CN116830209A

CN116830209A - System and method for treating depression using digital therapy

Info

Publication number: CN116830209A
Application number: CN202280013405.1A
Authority: CN
Inventors: A·福布斯; J·多尔蒂; B·亚科韦罗; D·C·卡彭特; M·J·沃德
Original assignee: Crick Therapeutics Ltd; Otsuka Usa Co
Current assignee: Crick Therapeutics Ltd; Otsuka Usa Co
Priority date: 2021-01-05
Filing date: 2022-01-05
Publication date: 2023-09-29

Abstract

Systems and methods for treating depression via digital therapy. Digital therapy may be configured to provide memory task exercises according to a schedule and psychological treatment courses according to another schedule. The psychological therapy lesson may include animated video configured to provide therapeutic intervention through at least one of emotion adjustment, behavioral activation, and cognitive reconstruction. These two schedules may define a six week treatment period. The memory task exercises may include Emotion Facial Memory Task (EFMT) exercises, and the psychotherapy lessons may include Cognitive Behavioral Therapy (CBT) lessons.

Description

System and method for treating depression using digital therapy

Cross Reference to Related Applications

The present application claims priority from 35U.S. C. ≡119 (e) to U.S. patent application Ser. No.63/176,697 filed on day 19 of 4 of 2021 and U.S. patent application Ser. No.63/134,099 filed on day 5 of 2021, the entire contents of which are incorporated herein by reference.

Background

Mood disorders may be characterized as distortion or general mental or emotional states that are inconsistent with the actual situation of an individual. Depending on the severity, mood disorders may interfere with an individual's professional and social abilities. Examples of mood disorders include Major Depressive Disorder (MDD), bipolar disorder, seasonal affective disorder, circulatory disorder, persistent depression (dysthymia), destructive mood regulating disorder, depression associated with medical conditions, and depression caused by substance use or drugs.

For example, an individual diagnosed with an emotional disorder of MDD may have a sustained depression or depression in emotion, a reduced interest in pleasurable activities, feelings of guilt or invaluable, insufficient energy, inattention, altered appetite, psychomotor agitation, sleep disorders, or suicidal thoughts. These symptoms can have a serious impact on the overall health of the individual. In fact, MDD is considered to be a major cause of disability worldwide from the total years lost by disability. Some studies have shown that the expenditure associated with depression in the united states can be as high as several billion dollars, with employers bearing significant direct medical costs and significant losses due to absences, attendance and disabilities. Despite the therapeutic options for depression, there is still a need to improve the outcome of treatment. In addition, many patients diagnosed with mood disorders such as MDD are not adequately treated due to the various disorders for which standard care is achieved.

Disclosure of Invention

The disclosed subject matter includes systems and methods for providing therapy content via digital therapy ("DTx") to treat mood disorders, such as depression, particularly Major Depressive Disorder (MDD). The therapy content may include memory task exercises, psychotherapy lessons, and/or other content. The memory task exercise may include sequentially displaying two or more emoticons to a patient receiving a depression treatment. The emoticons may be configured to depict certain emotions. The patient may be prompted to determine whether the various emotions depicted by the displayed emoticons match each other. A patient response may be received indicating whether the respective emotions match.

The psychotherapy lesson may be encoded as content such as video (in particular animated video), audio (such as songs, narration, etc.), haptic content or other forms of content. The content of the psychotherapy lesson may be configured to provide therapeutic intervention via at least one of affective modulation (ER), behavioural Activation (BA) or Cognitive Reconstruction (CR).

According to an embodiment, therapy content may be provided according to a therapy schedule. The treatment schedule may define the treatment period (duration of treatment) and timing (when provided) of the digital therapy. For example, memory task exercises may be provided according to a treatment schedule. Likewise, psychological treatment courses may be provided according to a treatment schedule that may be the same as or separate from the treatment schedule of the memory task exercises. In other words, a single treatment schedule may define the duration and/or timing of the memory task exercises and the psychotherapy session, or a first treatment schedule may define a first duration and timing of the memory task exercises and another second treatment schedule may define a second duration and timing of the psychotherapy session.

The treatment schedule (whether a single schedule or separate schedules) of the memory task exercises and psychological treatment sessions may define a specific treatment period, such as, for example, a six week treatment period.

In one or more embodiments, the memory task exercises may include Emotion Facial Memory Task (EFMT) exercises, and the psychotherapy lesson may include Cognitive Behavioral Therapy (CBT) lessons. During the course of the treatment period, the EFMT exercises and CBT lessons may each be provided at different frequencies (such as 3 days per week, every other day, etc.).

Drawings

Fig. 1 is a system diagram of an example of digital therapy for treating depression, according to various embodiments.

Fig. 2 is an example of a process for delivering therapy content via digital therapy, according to various embodiments.

Fig. 3A-3C, 4A, 4B, 5A, and 5B are examples of images of a psychotherapy session rendered by digital therapy according to various embodiments.

Fig. 6 illustrates an example of a treatment schedule for delivering therapy content via digital therapy, in accordance with various embodiments.

Fig. 7 is a diagram of an example of a system for delivering therapy content via digital therapy, according to various embodiments.

Fig. 8 is a diagram of an example of system components of one or more devices for delivering therapy content via digital therapy, according to various embodiments.

Detailed Description

The disclosed subject matter relates generally to digital therapy (DTx). DTx may refer to the treatment of diseases such as mood disorders by using therapy content that may be encoded in computer readable form.

