Providing training to resolute unadaptive behavior of a user with

Abstract

Systems and methods are provided herein for providing training by presenting visual elements to address a user's undesirable adaptation behavior. The server may identify a session defining a plurality of tasks of the user performed using at least one hand of the user holding the display to address a tendency of a behavior associated with a symptom of the user. The server may provide a first indication to perform a first task using at least one hand. The server may provide a second indication after the first task to perform a second task using the at least one hand. The server may provide a third indication after the second task to perform a third task using the at least one hand. The user may administrate an effective amount of medicament while at least partially performing the task.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 529,503, filed on July 28, 2023, entitled “Providing Training Through Presentation of Visual Elements to Address Maladaptive Behavior of Users with Skin Pathologies,” and claims priority to U.S. Provisional Patent Application No. 63 / 547,286, filed on 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 herein by reference in its entirety. Background Art

[0003] Skin diseases can cause itching in infected areas of the skin, causing the subject to reflexively scratch the infected area. The urge to scratch the skin caused by skin diseases will be difficult for individuals to resist. Scratching at these symptoms in an attempt to calm the symptoms may provide temporary relief, but will cause further skin problems and further aggravate the skin disease. This maladaptive behavior (e.g., scratching) may cause harm to the individual experiencing the symptoms by interrupting the individual's normal activities. Scratching may also hurt the skin. For example, scratching at a psoriasis lesion may cause psoriasis to worsen, or may damage the skin barrier and bleed. Other complications from scratching may include skin infection, skin flaking, or skin discoloration.

[0004] Under medication, an individual may take medication to reduce the severity of the itching of a skin condition. Preventive medications can also help minimize the likelihood that an individual will experience itching. These medications may require a prescription and may be oral or topical. Topical and oral medications may be inconvenient or embarrassing for an individual to administer on an ongoing basis, especially when the individual experiences itching in a public place or on an inappropriate part of the individual's body. Sometimes, an individual may have to wait to administer medication due to the individual's location or the location of the skin condition. Additionally, there are times when an individual may not have a prescription for a skin condition or may not currently have medication. Experiencing itching for any length of time may be extremely uncomfortable for an individual, and the individual's maladaptive tendency to scratch may become unbearable.

[0005] Additionally, therapeutic practices that relieve the effects of itch can reduce the severity of maladaptive scratching. Certain behavioral therapies can help individuals reduce or eliminate the urge to scratch. Accessing these behavioral therapies can be difficult, especially when an individual feels the urge to scratch. Additionally, without consistent compliance, the therapy may not be helpful for an individual. Finally, it can be difficult to determine which therapies are most beneficial for an individual or whether a combination of therapies is most beneficial. Summary of the invention

[0006] To address these and other technical challenges, the service can provide a series of interventions for digital therapy, aimed at reducing the frequency, intensity or tendency of maladaptive behaviors related to skin diseases in users. These tasks consist of inhibitory control training, habit reversal therapy (habit reversal therapy, HRT) and urge surfing. Using a combination of these three tasks through a computing device (e.g., a user's smart phone), the user's ability to control maladaptive behaviors or impulses can be improved in a collaborative manner. Tasks can include different actions performed by the user, such as by means of an end-user device associated with the user. The purpose of each different task and its corresponding action will be to resolve or reduce the frequency, intensity or tendency of maladaptive behaviors (e.g., responding to itching on the skin) of the subject. The service can identify and select tasks based on the sequential sorting of tasks or based on requests initiated by the user via the user's device.

[0007] Through the use of a combination of go / no-go training, habit reversal therapy (HRT), and encouraged entertainment through a computing device (e.g., a smartphone), a user's ability to control maladaptive behaviors or impulses can be improved in a synergistic manner. Controlling maladaptive impulses can be an aspect of treating or addressing symptoms of a skin disease such as atopic dermatitis or psoriasis. Under go / no-go training, a user can be instructed to perform an action and then subsequently refrain from performing the action, thereby initiating neuroplasticity for the user.

[0008] The combination of these interventions can produce a synergistic effect by unexpectedly combining two opposing approaches: a top-down approach using habit reversal therapy and encouraging recreation and a bottom-up approach using inhibitory control. The top-down approach can refer to intentional, observable training that gives the user a set of conscious tools to decide how to engage in a response, rather than succumbing to impulses by giving the user a set of conscious tools to decide how to engage in a response, rather than succumbing to normal automatic responses. The bottom-up approach can refer to subconscious training to train the user to subconsciously improve the user's ability to control their responses to maladaptive behaviors. In addition, by exposing the user to a combination of these interventions, the efficacy of medications the user is taking for skin conditions can be improved or enhanced as the user becomes less likely to engage in maladaptive behaviors (e.g., scratching).

[0009] The user can adapt to reduce the focus on maladaptive impulses or resist the impulses. The core of habit reversal therapy is to guide the user to realize that resisting the impulse will cause the impulse to disappear, and then replace the maladaptive behavior with an observable adaptive behavior. HRT can help reduce unwanted repetitive behaviors by enabling the user to realize that the maladaptive behavior begins and then replaces this maladaptive behavior with another physically incompatible behavior. For example, instead of scratching at a skin disease, the HRT task or action may prompt the user to pinch her fingers together. For other preferred behaviors, this replacement of maladaptive behavior may cause anxiety or uneasiness in the user. In this case, increasing encouraging entertainment helps to alleviate the negative emotions caused by avoiding maladaptive behavior. Encouraging entertainment can motivate users to persist in performing maladaptive behaviors by force, such as by playing games, visualizing calming scenes, or through biofeedback, such as pupil dilation or heart rate control.

[0010] The combination of these therapies can greatly reduce the tendency to perform maladaptive behavior. As an illustrative example, the combination can include a service that provides a game to the user through the user's mobile device. The user can place his thumb on the mobile device to control the game based on the prompt from the game and tilt the mobile device in the right direction. The illustrative example shows an alternative behavior to prevent the user from scratching, because holding the phone is an incompatible behavior, thereby combining HRT. To continue the illustrative example, a prompt may appear during the game, which prompts the user to stop the main task (such as phone tilt), and alternatively stay on the mobile device with the user's hand for a period of time. The action will include a go / no go (GNG) therapy. In addition, real-time biofeedback can control the game and its clues, thereby helping the user to achieve concentration in the form of encouraging entertainment. This treatment combination provided by the service will cause the performance of maladaptive behavior to be reduced.

[0011] To provide these therapies, the service may select user tasks and associated actions for the user to send to the end user device. The service may also time the delivery or presentation of the action to the user to avoid the user having to actively access the digital therapeutic application on their device when suffering from itching. The service may time the delivery or presentation of the action to the user after the previous task is completed. In addition, as the service obtains additional data about the user, the service may be able to select tasks and actions that are more targeted to the specific user and his or her condition, and may store this data in the user's profile. The service may select subsequent tasks based on at least previous tasks, completion of previous tasks, the user's profile, or the user's evaluation of the performance of previous tasks, etc.

[0012] Since the application is operated on the subject's mobile device or at least a mobile device that can be easily and reliably accessed, for example, according to a predetermined frequency (e.g., once a day), the application provides real-time support to the subject. For example, once a request to initiate a session is received from the user, the application initiates the session in real time (i.e., within at least a few milliseconds from receiving the request). This prompt guidance cannot be achieved by face-to-face visits, phone calls, video conferences, or even text messages between the user and a health care provider (e.g., a dermatologist). In this way, the application can provide and customize tasks for the user based on the user's performance. This can create an iteratively improved service for the user, wherein the total bandwidth and data communication are minimized due to the increased usefulness of each task.

[0013] In addition, users can easily receive tasks related to the condition to help retrain maladaptive scratching for those with skin diseases. This can reduce or eliminate the barrier for users to physically access their devices when combating maladaptive scratching. By selecting tasks sent to users to address the subject's scratching tendency, the quality of human-computer interaction (HCI) between users and devices can be improved. In addition, since the messages are more related to the user's symptoms, unnecessary consumption of computing resources (e.g., processing and memory) and network bandwidth of services and user devices can be reduced relative to sending invalid messages. In addition, in the context of digital therapeutic applications, such personalized selection of tasks can lead to the delivery of user-specific interventions to improve the subject's compliance with treatment. This can not only lead to higher compliance with therapeutic interventions, but also improve the subject's maladaptive behavior.

[0014] Various aspects of the present disclosure relate to systems and methods for providing training through visual elements to address maladaptive behaviors. The system may include a computing system having one or more processors coupled to a memory. The computing system may identify a session that defines a plurality of tasks for a user, the plurality of tasks being performed using at least one hand of the user holding a display to address a tendency for a behavior associated with a symptom of the user. The computing system may provide a first indication to perform a first task of the plurality of tasks using at least one hand in a first portion of the session. After the first task, the computing system may provide a second indication to perform a second task of the plurality of tasks using at least one hand in a second portion of the session. After the second task, the computing system may provide a third indication to perform a third task of the plurality of tasks using at least one hand in a third portion of the session.

[0015] In some embodiments, the set of tasks may include one or more of the following: (i) a go / no-go task for prompting a user to perform or decline a first action, (ii) a habit reversal therapy task for prompting a user to perform a second action instead of performing a third action associated with the maladaptive behavior, and (iii) an encouragement and entertainment task for prompting a user to perform a fourth action within a tendency duration of the maladaptive behavior. In some embodiments, the computing system may provide a second indication in response to completion of the first task, and providing a third indication further includes providing a third indication in response to completion of the second task. In some embodiments, at least one of the tasks is at least one of performing an interaction or non-interaction with a stimulus associated with a symptom, the stimulus comprising at least one of text, an image, or audio.

[0016] In some embodiments, the computing system may receive a request from the user indicating the start of a behavior associated with the symptom. The computing system may initiate a session to address the tendency of the behavior associated with the symptom in response to receiving the request. In some embodiments, the computing system may receive sensory data for identifying one or more physiological measurements of the user while performing the first task. The computing system may modify the second task based on one or more physiological measurements of the user identified in the sensory data. In some embodiments, the one or more physiological measurements may also include at least one of a breathing pattern, pupil dilation, heart rate, skin conductivity, or oxygen saturation.

[0017] In some embodiments, the computing system may determine a score based on the performance of at least one task. The score may identify at least one of: (i) the user's compliance with the at least one task, or (ii) the likelihood of overcoming the tendency to the behavior. In some embodiments, the computing system may generate feedback for providing to the user based on the performance of the at least one task. In some embodiments, the symptom includes a skin disease corresponding to at least one of atopic dermatitis or psoriasis, and the user takes medication for addressing the skin symptom at least partially concurrently with the session to address the tendency to scratch the maladaptive behavior.

[0018] Various aspects of the present disclosure relate to systems and methods for reducing the frequency or intensity of maladaptive behaviors associated with a desired user's skin disease. A computing system may obtain a first metric associated with the user before a plurality of time instances. The computing system may use at least one hand holding a display to repeatedly perform presentation of corresponding instructions for a task in a plurality of tasks within 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. When the second metric is (i) increased by at least a first predetermined margin compared to the first metric, or (ii) reduced by at least a second predetermined margin compared to the first metric, a reduction in the frequency or intensity of maladaptive behaviors associated with the skin disease may be considered to have occurred in the user.

[0019] In some embodiments, maladaptive behavior may include one of the following: (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 on the affected epidermal tissue. In some embodiments, skin diseases may include at least one of the following: (i) atopic dermatitis, (ii) contact dermatitis, (iii) psoriasis, (iv) urticaria, (v) nodular prurigo, (vi) flat warts, (vii) acne vulgaris, (viii) drug-induced rash, (xi) chapped skin, or (x) uremia. In some embodiments, skin diseases may be caused by at least one of infection, allergy, or genetic mutation.

[0020] In some embodiments, a reduction may be considered to have occurred when the second metric increases by a first predetermined threshold margin compared to the first metric, and the first metric and the second metric may be Dermatology Life Quality Index (DLQI) values. In some embodiments, a reduction may be considered to have occurred when the second metric decreases by a second predetermined threshold margin compared to the first metric, and the first metric and the second metric may be Peak Pruritus Numeric Rating Scale (PP-NRS) values. In some embodiments, a reduction may be considered to have occurred when the second metric increases by a first predetermined threshold margin compared to the first metric, and the first metric and the second metric may be Patient Reported Outcomes Measurement Information System (PROMIS) values.

[0021] In some embodiments, a reduction may be considered to occur when the second metric is reduced by a second predetermined threshold margin compared to the first metric, and wherein the first metric and the second metric are patient-oriented eczema measurements (POEM) values. In some embodiments, a reduction may be considered to occur when the second metric is reduced by a second predetermined threshold margin compared to the first metric, and the first metric and the second metric may be Psoriasis Symptom Inventory (PSI) values. In some embodiments, a reduction may be considered to occur when the second metric is reduced by a second predetermined threshold margin compared to the first metric, and the first metric and the second metric may be Sleep-Related Itch and Scratching Scale (SRISS) values. In some embodiments, a reduction may be considered to occur when the second metric is reduced by a second predetermined threshold margin compared to the first metric, and the first metric and the second metric may be Scratching Intensity and Impact Scale (SIIS) values. In some embodiments, the first metric and the second metric may be computerized cognitive assessment values.

[0022] In some embodiments, the user can be an adult diagnosed with a skin disease and is associated with a first metric that meets a baseline threshold. In some embodiments, the first metric can be an itch numerical rating scale (NRS) that is less than or equal to a baseline threshold of 4. In some embodiments, the user can take medicine at least partially with the first time instance or multiple second time instances to solve the skin disease. In some embodiments, the medicine can include one of the following items: capsaicin, diflorasone, diphenhydramine, doxepin, hydrocortisone, prednisone, prednicarbate, pimecrolimus, tetracaine, tacrolimus, terbinafine, or dexamethasone (ZEMA lotion) etc.

[0023] In some embodiments, the plurality of tasks may include (i) a go / no-go task for prompting a user to perform or decline a first action, (ii) a habit reversal therapy task for prompting a user to perform a second action instead of performing a third action associated with the maladaptive behavior, and (iii) an encouragement entertainment task for performing the third action for the duration of the maladaptive behavior. In some embodiments, a task for a time instance of the plurality of time instances may be modified based on response data from the user while another task is performed in a previous time instance prior to the time instance.

[0024] In some embodiments, the tasks of the time instances of multiple time instances can be modified based on the scores determined from another task that performs the multiple tasks in a previous time instance before the first time instance. In some embodiments, the tasks of the time instances can be modified to change the order of execution, the length of time to complete the tasks, or the difficulty of performing the tasks. In some embodiments, the tasks of the time instances of multiple time instances can be independent of another task in the previous time instance before the first time instance. In some embodiments, the range of the multiple time instances is between 2 weeks and 6 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 control therapy. In some embodiments, a user can belong to a treatment group and a second user can belong to a control group. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The above and other objects, aspects, features and advantages of the present disclosure will become more apparent and better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0026] Figure 1 depicts a block diagram of a system for providing training to address maladaptive behaviors of a user by presenting visual elements in accordance with an illustrative embodiment;

[0027] Figure 2 depicts a block diagram of a process for identifying a session, receiving a request indicating the start of an activity, and providing instructions for performing a task in a system for providing training in accordance with an illustrative embodiment;

[0028] Figure 3 depicts a block diagram of a process for evaluating user performance based on response data in a system providing training in accordance with an illustrative embodiment;

[0029] Figure 4 depicts a block diagram of a process for providing feedback to a user and determining a task based on performance of the task in a system for providing training in accordance with an illustrative embodiment;

[0030] Figure 5A and Figure 5B depicts a flow chart of a method for providing training to address maladaptive behavior of a user by presenting visual elements in accordance with an illustrative embodiment;

[0031] Figure 6 depicts a block diagram of an environment for presenting tasks on a device in a system for providing training to address maladaptive behaviors of a user via presenting visual elements in accordance with an illustrative embodiment;

[0032] 7A to 7Cdescribes exemplary user interfaces for various types of interventions in a system for providing training to address maladaptive behaviors of a user with a skin condition in accordance with an illustrative embodiment;

[0033] FIG. 8A to FIG. 8B depicts a screenshot of an exemplary user interface for recreational training of a system for providing training to address maladaptive behaviors of a user in accordance with an illustrative embodiment;

[0034] 9A to 9C depicts a screenshot of an exemplary user interface for encouraging recreational training of a system for providing training for addressing maladaptive behaviors of a user by presenting visual elements in accordance with an illustrative embodiment;

[0035] FIG. 10A to FIG. 10B depicts a screenshot of an exemplary user interface for a go / no-go training system for providing training for addressing maladaptive behaviors of a user by presenting visual elements in accordance with an illustrative embodiment;

[0036] Fig.11 depicts a screenshot of an exemplary user interface for go / no-go training in a system for providing training to address maladaptive behaviors of a user by presenting visual elements in accordance with an illustrative embodiment;

[0037] Fig.12 depicts a screenshot of an exemplary user interface for go / no-go coaching in a system for providing coaching to address maladaptive behaviors of a user with a skin condition in accordance with an illustrative embodiment;

[0038] Fig.13 depicts a screenshot of an exemplary user interface in a system for providing training to address maladaptive behaviors of a user with a skin condition in accordance with an illustrative embodiment;

[0039] FIG. 14A to FIG. 14D depicts a screenshot of an exemplary user interface for go / no-go training in a system for providing training to address maladaptive behaviors of a user by presenting visual elements in accordance with an illustrative embodiment;

[0040] FIG. 15A to FIG. 15D depicts a screenshot of an exemplary user interface for go / no-go training in a system for providing training to address maladaptive behaviors of a user by presenting visual elements in accordance with an illustrative embodiment;

[0041] Fig.16depicts a screenshot of an exemplary user interface with options for various interventions in a system for providing training to address a user's maladaptive behavior by presenting visual elements in accordance with an illustrative embodiment;

[0042] FIG. 17A to FIG. 17M depicts a screenshot of an exemplary user interface for providing training in a system for addressing maladaptive behaviors of a user by presenting visual elements in accordance with an illustrative embodiment;

[0043] Fig.18 A flow chart depicting a method of reducing the frequency or intensity of maladaptive behaviors associated with a skin condition in a user in need thereof, according to an illustrative embodiment;

[0044] Fig.19 Describes a timeline of study designs used to evaluate inhibitory control, habit reversal therapy, and encouraging recreation to interrupt scratching in subjects with skin conditions; and

[0045] Fig. 20 is a block diagram of a server system and a client computer system in accordance with an illustrative embodiment. DETAILED DESCRIPTION

[0046] In order to read the description of the following embodiments, it will be helpful to list the various parts of the specification and their respective contents below:

[0047] Part A describes systems and methods for providing training to address maladaptive behaviors of a user by presenting visual elements;

[0048] Part B describes systems and methods for reducing the frequency or intensity of maladaptive behaviors associated with a skin disorder in a user;

[0049] Section C describes a network and computing environment that can be used to practice the embodiments described herein.

