in digital therapeutics targeting maladaptive behaviors associated with urticaria

[0249] In one embodiment, the CT-100-D-003 DiNaMo application (also referred to herein as the application) (e.g., application 125) is administered to an individual with a skin condition. The individual with the skin condition is selected based on having an Itch Numeric Rating Scale (NRS) of ≧4, specifically diagnosed with or at risk for urticaria. Treatment is for 2-28 weeks according to the protocol. The individual receiving the treatment is expected to show improvement in at least one instruction-related symptom as measured by, among others, computerized compliance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS. The improvement in at least one instruction-related symptom in the individual receiving the application is expected to be statistically significant compared to any improvement in the corresponding instruction-related symptom observed in the individual receiving the digital control or CAU.

[0250] Example 6: Use of CT-100-D-003DiNaMo in digital therapeutics targeting maladaptive behaviors associated with Prurigo Nodularis

[0251] In one embodiment, the CT-100-D-003DiNaMo application (also referred to herein as the application) (e.g., application 125) is administered to an individual with a skin condition. The individual with the skin condition is selected based on having an Itch Numeric Rating Scale (NRS) of ≧4, specifically diagnosed with or at risk for prurigo nodularis. Treatment is for 2-28 weeks according to the protocol. The individual receiving the treatment is expected to show improvement in at least one instruction-related symptom as measured by, among others, computerized compliance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS. The improvement in at least one instruction-related symptom in the individual receiving the application is expected to be statistically significant compared to any improvement in the corresponding instruction-related symptom observed in the individual receiving the digital control or CAU.

[0252] Example 7: Use of CT-100-D-003DiNaMo in digital therapeutics targeting maladaptive behaviors associated with Lichen planus

[0253] In one embodiment, the CT-100-D-003DiNaMo application (also referred to herein as application) (e.g., application 125) is administered to an individual with a skin condition. The individual with the skin condition is selected based on having an Itch Numeric Rating Scale (NRS) of ≥ 4, specifically diagnosed with or at risk for Lichen Planus. Treatment is for 2-28 weeks according to the protocol. Patients receiving treatment are expected to show improvement in at least one instruction-related symptom as measured by computerized compliance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS, among others. The improvement in at least one instruction-related symptom in individuals receiving the application is expected to be statistically significant compared to any improvement in the corresponding instruction-related symptom observed in individuals receiving digital control or CAU.

[0254] Example 8: Use of CT-100-D-003DiNaMo in digital therapeutics targeting maladaptive behaviors associated with acne vulgaris

[0255] In one embodiment, the CT-100-D-003DiNaMo application (also referred to herein as the application) (e.g., application 125) is administered to an individual with a skin condition. The individual with the skin condition is selected based on having an Itch Numeric Rating Scale (NRS) of ≧4, specifically diagnosed with or at risk for acne vulgaris. Treatment is for 2-28 weeks according to a protocol. Individuals receiving treatment are expected to show improvement in at least one instruction-related symptom as measured by, among others, computerized compliance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS, etc. The improvement in at least one instruction-related symptom in individuals receiving the application is expected to be statistically significant compared to the corresponding instruction-related symptom improvement observed in individuals receiving digital control or CAU.

[0256] Example 9: Use of CT-100-D-003DiNaMo in digital therapeutics targeting maladaptive behaviors associated with drug-induced rash

[0257] In one embodiment, the CT-100-D-003DiNaMo application (also referred to herein as the application) (e.g., application 125) is administered to an individual with a skin condition. The individual with the skin condition is selected based on having an itch numerical rating scale (NRS) of ≥ 4, and, among other things, diagnosed with or at risk for a drug-induced rash. Treatment is for 2-28 weeks according to the protocol. The individual receiving the treatment is expected to show improvement in at least one instruction-related symptom as measured by, among other things, computerized compliance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS. The improvement in at least one instruction-related symptom in the individual receiving the application is expected to be statistically significant compared to the improvement in the corresponding instruction-related symptom observed in the individual receiving the digital control or CAU.