Individuals (also referred to herein as "patients") who have been diagnosed with an mood disorder, such as MDD, may have sustained negative feelings and emotions. This situation affects the feeling, thinking and behavior of an individual, which can lead to various emotional and physical problems. Individuals may experience difficulties in normal daily activities such as work, school, social activities, and/or relationships with others. Symptoms of depression will manifest during periodic episodes, which may occur daily, weekly, monthly, or at other intervals. Symptoms may include, but are not limited to (this is not meant to be limiting with other lists) sad or hopeless sensations; anger outbreaks, dysphoria, or depression; losing interest or fun to entertainment or hobbies; sleep disorders, including insomnia or hypersomnia; tired and lack of energy; anorexia and/or weight loss; craving for food increases and/or weight increases; anxiety, agitation or anxiety; slow down thinking, speaking or physical action; feel that oneself has no value or guilt, enthusiasm in past failure or self-responsibility; difficulty in thinking, focusing on, making decisions, and/or memorizing; frequent or recurrent thoughts of death or suicide; and/or unexplained physical problems.

According to embodiments disclosed herein, a DTx may include electronic content and/or instructions that program one or more computer devices to administer the electronic content, receive patient interactions with the electronic content, and/or perform other operations to treat a patient's mood disorder. Thus, DTx may be administered to a patient in various ways (such as via one or more computer devices). The one or more computer devices may include an application server, a user device, and/or other devices programmed with a DTx or portion thereof.

In particular, the functionality of the DTx described herein may operate at the user device, the application server, or both the treatment device and the application server. The user device may generally be operated by the patient and/or a user such as a clinician. In some embodiments, the user device may include a patient's mobile device and/or other devices programmed with computer program instructions. In some embodiments, the user device may access some or all of the functionality of the DTx via an Application Programming Interface (API) exposed by the application server.

In some embodiments, the DTx is configured to render and process therapy content specifically tailored for treating an mood disorder. The therapy content can be individually customized according to the specific situation of the patient. In some embodiments, the specific therapy content to be provided to the patient is obtained from a database of therapy content. Depending on the progress of the patient, different therapy content may be selected and provided to the patient. In some embodiments, the therapy content and feedback provided by the patient to the therapy content may be encrypted to prevent unauthorized access to the patient's confidential health data. Furthermore, the patient may not have access to certain therapy content at different times. This may ensure that targeted therapy content is provided to the patient at the appropriate time.

The therapy content may include video, audio, tactile or olfactory elements, alone or in combination. Furthermore, the therapy content may be interactive, prompting for input or response from the patient. The interactive therapy content may also passively obtain feedback, such as by capturing biometric information (such as pulse, blood pressure, pulse blood oxygen concentration, respiration rate, etc.) from a biometric sensor worn by the patient, monitoring facial expressions (such as using computer vision processing) to perform emotion recognition, performing eye gaze tracking (such as determining whether the patient is consuming therapy content), and so forth. The therapy content may be configured to be delivered to (or consumed by) the patient according to a predefined treatment regimen, which may also be referred to as a "dosing regimen. The DTx may be prescribed and/or "over the counter" by a patient's healthcare provider (HCP). The DTx may be implemented in the form of a software app or other type of software module that may execute on one or more computing devices, such as a web server, desktop computer, notebook computer, tablet computer, smart phone, or other computing device. The therapy content may be rendered using an output component of the computing device (such as a monitor, touch screen, speaker, etc.).

The therapeutic content of DTx may be provided as an independent treatment of mood disorders (e.g., MDD), or as an adjunct to other types of treatment such as antidepressant therapy (ADT). Exemplary ADTs may include selective 5-hydroxytryptamine reuptake inhibitors (SSRI), 5-hydroxytryptamine and norepinephrine reuptake inhibitors (SNRI), and Norepinephrine and Dopamine Reuptake Inhibitors (NDRI). SSRI may include escitalopram, citalopram, fluoxetine, paroxetine and sertraline. The SNRI may include duloxetine, venlafaxine ER/XR, and desvenlafaxine. The NDRI can include bupropion XL/SR.

Depression is a disease in which the patient's nerve connectivity is altered. The combination of memory task exercises and mental therapy sessions performed on patients are designed to address cognitive control networks and emotion management networks to help restore proper neural connectivity. The technology described herein provides an improvement over existing mood disorder therapies because combination therapies are directed to improving neurological function through memory task exercises and enhancing such improvement by adapting the patient to specifically designed psychotherapy courses that utilize the improved neurological function. Thus, the combination therapy provides better therapeutic effects than the memory task exercise alone. Furthermore, for embodiments in which the DTx is implemented on the patient's device, the DTx may facilitate therapeutic intervention, whether through a remote network connection between the treatment device and the backend application server or in an offline mode without such a remote network connection. DTx may also be provided to patients from various socioeconomic contexts, even to patients who are not receiving traditional mood disorder treatment. Thus, individuals in various industries may be able to overcome the daily challenges presented by mood disorders.

Fig. 1 is a system diagram of an example of a DTx 100, the DTx 100 may include therapy content 102 for treating an mood disorder, such as MDD. The therapy content 102 may be provided to the patient via a mobile application, API, or other interface. For example, the patient may access a mobile application stored in memory on the user device of the patient to administer therapy content 102 to the patient. The mobile application may be a native application, an application executed through a web browser, or a web application. In some embodiments, the mobile application may connect the patient's mobile device to a backend server that stores data including therapy content 102. The various components of therapy content 102 can be accessed by a mobile device from a backend server across one or more communication networks (such as the internet, an intranet, etc.).