[0050] A. Systems and methods for providing training to address maladaptive behaviors of users by presenting visual elements

[0051] Reference now Figure 1, which depicts a block diagram of a system 100 for providing training to address maladaptive behaviors of a user by presenting visual elements. In general, the system 100 may include at least one session management service 105 and a set of user devices 110A-110N (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., the depicted first user device 110A) 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 user interface elements 135). The session management service 105 may include at least one session manager 140, a task selector 145, a measurement detector 150, or at least one performance evaluator 155, etc. The session management service 105 may include or have access to at least one database 160. The database 160 may store, maintain, or otherwise include one or more user profiles 165A-N (hereinafter generally referred to as user profiles 165 ) and one or more tasks 170A-N, etc. The functionality of the application 125 may be performed in part on the session management service 105 .

[0052] In more detail, the session management service 105 can (sometimes generally referred to herein as a computing system or service) be any computing device that includes one or more processors coupled to memory and software and is capable of performing the various processes and tasks described herein. The session management service 105 can communicate with one or more user devices 110 and a database 160 via a network 115. The session management service 105 can be located, positioned at, or otherwise associated with at least one server group. The server group can correspond to a data center, a branch office, or a site where one or more servers corresponding to the session management service 105 are located. The session management service 105 can be located, positioned at, or otherwise associated with one or more client devices 110. Some components of the session management service 105 can be located within the server group, and some components can be located within the client device. For example, the session manager 140 can operate or be located on the user device 110A, and the task selector 145 can operate or be located on the server group.

[0053] Within the session management service 105, the session manager 140 can identify a session that defines a set of tasks 170 that are performed by the user on the respective user devices 110 by the applications 125. The task selector 145 can select at least one task 170 provided to the user device 110 via the session manager 140. The task selector 145 can select a task 170 based on the performance of a previously selected task. The measurement detector 150 can receive sensory data from the user via the user device 110, and can modify the task 170 or the selection of the task 170 based on the measurements included in the sensory data. The performance evaluator 155 can determine a score based on the performance of one or more tasks 170, and can provide feedback to the user via the application 125 presented on the user device 110.

[0054] The user device 110 (sometimes referred to herein as an end-user computing device or client device) can 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 can communicate with the session management service 105 and the database 160 via the network 115. The user device 110 can be a smart phone, other mobile phone, tablet computer, wearable computing device (e.g., smart watch, glasses), or laptop computer. The user device 110 can be used to access the application 125. In some embodiments, the application 125 can be downloaded and installed on the user device 110 (e.g., via a digital distribution platform). In some embodiments, the application 125 can be a web application with resources accessible via the network 115.

[0055] In some embodiments, the user device 110 may be coupled to at least one sensor 120. The sensor 120 may provide sensory data about the user or the user's performance to the user device 110 or the session management service 105. 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 pattern, blood oxygen saturation, or response time. The sensor 120 may sense, detect, or identify data related to the user or his 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 speech, heartbeat, 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 quantum image sensor, etc. 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.

[0056] Next, the sensors 120 may include one or more pulse oximeters to detect the oxygen saturation of the user's blood. In some embodiments, the sensors 120 may detect the response time of the user's interaction 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, or the cardioid sensor may detect the user's pulse rate or heart shape changes. For example, an audio sensor may detect the user's breathing pattern. The data accumulated from the sensors 120 may be processed by the session management service 105 or the application 125.

[0057] The application 125 executed on the user device 110 can be a digital therapy application, and can provide a session (sometimes referred to herein as a therapy session) to address the tendency of maladaptive behavior associated with the user's condition. The behavior can include maladaptive scratching prompted by a condition such as a skin disease. The skin disease may cause other maladaptive behaviors, such as skin prying, squeezing, or rubbing. Other behaviors may cause or be related to the user's condition. The application 125 can be used to present tasks that prompt the user to perform actions to reduce the frequency, intensity, or tendency to engage in behaviors associated with the user's condition. Tasks can be presented to the user as a result of sending a request to start a session, a detected measurement result of the user received from the client device, or a scheduled time or period, etc.

[0058] The user of application 125 may suffer from or be at risk of a skin disease. The skin disease may be, for example, atopic dermatitis, contact dermatitis, psoriasis, urticaria, prurigo nodularis, lichen planus, acne vulgaris, drug-induced rash, xerochaetosis, uremia, non-contact dermatitis (eczema), allergic reactions (e.g., allergic reactions to plants, drugs or other exposures), burns, rashes, scabies, urticaria or insect bites, etc. The user may engage in maladaptation or other behaviors to try to reduce or mitigate the effects of the skin disease. For example, the user may scratch, pry, rub or otherwise physically stimulate the skin affected by the pathology. The user may take medication to address the pathology at least partially at the same time through the session provided by application 125. The medication may be at least orally administered or topically administered. For example, a user may take or apply capsaicin, diflorasone, diphenhydramine, doxepin, hydrocortisone, prednisone, prednicarbate, pimecrolimus, tetracaine, tacrolimus, terbinafine, corticosteroids, vitamin D analogs, retinoic acid, calcineurin inhibitors, immunosuppressants, or antihistamines, etc. The medication may be an effective amount (e.g., dosage or frequency) that is sufficient to affect a positive outcome or symptom reduction (e.g., a reduction in itching or scratching tendency). When the medication is taken while at least partially using the application 125, the efficacy of the medication in addressing the user's maladaptive behavior may be improved or enhanced.

[0059] Depending on the specific skin disease, a variety of medications or treatment regimens can be used to treat the skin diseases described herein. For example, treatment or treatment options can include, but are not limited to, behavioral therapy, avoidance therapy, hormone replacement therapy (HRT), antibiotics, antihistamines, laser skin resurfacing, creams, ointments or gels, moisturizers, oral medications, steroid pills, creams or injections, surgical procedures, skin cleansers, and lifestyle changes, among others.

[0060] Atopic dermatitis (also known as atopic eczema) refers to a non-contagious, long-term inflammation of the skin. The causes of atopic dermatitis are thought to involve genetics, immune system dysfunction, and environmental exposures. Exposure to certain chemicals or irritants may exacerbate the symptoms of atopic dermatitis. Various treatments for atopic dermatitis include strengthening the skin barrier with moisturizers, anti-inflammatory corticosteroid creams, dietary exclusions, light therapy, calcineurin inhibitors, and antihistamines.

[0061] Contact dermatitis is a non-infectious acute or chronic inflammation of the skin caused by chemical or physical factors. Symptoms of contact dermatitis include itchy or cracked skin, rash, lumps, blisters or swelling. Contact dermatitis is caused by long-term exposure to irritants, resulting in direct damage to the epidermal cells of the skin, which activates the immune response, resulting in an inflammatory skin reaction.

[0062] Psoriasis is a skin disease that causes an itchy, scaly rash, most commonly on the knees, elbows, trunk, and scalp. Psoriasis is a common, chronic disease with no cure. It can be painful, interfere with sleep, and make it difficult to concentrate. The condition tends to go through cycles of weeks or months before gradually subsiding. In people with a genetic predisposition to psoriasis, common triggers include infections, wounds or burns, and certain medications. The five main types of psoriasis are plaque, maculoid, inverse, pustular, and erythrodermic. Various treatments include steroid creams, vitamin D3 cream, ultraviolet light, immunosuppressive drugs (such as methotrexate), and biologic therapies that target specific immune pathways.

[0063] Hives, or urticaria, is an acute rash with red, raised, itchy bumps that may feel hot or stinging. Hives usually occur after an infection or due to an allergic reaction, such as to medications, insect stings, or foods. Other causes of hives may include psychological stress, hay fever, asthma, or cold temperatures. Treatment may include avoiding the allergen, antihistamines, corticosteroids, or leukotriene inhibitors. Immunosuppressants are used in long-term, severe cases.

[0064] Prurigo nodularis is a chronic skin disease characterized by itchy, nodular lesions on the trunk, arms, and legs. Prurigo nodularis is often associated with other skin diseases such as atopic dermatitis. Other known causes are autoimmune diseases, thyroid disease, lymphoma, and kidney failure. Treatments include steroids, dupilumab, vitamins, cryosurgery, thalidomide, and UVB light, among others.

[0065] Lichen planus refers to a chronic inflammatory and autoimmune disease that affects the skin, nails, hair, and mucous membranes. Lichen planus is characterized by polygonal, flat-topped, violaceous papules and plaques with a reticular pattern of fine white scales (Wickham striae), usually affecting the dorsum of the hands, wrists and forearms, trunk, anterior calves, and oral mucosa, and may include popular, annular, linear, hypertrophic, atrophic, bullous, actinic, ulcerative, pigmented, follicular, or inverted lesions.

[0066] Xerochaetosis (also known as cracked skin) refers to a common condition that affects the moisture and barrier function of the skin. Causes of chapped skin include abnormalities in the barrier function of the skin's stratum corneum. These abnormalities may be caused by dry climates, overheating, environmental or chemical irritation, burns, autoimmune diseases, and abrasions.

[0067] Acne vulgaris is a chronic skin disease caused by clogged hair follicles on the surface of the skin. Acne can be classified as mild, moderate or severe to determine the appropriate treatment plan. Acne nodules or masses are usually polymorphic and take a variety of forms, including open or closed comedones, papules, pustules or cysts.

[0068] Uremia refers to high levels of urea in the blood. Urea is one of the main components of urine. It can be defined as excess amino acid and protein metabolism end products in the blood, such as urea and creatinine, which are usually excreted in the urine. Uremia is usually caused by reduced kidney function or kidney failure. Symptoms of uremia include dry, cracked skin, itching, calcification, and uremic frostbite, etc.

[0069] 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.

[0070] Depending on the configuration on the application 125, the application 125 may include, present, or otherwise provide a user interface 130 including one or more user interface elements 135 to the user of the user device 110. The user interface elements 135 may correspond to visual components of the user interface 130, such as command buttons, text boxes, check boxes, radio buttons, menu items, sliders, etc. In some embodiments, the application 125 may be a digital therapy application and may provide sessions (sometimes referred to herein as therapy sessions) via the user interface 130 to address the tendency of maladaptive scratching.

[0071] Application 125 may receive instructions for presenting task 170 to the user. Task 170 may be or include a stimulus or action to be presented to the user in text form, as an image, video, auditory or other presentation, and may include instructions for the user to perform an action to reduce or mitigate the desire or tendency to engage in maladaptive behavior. Task 170 may include interacting with user device 110 or not interacting. For example, task 170 may include tapping user interface 130 or not tapping user interface 130 for a duration. Task 170 may include instructions for the user to reduce the severity of their symptoms. For example, the message may include instructions intended to improve the user's calmness or mental endurance. Task 170 may include an interactive interface that enables the user to participate in one or more therapies designed to reduce the tendency to engage in maladaptive behavior through user interface 130. For example, the user may play a game on user device 110 presented by application 125 that addresses the behavior in combination with one or more therapies.

[0072] Therapies for reducing behavioral tendencies associated with skin diseases may include inhibitory control training, habit reversal therapy, or encouraging entertainment paradigms. Inhibitory control training may include tasks such as GNG tasks, in which the user is prompted by task 170 to perform an action for a period of time and then avoid performing the action for a period of time. HRT may refer to a therapy in which the user is instructed to replace maladaptive behavior with allowed behavior. In some implementations, the allowed behavior may be physically incompatible with the maladaptive behavior, thereby preventing the user from engaging in maladaptive behavior when the user performs the allowed behavior. Encouraging entertainment may refer to a therapy that distracts or helps the user persist by resisting the tendency to engage in maladaptive behavior (e.g., through an application 125 operating on a user device 110).

[0073] The database 160 may store and maintain various resources and data associated with the session management service 105 and the applications 125. The database 160 may include a database management system (DBMS) for arranging and organizing 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. When executing 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 in accordance with the execution of such operations.

[0074] Such operations may include maintaining a user profile 165 (sometimes referred to herein as a subject profile). User profile 165 may include information related to the user's condition, as described herein. For example, user profile 165 may include information related to the severity of symptoms, the occurrence of symptoms (such as itching caused by a skin disease), medications or treatments taken by the user for the symptoms, the duration of the symptoms, etc. User profile 165 may be updated in response to scheduling, periodically (e.g., daily, weekly), changes in user information (e.g., input by the user via user interface 130 or learned from user device 110), or by a clinician (e.g., a doctor or nurse) addressing the user's symptoms, etc.

[0075] The user profile 165 may store and maintain information related to the user of the application 125 via the user device 110. Each user profile 165 may be associated with or correspond to a corresponding subject or user of the application 125. The user profile 165 may contain or store information for each session performed by the user. The information for the session may include various parameters or tasks 170 of previous sessions performed by the user, and may be initially empty. The user profile 165 may enable simplified communication with the user by presenting to the user tasks that are most likely to help the user resolve her condition or reduce the tendency to engage in maladaptive behavior based at least on the user profile 165. This targeted approach may reduce the need to communicate with the user multiple times, thereby reducing bandwidth and increasing the benefits of user-computer interaction.

[0076] In some embodiments, the user profile 165 may identify or include information about a treatment regimen performed by the user, such as the type of treatment (e.g., therapy, medication, or psychotherapy), duration (e.g., days, weeks, or years), and frequency (e.g., daily, weekly, quarterly, annually), etc. The user profile 165 may include data collected by the sensor 120, such as the user's heart rate, breathing pattern, 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 value (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 completing the task 170.

[0077] In addition, identification of tasks 170 may be stored and maintained on database 160. For example, database 160 may maintain tasks 170 using one or more data structures or files (e.g., extensible markup language (XML), comma separated value (CSV) delimited text files, or structured query language (SQL) files). Each task 170 may prompt a user via application 125 to perform an action 220 via application 125. For example, application 125 may receive instructions to present an activity to be performed as part of a task 170. Tasks 170 may provide behavioral therapies, including cognitive behavioral therapy, habit reversal therapy, biofeedback, and relaxation therapy, which may also help reduce the tendency to engage in maladaptive behaviors. Tasks 170 may be presented as games, activities, or actions performed by a user via user interface 130. For example, task 170 may prompt a user to punch with her hands, interact with user interface 130, or instruct the user to avoid actions performed via user interface 130 or their own body.