[0258] Example 10: Use of CT-100-D-003DiNaMo in digital therapeutics targeting maladaptive behaviors associated with xeroderma

[0259] In one embodiment, the CT-100-D-003DiNaMo application (also referred to herein as the application) (e.g., application 125) is administered to an individual with a skin condition. The individual with the skin condition is selected based on having an Itch Numeric Rating Scale (NRS) of ≧4, specifically diagnosed with or at risk for xerosis. Treatment is for 2-28 weeks according to the protocol. Treated individuals are expected to show improvement in at least one instruction-related symptom as measured by, among others, computerized compliance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS. The improvement in at least one instruction-related symptom in individuals receiving the application is expected to be statistically significant compared to the improvement in the corresponding instruction-related symptom observed in individuals receiving digital control or CAU.

[0260] Example 11: Use of CT-100-D-003DiNaMo in digital therapeutics targeting maladaptive behaviors associated with uremia

[0261] In one embodiment, the CT-100-D-003 DiNaMo application (also referred to herein as the application) (e.g., application 125) is administered to an individual with a skin condition. The individual with the skin condition is selected based on having an Itch Numeric Rating Scale (NRS) of ≧4, specifically diagnosed with or at risk for uremia. Treatment is for 2-28 weeks according to the protocol. The individual receiving the treatment is expected to show improvement in at least one instruction-related symptom as measured by, among others, computerized compliance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS. The improvement in at least one instruction-related symptom in the individual receiving the application is expected to be statistically significant compared to the improvement in the corresponding instruction-related symptom observed in the individual receiving the digital control or CAU.

[0262] (C. Network and Computing Environment) Various operations described herein may be implemented on a computer system. FIG. 20 shows a simplified block diagram of a representative server system 2000, a client computer system 2014, and a network 2026 that may be used to implement certain embodiments of the present disclosure. In various embodiments, the server system 2000 or a similar system may implement the services or servers described herein or portions thereof. The client computer system 2014 or a similar system may implement the clients described herein. The system 100 described herein may be similar to the server system 2000. The server system 2000 may have a modular design incorporating multiple modules 2002 (e.g., blades in a blade server embodiment), and although two modules 2002 are shown, any number may be provided. Each module 2002 may include a processing unit 2004 and local storage 2006.

[0263] The processing unit 2004 may include a single processor, which may have one or more cores, or multiple processors. In some embodiments, the processing unit 2004 may include a primary processor and one or more special purpose co-processors, such as graphics processors, digital signal processors, etc. In some embodiments, some or all of the processing units 2004 may be implemented using customized circuitry, such as application specific integrated circuits (ASICs) or field programmable gate arrays (FPGAs). In some embodiments, such integrated circuits execute instructions stored in the circuitry itself. In other embodiments, the processing unit 2004 may execute instructions stored in the local storage 2006. Any combination of any type of processor may be included in the processing unit 2004.

[0264] The local storage 2006 may include volatile storage media (e.g., DRAM, SRAM, SDRAM, etc.) and / or non-volatile storage media (e.g., magnetic or optical disks, flash memory, etc.). The storage media incorporated in the local storage 2006 may be fixed, removable, or upgradeable, as desired. The local storage 2006 may be physically or logically divided into various sub-units, such as a system memory, a read-only memory (ROM), and a permanent storage device. The system memory may be a volatile readable and writeable memory, such as a readable and writeable memory device or a dynamic random access memory. The system memory may store some or all of the instructions and data that the processing unit 2004 needs at run time. The ROM may store static data and instructions that the processing unit 2004 needs. The permanent storage device may be a non-volatile readable and writeable memory device, and may store instructions and data even when the module 2002 is powered off. As used herein, the term "storage medium" includes any medium capable of storing data indefinitely (subject to overwriting, electrical disturbance, power loss, etc.), and does not include carrier waves and transitory electronic signals propagated across wireless or wired connections.

[0265] In some embodiments, local storage 2006 may store one or more software programs executed by processing unit 2004, such as an operating system and / or programs that implement various server functions, such as functions of system 100 or any other system described herein, or any other server associated with system 100 or any other system described herein.

[0266] "Software" generally refers to sequences of instructions that, when executed by the processing unit 2004, cause the server system 2000 (or portions thereof) to perform various operations, thus defining one or more specific machine embodiments that perform and execute the operations of a software program. The instructions may be stored as firmware resident in a read-only memory and / or as program code stored in a non-volatile storage medium that can be read into a volatile working memory for execution by the processing unit 2004. The software may be implemented as a single program or as a collection of separate programs or program modules that interact as desired. From the local storage 2006 (or non-local storage, described below), the processing unit 2004 may retrieve program instructions to perform and data to process in order to perform the various operations described above.