The therapy content 102 of the DTx 100 may include one or more components such as memory task exercises 104, psychotherapy lessons 106, and messaging 108. The memory task exercises 104, the mental therapy lessons 106, and/or the messaging 108 may be rendered and processed individually or in combination according to a treatment schedule. When used in combination, the memory task exercise 104, the psychotherapy lesson 106, and/or the messaging 108 can be used as a synergistic combination therapy for treating depression that provides an improvement over traditional mood disorder treatments (such as being usable by a larger subset of the population, less expensive than medications).

The memory task exercise 104 may address an imbalance between an overactive emotional processing region and a low active forehead lobe region of the patient, which may be the source of cognitive control impairment for the patient. The memory task exercise 104 may be encoded with interactive digital content and tasks associated with the DTx 100 to be performed by the patient. The memory task exercise 104 may thus refer to interactive digital content and operations that prompt a user to perform a task and receive input from the user related to the task. For illustration, the memory task exercise 104 will be described in the context of a user device (such as user device 710 shown in FIG. 7) that provides the memory task exercise 104. The digital interactive content may include a series of images with corresponding visual elements. The memory task exercise 104 can also include instructions that prompt the patient to recall whether visual elements in the currently displayed image match visual elements in the previously viewed image. As an example, a first image depicting a first emotion may be displayed via a user interface rendered on a mobile device of a patient, followed by a second image depicting a second emotion (which may be the same or different than the first emotion), followed by a third image depicting a third emotion (which may be the same or different than the first and/or second emotion), and so forth. Then, after displaying the third image, the digital media may request the patient to identify whether the third image depicts the same (or similar) emotion as that of the first or second image. In other words, the digital media may request that the patient determine whether the nth image depicts the same or similar emotion as the (N-M) th image. This form of memory task exercise 104 is referred to as an N-back (back N) memory task.

The process of identifying visual elements in the corresponding image may trigger the amygdala (amygdala) of the patient. Recall whether the current visual element is the same or different process as previously seen can mobilize the dorsolateral prefrontal cortex of the patient by exercising cognitive control capabilities. Thus, the memory task exercise 104 may repair dysfunctional brain circuits and/or restore nerve connections by strengthening certain portions of the patient's nerve function. The memory task exercise 104 may serve as an intervention step during therapy for performing cognitive emotion training to repair a nonfunctional or erroneous brain circuit.

In some embodiments, the memory task exercise 104 may be encoded as digital media to be administered to and interacted with by the patient (such as using the patient's mobile device). For example, the computer program instructions may encode the memory task exercise 104 and be executed by a computing device. Different memory task exercises may be provided to the patient by accessing different data. For example, data representing first computer program instructions implementing a first memory task exercise may be accessed via a computing device of a first patient, while data representing second computer program instructions implementing a second memory task exercise may be accessed via a computing device of a second patient. In some cases, the data may be accessed based on a patient-unique identifier (such as an IP address, MAC address, and/or serial number associated with the patient's computing device). In some embodiments, the data may be accessed based on login credentials provided by the patient (such as a user name/password, facial recognition authentication, retinal scan, etc.). It should be appreciated that as described herein, "accessing," "retrieving," and/or "providing" the memory task exercise 104 can include accessing, retrieving, and/or providing data including computer program instructions implementing a given one or more memory task exercises 104.

The psychotherapy lessons 106 may be directed to symptoms of depression such as full or no thinking, individualization, catastrophe, inactivity, and social isolation. The psychotherapy lesson 106 can address these poorly adapted thinking patterns and behaviors by stimulating the development of conscious disbeliefs on the thinking and behavior patterns, as well as alternative behavioral and empirical interpretations. The psychotherapy lesson 106 may also prompt the patient to complete an activity or task. Thus, the psychotherapy lesson 106 may be configured to assist the patient in properly utilizing or acquiring new skills that are possible via the memory task exercise 104 to repair dysfunctional loops and/or restore neural connections. The psychotherapy lesson 106 can also help the patient gradually achieve better execution control of depression emotions as he experiences the psychotherapy lesson 106 and completes the memory task exercise 104.

The psychotherapy lesson 106 may be provided to the patient as digital media such as, for example, video (such as animated video), audio, tactile information, text information, or other forms of media, or combinations thereof. For example, video data representing video created to convey a particular psychological treatment course to a patient may be accessed by the patient using the patient's computing system. In some cases, video data may be selected from a database of data representing psychotherapy lessons 106. The video data representing various psychological treatment sessions may include metadata indicating specific parameters associated with a given psychological treatment session. For example, a given video depicting a particular psychotherapy lesson may be marked with one or more labels indicating what the video includes, the intended recipient of the video, the duration of the video, the emotion or set of emotions conveyed by the video, one or more skills introduced by the video, or other labels, or a combination thereof. In some embodiments, the DTx 100 may monitor the progress of the patient through the therapy process to determine which psychotherapy courses 106 have been consumed by the patient to determine which additional psychotherapy courses 106 are to be provided to the patient next. As described herein, "accessing," "retrieving," and/or "providing" psychotherapy lessons 106 can include providing data including computer program instructions to be executed by a patient's computing device to implement a particular psychotherapy lesson.