[0078] In response to presenting an instruction prompting the user to perform a specified task 170, the user can use the application 125 to record the execution or completion of the task 170. Examples of task 170 may include breathing exercises, mind-body exercises, or hand exercises, etc. Task 170 may include GNG tasks, HRT tasks, encouraging entertainment tasks, or combinations thereof, etc. Task 170 may be based on text, images, or videos, as well as other presentation methods. Task 170 may be presented to the user via a user interface 130 running on the application 125. Each task 170 may identify or include information to be presented via the user interface 130 of the application 125. For example, the information of task 170 may include reminders of the task 170 of performing a session or the action of performing a mitigation behavior. Task 170 may be delivered periodically, such as daily, weekly, or monthly, etc. Task 170 may be delivered according to a plan or in response to receiving an instruction from a user. Task 170 may be derived from a library of pre-generated psychotherapy activities or actions and / or a library of pre-generated engagement messages. Tasks 170 may include reminders for the subject to take medication, practice activities, or perform other actions that may reduce maladaptive scratching tendencies, as well as other behaviors. Tasks 170 may be personalized based on the user's activities, compliance, or performance associated with the regimen. For example, tasks 170 may be personalized based on information in user profile 165, or based on other tasks 170 in which the user has already participated.

[0079] Reference now Figure 2 , which depicts a block diagram of a process 200 for identifying a session, receiving a request indicating the start of a behavior, and providing an indication of performing a task in the system 100 to provide training to address a maladaptive behavior in a user. The process 200 may include or correspond to operations performed in the system 100 to present a user interface to a user with a skin disease. Under the process 200, the session manager 140 executed on the session management service 105 may access the database 160 to retrieve, extract, or otherwise identify a user profile 165 of a user 210 (sometimes referred to herein as a subject, patient, or person) of an application 125 on a user device 110. The user profile 165 may identify or define information associated with the user 210, the instance of the application 125 on the user device 110, and the user device 110, etc. For example, the user profile 165 may identify that the user 210 has a particular tendency to engage in maladaptive scratching. The user profile 165 may identify that the user 210 takes medication to address a skin disease or other symptoms and the frequency of maladaptive behavior in the user 210, etc.

[0080] By identifying the user profile 165, the session manager 140 can determine or identify a session for the user 210 to address the behavioral tendency. The session can correspond to, include or define a set of tasks 170 to be performed by the user 210 via the application 125. Each task 170 can be performed by the user 210 using at least one hand of the user 210. The task 170 can define, specify or otherwise identify at least one action 220A-N (hereinafter referred to as action 220) and at least one duration 225 for each action 220. The action 220 can be, for example, holding the hand of the user 210, using the hand to tap or otherwise interact with the user interface 130 through the UI element 135 to form a tapping action by the hand of the user 210 and other actions involving one or more hands of the user 210. The action 220 can involve activities that do not require the use of the user's hands. For example, the action 220 can include focusing on a point on the screen of the user device 110, practicing breathing exercises, or tapping the feet of the user 210, etc. Each task 170 may also have a set duration 225 ranging from a few seconds (eg, forty seconds) to a few minutes (eg, three minutes) to a few hours (eg, three hours). Each task may include one or more actions 220 to be performed as part of the task.

[0081] Task 170 can specify different groups of actions 220 for various types of tasks. Each task 170 can correspond to different therapies, such as HRT, GNG or encouraging entertainment, etc. Task 170 may include one or more actions corresponding to the therapy associated with task 170. For example, when task 170 is a GNG task, action 220 may include a first action 220A for a user to press the screen of user interface 130 within a first duration 225. The first duration 225 may be any time range of the GNG task, such as 5-10 minutes. In this example, application 125 may prompt the user to press the screen of user interface 130 for seven minutes, and then application 125 may present second action 225B. Second action 225B may include prompting the user to stop pressing the screen within a second duration 225.

[0082] Next, when task 170 is an HRT task, action 220 may include prompting the user to understand that resisting impulse (e.g., maladaptive behavior of scratching) may cause the impulse to subside and guide the user to perform a permissible behavior different from maladaptive behavior. For example, the first action 220A may remind the user of clues indicating the beginning of maladaptive behavior, such as tingling sensation of the skin, increased heart rate or other indications. The second action 220B of the HRT task 170 may prompt the user to clench his fist, focus on a point on the user interface 130, or pinch the user's fingers together within a duration 225. In some embodiments, for the HRT task, the duration 225 may be 2-3 minutes. When task 170 is an encouragement entertainment task, task 170 may include actions related to the discomfort caused by the tendency to manage the execution of maladaptive behavior and the resistance tendency. The first action 220A of the encouragement entertainment task may be to play a game associated with the application 125, watch a video associated with the application, or control the application based on the information detected by the sensor 120 within the duration 225 of the tendency of maladaptive behavior. For the encouragement entertainment task, the duration 225 may be 2-5 minutes.

[0083] The user profile 165 may include information about previous sessions, such as previous tasks 170 performed 210 by the user in response to previous instructions 215, requests 205 initiated by the user 210 for the session, performance associated with tasks 170 having been performed 210 by the user, medication taken by the user 210 to address the user's condition, or information detected by the sensor 120, etc. The user profile 165 may also identify or include information about recorded performance of maladaptive behaviors, such as the number of occurrences of a tendency to perform maladaptive behaviors, the number of occurrences of performing maladaptive behaviors, the duration of previous occurrences, and the taking of medications, etc. The user profile 165 may initially lack information about previous 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 be provided to the user 210 via the application 125 in a session.

[0084] The session manager 140 may initiate a session in response to receiving a request 205 from a user 210 via an application 125. The user 210 may provide the request 205 to start the session via the user interface 130 executed by the application 125. The request 205 may include information related to the onset of the user's symptoms. The request 205 may include attributes associated with the symptoms, such as an identification of the user 210 or a user profile 165, symptoms associated with the user's 210 symptoms, the time of the request 205, the severity of the tendency, and the like. The application 125 operating on the user device 110 may generate the request 205 sent to the session manager service 105 in response to the user 210 interacting with the application 125. In some embodiments, the session manager 140 may initiate a session in response to a predetermined session time, detection by a sensor 120, based on the user 210 using a prescribed medication to address the symptom, and the like.

[0085] For a session, the task selector 145 may identify or select tasks 170 to be provided to the user 210 via the application 125. The tasks 170 are selected based on the completion of previous tasks 170, based on information in the user profile 165, or based on the severity of the tendency to perform maladaptive behaviors, etc. In some embodiments, the session manager 140 may select a set of tasks 170 to be provided to the user 210. For example, the session manager 140 may select a first task (e.g., go / no go), a second task (e.g., HRT), and then a third task (e.g., encourage entertainment). The task selector 145 may select tasks 170 based on the user profile 165. The user profile 165 may include historical information related to the user's condition, such as the occurrence or type of symptoms, the time when the symptoms occurred, the intensity of the tendency to perform maladaptive behaviors, demographic information, prescription information, location information, etc. For example, the task selector 145 may select tasks 170 that have historically improved the user's tendency to perform maladaptive behaviors.

[0086] In some embodiments, task selector 145 can select task 170 based on the scheduled plan of task. For example, task selector 145 can select task 170 as GNG treatment task according to the scheduled plan of task. In this illustrative example, task selector 145 can select subsequent tasks based on the subsequent tasks of scheduled plan. For example, the scheduled plan of task 170 can include the first task corresponding to GNG therapy, the second task corresponding to HRT therapy or the third task corresponding to encouraging recreational therapy. In some embodiments, task selector 145 can select task 170 based on a set of rules. The rule can be configured to provide task 170 or a set of tasks 170 in a systematic, objective and treatment-effective manner, to target potential causes or alleviate the condition in user 210 or the symptom of dermatopathy. The rule can be based on the completion time of task 170, the execution of user profile 165, task 170 or other attributes of system 100.

[0087] When selected, the session manager 140 may provide, send, or otherwise send the task 170 or the instruction 215 to the user device 110. In some embodiments, the session manager 140 may send instructions for presenting the task 170 via the user interface 130 of the application 125 on the user device 110. The instructions may include, for example, instructions about which user interface elements 135 to use, and may identify content to be displayed on the user interface elements 135 of the user interface 130. The instructions may further identify 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 running 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 perform related to their session. For example, the instructions may display a message instructing the user to take medication associated with their session. The instructions may include a task 170 that identifies or includes at least one stimulus associated with a condition. The stimulus may include text, an image, or audio presented by the user device 110 via the application 125. For example, the stimulus may include the presentation of an image indicating that the user 210 is interacting with the application 125 via the user interface 130, such as in FIG. 7A to FIG. 13 Described in .

[0088] In some embodiments, the session manager 140 may calculate, identify, or otherwise determine the time to send or present an indication 215 via the user interface 130 of the application 125. In some embodiments, the session manager 140 may maintain a timer to count the time that has passed since the previous indication 215 was presented. The timer may count the time that has passed from the receipt of the indication 215 being read, from the transmission sent from the application 125 as part of the transmission protocol, or from the transmission of the indication 215 from the session management service 105, etc. In some embodiments, the session manager 140 may maintain a timer to count the time that has passed since the previous task was performed. Using the timer, the session manager 140 may determine whether the time that has passed exceeds a threshold. The threshold may depict, identify, or define the amount of time that the indication 215 is provided for presentation. When the time that has passed exceeds the threshold, the session manager 140 may send the indication 215. Conversely, if the time counted by the timer does not exceed the threshold, the session manager 140 may refrain from sending the indication 215 and may continue to update the time.

[0089] In some embodiments, session manager 140 may provide indications 215 according to a schedule. The schedule may identify or specify the times at which indications 215 are to be presented or sent. For example, a schedule may provide for indications to be presented hourly, daily, or weekly. The schedule may be defined according to a prescription medication schedule or based on historical data of the user, such as contained in user profile 165. When the time matches the schedule, session manager 140 may provide indications 215 for display on user interface 130.

[0090] Once the indication 215 is received, the application 125 on the user device 110 can render, display or otherwise present the indication 215. The indication 215 can be presented through one or more user interface elements 135 of the user interface 130 of the application 125 of the user device 110. The presentation of the UI element 135 can be based on the 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 executed on the user device 110. The user 210 can perform one or more actions 220 of the task 170 within the duration 225. Performing the task 170 may include performing an interaction or non-interaction with the stimulus. The interaction with the stimulus may include speaking to the user device 110 or making another noise, pressing or tapping one or more of the user interface elements 135, rotating or otherwise manipulating the user device 110, etc. Non-interaction with the stimulus may include not tapping or pressing the user interface 130 or a portion of the user interface 130, or keeping the user device 110 in a specified position. If the user 210 does not complete the task, the session manager 140 may send a subsequent indication 215 to prompt the user 210 to complete the task, or the session manager 140 may abort the task 170 when the threshold period has passed. With the completion of the task 170, the application 125 may send the completion of the task 170 from the user device 110.

[0091] In some embodiments, the application 125 may render, display, or otherwise present the indication 215 independently of the session management service 105. The application 125 may share or have the same functionality as the session manager 140 described above. For example, the application 125 may maintain a timer to keep track of the time that has elapsed since the previous indication 215 was presented. The application 125 may compare the elapsed time to the time limit of the indication 215. When the elapsed time exceeds the time limit, the application 125 may determine to present the indication 215. The application 125 may also use a schedule to determine when to present the indication 215. The application 125 may present the indication 215 for display via the user interface 130 on the user device 110. The indication 215 may include a response mechanism (e.g., a user interface element 135) to provide information related to the symptoms of the user 210 and to indicate acceptance or rejection of the task 170.

[0092] Reference now Figure 3, which depicts a block diagram of a process 300 for evaluating user performance based on response data in a system 100 for providing training to address maladaptive behaviors of a user. The process 300 may include or correspond to an operation of configuring a visual element for presentation to address maladaptive behaviors of a user. In the process 300, in general, a measurement detector 150 on a session manager service 105 may retrieve, identify, or otherwise receive response data 310 from an application 165 running on a user device 110. In some embodiments, as a result of a threshold time passing, the measurement detector 150 may periodically receive response data 310 by querying the user device 110 for response data 310, where the response data 310 is outside the range of response data of 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 for data transmission. The measurement detector 150 may query the response data 310 after a threshold time has passed. For example, the measurement detector 150 may receive the response data 310 if the time for the user to perform the task 170 exceeds a threshold time.

[0093] Response data 310 may include or identify user interactions of user 210 with task 170. Response data 310 may include the time at which the tasks were completed. For example, response data 310 may include that the user spent four minutes on the first task and seven minutes on the second task. Response data 310 may include the total time to complete the session, and may also include the time to start the session and the time to complete the session. Response data 310 may identify UI elements that were interacted with during duration 225 of task 170. For example, response data 310 may include a list of buttons, toggles, or other user interface elements selected by user 210 at a specified time during the execution of task 170. Response data 310 may include other information, such as the location of user 210 when executing the session, such as geographic location, IP address, GPS location, triangulation of cellular towers, etc. Response data 310 may include measurements 305. Measurements 305 may include measurements of time, location, or user data, etc.

[0094] 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 for detecting 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 measurement 305 may include a breathing pattern (e.g., a length sequence of inhalation and exhalation), pupil dilation (e.g., a change in the diameter of the user's pupil), a heart rate (e.g., heart beats per minute or an acceleration of the heart rate), a blood oxygen level (e.g., oxygen saturation within the user 210), a blink pattern (e.g., a blink rate of the user's eyes), a humidity level (e.g., the user's skin or breathing), the skin conductivity of the user 210, the activity level of the user 210 (e.g., steps per day or other activity indicators), the weight of the user, the height of the user, the focus level of the user (e.g., how far the user 210 can look at the user device 110, or engage in a task 170 or the skin conductivity of the user), etc. Measurement detector 150 may store these measurements 305 and other response data 310 in database 160 .

[0095] Using the response data 310, the performance evaluator 155 may 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 may identify the reaction time or correctness of the user 210 in performing the task 170, the user's 210 compliance with the task 170, or the likelihood of overcoming a tendency toward maladaptive behavior, etc. For example, the performance evaluator 155 may determine from the response data 310 that the user 210 did not perform one or more actions 220 of the task 170 within a threshold time (e.g., reaction time), or that the user 210 did not perform an action 220 of the task 170 within a threshold time (e.g., reaction time).

[0096] The compliance of the user 210 with the task 170 may be based on whether the response time of the user 210 to the action 220 of the task 170 exceeds or falls below 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 in the task 170 or is not compliant with the task 170. The compliance of the user 210 may be based on the responses provided by the user via the user interface element 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 when the button is not indicated, the user 210 may have low compliance. Conversely, if the user 210 completes the task 170 within a threshold time period and performs a threshold number of actions 220 in accordance with the task 170, the user 210 may have high compliance.

[0097] The performance evaluator 155 may calculate, generate or otherwise determine a score 315 associated with the likelihood of overcoming a tendency to a behavior. The likelihood of overcoming a behavioral tendency may refer to, include or be associated with the probability that the user 210 will stop engaging in maladaptive behavior. For example, if the user 210 successfully resists the tendency each time the tendency occurs, the user 210 may be considered to have a 100% rate of overcoming the tendency of the behavior. The likelihood of overcoming a behavioral tendency may 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 has been generated, or until the user 210 has performed a threshold number of tasks 170. The performance evaluator 155 may determine the likelihood of overcoming a behavioral tendency based at least on the selection of a user interface element 135 during a session, a user profile 165, a session time, a task time 170, an action time 220, etc. In this example, the performance evaluator 155 may generate a score associated with the performance of the user 210 on at least one of the tasks 170.

[0098] Reference now Figure 4 , which depicts a block diagram of a process 400 for providing feedback to a user and determining a task based on performance of one or more tasks in a system 100 for providing training to address maladaptive behaviors of a user. The process 400 may include or correspond to operations performed in the processes 100, 200, or 300. In the process 400, the task selector 145 may identify or select a task 170' to select the session manager 140 provided via the application 125. In some embodiments, the task 170' may be part of a session after performing a portion of the task 170. For example, the task 170' may be performed in the second or third portion of the session, while the task 170 is performed in the first portion of the session. In some embodiments, the task 170' may be used in another session separate from the session in which the task 170 is performed. The selection of the task 170' may be based on a previous task 170, a user profile 165, a measurement 305, a rating 315, or a request 205. The task selector 145 may select a subsequent task 170' of the task 170 based on the performance of the user 210 in the previous task 170. For example, if the measured value 305 indicates increased ECG, the task selector 145 may select the encouraging entertainment task 170 ′ over the GNG task.

[0099] 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 state, an emotional state, or other state of the user 210 that is related to the physiology of the user 210. For example, an increased heart rate of the user 210 may indicate that the user 210 is anxious or stressed about the urge to scratch the affected skin. In this example, the task selector 145 may select a task 170' corresponding to the encouraging entertainment task to address the user's anxiety. 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' based on the physiological measurements 305.