[0267] In some server systems 2000, multiple modules 2002 may be interconnected via a bus or other interconnect 2008 to form a local area network that supports communication between the modules 2002 and other components of the server system 2000. The interconnect 2008 may be implemented using a variety of technologies, such as server racks, hubs, routers, etc.

[0268] A wide area network (WAN) interface 2010 may provide data communication capability between a local area network (e.g., through interconnect 2008) and a network 2026, such as the Internet. Other technologies may be used to communicatively couple the server system with the network 2026, including wired technologies (e.g., Ethernet, IEEE 802.3 standard) and / or wireless technologies (e.g., Wi-Fi, IEEE 802.11 standard).

[0269] In some embodiments, the local storage 2006 is intended to provide working memory for the processing unit 2004, providing fast access to programs and / or data being processed while reducing traffic on the interconnect 2008. Storage of larger amounts of data can be provided over a local area network by one or more mass storage subsystems 2012, connectable to the interconnect 2008. The mass storage subsystems 2012 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 store or other collection of data described herein as produced, consumed or maintained by a service or server can be stored in the mass storage subsystem 2012. In some embodiments, additional data storage resources are accessible via the WAN interface 2010 (potentially increasing latency).

[0270] The server system 2000 may operate in response to requests received via the WAN interface 2010. For example, one of the modules 2002 may implement a supervisory function and assign individual tasks to the other modules 2002 in response to received requests. Work allocation techniques may also be used. Once a request has been processed, a result may be returned to the requester via the WAN interface 2010. Such operations may generally be automated. Additionally, in some embodiments, the WAN interface 2010 may interconnect multiple server systems 2000 to provide a scalable system capable of managing large volumes of activity. Other techniques for managing server systems and server farms (collections of cooperating server systems) may be used, including dynamic resource allocation and reallocation.

[0271] The server system 2000 can interact with a variety of user-owned or user-operated devices over a wide area network such as the Internet. One example of a user-operated device is shown in Figure 20 as client computing system 2014. The client computing system 2014 can be implemented as a consumer device, such as, for example, a smartphone, other mobile phone, tablet computer, wearable computing device (e.g., smart watch, glasses), desktop computer, laptop computer, etc.

[0272] The client computing system 2014 may include computer components such as a processing unit 2016, a storage device 2018, a network interface 2020, a user input device 2022, and a user output device 2024. The client computing system 2014 may be computing devices implemented in a variety of form factors, such as desktop computers, laptop computers, tablet computers, smartphones, other mobile computing devices, wearable computing devices, etc.

[0273] The processing unit 2016 and storage device 2018 may be similar to the processing unit 2004 and local storage 2006 described above. Appropriate devices may be selected based on the requirements placed on the client computing system 2014. For example, the client computing system 2014 may be implemented as a "thin" client having limited processing capabilities or as a high-powered computing device. The client computing system 2014 may include program code executable by the processing unit 2016 to enable various interactions with the server system 2000.

[0274] The network interface 2020 may provide a connection to a network 2026, such as a wide area network (e.g., the Internet) to which the WAN interface 2010 of the server system 2000 is also connected. In various embodiments, the network interface 2020 may include a wired interface (e.g., Ethernet) and / or a wireless interface implementing various RF data communication standards, such as Wi-Fi, Bluetooth, or cellular data network standards (e.g., 3G, 4G, LTE, etc.).

[0275] The user input device 2022 may include any device (or devices) by which a user can provide signals to the client computing system 2014, which can interpret the signals as indicating a particular user request or information. In various embodiments, the user input device 2022 may include any or all of a keyboard, a touchpad, a touchscreen, a mouse or other pointing device, a scroll wheel, a click wheel, a dial, a button, a switch, a keypad, a microphone, and the like.

[0276] The user output devices 2024 may include any device by which the client computing system 2014 can provide information to a user. For example, the user output devices 2024 may include a display that displays images generated by or delivered to the client computing system 2014. The display may incorporate a variety of image generating technologies, such as liquid crystal display (LCD), light-emitting diode (LED) displays including organic light-emitting diodes (OLED), projection systems, cathode ray tubes (CRT), and the like, along with supporting electronics (e.g., digital-to-analog or analog-to-digital converters, signal processors, and the like). Some embodiments may include devices such as a touch screen that function as both an input and output device. In some embodiments, other user output devices 2024 may be provided in addition to or instead of a display. Examples include indicator lights, speakers, tactile "display" devices, printers, and the like.