Messaging 108 may be implemented via Short Message Service (SMS), multimedia Message Service (MMS), push notification, etc. Messaging 108 includes providing a message to the patient, where the message may be periodically transmitted, such as daily, weekly, monthly, etc. The message provided via messaging 108 may include text, animation, pictures, audio, haptic responses, or other digital media, or a combination thereof. The messaging 108 may derive messages from a pre-generated psychological therapy message library and/or a pre-generated participation (reminder) message library. In some embodiments, messaging 108 may include dynamically generating one or more messages using artificial intelligence and/or machine learning techniques (such as via chat robots). In some embodiments, the messaging 108 may implement natural language processing techniques to determine an appropriate message intent, and may select and/or generate a message based on the determined intent.

The messaging 108 may select a particular message to augment the psychotherapy lesson 106 and may deliver the message to synchronize with the patient's progress through the psychotherapy lesson 106. The DTx100 may include logic for selecting and transmitting messages according to any desired interval, such as 0-4 messages per day. The logic may indicate that one or more particular messages are to be provided to the patient based on a most recently completed memory task exercise and/or psychotherapy session, memory task exercise and/or psychotherapy session to be consumed by the patient, input provided by the patient in response to the most recent memory task exercise and/or psychotherapy session, a request from a clinician or other mental health provider, or based on other criteria. The messaging 108 may include generating and providing a link for the patient to access one or more of the psychotherapy courses 106, which may be previously viewed psychotherapy courses or new psychotherapy courses, in which skills or strategies for improving the ability of the patient to handle difficult moments have been or are to be conveyed.

Messaging 108 may include providing reminders to the patient to complete memory task exercises 104 and psychotherapy lessons 106 during the course of treatment schedule. This may include providing a notification to the patient's mobile device to indicate the particular memory task exercise and/or psychotherapy session to be completed by the user. The notification may be a displayed alert (such as a notification message displayed on a display screen of the patient's mobile device), a tactile alert (such as vibrating the patient's mobile device to indicate an action to be performed), or may be of other notification type. The messaging 108 may also be configured to provide an indication of the difficulty or utility of completing the memory task exercise 104 and/or the psychotherapy lesson 106 to further enhance patient participation and motivation. Messaging 108 may provide messages personalized based on the activity, compliance, and/or performance of the patient associated with the DTx 100, past messages provided to the patient (or to a patient having similar attributes such as age, gender identified, educational level), and the like.

In some embodiments, a scoring function may be used to select a particular message to be provided to a patient, the scoring function configured to score messages (or message components used to generate messages) and rank the messages based on the score. For example, each message may include a tag indicating the emotion to be expressed to/by the patient. For example, there may be n message states, each referring to a particular emotion, idea, condition, etc. of the patient. Based on the memory task exercises and/or the psychotherapy lessons that the patient is (is) to accomplish, the scoring function may calculate a score representing the best message to provide to the patient based on the patient profile. The patient profile may include a patient profile vector (such as an n-dimensional vector), where each dimension refers to one of n message states and has a value that indicates how appropriate the message state is for the patient. Based on the patient profile vector and the vector representing the message, the scoring function may determine which message (such as the message with the highest score) to select. In some embodiments, the value of each attribute of the patient profile vector may be updated based on the memory task exercises and/or psychological treatment sessions performed by the patient, patient feedback provided during the treatment schedule, or other factors.

Fig. 2 illustrates an exemplary process 200 for delivering therapy content 102 of a DTx 100 in accordance with various embodiments. At 202, access to a DTx 100 may be provided. For example, the DTx 100 may be made available as downloadable software for a local computing device (such as a desktop computer, notebook computer, tablet, smart phone, mobile device, or other computing device). The local computing device may be associated with the patient or the patient's HCP. The local computing device may execute software for rendering and processing therapy content 102 of the DTx 100. Alternatively, the DTx 100 may be hosted and executed on a web server and accessed by a local computing device over a wired or wireless network (such as via an API).

At 204, one or more memory task exercises 104 can be provided. For example, software for the DTx 100 may be executed on a web server or a local computing device. Execution of the software of the DTx 100 may cause the memory task exercise 104 to be provided to the patient via the patient's computing device (such as a mobile device). The local computing device may then render or display the memory task exercise 104. Alternatively, the DTx 100 may be stored on the local computing device such that no access to a network connection is required to receive the therapy content 102. The software for the DTx 100 may include computer program instructions that, when executed by a computing device of a patient, implement one or more of the memory task exercises 104. In some embodiments, the software for the DTx 100 may include logic configured to determine the status of the patient during the treatment schedule, and may select a particular memory task exercise to provide to the patient. For example, software for the DTx 100 may determine a memory task exercise based on previously provided memory task exercises. In some embodiments, software for the DTx 100 may limit access to memory task exercises that are not provided to the patient. For example, if there are ten total memory task exercises, then for a given treatment date/time one of the memory task exercises may be selected and the remaining nine memory task exercises may be prevented from being accessed or otherwise provided to the patient.

At 206, one or more patient inputs associated with the memory task exercise 104 can be received and processed. In some embodiments, the patient may provide the input via the patient's computing device. As an example, the patient may select a Graphical User Interface (GUI) that is rendered on a display screen of the patient's computing device. The selection may be detected via a touch screen, via voice input, via eye tracking, or via other detection techniques, or a combination thereof. Further, the patient may select the option using an input device (such as using a computer mouse, joystick, wearable device, etc.) coupled to the patient's computing device. Upon detecting an input, such as detecting a change in capacitance at a particular location on the touch screen that indicates that the user touched that location on the touch screen, the computing device may determine an action (if any) to be performed in response. The action may be an executable action to be performed by the computing device, such as causing the content to be rendered. Alternatively, the actions may cause a message/request (such as HTML) request to be sent from the computing device to another computing device, server, or another computing component, or a combination thereof. For example, patient input may be transformed into a data request that is transmitted over a network to a network server. Upon receiving the data request, the network server may store the data, retrieve the data, send the data to the computing device and/or another computing device, or perform other actions. As an example, the web server may select a memory task exercise and/or a psychotherapy lesson based on the submitted request, and may provide data including computer program instructions that, when executed by the patient's local computing device, cause the memory task exercise and/or the psychotherapy lesson to be rendered for the patient.