[0100] In some embodiments, the task selector 145 may identify or select a task 170' based on the time measurement of the measurement 305. In some embodiments, the task selector 145 may select a task 170' based on the reaction time measured during the task 170. For example, the task selector 145 may select a task 170' having a longer duration 225' to allow for a longer reaction time measured during performance of the task 170. 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, if the measurement 305 indicates that the user 210 has an increased tendency to engage in maladaptive behavior, and if the measurement 305 indicates that the user 210 performed a previous task 170 below a threshold time, the task selector 145 may select the action 220' of the task 170' corresponding to the shorter duration 225.

[0101] The task selector 145 may identify or select a task 170' based on the score 315. In some embodiments, the task selector 145 may select a task 170' based on the score 315 corresponding to reaction time or correctness. For example, if the score corresponding to reaction time is below a threshold level, the task selector 145 may select the task 170' to have a longer duration 225' than the task 170. If the score corresponding to the correctness of the previous task 170 is below a threshold, the task selector 145 may select the task 170' to include a higher number or a lower number of actions 220'. In some embodiments, the task selector 145 may select the task 170' based on reaction time and correctness of the previous task or any previous task.

[0102] The task selector 145 may select a task 170' based on the compliance of the user 210. For example, the task selector 145 may select a task 170' that corresponds to the user's compliance with a previous task 170. If the user 210 has low compliance with the task 170, the task selector 145 may select a task of a different type of therapy than the previous task 170. Conversely, if the user 210 exhibited low compliance with that type of therapy in the previous task 170, the task selector 145 may select the same type of therapy for the task 170'. The task selector 145 may use any combination of the tasks 170, the user profile 165, the measurements 305, or the scores 315 to determine to select or modify the task 170'. For example, the task selector 145 may use the heart rate of the user 210 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 operating on the user device 110.

[0103] In some embodiments, the task selection may select a task 170' in response to a completion of a task 170. For example, the session manager 140 may retrieve, identify, or otherwise receive a completion of a task 170 from the user device 110. Upon receipt, the session manager 140 may process or parse the completion to determine, extract, or identify information related to the user 210, the propensity to perform maladaptive behavior, the task 170, or other information related to the user's condition or the task 170. Upon receiving the completion of the first task 170, the session manager 140 may provide a second task 170'.

[0104] By selecting task 170', session manager 140 may send, provide, or otherwise transmit at least one indication 215'. The transmission of indication 215' may be similar to the transmission of indication 215 discussed in process 200. Instruction 215' may be an instruction for presenting task 170 to application 125 on user device 110 via user interface 130. The instruction may include, for example, a description of UI element 135 to be used, and may identify content to be displayed on UI element 135 of user interface 130. The instruction may further identify or include task 170'. The instruction may be a code, data packet, or control for presenting task 170 to user 210 via application 125 running on user device 110. The instruction may include task 170 that identifies or includes at least one stimulus associated with the condition. The stimulus may include text, an image, or audio presented by user device 110 via application 125. For example, the stimulus may include the presentation of an image that indicates user 210 interacting with application 125 via user interface 130, such as in FIG. 7A to FIG. 13 Described in .

[0105] Once the indication 215' is received, the application 125 on the user device 110 can render, display or otherwise present the indication 215'. The indication 215' can be presented via one or more user interface elements 135 of the user interface 130 of the application 125 on the user device 110. The presentation of the UI element 135 can be based on the 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 executed on the user device 110. The user 210 can perform one or more actions 220 of the task 170' within the duration 225. Performing the task 170' can include performing an interaction or non-interaction with the stimulus. The interaction with the stimulus can include speaking to the user device 110 or making another noise, pressing or tapping one or more of the user interface elements 135, rotating or otherwise manipulating the user device 110, etc. The non-interaction with the stimulus can include not tapping or pressing the user interface 130 or a portion of the user interface 130, or keeping the user device 110 in a specified position. If user 210 does not complete the task, session manager 140 may send a subsequent indication 215' to prompt user 210 to complete the task, or session manager 140 may abort task 170' when a threshold period of time has passed. With the completion of task 170', application 125 may send completion of task 170' from user device 110.

[0106] 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 feedback based at least on the user 210's performance of the task 170, the user profile 165, the request 205, the measurement 305, or the rating 315. The feedback may include text, video, or audio presented to the user 210 via the application 125 displayed by the user interface 130. The feedback may include a presented rating 315, a string or phrase, or audio or tactile feedback, etc. The feedback may display a message, such as a motivational message, a suggestion for improved performance, a congratulatory message, a comforting message, etc. The feedback may include a presentation of the rating 315. The session manager 140 may generate feedback based on the measurement 305. In some embodiments, the session manager 140 may generate feedback during the user 210's performance of the task 170.

[0107] Upon generation, the session manager 140 may send, transmit, 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 depict an increased skin conductivity of the user 210 during performance of the task 170, which may indicate an increased focus of the user 210 on the task 170. The session manager 140 may then generate feedback corresponding to the increased skin conductivity, such as a motivational message displayed on the user interface 130. Likewise, the measurement 305 may depict an increased heart rate of the user 210, which may indicate an increased stress or anxiety of the user 210. The session manager 140 may then present calming feedback, such as a relaxation message, on the user interface 130.

[0108] The session manager 140 may present the rating 315 in conjunction with the feedback or separately from the feedback. For example, the session manager 140 may present the rating 315 as part of the feedback, or may present the rating 315 at a different time than presenting the feedback, or may not present the rating 315 at all. The session manager 140 may send the feedback via the indication 215' or as a separate communication. The session manager 140 may send the feedback as part of a subsequent task 170'. For example, the session manager 140 may include the next task 170' in the indication 215 as well as feedback on the performance of the previous task 170. In this way, the user 210 may be made aware of their progress in addressing their tendency to engage in maladaptive behavior.

[0109] The session management service 105 may repeat the above functions (e.g., process 200, process 300, and process 400) over multiple sessions. The number of sessions may exceed a set number of days, weeks, or even years, or may not have a clear endpoint. By repeatedly selecting tasks 170 based at least on measurements 305, user profiles 165, or ratings 315, the user 210 will be able to receive content to help mitigate the tendency to engage in maladaptive behaviors. This can overcome the difficulties faced by the user 210 in accessing such care, even when suffering from conditions that may otherwise inhibit the user from seeking treatment or even physically accessing the user device 110. In addition, by performing the tasks 170 when presented through the user interface 130 of the application 125, the quality of the human-computer interaction between the user 210 and the user device 110 can be improved.

[0110] Because tasks 170 are more relevant to the user's symptoms (e.g., skin disease), users 210 are more likely to engage in such tasks 170 when presented via user device 110. This can reduce unnecessary consumption of computing resources (e.g., processing and storage) of the service and user device 110 and reduce the use of network bandwidth relative to otherwise sending ineffective or irrelevant tasks 170. In addition, in the context of digital therapeutic applications, personalized selection of tasks 170 can result in the delivery of user-specific interventions to improve the subject's compliance with treatment. This can not only lead to higher compliance with therapeutic interventions, but also lead to potential improvements in the user's symptoms or tendency to engage in maladaptive behaviors.

[0111] Reference now Figure 5A and Figure 5B , which depicts a method 500 for providing training to address maladaptive behaviors of a user by presenting visual elements. The figures describe operations performed by the client and operations performed by the service, respectively. The method 500 may be implemented or performed using any of the components detailed herein (e.g., the session management service 105 and the user device 110). Figure 5A Initially, in method 500, a service (e.g., session management service 105) may identify a session (505). The service may provide a first indication (e.g., indication 215) of a first task (e.g., task 170) to a client (e.g., user device 110) (510). The client may present the first indication of the first task (515). Upon completing the first task, the service may determine whether to respond to the information (520). Upon receiving the response information, the service may modify the second task (e.g., task 170') (525). The service may provide a second indication (e.g., indication 215') of the second task (530). The client may perform the second task (535). The service may determine a score associated with the performance of one or more tasks (540). The service may provide feedback to the client (545). The client may receive the feedback (550), for example, via a user interface.

[0112] Go to Figure 5B , upon completing the second task, the service may determine whether to respond to the information (555). Upon receiving the response information, the service may modify a third task (e.g., task 170') (560). The service may provide a third indication of the third task (e.g., indication 215') (565). The client may present the third indication of the third task (570). The service may determine a score associated with the performance of one or more tasks (575). The service may provide feedback to the client (580). The client may receive the feedback, for example, via a user interface (585).

[0113] Reference now Figure 6, which depicts an exemplary system 600 for presenting a task on a device 605, the system 600 being used to provide training to address a user's maladaptive behavior by presenting visual elements. The system may involve a client device 605 (e.g., a user device 110), a left hand 610A, and a right hand 610B. The client device 605 may include an application 125 and a sensor 120 installed thereon. In some embodiments, the client device 605 may be similar to the user device 110 and may execute the application 125. The application 125 may appear on a user interface or display of the client device 605. In some embodiments, the application 125 may be presented as a game, image, video, or interactive application 125 on the user device 605. One or both hands 610 may be used to interact with the device 605 to perform one or more tasks 170. The device 605 may include one or more user elements, such as a user interface element 135, to accept input from the hand 610. Hand 610 may press the screen of client device 605 for input, hand 610 may manipulate or rotate client device 605 to register (via detection by an accelerometer, gyroscope, or other sensor in sensors 120 ) movement of client device 605 , or hand 610 may simply hold client device 605 .

[0114] Because the application program is operated on the mobile device of the subject or at least the mobile device that it can easily and reliably access according to a predetermined frequency (for example, once a day), the application program provides real-time support to the subject. For example, once a request to initiate a session is received from the user, the application program initiates the session in real time (that is, within at least a few milliseconds from receiving the request). This prompt guidance cannot be realized by face-to-face visits, phone calls, video conferences or even text messages between the user and the health care provider (for example, a dermatologist). In this way, the application can provide and customize tasks for the user based on the performance of the user. Due to the increase of each useful task, it is possible to create iteratively improved services for the user, and minimize the total bandwidth and data communication.

[0115] 7A to 7C Screen shots of exemplary user interfaces 700 through 725 for a system for providing training to address user maladaptive behaviors by presenting visual elements are depicted. Fig. 7ADepicted is a GNG therapy task operated by an application on a client device. The client device displays a user interface 700 "exercise" (e.g., interacting with the client device). The client device displays a user interface 705 "itch" (e.g., not interacting with the client device). When the words displayed on the screen are not related to maladaptive behavior, the GNG task encourages the user to interact with the device, as in user interface 700. Then, when user interface 705 displays words related to maladaptive behavior, the GNG task displays the user not interacting with the client device. Figure 7B An exemplary HRT task including steps 720 is displayed. In the first display 710, a first step 720A and a second step 720B are depicted. In the second display 715, a third step 720C and a fourth step 720D are depicted. Steps 720 on displays 710 and 715 depict an HRT task that includes performing operations with the user's hands to perform functions that are physically incompatible with maladaptive behaviors. Figure 7C The GNG task interface is depicted. Display 725 depicts the action of a task to tap a circle as fast as possible. Display 730 depicts the action of a task to keep responding while the phone vibrates or provides tactile feedback.

[0116] Reference now Fig. 8A and Figure 8B , which depicts a set of screenshots of an exemplary user interface (800 to 815) for a system for providing training to address user maladaptive behavior by presenting visual elements. Fig. 8A A first user interface 800 depicts a series of balls falling in response to a user providing an initial tap on the user interface 800. A second user interface 805 depicts a user interacting with the balls on the user interface 805 by pressing the user interface 805 with his thumb. Figure 8B Depicted is an encouraging entertainment task that includes a first user interface 810 and a second user interface 815. The first user interface 810 prompts a user to place their thumb on the user interface 810. The second user interface 815 displays a shape emanating from the user's thumb position.

[0117] Reference now 9A to 9C , which depicts a set of screenshots of exemplary user interfaces (900 to 945) of a system for providing training to address user maladaptive behavior by presenting visual elements. Fig.9ADescribe the GNG task for the user to perform according to the GNG task, which includes a first user interface 900, a second user interface 905 and a third user interface 910. The first user interface 900 depicts words associated with maladaptive behavior, and the user avoids interacting with the word. The second user interface 905 depicts words that are not associated with maladaptive behavior, or words with positive associations. During the second user interface 905, the user can perform actions to capture positive words or neutral words. In the third user interface 910, the words associated with the maladaptive behavior are displayed for the user to ignore. Fig. 9B 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 is depicted. During the GNG task, the user will capture positive or neutral words that are not related to maladaptive behavior or skin disease. On the contrary, the user ignores words associated with maladaptive behavior or skin disease. Fig. 9C A GNG task is described that includes user interfaces 935 to 960 in which a user interacts with neutral or positive words, for example by "hitting" them.

[0118] Reference now Fig. 10A and Fig. 10B , which depicts screenshots of exemplary user interfaces (1005 to 1025) of a system for providing training to address maladaptive behavior in a user by presenting visual elements. Fig. 10A Depicted is 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 word or a neutral word and allowing words associated with maladaptive behavior or skin disease to fall to the bottom. Fig. 10B Depicted is a GNG task that includes a first user interface 1015, a second user interface 1020, and a third user interface 1025. In this embodiment of the GNG task, a user can interact with (eg, "pop up") bubbles that contain positive or neutral words.

[0119] Reference now Fig.11 , which depicts a screenshot of an example task 1105 of a system for providing training to address a user's maladaptive behavior by presenting visual elements. The example task 1105 can be performed by the application 125 via the user device 110. The user can interact with the task 1105 through a user interface (e.g., user interface 130). Task 1105 can be a GNG task and can include the user moving a ball to either side of the user interface depending on whether the word displayed is related to maladaptive behavior or skin disease or is neutral. Now referring to Fig.12, which depicts a screenshot of an exemplary task of a system including user interfaces 1205 to 1215 for providing training to address a user's maladaptive behavior by presenting visual elements. The exemplary task may be a GNG task and may include a user interacting with the user interfaces 1205 to 1215 by clicking on the screen when a displayed word is positive or neutral. Now referring to Fig.13 , which depicts screenshots of an exemplary task of a system including user interfaces 1305 to 1315 for providing training to address maladaptive behaviors of a user by presenting visual elements. The exemplary task may be a GNG task and may include a user interacting with user interfaces 1305 to 1315 if the displayed word is positive or neutral.

[0120] Reference now FIG. 14A to FIG. 14D , which depicts screenshots of exemplary user interfaces 1400 to 1415 for go / no go training in a system for providing training. User interface 1400 can be a prompt to the user that the go / no go training is ready to begin. User interface 1405 can follow user interface 1400 and can instruct the user to hold a button with a word that is neutral with respect to skin disease (e.g., "hiking"). User interface 1410 can be presented after user interface 1405 and can indicate to the user that the go / no go task is about to be completed. User interface 1415 can be displayed after user interface 1410 and can signal the user that the task is complete.

[0121] Reference now FIG. 15A to FIG. 15D , which depicts screenshots of exemplary user interfaces 1500 to 1515 for a go / no go training system for providing training. User interface 1500 may indicate that a user has completed all rounds (or sessions) in a given day. User interface 1505 may be a starting screen for a go / no go training task. User interface 1510 may indicate a total number of available rounds for a user to perform. User interface 1515 may indicate that a user has performed one of a total of three available rounds on a given day.

[0122] Reference now Fig.16 , which depicts a screenshot of an exemplary user interface 1600 having options for providing various interventions in a system for training. The user interface 1600 may include a set of user interface elements corresponding to the available types of training, such as combination tasks, go / no-go tasks, habit reversal therapy tasks, and encouraging entertainment tasks. A user of the application may select one of the user interface elements to request provision of the corresponding task. Referring now to FIG. 17A to FIG. 17M, which depicts screenshots of exemplary user interfaces 1700 to 1760 for encouraging recreational training in a system for providing training. User interfaces 1700 to 1760 may be presented upon selection of the encourage recreational training option in user interface 1600. User interfaces 1700 to 1760 may display deformation of the plaque so as to draw the user's attention away from maladaptive behavior (e.g., scratching) during enforcement of such behavior by such visualization.

[0123] B. Methods of reducing the frequency or intensity of maladaptive behaviors associated with a skin disorder in a user in need thereof

[0124] Reference now Fig.18 , which depicts a flow chart of a method for reducing the frequency or intensity of maladaptive behaviors associated with skin diseases in a user in need. Method 1800 can be performed by any component or participant described herein, such as session management service 105, user device 110, or user 210, etc. Method 2000 can be used in conjunction with any function or action described in Part A or Part B herein. In general, method 1800 may include obtaining a baseline metric (1805). Method 1800 may include selecting a task (1810). Method 1800 may include presenting an indication of performing a task (1815). Method 1800 may include obtaining a session metric (1820). Method 1800 may include determining whether to continue (1825). Method 1800 may include determining whether the session metric is an improvement relative to the baseline metric (1830). Method 1800 may include determining a reduction shown when the session metric is determined to be an improvement relative to the baseline metric (1835). The method 1800 may include determining that a lack of decrease is shown when the session metric is determined to be not improved relative to the baseline metric ( 1840 ).