[0277] Some embodiments include electronic components, such as a microprocessor, storage, memory, etc., that store computer program instructions on a computer-readable storage medium. Many of the features described herein can be implemented as a process specified as a set of program instructions encoded on a computer-readable storage medium. These program instructions, when executed by one or more processing units, cause the processing units to perform various operations as indicated in the program instructions. Examples of program instructions or computer code include machine code, such as produced by a compiler, and files containing high-level code that are executed by a computer, electronic component, or microprocessor using an interpreter. Through appropriate programming, the processing units 2004 and 2016 can provide various functionalities for the server system 2000 and the client computing system 2014, including any of the functionalities described herein as being executed by a server or client, or other functionalities.

[0278] It will be understood that the server system 2000 and the client computing system 2014 are exemplary and that variations and modifications are possible. Computer systems used in connection with embodiments of the present disclosure may have other capabilities not specifically described herein. Additionally, while the server system 2000 and the client computing system 2014 are described with reference to certain blocks, it should be understood that these blocks are defined for convenience of description and are not intended to imply a particular physical arrangement of component parts. For example, different blocks may, but need not, be located in the same facility, in the same server rack, or on the same motherboard. Additionally, the blocks need not correspond to physically distinct components. The blocks may be configured to perform various operations, for example, by programming a processor or providing appropriate control circuitry, and the various blocks may or may not be reconfigurable depending on how the initial configuration is obtained. The embodiments of the present disclosure may be realized in a variety of apparatuses, including electronic devices implemented using any combination of circuitry and software.

[0279] Although the present disclosure has been described with respect to specific embodiments, those skilled in the art will recognize that numerous modifications are possible. The 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. The embodiments of the present disclosure can be implemented using any combination of dedicated components and / or programmable processors and / or other programmable devices. The various processes described herein can be implemented on the same processor or different processors, in any combination. Where components are described as being configured to perform certain operations, such configuration can be achieved, for example, by designing electronic circuitry to perform the operations, by programming programmable electronic circuitry (such as a microprocessor) to perform the operations, or any combination thereof. Furthermore, while the embodiments described above may refer to specific hardware and software components, those skilled in the art will recognize that different combinations of hardware and / or software components can also be used, and that certain operations described as being implemented in hardware can also be implemented in software, or vice versa.

[0280] A computer program incorporating various features of the present disclosure may be encoded and stored on a variety of computer readable storage media. Suitable media include magnetic disks or tapes, optical storage media such as a compact disk (CD) or digital versatile disk (DVD), flash memory and other non-transitory media. A computer readable medium on which the program code is encoded may be packaged with a compatible electronic device, or the program code may be provided separately from the electronic device (e.g., via internet download or as a separately packaged computer readable storage medium).

[0281] Therefore, although the disclosure has been described in terms of specific embodiments, it will be understood that the disclosure is intended to cover all modifications and equivalents that are within the scope of the following claims.

Claims

1. 1. A method of providing training via visual elements for presentation to address a maladaptive behavior of a user, comprising: identifying, by a computing system, a session defining a plurality of tasks for the user to be performed using at least one of the user's hands holding a display to address behavioral tendencies associated with the user's state; providing, by the computing system, first instructions for performing a first task of the plurality of tasks using at least one hand during a first portion of the session; providing, by the computing system, second instructions to perform a second one of the plurality of tasks using at least one hand during a second portion of the session subsequent to the first task; and providing, by the computing system, third instructions to perform a third task of the plurality of tasks using at least one hand during a third portion of the session subsequent to the second task; A method comprising:

2. 2. The method of claim 1, wherein the plurality of tasks includes one or more of: (i) a go / no-go task that prompts the user to perform or withhold a first action; (ii) a habit reversal therapy task that prompts the user to perform a second action instead of performing a third action associated with the maladaptive behavior; and (iii) an urge surfing task that prompts the user to perform a fourth action for a duration of the tendency for the maladaptive behavior.

3. 2. The method of claim 1, wherein providing the second instructions further comprises providing the second instructions in response to completion of the first task, and providing the third instructions further comprises providing the third instructions in response to completion of the second task.

4. 2. The method of claim 1, wherein at least one of the tasks is to perform at least one of interaction or non-interaction with a stimulus associated with the condition, the stimulus including at least one of text, image, or sound.