At 208, one or more of the psychotherapy courses 106 may be rendered. The particular psychotherapy lesson to be rendered at the local computing device may be selected based on a treatment schedule, a request from the patient and/or HCP of the patient, or other criteria or combination thereof. For example, the treatment schedule may indicate that at a first time (such as a first day of treatment), a first cardiac treatment session will be selected and data including the first cardiac treatment session (such as a computer program designed to render particular content for the patient) may be provided to the patient's computing device, while at a second time (such as an nth day of treatment), a second cardiac treatment session may be selected and provided to the patient's computing device. In some embodiments, the software for the DTx100 may be executed on a web server or local computing device.

At 210, one or more messages may be generated and presented to a patient. The message may be generated at a network server or on a local computing device. The message may then be delivered and/or caused to be displayed using a graphical user interface of the local computing device. In some cases, chat robots, natural language processing techniques, or other techniques may be used to dynamically generate messages. For example, based on input parameters of a chat robot that may be trained to generate messages with various input parameters, the chat robot may generate and provide messages for messaging 108 of DTx100 to a patient. If the message is pre-generated and stored in memory, the particular message may be selected based on input parameters associated with the psychological treatment course rendered at 208, feedback from the patient, instructions provided by the HCP, or based on other criteria or a combination thereof. The stored messages may include tags indicating emotion, concept, thought, phrase, spell, or other awareness messages conveyed by the respective messages. Based on input parameters included in the request for information (such as may be generated after determining that the patient has consumed the psychotherapy lesson), the most appropriate message may be identified from the stored messages and may be provided to the patient. For example, a similarity score may be calculated based on a feature vector representing a message and a feature vector representing a request for a message (such as euclidean distances between the location of the requested message and the location of each stored message in a feature space may be calculated).

In some embodiments, the rendering and/or processing of the memory task exercises, the psychotherapy lessons, and/or the messaging may be done sequentially (such as first the memory task exercises, then the psychotherapy lessons, then the messages). However, in some embodiments, the memory task exercises, the psychotherapy lessons, and the messaging may be performed in a different order (such as first the memory task exercises, then the psychotherapy lessons, then the messages, then another message). Other orders of consuming the DTx 100 are also possible.

In some embodiments, the delivery of the memory task exercise 104, the mental therapy session 106, and/or the messaging 108 may follow a predetermined therapy schedule that may be specified by the HCP or recommended by the provider of the DTx 100. The delivery of therapeutic content 102 of DTx 100 according to a treatment schedule may be clinically validated for the treatment of one or more symptoms of depression. It should be appreciated that aspects of the treatment schedule may be adjusted or varied based on recommendations of the HCP and/or the specifics of the patient using the DTx 100. For example, in an example, the treatment schedule may have a duration of six weeks. As another example, the treatment schedule may have a duration of four weeks. The specific duration of the treatment schedule may be configured by the HCP or provider of the DTx 100 and may be based on evidence of clinical support indicating the efficacy of the treatment to be provided.

Emotion Facial Memory Task (EFMT)

In some embodiments, the memory task exercise 104 of the DTx 100 may comprise an Emotion Facial Memory Task (EFMT) exercise. In some cases, the DTx 100 is implemented via computer program instructions such that, when executed, cause one or more memory task exercises from the memory task exercise 104 to be transferred to the patient via the patient's computing device. EFMT exercises can be configured to repair neural connections in the impaired brain circuit via simultaneous emotion recognition and working memory tasks. EFMT exercises can mobilize two parts of the brain simultaneously that regulate cognitive functions that may be impaired in patients experiencing MDD. Exercise may cause the patient's amygdala (such as it regulates emotion) and/or dorsolateral prefrontal cortex (such as it controls cognition) to be active, resulting in a change in the short-term plasticity of the patient's brain network. Thus, EFMT exercises can address cognitive and affective deficiencies commonly associated with MDD. Using an N-back memory task (such as identifying a person's emotion based on a face image when the person expresses a particular emotion), EFMT exercises aim to enhance cognitive control over emotion information processing.

During an EFMT exercise, a series of emoticons may be displayed sequentially to the patient. The expression image refers to an image depicting a specific emotion. For example, the image may depict a face that expresses emotions (such as anger, aversion, fear, and happiness). In some embodiments, each image may be displayed for a predetermined amount of time. The predetermined amount of time may include any suitable interval, such as between 0.1 seconds and 5.0 seconds. Each image may be displayed for the same predetermined amount of time, but some images may be displayed for different amounts of time. In some cases, the image may be displayed for a first predetermined amount of time or a second predetermined amount of time (or other predetermined amount of time). In some embodiments, the amount of time that some or all of the images are displayed is random and/or configurable. For example, the HCP may determine that the amount of time to display an image to the patient is too short or too long, and may adjust the amount of time. The adjustment may be made via the HCP entering a request to their computing device, which sends instructions to the patient's computing device to adjust the amount of time.