[0125] In more detail, 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) who suffers from or is diagnosed with a skin disease. The skin disease may include, for example, one or more of atopic dermatitis, contact dermatitis, psoriasis, urticaria, prurigo nodularis, lichen planus, acne vulgaris, drug-induced rashes, dry cracks, uremia, or non-contact dermatitis (eczema). The skin disease may be caused by infection (e.g., from a disease such as chickenpox), allergy (e.g., to plants, animals, drugs, or other exposures), or genetic mutations, etc. The maladaptive behavior associated with the skin disease may include, for example, at least one of a user's continuous scratching of the affected epidermal tissue, intermittent scratching of the affected epidermal tissue, or a reflex reaction to pruritus on the affected epidermal tissue.

[0126] The baseline measurement can be obtained (e.g., by a computing device) before any time instance or session during which a user performs a task via a digital therapeutic application (e.g., the application 125 described herein or a research application). The baseline measurement can indicate the user's condition relative to the severity of the skin disease and the maladaptive behavior associated with the user's daily life and activities. The baseline metric can include, for example, a Dermatology Life Quality Index (DLQI) value, a Peak Pruritus Numerical Rating Scale (PP-NRS) value, a Patient-Reported Outcome Measurement Information System (PROMIS) value, a Patient-Oriented Eczema Measure (POEM) value, a Psoriasis Symptom Inventory (PSI) value, an Eczema Area and Severity Index (EASI), a Digital EASI (EASI-dig), a Topical Dermatitis Score (SCORAD), a Patient-Oriented SCORAD (PO-SCORAD), PASI (Psoriasis Area and Severity Index) or a Self-Administered PASI (SA-PASI), a computerized cognitive assessment value, etc. Before performing any task, the user can have an initial baseline metric that meets a baseline threshold. The threshold may depict, define, or identify a value of an initial metric at which a user is identified as suitable or qualified to perform a task by a digital therapeutic application. The initial metric may be, for example, an Itch Numerical Rating Scale (NRS), and the baseline threshold may be a value of 4 or less.

[0127] Users can have any demographic or characteristics, such as by age (e.g., adult (age 18+) or late adolescent (age 18-24)) or gender (e.g., male, female, or other), etc. At least partially concurrently with the time instance or session in which the user is to perform the task, the user may be taking medication to address the condition. 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, etc. The medication may be an effective amount (e.g., dosage or frequency) that may be sufficient to affect a positive outcome or symptom reduction (e.g., a reduced tendency to itch or scratch). By concurrently with the tasks performed via the digital therapeutic application, the efficacy of the medication in addressing the user's maladaptive behavior may be improved or enhanced.

[0128] In some embodiments, there may be at least two groups of trials for testing the efficacy of digital therapeutic applications. The first group may include a group of users (e.g., including users) of the 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 or learning application described herein). As discussed herein, tasks may include, for example, perform or not perform tasks, HRT tasks, and encourage entertainment tasks, or any combination thereof. The second group may include another group of users for the control group. The users of the second group may be exposed to or provided with a control therapy (sometimes referred to herein as a placebo or standard therapy).

[0129] Control therapy may exclude tasks intended to address the skin disease and performed via a digital therapy application. In some embodiments, control therapy may include tasks performed via an application on a computing device that is inert to the skin disease or related symptoms. The task may include any task other than go / no-go training, HRT, and entertainment tasks as described herein for the digital therapy application. In some embodiments, control therapy may include an inert version of go / no-go training, in which stimuli are presented to the user without any association with the skin disease. An inert version of go / no-go training may lack stimuli to not go. Applications for control therapy may also lack HRT and encourage entertainment tasks.

[0130] In some embodiments, controlled therapy may include an inert version of HRT, in which prompts are presented to the user to perform tasks unrelated to the skin disease. For example, an inert version of HRT may prompt the user to perform breathing or running movements without any prompts about taking actions about scratching or reflex actions in response to an itch. In some embodiments, controlled therapy may include an inert version of urging entertainment. For example, an inert version of encouraging entertainment may lack any messaging about the skin disease to the user. Controlled therapy may include other forms of cognitive behavioral therapy.

[0131] In some embodiments, the control therapy may include a care as usual (CAU) treatment regimen. A CAU treatment regimen may lack the digital therapeutic applications described herein. For example, a CAU treatment regimen may allow a user to receive medication for a skin disease on a predetermined basis (e.g., one to three times a day) and may include an assessment of the skin disease in person 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 group and the control group (e.g., receiving an inert version or CAU).

[0132] Method 1800 may include identifying or selecting a task from a set of tasks (1810). For a time instance or for a portion of a session at a given time instance, a task may be selected (e.g., by a computing device) from a set of tasks. The set of tasks may be tasks that mitigate, alleviate, or otherwise reduce the frequency or intensity of maladaptive behaviors associated with a skin condition on a portion of a user (e.g., scratching skin affected by eczema) by having the user perform actions using a display of a computing device. The set of tasks from which tasks are selected may include, for example, a go / no-go task for prompting a user to perform or decline a first action, a habit reversal therapy task for prompting a user to perform a first action instead of performing a second action associated with the maladaptive behavior, and an encouragement entertainment task for performing a third action for the duration of the maladaptive behavior, among others. Many factors may be used to select tasks, such as those detailed herein in Part A.

[0133] Method 1800 may include providing or presenting instructions to perform the selected task (1815). The digital therapy application running on the computing device may display, render, or otherwise present instructions in a specified manner to perform the task of holding the display with one hand or two hands. The instructions may be presented via one or more user interface elements presented by a graphical user interface of the digital therapy application. The instructions may instruct the user to perform the task for a period of time during the session. For example, the go or no go task may last 5 to 10 minutes, the HRT task may last 2 to 3 minutes, and the encouragement and entertainment task may last 2 to 5 minutes.

[0134] Method 1800 may include retrieving, identifying, or otherwise obtaining session metrics (1820). The session metrics may be associated with a user (e.g., user 210) with respect to a skin condition or an associated maladaptive behavior. The session metrics may be obtained (e.g., by a computing device) after performing at least one of a time instance or session during which the user performs a task via a digital therapeutic application. As a result of the task performance, the baseline measurement may indicate the condition of the user with respect to the severity of the skin condition and the associated maladaptive behavior to the user's daily life and activities. The session metrics may include, for example, a Dermatology Life Quality Index (DLQI) value, a Peak Pruritus Numerical Rating Scale (PP-NRS) value, a Patient Reported Outcomes Measurement Information System (PROMIS) value, a Patient Oriented Eczema Measure (POEM) value, a Psoriasis Symptom Inventory (PSI) value, a Scratching Intensity and Impact Scale (SIIS) value, a Sleep-Related Itch and Scratching Scale (value), an Eczema Area and Severity Index (EASI), a Digital EASI (EASI-dig), a Scoring System for Atopic Dermatitis (SCORAD), a Patient Oriented SCORAD (PO-SCORAD), a PASI (Psoriasis Area and Severity Index), or a Self-Administered PASI (SA-PASI), a computerized cognitive assessment value, etc. The session metrics may be the same type of metrics as the baseline metrics. The session metrics may be obtained from users of both the treatment group and the control group.

[0135] Method 1800 may include identifying or determining whether to continue (1825). The determination may be based on a set length of the trial (e.g., number of days, weeks, or years), a set number of time instances during which one or more tasks are performed, or a set number of tasks to be provided to the user. For example, the set number of time instances may be between 2 weeks and 6 months relative to obtaining the baseline metric. When the amount of time since obtaining the baseline metric exceeds the set length, the determination may be to stop providing additional tasks.

[0136] On the contrary, when the amount of time since the baseline metric is obtained does not exceed the set length, it is determined that the additional task continues to be provided and repeated from (1810). The selection or modification of the task of the next time instance or session can be based on the execution of the task in the previous time instance or session. In some embodiments, the next task can be modified based on the response data from the user when the task in the previous time instance or session is executed. In some embodiments, the next task can be modified based on the score determined from the execution of the task in the previous time instance or session. The task can be modified, for example, by the order of execution (for example, relative to other tasks), the length of time to complete the task, and the difficulty of executing the task. The selection or modification of the task of the next time instance or session can be independent of the execution of the task in the previous time instance or session.

[0137] Method 1800 may include identifying or determining whether a session metric is an improvement relative to a baseline metric (1830). The improvement may correspond to a decrease in the frequency or intensity of self-maladaptive behaviors associated with a skin condition. An improvement may be shown 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 session metric at which it is determined that the user exhibits a decrease in the frequency or intensity of self-maladaptive behaviors associated with a skin condition. Displaying an improvement by an increase or decrease may depend on the type of metric used to measure the user relative to the skin condition or the associated maladaptive behavior. The margin may also depend on the type of metric used, and may generally correspond to a difference in value that indicates a significant difference to a clinician or user regarding the skin condition or maladaptive behavior, or a statistically significant result that indicates a difference in value between a baseline and session metric.

[0138] 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 a change in baseline and session metrics in the treatment group and a change in baseline and session metrics in a control group (e.g., receiving a control treatment). The difference may be based on any number of statistical tests, such as a t-test, a z-test, a chi-square test, etc.

[0139] Method 1800 may include determining that a reduction is shown when the session metric is determined to be improved by a first predetermined margin relative to the baseline metric (1835). In some embodiments, a reduction may be considered to have occurred when the session DLQI metric increases by a first predetermined threshold margin compared to the baseline DLQI metric. In some embodiments, a reduction may be considered to have occurred 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 be considered to have occurred when the session PROMIS metric increases by a first predetermined threshold margin compared to the baseline PROMIS metric. In some embodiments, a reduction may be considered to have occurred when the session POEM metric decreases by a first predetermined threshold margin compared to the baseline POEM metric. In some embodiments, a reduction may be considered to have occurred when the session PSI metric decreases by a first predetermined threshold margin compared to the baseline PSI metric.

[0140] In some embodiments, a reduction may be considered to have occurred when a session EASI metric (or EASI-dig) decreases by a first predetermined threshold margin compared to a baseline EASI metric (or EASI-dig). In some embodiments, a reduction may be considered to have occurred when a session SCORAD metric decreases by a first predetermined threshold margin compared to a baseline SCORAD metric. In some embodiments, a reduction may be considered to have occurred when a session PO-SCORAD metric decreases by a first predetermined threshold margin compared to a baseline PO-SCORAD metric. In some embodiments, a reduction may be considered to have occurred when a session SA-PASI metric decreases by a first predetermined threshold margin compared to a baseline SA-PASI metric. In some embodiments, a reduction may be considered to have occurred when a session computerized cognitive assessment metric decreases by a first predetermined threshold margin compared to a baseline computerized cognitive assessment metric.

[0141] Method 1800 may include determining that no reduction is shown when the session metric is determined to be not improved over the baseline metric by a second predetermined margin (1840). In some embodiments, a reduction is not considered to have occurred 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 is not considered to have occurred 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 is not considered to have occurred 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 is not considered to have occurred 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 is not considered to have occurred when the session PSI metric has not decreased by a first predetermined threshold margin compared to the baseline PSI metric.

[0142] In some embodiments, a reduction is not considered to have occurred when a session EASI metric (or EASI-dig) does not decrease by a first predetermined threshold margin compared to a baseline EASI metric (or EASI-dig). In some embodiments, a reduction is not considered to have occurred when a session SCORAD metric does not decrease by a first predetermined threshold margin compared to a baseline SCORAD metric. In some embodiments, a reduction is not considered to have occurred when a session PO-SCORAD metric does not decrease by a first predetermined threshold margin compared to a baseline PO-SCORAD metric. In some embodiments, a reduction is not considered to have occurred when a session SA-PASI metric does not decrease by a first predetermined threshold margin compared to a baseline SA-PASI metric. In some embodiments, a reduction is not considered to have occurred when a session computerized cognitive assessment metric does not decrease by a first predetermined threshold margin compared to a baseline computerized cognitive assessment metric.

[0143] Protocol—A randomized, controlled, exploratory basket study to evaluate inhibitory control, habit reversal therapy, and recreational encouragement for interrupting scratching in atopic dermatitis and psoriasis.

[0144] 1. Overview of the Solution

[0145] summary

[0146] CT-100 (e.g., application 125) is a platform that provides interactive software-based treatment components that can be used as part of multimodal treatments in future software-based digital treatments. One type of CT-100 component is Digital Neural Activation and Modulation (DiNaMo TM ) components. DiNaMo components target key neurological systems (including but not limited to those related to sensation, perception, emotion, pain, attention, cognitive control, and social and self-processing) to optimally improve the patient’s health.

[0147] DiNaMo, an inhibitory control, habit reversal therapy (HRT), and encouragement-recreation combination, is designed to control impulses (e.g., scratching) through a combination of bottom-up and top-down approaches. Go / No-Go (GNG) training (an inhibitory control task) will help individuals implicitly train inhibitory control skills to better resist sudden impulses. HRT interferes with these habitual activities by providing physically incompatible alternative behaviors to prevent engagement in the undesirable behavior. Finally, encouragement-recreation helps train individuals to experience the urge without giving in, acknowledge the uncomfortable feeling, and recognize that the feeling will eventually pass even without engaging in the desired behavior.

[0148] The aim of the proposed study was to evaluate the initial impact of the DiNaMo component (study app) on the intensity of unwanted behaviors and related outcomes (inhibitory control and general quality of life [QoL]) in various conditions (e.g., atopic dermatitis and psoriasis). The results of this study could be used as a component in future prescription digital therapeutics (PDT).

[0149] Target

[0150] To assess trends compared to a digital control to identify changes in intensity of undesirable behaviours and associated outcomes (inhibitory control and general QoL) as measured by computerised cognitive assessments of indication-specific measures, QoL measures and inhibitory control. To explore the feasibility and acceptability of a home-based digital treatment combining GNG, HRT and recreational supervision training by studying app engagement, user experience questionnaires and qualitative interviews.

[0151] To assess the safety of the study app. To explore the feasibility and acceptability of home-based digital treatments combining GNG, HRT, and recreational supervision training through study app engagement, user experience questionnaires, and qualitative interviews.

[0152] Evaluation Criteria

[0153] Exploratory End Points

[0154] • Change from baseline to end of study in the Pruritus Peak Numerical Rating Scale (PP-NRS) or other pruritus behavioral measures.

[0155] • Change from baseline to end of study on the Scratching Intensity and Impact Scale (SIIS) or other scratching behavior measures.

[0156] Change from baseline to end of study on the Sleep-Related Itch and Scratching Scale (SRISS).

[0157] Change in Dermatology Life Quality Index (DLQI) from baseline to end of study.

[0158] Changes from baseline to end of study in specific indications

[0159] ·use Change from baseline to end of study on QoL symptoms assessed by the PROMIS-29+2 Profile v2.1 (PROMIS-29+2 Preference [PROr]) scale.

[0160] Changes from baseline to end of study on computerized cognitive assessment measures.

[0161] Engagement in the research app through metrics such as daily app usage and daily time in the research app.

[0162] Research app experience assessed via a user experience questionnaire and optional qualitative interview after the research app treatment period.

[0163] · The proportion of participants who improved as measured by the Global Rating of Change (GRC) score at the end of the study.

[0164] Secure endpoints

[0165] The frequency and severity of adverse events (Aes), serious Aes, and study withdrawals due to Aes.

[0166] Frequency and severity of AEs associated with worsening of symptoms related to the indication.

[0167] Study Design

[0168] Reference now Fig.19, which depicts a timeline of study designs used to evaluate inhibitory control, habit reversal therapy, and encouragement of recreation to interrupt scratching in atopic dermatitis and psoriasis.

[0169] Screening Period (Day -28 to Day -1): Participants will be screened for up to 14 days, including electronic informed consent. During this period, assessments will be conducted (e.g., in person or remotely) according to the Plan of Activities and Assessments (SoA). Screening and baseline visits may be conducted on the same day.

[0170] Baseline Virtual Visit (Day 0): Eligible participants will be contacted for a baseline visit to review and confirm eligibility and for identity verification. Participants will be considered eligible to enter the study if they meet all inclusion criteria and do not meet exclusion criteria, based on investigator assessment. Eligible participants will be randomized during the virtual study visit on Day 0. Participants will be randomized in a 1:1 ratio within their indication (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.