5. 10. The method of claim 1 further comprising: receiving, by the computing system, a request from the user directing initiation of the action associated with the state; and initiating, by the computing system in response to receiving the request, the session to address the behavioral tendency associated with the condition; A method comprising:

6. 10. The method of claim 1 further comprising: receiving, by the computing system, sensory data identifying one or more physiological measurements of the user while performing the first task; modifying, by the computing system, the second task based on the one or more physiological measurements of the user identified in the sensory data; A method comprising:

7. 7. The method of claim 6, wherein the one or more physiological measurements further include at least one of breathing pattern, pupil dilation, heart rate, skin conductance, or oxygen saturation.

8. 2. The method of claim 1, further comprising determining, by the computing system, a score based on performance of at least one of the tasks, the score identifying at least one of (i) a degree of compliance of the user with the at least one task, or (ii) a likelihood of overcoming the behavioral tendency.

9. The method of claim 1 , further comprising generating, by the computing system, feedback to be provided to the user based on performance of at least one of the tasks.

10. 2. The method of claim 1, wherein the condition comprises a skin condition corresponding to at least one of (i) atopic dermatitis, (ii) contact dermatitis, (iii) psoriasis, (iv) urticaria, (v) prurigo nodularis, (vi) lichen planus, (vii) acne vulgaris, (viii) drug-induced rash, (xi) xeroderma, or (x) uremia, and the user is taking a medication to address the skin condition in at least partial association with the session to address the tendency to engage in maladaptive scratching behavior.

11. 1. A system for configuring visual elements to reduce a user's tendency for maladaptive behavior, comprising: A computing system having one or more processors coupled to a memory, the computing system comprising: identifying a session defining a plurality of tasks for a user to be performed using at least one of the user's hands holding a display to address behavioral tendencies associated with the user's condition; providing first instructions to perform a first task of the plurality of tasks using the at least one hand during a first portion of the session; providing second instructions subsequent to the first task for performing a second one of the tasks using the at least one hand during a second portion of the session; and providing third instructions subsequent to the second task for performing a third task of the plurality of tasks using the at least one hand during a third portion of the session; and A system configured to:

12. 12. The system of claim 11, wherein the plurality of tasks includes one or more of: (i) a go / no-go task that prompts the user to perform or withhold a first action; (ii) a habit reversal therapy task that prompts the user to perform a second action instead of performing a third action associated with the maladaptive behavior; and (iii) an urge surfing task that prompts the user to perform a fourth action for a duration of the tendency for the maladaptive behavior.

13. 12. The system of claim 11, wherein providing the second instructions further comprises providing the second instructions in response to completion of the first task, and providing the third instructions further comprises providing the third instructions in response to completion of the second task.

14. 12. The system of claim 11, wherein at least one of the tasks is to perform at least one of interaction or non-interaction with a stimulus associated with the condition, the stimulus including at least one of text, image, or sound.

15. 12. The system of claim 11, wherein the computing system further comprises: receiving a request from the user indicating initiation of the action associated with the state; and initiating the session to address the behavioral tendency associated with the condition in response to receiving the request; A system configured to:

16. 12. The system of claim 11, wherein the computing system further comprises: receiving sensory data identifying one or more physiological measurements of the user while performing the first task; and modifying the second task based on the one or more physiological measurements of the user identified in the sensory data; A system configured to:

17. 17. The system of claim 16, wherein the one or more physiological measurements further include at least one of breathing pattern, pupil dilation, heart rate, skin conductance, or oxygen saturation.

18. 12. The system of claim 11, wherein the computing system is further configured to determine a score based on performance of at least one of the tasks, the score identifying at least one of (i) a degree of compliance of the user with the at least one task, or (ii) a likelihood of overcoming the behavioral tendency.

19. 12. The system of claim 11, wherein the computing system is further configured to generate feedback to provide to the user based on performance of at least one of the tasks.

20. 12. The system of claim 11, wherein the condition includes a skin condition corresponding to at least one of (i) atopic dermatitis, (ii) contact dermatitis, (iii) psoriasis, (iv) urticaria, (v) prurigo nodularis, (vi) lichen planus, (vii) acne vulgaris, (viii) drug-induced rash, (xi) xerosis, or (x) uremia, and the user is taking medication to address the skin condition in at least partial association with the session to address the tendency for maladaptive scratching behavior.

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