Each expression image may represent a respective expression within a set of expressions. The set of expressions may include any number of different emotions, such as happiness, fear, anger, sadness, surprise, aversion, and the like. The emoticons may be facial images or face images, each of which may depict the face of a person depicting a particular emotion. The emotions depicted in the series of facial images may be displayed randomly or in a predetermined order. For example, an image such as depicting emotion "happy" may be followed by an image depicting emotion "worry", which may be followed by an image depicting emotion "anger", which may be followed by an image depicting emotion "sad", which may be followed by an image depicting emotion "surprise", which may be followed by an image depicting emotion "aversion". The order of the portrayed emoticons may be varied or repeated during the EFMT exercise and/or between different instances of the EFMT exercise. The predetermined sequence may be configured to trigger or engage certain areas of the patient's brain and/or release one or more chemicals (such as acetylcholine, dopamine, norepinephrine, glutamate, serotonin, GABA, glycine, aspartic acid, epinephrine, nitric oxide, and neuropeptides) to alleviate symptoms of MDD.

The emoticons may depict facial expressions of persons of any age, gender and/or race. The emoticons may be rendered in gray scale, color, or a combination thereof. The emoticons may be in the form of photographs, illustrations or animations. Those of ordinary skill in the art will recognize that video, gif, audio, and/or other forms of content may be used in place of, or in addition to, the aforementioned image types. The emoticons may be configured to correspond to particular emotional intensities (such as 90% intensity, 80% intensity, 70% intensity, 60% intensity, 50% intensity, etc.). It should be appreciated that an expressive image with higher intensity may be easier to identify than an image with a lower intensity level. The emotional intensity of a given emoticon may be determined in advance by the HCP or other clinical support. For example, the depicted image may be assigned an intensity "level" by the patient, which may be used to calculate the overall intensity of the emotion for a particular expressive image. In some cases, the level of emotional crazy for a given expressive image may be determined using one or more computer vision techniques that compare the image to a predetermined image classified as having a particular level of intensity. The embedding of the given emoji image may be calculated using the computer vision model, and accordingly, a similarity between a location of the given emoji image in an n-dimensional feature space of the computer vision model and a location in the feature space corresponding to a particular emotional intensity may be calculated.

Each EFMT exercise may be configured as a modified N-back working memory task. That is, after a predetermined number of emoji images are displayed, the patient may be asked if the emotion observed on the currently presented emoji image is the same or different than the emotion observed on the images displayed on the previous N images (such as 1-back, 2-back, 3-back, 4-back, etc.). N may be any integer, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, or greater. In some embodiments, the computer program instructions may cause rendering of a GUI that allows the patient to provide input/responses via their computing device. After providing the response, one or more additional emoticons may be displayed and the patient may again be asked if the emotion observed on the currently presented image is the same or different than that observed on the images displayed on the N images back. In some embodiments, the next image displayed may be selected from a set of possible emoji images based on a response provided by the patient. The response provided may be a binary response (such as yes or no). In some embodiments, a third option (such as "uncertain" or "unaware") may also be provided. Each response of the patient may be (part of) the trial. The patient may be required to complete any suitable number of trials during a round. For example, the number of experiments in a round may be 1 or more, 5 or more, 10 or more, 15 or more, 20 or more, 25 or more, or other numbers of experiments. As illustrative examples, a round may include 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 trials. Each EFMT exercise may include any suitable number of rounds. For example, the number of wheels in a given EFMT exercise may be 1 wheel or more, 5 wheels or more, 10 wheels or more, 15 wheels or more, 20 wheels or more, 25 wheels or more, or other number of wheels. As illustrative examples, the EFMT exercise may include 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 rounds.

In some embodiments, statistical information about the response provided by the patient may be obtained. The statistical information may be used to determine the effectiveness of the EFMT exercise, the patient's participation level, or other aspects of the therapy. For example, in addition to providing an indication of the response, the amount of time between when the image is rendered and when the response is detected may also be provided. It is believed that a long delay time (such as greater than a threshold amount of time, such as 2 seconds, 5 seconds, 10 seconds, 30 seconds, or other amount of time) may indicate that the emotion expressed by the rendered image may be unclear, indicating that the image may need to be removed from the EFMT exercise, updated, or otherwise adjusted to improve the therapy effectiveness of the image.

The number of patient correct responses may be used to determine one or more scores. The score may reflect the number of correct responses of the patient after completion of some or all of the trials in one or some or all of the rounds in the exercise. During exercise, the patient's score may change or adjust with each new correct (or incorrect) response. At the end of the exercise and/or at the end of a set of exercises, the patient's total score may reflect the number of correct responses submitted during the exercise. In some embodiments, in addition to storing whether the patient is correct or incorrect, the response may also indicate a response provided by the patient. The response of a given EFMT exercise may be analyzed to determine response patterns, abnormalities, or other aspects of the response, which may be used to improve therapy treatment. For example, the number of instances that a patient responds with a particular emotion (such as "sadness", "depression", "anger", etc.) may indicate the mental state of the patient. Thus, the HCP may identify appropriate therapeutic interventions and provide them to the patient.