[0171] Intervention Period (Day 1 to Day 28-84): Participants in the study app group will access and perform tasks daily as directed by the study app, e.g., 120 minutes per day, 3-10 times per day, 3-7 days per week, for 4-12 weeks. In some aspects, participants will be instructed to access and perform tasks daily during weeks 2-28, 2-20, 2-15, 2-12, 2-10, or 2-8. Participants in the control group will receive a digital control app and perform tasks for approximately 1-10 minutes per day, 3-7 days per week, for 4-12 weeks. Both groups will be evaluated every 2-6 weeks during the 4-12 week intervention period. At the end of the treatment period, the study app will be deactivated and participants in the study app group will complete a user experience questionnaire.

[0172] Follow-up period (1 to 24 weeks): A group of participants will be invited to complete an optional qualitative interview at the end of treatment and 7 days later. Participants will not perform any activities in their respective apps.

[0173] Planned Number of Participants: There will be a minimum of 15-200 participants per indication and a minimum of 30-400 participants total.

[0174] Study Entry Criteria

[0175] Inclusion Criteria: Participants will be eligible for entry into the study if they meet all of the following criteria:

[0176] 1. Fluent in written and spoken English, able to read, understand and sign the Informed Consent Form (ICF).

[0177] 2. Live in the United States.

[0178] 3.18 years old or above.

[0179] 4. During the baseline period, itching NRS ≥ 4.

[0180] 5. Meet the inclusion criteria for the specific indication reported by the study participant and provide adequate clinical documentation. (Documentation will be provided to the research team upon request.)

[0181] 6. Have an active email address and be willing and able to receive and respond to email messages.

[0182] 7. Access to an internet connection during the study period.

[0183] 8. Willing and able to comply with the study protocol and assessments.

[0184] 9. Whether you were the only user of an iPhone with iPhone operating system (OS) 14 or higher or an Android smartphone with Android operating system 10 or higher during the study period.

[0185] 10. Willing and able to receive Short Message Service (SMS) text messages and notifications on their smartphone.

[0186] Exclusion Criteria: Participants will not be eligible for the study if they meet any of the following criteria:

[0187] 1. Pregnant or planning to become pregnant.

[0188] 2. Vision, dexterity, or cognitive deficits so severe that they are unable to use application-based, reaction time-based activities at the discretion of the investigator.

[0189] 3. Severe mental disorder involving a history of psychosis (e.g., schizophrenia, bipolar disorder, or severe personality disorder).

[0190] 4. Psychiatric hospitalization in the past 6 months.

[0191] 5. Participation in any research study (including psychotherapy, mindfulness, cognitive training, or drug therapy studies) within the past 3 months.

[0192] 6. Indication or change of primary disease-specific medication within 30 days before entering the study.

[0193] 7. Self-reported substance use disorder in the past year.

[0194] 8. Currently experiencing a skin infection.

[0195] 9. Plans to introduce new treatments during the 7-39 week study period (including studies on psychotherapy, mindfulness, cognitive training, or drug treatment).

[0196] 10. Predict changes in current medication or psychotherapy treatment regimen during the 7-39 week study period.

[0197] Eligible participants in the study app group will download and install the study app on their smartphones at the baseline visit (Day 0).

[0198] Treatment plan: Learning APP: 4-12 weeks (10-10 minutes per day, 3-10 times per day, 3-7 days per week)

[0199] Study Duration: Participation in the study will last approximately 7-39 weeks:

[0200] Screening period: up to 2 weeks

[0201] Intervention period: 4-12 weeks

[0202] Follow-up period: 1-24 weeks at most

[0203] Sample size

[0204] There were at least 60–120 participants per indication, for a total of 120–240 participants. This sample size should be sufficient to measure effect size with relative precision; however, this study was exploratory in nature and was used to estimate effect size.

[0205] Statistical analysis

[0206] Descriptive statistics will be used to summarize the changes from baseline. Analysis of covariance (ANCOVA) models will be used to analyze the changes from baseline to the end of the study in PROMIS-29+2 subscales, computerized cognitive assessment measures and DLQI, PP-NRS or other itch measures, SIIS or other scratching measures, and SRISS to estimate the differences between the two treatment groups. The model uses the change from baseline as the dependent variable and the treatment group, indication, and baseline value as covariates in the model. The 95% confidence interval (CI) and bilateral p-value for the null hypothesis of no difference between the two groups will be provided. The least squares method of the treatment effect will be provided. In addition, the least squares means, 95% Cis and p-values ​​for the null hypothesis of no change relative to baseline will be provided for each treatment group.

[0207] For indication specific measures such as Patient Oriented Eczema Measure (POEM), Psoriasis Symptom Scale (PSI), Eczema Area and Severity Index (EASI), Digital EASI (EASI-dig), Scoring of Atopic Dermatitis (SCORAD), Patient Oriented SCORAD (PO-SCORAD), Psoriasis Area and Severity Index (PASI), or Self-Administered PASI (SA-PASI), the change from baseline to end of study for each treatment group will be provided, along with the 95% CI and two-sided p-value for the null hypothesis of no difference between treatment groups. The CI and p-value will be based on a 2-sample t-distribution. The 95% CI for the change from baseline to end of study within each group will be provided, along with a two-sided p-value for the null hypothesis of no change using a 1-sample (before and after) t-distribution.

[0208] Activities and Assessment Plan

[0209] Descriptive statistics will be used for user experience as well as engagement and safety parameters.

[0210]

[0211] Abbreviations: AE = adverse event; DLQI = Dermatology Life Quality Index; EOS = end of study; ET = early termination; GRC = global rating of change;

[0212] ID = identifier; NA = not available; PHQ-8 = Patient Health Questionnaire Depression Scale; PP-NRS = Peak Pruritus Numerical Rating Scale; -29 = Patient-Reported Outcomes Measurement Information System - Profile v2.1; PROPr = PROMIS-29+2 Preference; SAE = Serious Adverse Event; SIIS = Scratching Intensity and Impact Scale; SRISS = Itch and Scratching Scale Related to SLEE.

[0213] a Remote access will be provided as needed via video conferencing platforms.

[0214] d After the intervention period, the corresponding app will become inactive on days 28-84. After days 28-84 or after withdrawal from the study, participants will no longer be able to access the content provided by the app.

[0215] 2. Introduction

[0216] Research principles

[0217] CT-100 is a platform that provides interactive software-based therapeutic components that can be used as part of multimodal treatments in future software-based digital therapeutics. One type of CT-100 component is the Digital Neural Activation and Modulation (DiNaMo) component. 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 patients' cognitive and psychological well-being.

[0218] DiNaMo, an inhibitory control, habit reversal therapy (HRT), and encouraged recreation combination, aims to control recreation (e.g., scratching) through a combination of bottom-up and top-down approaches. Go / No-Go (GNG) training (an inhibitory control task) will help individuals implicitly train inhibitory control skills to better resist oncoming urges. HRT interferes with these habitual activities by providing physically incompatible alternative behaviors to prevent engagement in the undesired behavior. Finally, encouraged recreation helps train individuals to experience the urge without giving in, acknowledge the uncomfortable feeling, and recognize that the feeling will eventually pass even without engaging in the desired behavior.

[0219] The aim of the proposed study was to evaluate the initial impact of the DiNaMo component (study app) on the intensity of unwanted behaviors and related outcomes (inhibitory control and general quality of life [QoL]) in various conditions (e.g., atopic dermatitis and psoriasis). The results of this study could be used as a component in future prescription digital therapeutics.

[0220] Task

[0221] Inhibitory Control: Inhibitory control refers to an individual's ability to inhibit responses based on impulsive and habitual behaviors. Inhibitory control can be assessed with a variety of cognitive tasks, but the most common is the GNG task. In this task, there are two possible stimuli: a "go," prompting the individual to respond, and a "no-go," prompting the individual to refuse to respond. The "go" stimulus appears more frequently, establishing the response as a habitual action, thereby making the "no-go" condition more challenging.

[0222] Habit Reversal Therapy: HRT helps reduce unwanted repetitive behaviors. The first step is to become aware of the cues that indicate the onset of the behavior one wishes to stop, and the second step is to replace that behavior with another that is physically incompatible.

[0223] Encourage Recreation: Recreation is a technique for managing undesirable habits, desires, or behaviors. A person learns to tolerate the discomfort of an unacted urge and is taught how to ride it out, just as a surfer rides a wave and it passes by.

[0224] Application (CT-3-D-003DiNaMo component)

[0225] The CT-HRT-D-003DiNaMo component (e.g., App 125) will combine inhibitory control training with HRT and encouraged play using the GNG paradigm. It is hypothesized that the GNG will instill plastic changes in the brain. These changes can be exploited through subsequent HRT sessions to teach alternative behaviors in the context of itch and encouraged play, teaching control of anxiety that may arise from an unscratched itch.

[0226] This training consists of regular challenging exercises. In this study, a 15-min daily treatment regimen between GNG training, HRT, and encouraged recreation will be delivered over 4-12 weeks, which will have similar total time on task and treatment duration compared to previous studies in the literature.

[0227] The control group will use a digital control app. The digital control app is designed to be an inactive version of GNG training. Participants will only receive neutral “go” stimuli; no disease-related “no-go” stimuli will be presented, nor will there be any mention of these components of the task. HRT and encouraging recreation will not be included in the control app.

[0228] Care as Usual Control: A Care as Usual (CAU) control group completes the assessment only and does not use the study app. A study may or may not have a CAU control group.

[0229] 3. Goals and End Points

[0230] The research objectives are:

[0231] To assess trends in the study app intervention group compared with the digital control app group for changes in undesirable behavior intensity and related outcomes (inhibitory control and general QoL) as measured by indication-specific measures, QoL measures, and computerized cognitive assessments of inhibitory control.

[0232] To explore the feasibility and acceptability of home-based digital therapy combining GNG, HRT, and recreational supervision training by studying app engagement, user experience questionnaires, and qualitative interviews.

[0233] This study was exploratory in nature and did not seek to assess specific statistical endpoints. The study endpoints are listed in Table 1.

[0234] Table 1: Study endpoints

[0235]

[0236]

[0237] 4. Study Design

[0238] Overall Design

[0239] refer to Fig.19 , a randomized virtual study evaluating the investigational app versus a digital control app (or CAU) in participants with atopic dermatitis and psoriasis. The study includes a screening period of up to two weeks, an intervention period of 1-12 weeks, and a follow-up period of 1-24 weeks. Participants who meet the eligibility criteria will be randomized into the study on Day 0 (baseline visit).

[0240] Screening Period (Day -14 to Day 0): Participants will undergo screening for up to 14 days, including electronic informed consent. Assessments during this period will be conducted remotely according to the Plan of Activities and Assessments (SoA). Participants will be considered eligible if they meet all inclusion criteria and do not meet exclusion criteria, based on investigator assessment. Screening and baseline visits can be conducted on the same day.

[0241] Baseline Virtual Visit (Day 0): Eligible participants will be contacted for a baseline visit to review and confirm eligibility and for identity verification. Based on investigator assessment, participants will be considered eligible to enter the study if they meet all inclusion criteria and do not meet exclusion criteria.

[0242] Eligible participants will be randomized during a virtual study visit on Day 0. Participants will be randomized 1:1 (study app: control) within their indication. Participants randomized to the study app treatment arm will download and activate the app on their personal primary iPhone or Android smartphone.

[0243] Intervention Period (Day 1-28): Study App Group Participants will access and perform tasks daily for up to 10-60 minutes, 3-7 days per week, for 4-12 weeks, as directed by the study app. Assessments will be conducted according to the Schedule of Activities and Assessments (SoA). Control Group Participants will receive a Digital Control App (or CAU). Both groups will be assessed every 2-6 weeks during the 1-12 week intervention period.

[0244] At the end of the treatment period, the study app will be discontinued and study app group participants will complete a user experience questionnaire.

[0245] Follow-up period (1 to 24 weeks): Participants will complete follow-up assessments based on the SoA. A subset of participants will be invited to complete an optional qualitative interview. Participants will not perform any activities in the study app (see Section 6.2).

[0246] Study Design Rationale

[0247] This study aims to assess the initial impact of the study app on the intensity of adverse behaviors and related outcomes. Participants will be assessed based on validated standard participant ratings. Participant engagement with the study app will be assessed based on participant usage data captured in the study app. Participant safety will also be assessed throughout the study. The scales and assessments are described below.

[0248] Study End Definition

[0249] The end of the study is defined as the last contact date, or the date of the last attempted contact, for the last participant who completed or withdrew from the study. For the purposes of this study, participants who complete assessments on Day 28-84 (+3) (end of study) will be defined as study completers.

[0250] 5. Study Population

[0251] After signing the Informed Consent Form (ICF), participants will be assigned a unique participant identifier (ID) at screening. Prospective approval of protocol deviations from recruitment and enrollment standards, also known as protocol waivers or exemptions, is not permitted.

[0252] Inclusion Criteria

[0253] Participants will be eligible for entry into the study if they meet all of the following criteria:

[0254] 1. Fluent in written and spoken English, able to read, understand and sign the ICF.

[0255] 2. Live in the United States.

[0256] 3.18 years old or above.

[0257] 4. Pruritus Numerical Rating Scale (NRS) ≥ 4 during baseline.

[0258] 5. Meet the inclusion criteria for the specific indication reported by the study participant and provide adequate clinical documentation. (Documentation will be provided to the research team upon request.)

[0259] 6. Have an active email address and be willing and able to receive and respond to email messages.

[0260] 7. Access to an internet connection during the study period.

[0261] 8. Willing and able to comply with the study protocol and assessments.

[0262] 9. Whether you were the only user of an iPhone with iPhone operating system (OS) 14 or higher or an Android smartphone with Android operating system 10 or higher during the study period.

[0263] 10. Willing and able to receive Short Message Service (SMS) text messages and notifications on their smartphone.

[0264] Exclusion criteria

[0265] Participants will be ineligible for entry into the study if they meet any of the following criteria:

[0266] 1. Pregnant or planning to become pregnant.

[0267] 2. Visual, dexterity, or cognitive deficits so severe that they cannot be used in application-based, reaction time-based activities at the discretion of the investigator.

[0268] 3. Severe mental disorders involving a history of psychosis (e.g., schizophrenia, bipolar disorder, or severe personality disorder.)

[0269] 4. Psychiatric hospitalization in the past 6 months.

[0270] 5. Participation in any research study (including psychotherapy, mindfulness, cognitive training, or drug therapy studies) within the past 3 months.

[0271] 6. Indication or change of primary disease-specific medication within 30 days before entering the study.

[0272] 7. Self-reported substance use disorder in the past year.

[0273] 8. Currently experiencing a skin infection.

[0274] 9. Plans to introduce new treatments during the 7-39 week study period (including studies on psychotherapy, mindfulness, cognitive training, or drug treatment).

[0275] 10. Predict changes in current medication or psychotherapy treatment regimen during the 7-39 week study period.

[0276] Lifestyle considerations: Participants should have normal access to their smartphones during the trial.

[0277] 6. Study Intervention

[0278] Study Application (APP): The study intervention being evaluated is the CT-100 DiNaMo component, a digital mobile application (e.g., App 125). Participants randomized to this group will download and install the study application on their own smartphone at the baseline visit (Day 0) and use the study application daily to perform DiNaMo training during the 1-12 week intervention period.

[0279] Digital Control: Participants randomized to the digital control group will download and install the digital control app on their own smartphone at the baseline visit (Day 0) and use the digital control app daily during the 4-12 week intervention period. Some participants may be randomized to the CAU control group and complete study assessments only during the 4-week intervention period.

[0280] App Download and Activation: During the baseline visit, study staff will assist randomized participants in downloading, installing, and activating their respective apps. For installation and activation instructions, see the CT-100-D-003 Study App Site Instructions. Only participants enrolled in the study can activate the app.

[0281] Application Deactivation and Uninstallation: After the intervention period (Day X) is over, the study application will become inactive and unavailable for use by participants. Participants who complete the study or terminate early will be notified by site personnel to uninstall the study application.

[0282] Measures to Minimize Bias: Randomization: Participants for each indication in the study will be randomized in a 1:1 ratio to either the study app or the digital control app. To mitigate participant expectations, participants in this trial will be blinded to the efficacy hypothesis. This means that eligible participants will be informed by trial site staff that a) they will be randomized to one of two digital therapeutic treatments for the duration of the trial, and b) the aim of the trial is to compare the effectiveness of these two digital therapeutic treatments, which may or may not improve indication-related symptoms. Participants must not be referred to as the “digital control app” or “control app”; both interventions should be referred to only as the study app.

[0283] Study Intervention Adherence: Participants will be informed to use the respective app (Learning App or Digital Control App) as directed by the app. Adherence to the regimen will not be defined in this study. However, app engagement will be measured.

[0284] Protocol Deviations: Please note that out-of-window visits are not considered protocol deviations unless the site fails to demonstrate efforts to remind the participant of the next appointment or fails to take corrective actions to change the participant's behavior.

[0285] Concomitant Therapy: Participants will continue their prescribed therapy during this study. Participants will self-report any changes in concomitant therapy at the end of the follow-up period.

[0286] 7. Research evaluation and process

[0287] The study assessments and procedures, including their timing, are summarized in the SoA. Study design requirements, including those specified in the SoA, must be followed and required for the study to be conducted. No waivers or exemptions from the protocol are permitted. Every effort should be made to ensure that the assessments and procedures required by the protocol are completed as described. Study and safety assessments are described below.

[0288] Study Evaluation: This study will be evaluated using the following criteria at the time specified in the SoA:

[0289] Screening Survey: The Screening Survey is a non-validated survey that describes the DiNaMo daily practice and asks participants to reflect on whether they are motivated and willing to commit to approximately 10-60 minutes of app delivery tracking and / or 4-60 minutes of practice. The survey also includes questions about demographics, medical history, medications, eligibility criteria, and pregnancy status. This questionnaire is completed by the participant.

[0290] Patient Health Questionnaire Depression Scale: The Patient Health Questionnaire Depression Scale (PHQ-8) is an 8-item self-report measure used to establish mood disorder diagnoses and grade mood symptom severity. The scale is completed electronically by participants.

[0291] Computerized Performance Measures: Computerized cognitive performance assessments will measure inhibitory control. These cognitive assessments will be conducted during the baseline visit and the ET / EOS visit.

[0292] The digital itch rating scale: Peak Pruritus (itch) NRS (PP-NRS) is a single-item outcome measure of patient-reported itch severity. Participants rate the "worst" itch in the previous 24 hours on a scale of 0 to 10, with 10 being the "worst itch imaginable." Itch can also be measured via a diary tracking mechanism or an itch perception questionnaire.

[0293] Scratching Intensity and Impact Scale: The Scratching Intensity and Impact Scale (SIIS) is a 13-item questionnaire that uses a 5-point type measure ranging from 0 (never) to 4 (always). Scratching can also be measured through wearable sensors that detect scratching, diary tracking mechanisms, or scratching intention scales.

[0294] Sleep-Related Itch and Scratching Scale: The Sleep-Related Itch and Scratching Scale (SRISS) is a 16-item questionnaire that uses a 5-point scale ranging from 0 (never) to 4 (always) to assess the impact of itching and scratching on various aspects of sleep in the past 7 days.

[0295] Dermatology Life Quality Index: The Dermatology Life Quality Index (DLQI) is a simple and practical questionnaire to assess the impact of skin disease and its treatment on participants' QoL.

[0296] -29+2 Profile v2.1: PROMIS-29 is part of the Patient Reported Outcomes Measurement Information System (PROMIS). PROMIS-29 is a brief assessment containing four items from seven PROMIS domains (mood, physical function, pain interference, depressive symptoms, fatigue, sleep disturbance, and ability to participate in social roles and activities), as well as one pain intensity question (0-10 NRS) and two cognitive function questions. PROMIS-29 is generic, not disease-specific (i.e., it can assess a patient's health regardless of disease or condition), and is intended for use in adults (ages >18 years). Scores are generated for all seven domains. The domains are assessed within 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. It takes approximately 7 minutes to complete. PROMIS29+2 also allows for the calculation of a PROMIS preference (PROr) score. This allows for the calculation of a single QoL summary score using the PROMIS subscales. The calculation is based on a scale from 0 (death) to 1 (perfect health).

[0297] User Experience Questionnaire (optional qualitative interview): The User Experience Questionnaire is a questionnaire developed to understand the participant's experience with the study app during the intervention phase. The questionnaire will ask questions related to perceived enjoyment, challenges, and related user experience. It will not contain questions related to clinical outcomes. This questionnaire will be completed electronically by the participant. It will take approximately 7 minutes to complete.

[0298] Additionally, a subset of participants may participate in qualitative user interviews based on phone or video conferencing. These interviews will collect additional information about the users’ experience with the app, such as favorite app features, usability of features, challenges associated with the intervention, or any other feedback from regular interactions with the app.

[0299] Global Rating of Change: The Global Rating of Change (GRC) is a self-reported, single-item, 10-point scale that assesses the participant's overall rating of improvement following the study intervention and its indications. This item will be completed electronically by the participant.

[0300] Patient Oriented Eczema Measure (POEM): POEM is a seven-item self-assessment measurement tool that captures the fluctuating and chronic nature of atopic eczema and provides a comprehensive assessment of a patient's symptoms.

[0301] Psoriasis Symptom Inventory (PSI): The PSI is an eight-item patient-reported outcome measure that assesses the severity of plaque psoriasis symptoms. Each item is scored on a 5-point scale.

[0302] Eczema Area and Severity Index (EASI): The EASI is a physician assessment tool that estimates disease severity in atopic dermatitis. Disease severity is assessed in four regions (head / neck, upper extremities, trunk, and lower extremities) by rating the severity of each of four symptoms (erythema, induration, scaling, and lichenification) on a scale of 0 to 3 (very severe). This value is then multiplied by an approximate affected area score ranging from 1 (<10%) to 6 (>90%) and then by a scaling factor to account for the proportional size of each region. All four items are added together to provide a composite score for disease severity. EASIdig uses digital images to automatically digitally assess and approximate EASI scores without the need for a medical overview.

[0303] The Scoring Assessment of Atopic Dermatitis (SCORAD) is a physician-assessed tool used to assess the severity of atopic dermatitis disease. Areas affected by the disease are masked on the body to provide an approximation of the affected area. For each of the areas, the intensity is assessed on a scale of 0 (none) to 3 (severe). Severity signs are a comprehensive assessment that takes into account redness, swelling, oozing, scratching, lichenification, and cracking. Finally, subjective symptoms are assessed, with the severity of itching and lethargy calculated on a 10-point scale ranging from 0 (no itch / lethargy) to 10 (worst). The final score is area affected / 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.

[0304] The Psoriasis Area and Severity Index (PASI) is a physician-assessed tool that estimates the severity of psoriasis. Disease severity is assessed in four regions (head / neck, upper extremities, trunk, and lower extremities) by assessing the severity of three symptoms (redness, thickness, and scaling) on ​​a scale of 0 to 4 (very severe). For each region, these severity scores are added together and then multiplied by a scaling factor to account for the proportional size of each region. This value is then multiplied by the approximate score of the affected area, which ranges from 0 (none) to 6 (90%-100%). Finally, these four region scores are added together to obtain the final PASI score. The self-administered PASI (SAPASI) or patient-oriented PASI (PO-PASI) is a patient-reported version of the same tool.

[0305] 8. Statistical considerations

[0306] The Statistical Analysis Plan (SAP) will be completed prior to database lock and will include more technical and detailed descriptions of the statistical analyses described in this section.

[0307] Sample size determination

[0308] Approximately 60-120 participants will be randomized in a 1:1 ratio (study APP: digital control APP or CAU) to each study indication, for a total of 120-240 participants. This sample size should be sufficient to measure effect size with relative precision; however, this study is exploratory in nature and is used to estimate effect size.

[0309] Analysis Set

[0310] For analysis purposes, the following analysis sets were defined:

[0311]

[0312]

[0313] General considerations

[0314] Descriptive statistics will include n, mean and standard deviation, median, and minimum and maximum values ​​for continuous variables. For categorical variables, Ns and percentages will be reported. Data will be tabulated by treatment group unless otherwise specified.

[0315] 95% confidence intervals (CIs) and statistical tests will be presented for some efficacy endpoints, and the planned analyses for each endpoint will be described in detail.

[0316] Data collection methods will be programmed to minimize missing data (e.g., answers must be given to advance to the next assessment question). SAP will handle incomplete questionnaires where domains or totals exist. In the case of missing complete questionnaires or interviews, no imputation will be performed and only observed data will be included in the analysis.

[0317] Disposition of Participants

[0318] This analysis will be performed on the registration analysis set. The number of participants who were enrolled, failed screening, were randomized, and completed the study will be listed. The number of subjects in each analysis set will be listed by treatment group within the indication.

[0319] Demographics and Baseline Characteristics

[0320] To assess the comparability of the two groups at baseline, demographic and baseline characteristics data will be summarized by treatment group within each indication and by treatment overall. These summaries will be provided for the modified intention-to-treat (mITT) set. If the difference in the total number of participants between the mITT and safety, intention-to-treat, and per-protocol analysis sets is greater than five, summaries for these sets will be provided.

[0321] Exploratory End-Point Analysis

[0322] The SAP will detail the derivation of endpoints, especially for questionnaires with multiple domains. Analyses of these endpoints will be performed by treatment group using the mITT set. Analyses will be repeated on the per-protocol set. Absolute values, changes from baseline to midweek (if applicable), and changes to the end of the study will be summarized using descriptive statistics.

[0323] Changes from baseline to the end of the study for PROMIS-29+2 subscales and PROPr, computerized cognitive assessment measures, DLQI, and PP-NRS will be analyzed using an analysis of covariance model to estimate differences between the two treatment groups. The model will have the change from baseline as the dependent variable and treatment group, indication, and baseline value as covariates in the model. The 95% CI and two-sided p-value for the null hypothesis of no difference between the two groups will be provided. Least squares means will be provided for treatment effects. In addition, the least squares means, 95% Cis, and p-values ​​for the null hypothesis of no change from baseline will be provided for each treatment group.

[0324] For the Patient Oriented Eczema Measure (POEM) and Psoriasis Symptom Scale (PSI) or other indication-specific measures, the change from baseline to the end of the study for each treatment group will be provided, along with the 95% CI and two-sided p-value for the null hypothesis of no difference between treatment groups. The CI and p-value will be based on a 2-sample t-distribution. The 95% CI for the change from baseline to the end of the study within each group will be provided, along with a two-sided p-value for the null hypothesis of no change using a 1-sample (before and after) t-distribution.

[0325] For measures assessed at baseline, every 2-6 weeks, and at the end of the study, mean (standard error) plots of changes from baseline by treatment group over time will be generated using the mITT set. Descriptive statistics will be used for user experience as well as engagement and safety parameters.

[0326] Example 1: Using CT-100-D-003DiNaMo in digital therapeutics to generally address maladaptive behaviors associated with skin conditions

[0327] In one example, the CT-100-D-003 DiNaMo application (also referred to herein as an application) (e.g., application 125) will be provided to individuals with skin diseases. Individuals with skin diseases will be selected based on an itch numerical rating scale (NRS) ≥ 4. Depending on the protocol, treatment will last for 2-28 weeks. It is expected that individuals receiving treatment will show improvement in at least one indication-related symptom, as measured by computerized performance measures, PP-NRS, SIIS, SRISS, DLQI or PROMIS, etc. Relative to any improvement in the corresponding indication-related symptoms observed in individuals receiving digital control or CAU, it is expected that the improvement in at least one indication-related symptom in individuals receiving the application will be statistically significant.

[0328] Example 2: Use of CT-100-D-003DiNaMo in digital therapeutics to address maladaptive behaviors associated with atopic dermatitis

[0329] In one example, the CT-100-D-003 DiNaMo application (also referred to herein as an application) (e.g., application 125) will be provided to individuals with skin diseases. Individuals with skin diseases will be selected based on an itch numerical rating scale (NRS) ≥ 4, and are particularly diagnosed with atopic dermatitis or at risk of atopic dermatitis. Depending on the protocol, treatment will last for 2-28 weeks. It is expected that individuals receiving treatment will show improvement in at least one indication-related symptom, as measured by computerized performance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS, POEM, SCORAD, PO-SCORAD, etc. Relative to any improvement in the corresponding indication-related symptom observed in individuals receiving digital control or CAU, it is expected that the improvement in at least one indication-related symptom in individuals receiving the application is statistically significant.

[0330] Example 3: Using CT-100-D-003DiNaMo in digital therapeutics to address maladaptive behaviors associated with psoriasis

[0331] In one example, the CT-100-D-003 DiNaMo application (also referred to herein as an application) (e.g., application 125) will be provided to individuals with skin diseases. Individuals with skin diseases will be selected based on an itch numerical rating (NRS) ≥ 4, and are particularly diagnosed with psoriasis or at risk for psoriasis. According to the protocol, the treatment will last for 2-28 weeks. It is expected that individuals receiving treatment will show improvement in at least one indication-related symptom, as measured by computerized performance measures, PP-NRS, SIIS, SRISS, DLQI, PROMIS, PSI or PASI, etc. Relative to any improvement in the corresponding indication-related symptom observed in individuals receiving digital control or CAU, it is expected that the improvement in at least one indication-related symptom in individuals receiving the application is statistically significant.

[0332] Example 4: Use of CT-100-D-003DiNaMo in digital therapeutics to address maladaptive behaviors associated with contact dermatitis

[0333] In one example, the CT-100-D-003 DiNaMo application (also referred to herein as an application) (e.g., application 125) will be provided to individuals with skin diseases. Individuals with skin diseases will be selected based on an itch numerical rating (NRS) ≥ 4, specifically diagnosed with contact dermatitis or at risk for contact dermatitis. Depending on the protocol, treatment will last for 2-28 weeks. It is expected that individuals receiving treatment will show improvement in at least one indication-related symptom, as measured by computerized performance measures, PP-NRS, SIIS, SRISS, DLQI or PROMIS, etc. The improvement in at least one indication-related symptom in individuals receiving the application is expected to be statistically significant relative to any improvement in the corresponding indication-related symptom observed in individuals receiving digital control or CAU.

[0334] Example 5: Use of CT-100-D-003DiNaMo in digital therapeutics to address maladaptive behaviors associated with urticaria

[0335] In one example, the CT-100-D-003 DiNaMo application (also referred to herein as an application) (e.g., application 125) is provided to individuals with skin diseases. Individuals with skin diseases will be selected based on an itch numerical rating (NRS) ≥ 4, and are particularly diagnosed with urticaria or at risk for urticaria. According to the protocol, treatment will last for 2-28 weeks. It is expected that individuals receiving treatment will show improvement in at least one indication-related symptom, as measured by computerized performance measures, PP-NRS, SIIS, SRISS, DLQI or PROMIS, etc. Relative to any improvement in the corresponding indication-related symptom observed in individuals receiving digital control or CAU, it is expected that the improvement in at least one indication-related symptom in individuals receiving the application will be statistically significant.

[0336] Example 6: Use of CT-100-D-003DiNaMo in digital therapeutics to address maladaptive behaviors associated with prurigo nodularis

[0337] In one example, the CT-100-D-003 DiNaMo application (also referred to herein as an application) (e.g., application 125) will be provided to individuals with skin diseases. Individuals with skin diseases will be selected based on an itch numerical rating (NRS) ≥ 4, and are particularly diagnosed as having nodular prurigo or at risk for nodular prurigo. According to the protocol, treatment will last for 2-28 weeks. It is expected that individuals receiving treatment will show improvement in at least one indication-related symptom, as measured by computerized performance measures, PP-NRS, SIIS, SRISS, DLQI or PROMIS, etc. Compared to any improvement in the corresponding indication-related symptom observed in individuals receiving digital control or CAU, it is expected that the improvement in at least one indication-related symptom in individuals receiving the application will be statistically significant.

[0338] Example 7: Use of CT-100-D-003DiNaMo in digital therapeutics to address maladaptive behaviors associated with tinea planus

[0339] In one example, the CT-100-D-003 DiNaMo application (also referred to herein as an application) (e.g., application 125) is provided to individuals with skin diseases. Individuals with skin diseases will be selected based on an itch numerical rating (NRS) of ≥4, who are specifically diagnosed as having flat muscles or at risk of flat muscles. According to the protocol, treatment will last for 2-28 weeks. It is expected that individuals receiving treatment will show improvement in at least one indication-related symptom, as measured by computerized performance measures, PP-NRS, SIIS, SRISS, DLQI or PROMIS, etc. Relative to any improvement in the corresponding indication-related symptom observed in individuals receiving digital control or CAU, it is expected that the improvement in at least one indication-related symptom in individuals receiving the application will be statistically significant.

[0340] Example 8: Use of CT-100-D-003DiNaMo in digital therapeutics to address maladaptive behaviors associated with acne vulgaris

[0341] In one example, the CT-100-D-003 DiNaMo application (also referred to herein as an application) (e.g., application 125) is provided to individuals with skin diseases. Individuals with skin diseases will be selected based on an itch numerical rating (NRS) ≥ 4, and are particularly diagnosed as suffering from or at risk of acne vulgaris. According to the protocol, treatment will last for 2-28 weeks. It is expected that individuals receiving treatment will show improvement in at least one indication-related symptom, as measured by computerized performance measures, PP-NRS, SIIS, SRISS, DLQI or PROMIS, etc. Relative to any improvement in the corresponding indication-related symptom observed in individuals receiving digital control or CAU, it is expected that the improvement in at least one indication-related symptom in individuals receiving the application is statistically significant.