It should be appreciated that the level of difficulty in successfully identifying whether the emotion observed on the currently presented image is the same or different than the emotion observed on the images displayed on the previous N images may increase as the value of N increases. Conversely, the difficulty level may decrease as the value of N decreases. Thus, the value of N may be adjusted (increased or decreased) to allow the patient to progress through the EFMT exercise or series of EFMT exercises while remaining challenging at a level appropriate for the patient. The adjustment of the integer N may be based at least in part on the percentage of correct responses to the total number of responses submitted. For example, N may be reset to n+1 if the percentage of correct responses at the predetermined time is greater than a first threshold percentage, or N may be reset to N-1 if the percentage of correct responses at the predetermined time is less than a second threshold percentage. If the percentage of correct response is between the first threshold percentage and the second threshold percentage, then N may not be adjusted. Although N is adjusted by +1 or-1 in the above example, any adjustment factor (such as 2, 3, 4, etc.) may be used. In some embodiments, the HCP may facilitate adjusting integer N based on the results of the real-time monitoring, and may submit instructions to adjust integer N via a computing device of the HCP. In some embodiments, integer N may be dynamically adjusted by DTx 100. For example, the DTx 100 may include real-time monitoring of treatment difficulty and may increase (or decrease) the integer N depending on the percentage of correct response obtained from the patient.

Alternatively, or in addition to adjusting the value of the integer N, the difficulty level of successfully identifying whether the emotion observed on the currently presented image is the same or different from the emotion observed on the image displayed on the previous N images may be increased or decreased by changing the intensity of the emotion depicted in the emoji image. For example, a patient may have more difficulty identifying a happy emotion represented at a 50% intensity level than at a 90% intensity level, as a lower intensity may provide less certainty for the emotion depicted. Thus, to make the exercise more challenging, one or more of the depicted emoticons may be configured to have a lower intensity level. Conversely, to facilitate exercise, one or more of the portrayed emoticons may be configured to have a higher intensity level.

In some embodiments, different images may be weighted. For example, image data representing an image may include weights corresponding to difficulty levels of the image. Different weights may be selected such that images depicting emotions having higher intensity levels are de-weighted, while images depicting emotions having lower intensity levels are de-weighted. Weighting images based on emotional intensity levels may improve overall results by taking into account errors made by the patient to images that are more difficult to correctly identify.

The integer N and/or emotional intensity level may be adjusted based on the patient fraction at any suitable interval or stage of the EFMT exercise. For example, the integer N and/or emotional intensity level may be adjusted after the patient completes a portion of the trial in one round such that the difficulty level changes as the patient progresses in one round. After the patient completes all trials in the round, the integer N and/or emotional intensity level may be adjusted so that the difficulty level changes as the patient moves to the next round. After the patient completes all rounds of exercises, the integer N and/or emotional intensity level may be adjusted so that the difficulty level changes as the patient moves to the next exercise. In some embodiments, the HCP may adjust the integer N and/or the emotional intensity level. In some embodiments, the integer N and/or emotional intensity level may be automatically adjusted by the DTx 100 based on the patient's response provided during the experiment, round, and/or memory task exercise.

Further examples of EFMT exercises are presented in U.S. Pat. No.10,123,737 (bulletin 11/13 in 2018) and 10,898,131 (bulletin 26 in 1/2021), PCT application No. PCT/US15/51791 filed on 23/9 in 2015; U.S. patent application Ser. No.17/156,195 filed on 22.1.2021; and U.S. provisional patent application serial No.62/054,371 filed on date 2014, 9, 23, each of which is incorporated herein by reference in its entirety for all purposes.

Cognitive behavioral therapy(CBT)

Psychological treatment session 106 of DTx 100 may include Cognitive Behavioral Treatment (CBT) session. CBT lessons may be configured to address other aspects of the MDD for which EFMT exercises may not be specifically directed, such as behavior and social dysfunction that may exacerbate depressed emotions. Each CBT lesson may include video (such as animated video or partially animated video), a set of images, audio, haptic feedback, or other content, or a combination thereof. CBT lessons may be of a predetermined length (such as about 3-5 minutes). The specific length of the CBT lesson may be configured to facilitate the convenience of electronic storage and transmission of CBT lesson files. The specific length may also be configured to deliver a desired therapeutic effect for a duration that is more likely to maintain the patient's attention. The video within the CBT lesson may be followed by a corresponding activity or task to be performed by the patient. Thus, the lesson may be configured to be internalized by the patient and take action.

The length of each CBT session can be carefully configured to maximize effectiveness, acceptance, and impact. For some patients, longer courses may be more difficult to view in its entirety than shorter courses. However, too short a course may not effectively address the behavioral and social dysfunction associated with MDD. In some embodiments, the length of the lesson can be adjusted (such as lengthened, shortened) to increase the effectiveness of the lesson content.

Each psychotherapy lesson 106 can have one or more parameters that can be configured to maximize the effectiveness and impact of the corresponding lesson. These parameters may include, but are not limited to (which is not meant to be limiting by other lists), the length of the psychotherapy session, the type of content of the psychotherapy session, and/or the nature of the content. As described above, the length of the psychotherapy session may be selected to maximize the likelihood that the patient receiving the content will consume the entire psychotherapy session and preserve the principles of the psychotherapy session. As an example, the duration of the psychological treatment session may be within 2-3 minutes. The content type refers to a format that can convey a psychological treatment course. For example, the types of content may include animated video, partially animated video, non-animated video, images or groups of images, text content, audio, haptic feedback, or other content types, or combinations thereof. Characteristics of the content of the psychotherapy lesson may include a color spectrum for the content (such as black and white, colors, color subsets), an effect applied to the content (such as blurring, rotation, edge smoothing, etc.), a speed of movement of a character/object depicted within the video (such as slowing down or speeding up the character/object), whether the content is displayed as 2D video/image content or 3D video/image content, complexity of the content (such as a hierarchical level of words used in the content), narration/concept of the content (such as selecting whether the story is a journey from one emotional state to another emotional state if the video/audio/text depicts the story, or another story type), or other characteristics, or a combination thereof. As an example, certain words/phrases/images may be restricted from being displayed to certain patients so as not to worsen the patient's current emotional state. Some words/phrases/images may be restricted to use together or for specific patient restrictions (such as providing a child with a suitable image/language that may or may not be for an adult). As another example, certain words/phrases/images may be pre-approved as appropriate for use with some or all patients. As yet another example, if the psychotherapy lesson includes video of character movements (such as walking), the speed of the character movements may be controlled to convey appropriate emotional states to the patient. For example, a rapidly moving character may cause an improper anxiety of the patient, and thus a psychotherapy lesson may be created to make the movement of the character moderate.