[0342] Example 9: Use of CT-100-D-003DiNaMo in digital therapeutics to address maladaptive behaviors associated with drug-induced rash

[0343] In one example, the CT-100-D-003 DiNaMo application (also referred to herein as an application) (e.g., application 125) is provided to individuals with skin diseases. Individuals with skin diseases will be selected based on an itch numerical rating (NRS) ≥ 4, and are specifically diagnosed as having a drug-induced rash or a risk of a drug-induced rash. According to the protocol, treatment will last for 2-28 weeks. It is expected that individuals receiving treatment will show an improvement in at least one indication-related symptom, as measured by computerized performance measures, PP-NRS, SIIS, SRISS, DLQI or PROMIS, etc. Compared to any improvement in the corresponding indication-related symptom observed in individuals receiving digital control or CAU, it is expected that the improvement in at least one indication-related symptom in individuals receiving the application is statistically significant.

[0344] Example 10: Use of CT-100-D-003DiNaMo in digital therapeutics to address maladaptive behaviors associated with dryness

[0345] In one example, the CT-100-D-003 DiNaMo application (also referred to herein as an application) (e.g., application 125) is provided to individuals with skin diseases. Individuals with skin diseases will be selected based on an itch numerical rating (NRS) ≥ 4, and are particularly diagnosed as dry cracking or at risk of dry cracking. According to the protocol, the treatment will last for 2-28 weeks. It is expected that individuals receiving treatment will show improvement in at least one indication-related symptom, as measured by computerized performance measures, PP-NRS, SIIS, SRISS, DLQI or PROMIS, etc. Relative to any improvement in the corresponding indication-related symptom observed in individuals receiving digital control or CAU, it is expected that the improvement in at least one indication-related symptom in individuals receiving the application will be statistically significant.

[0346] Example 11: Use of CT-100-D-003DiNaMo in digital therapeutics to address maladaptive behaviors associated with uremia

[0347] In one example, the CT-100-D-003 DiNaMo application (also referred to herein as an application) (e.g., application 125) is provided to individuals with skin diseases. Individuals with skin diseases will be selected based on an itch numerical rating (NRS) ≥ 4, particularly those diagnosed with uremia or at risk of uremia. According to the protocol, the treatment will last for 2-28 weeks. It is expected that the treated individuals will show an improvement in at least one indication-related symptom, as measured by computerized performance measures, PP-NRS, SIIS, SRISS, DLQI or PROMIS, etc. Relative to any improvement in the corresponding indication-related symptom observed in individuals receiving digital control or CAU, it is expected that the improvement in at least one indication-related symptom in the individuals receiving the application will be statistically significant.

[0348] C. Network and computing environment

[0349] Various operations described herein can be implemented on a computer system. Fig. 20A simplified block diagram of a representative server system 2000, a client computer system 2014, and a network 2026 that can be used to implement certain embodiments of the present invention is shown. In various embodiments, the server system 2000 or a similar system can implement the services or servers described herein or portions thereof. The client computer system 2014 or a similar system can implement the clients described herein. The system 100 described herein can be similar to the server system 2000. The server system 2000 can have a modular design incorporating multiple modules 2002 (e.g., blades in a blade server embodiment); although two modules 2002 are shown, any number of modules can be provided. Each module 2002 can include one or more processing units 2004 and local storage 2006.

[0350] One or more processing units 2004 may include a single processor (which may have one or more cores) or multiple processors. In some embodiments, one or more processing units 2004 may include a general purpose main processor and one or more special purpose coprocessors, such as a graphics processor, a digital signal processor, etc. In some embodiments, some or all of the processing units 2004 may be implemented using custom circuits, such as an application specific integrated circuit (ASIC) or a field programmable gate array (FPGA). In some embodiments, such an integrated circuit executes instructions stored on the circuit itself. In other embodiments, one or more processing units 2004 may execute instructions stored in local storage 2006. Any type of processor in any combination may be included in one or more processing units 2004.

[0351] The local storage 2006 may include volatile storage media (e.g., DRAM, SRAM, SDRAM, etc.) and / or non-volatile storage media (e.g., magnetic disks or optical disks, flash memory, etc.). The storage media incorporated into the local storage 2006 may be fixed, removable, or upgradeable as desired. The local storage 2006 may be physically or logically divided into various subunits, such as system memory, read-only memory (ROM), and permanent storage devices. The system memory may be a read-write memory device or a volatile read-write memory, such as a dynamic random access memory. The system memory may store some or all of the instructions and data required by one or more processing units 2004 at runtime. The ROM may store static data and instructions required by one or more processing units 2004. The permanent storage device may be a non-volatile read-write memory device that may store instructions and data even when the module 2002 is powered off. The term "storage media" as used herein includes any media in which data can be stored indefinitely (subject to overwriting, electrical interference, power loss, etc.), and excludes carrier waves and transient electronic signals that propagate wirelessly or through wired connections.

[0352] In some embodiments, local storage 2006 may store one or more software programs to be executed by one or more processing units 2004, such as an operating system and / or programs that implement various server functions (e.g., functions of system 100 or any other system described herein or any other one or more servers associated with system 100 or any other system described herein).

[0353] "Software" generally refers to a sequence of instructions that, when executed by one or more processing units 2004, causes the server system 2000 (or portions thereof) to perform various operations, thus defining one or more specific machine embodiments that execute and perform the operations of the software program. Instructions may be stored as firmware residing in a read-only memory and / or program code stored in a non-volatile storage medium, which may be read into a volatile working memory for execution by one or more processing units 2004. Software may be implemented as a single program or as a collection of separate programs or program modules that interact as desired. From local storage 2006 (or non-local storage described below), one or more processing units 2004 may retrieve program instructions to be executed and data to be processed in order to perform the various operations described above.

[0354] In some server systems 2000, multiple modules 2002 may be interconnected via a bus or other interconnect 2008, thereby forming 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, including server racks, hubs, routers, etc.

[0355] Wide area network (WAN) interface 2010 can provide data communication capabilities between a local area network (e.g., via interconnect 2008) and a network 2026, such as the Internet. Other technologies can be used to communicatively couple server system 2010 to network 2026, including wired (e.g., Ethernet, IEEE 802.3 standards) and / or wireless technologies (e.g., Wi-Fi, IEEE 802.11 standards).

[0356] In some embodiments, local storage 2006 is intended to provide working memory for one or more processing units 2004, thereby providing fast access to programs and / or data to be processed while reducing traffic on interconnect 2008. Storage for larger amounts of data can be provided on a local area network by one or more mass storage subsystems 2012 that can be connected to interconnect 2008. Mass storage subsystem 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 storage or other data collection described herein as being generated, used or maintained by a service or server can be stored in mass storage subsystem 2012. In some embodiments, additional data storage resources can be accessed via WAN interface 2010 (potentially with increased latency).

[0357] The server system 2000 can operate in response to requests received via the WAN interface 2010. For example, one module 2002 can implement a supervisory function and assign discrete tasks to other modules 2002 in response to received requests. Work distribution techniques can be used. When a request is processed, the result can be returned to the requester via the WAN interface 2010. This operation can typically be automated. Further, in some embodiments, the WAN interface 2010 can connect multiple server systems 2000 to each other, thereby providing a scalable system capable of managing a large number of activities. Other techniques for managing server systems and server farms (a collection of collaborative server systems), including dynamic resource allocation and reallocation, can be used.

[0358] The server system 2000 can interact with various user-owned or user-operated devices via a wide area network such as the Internet. Examples of user-operated devices are shown in FIG. Fig. 20 2014. The client computing system 2014 may be implemented as, for example, a consumer device such as a smartphone, other mobile phone, tablet computer, wearable computing device (e.g., smart watch, glasses), desktop computer, laptop computer, etc.

[0359] For example, the client computing system 2014 may communicate via the WAN interface 2010. The client computing system 2014 may include computer components, such as one or more processing units 2016, storage devices 2018, network interfaces 2020, user input devices 2022, and user output devices 2024. The client computing system 2014 may be a computing device implemented in a variety of form factors, such as a desktop computer, a laptop computer, a tablet computer, a smartphone, other mobile computing devices, a wearable computing device, etc.

[0360] The processing unit 2016 and storage device 2018 may be similar to the one or more processing units 2004 and local storage 2006 described above. Suitable devices may be selected based on the requirements to be placed on the client computing system 2014. For example, the client computing system 2014 may be implemented as a "thin" client with limited processing capabilities or as a high-power computing device. The client computing system 2014 may be provided with program code that can be executed by the one or more processing units 2016 to implement various interactions with the server system 2000.

[0361] 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.).

[0362] The user input device 2022 may include any device (or devices) through which a user may provide signals to the client computing system 2014; the client computing system 2014 may 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 touch pad, a touch screen, a mouse or other pointing device, a scroll wheel, a click wheel, a dial, buttons, switches, a keypad, a microphone, and the like.

[0363] The user output device 2024 may include any device through which the client computing system 2014 can provide information to the user. For example, the user output device 2024 may include a display-to-display image generated or delivered to it by the client computing system 2014. The display may incorporate various image generation technologies, such as a liquid crystal display (LCD), a light emitting diode (LED) display including an organic light emitting diode (OLED), a projection system, a cathode ray tube (CRT), etc., and supporting electronic devices (e.g., digital-to-analog or analog-to-digital converters, signal processors, etc.). Some embodiments may include a device such as a touch screen, which is used as both an input device and an output device. In some embodiments, other user output devices 2024 may be provided in addition to or in place of a display. Examples include indicator lights, speakers, tactile "display" devices, printers, etc.

[0364] Some embodiments include electronic components, such as microprocessors, storages and memories, which store computer program instructions in computer-readable storage media. Many features described in this specification can be implemented as processes designated as a group of program instructions encoded on a computer-readable storage medium. When these program instructions are performed by one or more processing units, they cause one or more processing units to perform the various operations indicated in the program instructions. Examples of program instructions or computer codes include machine codes such as produced by a compiler and files including high-level codes executed by a computer, electronic components or microprocessors using an interpreter. Through appropriate programming, one or more processing units 2004 and 2016 can provide various functions for server system 2000 and client computing system 2014, including any function or other functions described herein as being performed by a server or client.

[0365] It will be understood that the server system 2000 and the client computing system 2014 are illustrative, and various changes and modifications are possible. The computer system used in conjunction with the embodiments of the present invention may have other capabilities not specifically described herein. Further, although the server system 2000 and the client computing system 2014 are described with reference to specific blocks, it should be understood that these blocks are defined for the convenience of description and are not intended to imply a specific 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. Further, these blocks do not need to correspond to physically different components. Blocks may be configured to perform various operations, such as by programming a processor or providing appropriate control circuits, and various blocks may be reconfigurable or may not be reconfigurable, depending on how the initial configuration is obtained. Embodiments of the present invention may be implemented in various devices including electronic devices implemented using any combination of circuits and software.

[0366] Although the present invention has been described with respect to specific embodiments, it will be appreciated by those skilled in the art that many modifications are possible. Embodiments of the present invention may be implemented using various computer systems and communication technologies, including but not limited to the specific examples described herein. Embodiments of the present invention may be implemented using any combination of dedicated components and / or programmable processors and / or other programmable devices. Various processes described herein may be implemented on the same processor or on different processors in any combination. Where components are described as being configured to perform certain operations, such configurations may be implemented, for example, by designing electronic circuits to perform operations, by programming programmable electronic circuits (e.g., microprocessors) to perform operations, or any combination thereof. Further, although the above-described embodiments may refer to specific hardware and software components, it will be appreciated by those skilled in the art that different combinations of hardware and / or software components may also be used, and specific operations described as being implemented in hardware may also be implemented in software, and vice versa.

[0367] The computer program incorporating the various features of the present invention may be encoded and stored on a variety of computer-readable storage media; suitable media include disks or tapes, optical storage media such as compact disks (CDs) or digital versatile disks (DVDs), flash memory, and other non-transient media. The computer-readable medium encoded with the program code 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).

[0368] Therefore, although the invention has been described with respect to particular embodiments, it will be understood that the invention is intended to cover all modifications and equivalents within the scope of the appended claims.

Claims

1. A method for providing training to address maladaptive behavior of a user by presenting visual elements, comprising: identifying, by a computing system, 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 tendency in a behavior associated with a symptom of the user; providing, by the computing system, a first indication to perform 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, a second instruction after the first task to perform a second task of the plurality of tasks using at least one hand during a second portion of the session; as well as A third instruction is provided by the computing system after the second task to perform a third task of the plurality of tasks using at least one hand during a third portion of the session.

2. The method according to claim 1, wherein: The multiple tasks include one or more of the following: (i) a go / no-go task for prompting the user to perform or decline a first action, (ii) a habit reversal therapy task for prompting the user to perform a second action instead of performing a third action associated with the maladaptive behavior, and (iii) an encouragement and entertainment task for prompting the user to perform a fourth action within the tendency duration of the maladaptive behavior.

3. The method according to claim 1, wherein: Providing the second indication further includes providing the second indication in response to completion of the first task, and providing the third indication further includes providing the third indication in response to completion of the second task.

4. The method according to claim 1, wherein: At least one of the tasks is to perform at least one of an interaction or a non-interaction with a stimulus associated with the symptom, the stimulus comprising at least one of text, an image, or audio.

5. The method according to claim 1, further comprising: receiving, by the computing system, from the user a request indicating initiation of the behavior associated with the symptom; as well as The session is initiated by the computing system in response to receiving the request to address the behavioral tendency associated with the symptom.

6. The method according to claim 1, further comprising: receiving, by the computing system while performing the first task, sensory data identifying one or more physiological measurements of the user, and The second task is modified, by the computing system, based on the one or more physiological measurements of the user identified in the sensory data.

7. The method according to claim 6, wherein: The one or more physiological measurements also include at least one of breathing pattern, pupil dilation, heart rate, skin conductivity, or oxygen saturation.

8. The method according to claim 1, further comprising: A score is determined by the computing system based on performance of at least one of the tasks, the score identifying at least one of: (i) the user's compliance with at least one of the tasks, or (ii) a likelihood of overcoming a tendency toward the behavior.

9. The method according to claim 1, further comprising: Feedback is generated by the computing system for providing to the user based on performance of at least one of the tasks.

10. The method according to claim 1, wherein: The symptoms include skin symptoms corresponding to at least one of the following: (i) atopic dermatitis, (ii) contact dermatitis, (iii) psoriasis, (iv) urticaria, (v) nodular prurigo, (vi) flat warts, (vii) acne vulgaris, (viii) drug-induced rash, (xi) xerochaemia, or (x) uremia, wherein the user takes medication for addressing the skin symptoms at least partially concurrently with the session to address the tendency to engage in maladaptive scratching behavior.

11. A system for configuring visual elements to suppress a user's maladaptive behavior tendency, comprising: A computing system having one or more processors coupled to a memory and configured to: identifying 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 tendency in a behavior associated with a symptom of the user; providing a first instruction to perform a first task of the plurality of tasks using at least one hand during a first portion of the session; providing a second instruction after the first task to perform a second task of the plurality of tasks using at least one hand during a second portion of the session; as well as A third instruction is provided after the second task to perform a third task of the plurality of tasks using at least one hand during a third portion of the session.

12. The system according to claim 11, wherein: The multiple tasks include one or more of the following: (i) a go / no-go task for prompting the user to perform or decline a first action, (ii) a habit reversal therapy task for prompting the user to perform a second action instead of performing a third action associated with the maladaptive behavior, and (iii) an encouragement and entertainment task for prompting the user to perform a fourth action within the tendency duration of the maladaptive behavior.

13. The system according to claim 11, wherein: Providing the second indication further includes providing the second indication in response to completion of the first task, and providing the third indication further includes providing the third indication in response to completion of the second task.

14. The system according to claim 11, wherein: At least one of the tasks is to perform at least one of an interaction or a non-interaction with a stimulus associated with the symptom, the stimulus comprising at least one of text, an image, or audio.

15. The system according to claim 11, wherein: The computing system is further configured to: receiving a request from the user indicating initiation of the behavior associated with the symptom; and The session is initiated in response to receiving the request to address the behavioral tendency associated with the symptom.

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

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

18. 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) the user's compliance with at least one of the tasks, or (ii) a likelihood of overcoming a tendency to behave.

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

20. The system of claim 11, wherein: The symptoms include skin symptoms corresponding to at least one of the following: (i) atopic dermatitis, (ii) contact dermatitis, (iii) psoriasis, (iv) urticaria, (v) prurigo nodularis, (vi) flat warts, (vii) acne vulgaris, (viii) drug-induced rash, (xi) chapped skin, or (x) Uremia, wherein said user takes medication for addressing said skin symptom at least partially concurrently with said session, To address the tendency to scratch as a maladaptive behavior.

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