In some embodiments, parameters of the psychological treatment course may be adjusted for the duration of the treatment schedule. For example, as a patient progresses in the treatment of DTx 100, the content may be configured to account for improvements made by the patient or lack of improvements by the patient. The content included in the psychological treatment session may be configured such that the goal of defining each psychological treatment session varies with the duration of the treatment schedule. For example, content included in a first physiological treatment course of a patient's treatment schedule may be configured to introduce treatments to the patient and bind/contact the patient. In some cases, psychotherapy lessons 106 can include one or more "anchor" lessons. Within the treatment schedule, an indication of when the anchor course occurred may be stored. For example, the treatment schedule may indicate that every fifth course is an anchor course, but the frequency at which anchor courses occur may be varied and may be adjusted. It may be desirable to anchor courses to anchor specific courses/techniques/concepts for patients. In some cases, the anchor course may be quickly referenced by the patient so that the patient may re-reference the anchor course when needed. In some embodiments, the anchor lesson may be stored locally on the client's computing device, while other psychotherapy lessons may be accessed via a server. As an example, the anchor lesson may include breathing exercises and the treatment may include performing breathing exercises every N days, where N may be 1 or greater.

Each CBT session may focus on or utilize one or more psychotherapeutic principles such as emotion modulation (ER), behavioural Activation (BA), and Cognitive Reorganization (CR). Psychological treatment guidelines (such as ER, BA and/or CR) associated with the respective CBT lessons may be further supported by targeted messages to be communicated to the patient. Psychological treatment principles may be directed to the cognitive and affective processing network of the brain to restore them to their proper function. For example, a psychotherapy lesson may support new skills derived from the lesson content to repair dysfunctional neural circuits. In combination with EFMT, psychotherapy lesson 106 may provide significant improvement in the treatment of various mood disorders, such as MDD, as EFMT 104 may repair dysfunctional neural circuits, while psychotherapy lesson 106 may augment the repaired neural circuits (and surrounding/associated neural circuits). Thus, the treatment regimen may resemble the course of treating a dysfunctional physical condition (such as knee injury, shoulder injury, back injury, etc.). Treatment may include surgical intervention to "repair" the injured portion of the body-like EFMT "repairing" the neural circuitry of the brain-which may then be physically treated to strengthen the injured and/or surrounding portions of the body-like psychological treatment courses "strengthening" the neural circuitry of the brain and/or the surrounding/associated neural circuitry. As will be described in more detail below, additional intervening steps (such as messaging 108) may be included to help maintain the effectiveness of the treatment.

ER principles may refer to a patient's ability to regulate or control affective effects, or to regulate the extent of affective experience. In the context of MDD treatment, courses utilizing ER principles may enable a patient to experience painful emotions, such as sadness, anger, or desperate, without being engulfed by these emotions and responding in a deleterious manner. ER strategies within CBT curriculum may include positive ideas and feelings, tolerating difficult emotions and self-pacifying skills. Thus, CBT lessons for ER may be configured to provide the patient with skills and strategies to tolerate and overcome difficult emotions and moments that the patient may encounter.

CBT lessons employing ER principles may also be configured to deliver one or more different targeted messages that enforce these principles. For example, ER-based CBT lessons may be configured to convey a "new heading," which may help set the patient's desire and enhance the patient's motivation and commitment to treatment. The ER-based CBT lesson may be configured to convey "positive" concepts that may introduce the patient with "positive" concepts, including positive breathing exercises. The ER-based CBT lesson may be configured to convey "positive idea of difficult moments" which may help the patient identify difficult moments and difficult internal phenomena and attention switching between patient breathing. ER-based CBT lessons may be configured to convey "moment of difficulty in handling", which may provide or enhance the patient with a strategy to handle abrupt or strong negative emotions. The ER-based CBT lesson may be configured to communicate "different actions," which may help the patient identify adverse behavioral impulses associated with difficult emotions and take action. The ER-based CBT lesson may be configured to convey the mental state of "relax, repair, supplement energy," which may educate the patient about stress and relaxation response and/or provide an exercise that directs muscle relaxation, such as Progressive Muscle Relaxation (PMR), and/or positive sense relaxation.

BA guidelines may be used as a specific therapy technique within one or more CBT courses. During the depressive cycle, the patient may cope with sadness, depression, despair and/or anxiety by avoiding and/or disengaging from healthy activities such as daily living activities, physical activities and exercises, and interpersonal activities. This may exacerbate the negative emotional state of the patient. The BA-based CBT lessons may address these behavioral patterns by providing "action calls" to the patient, which are configured to help the patient re-engage in healthy activities and behaviors. Thus, BA-based CBT lessons can provide a patient with skills to identify and break down negative emotional behavioral cycles that may lead to patient withdrawal from physical and/or interpersonal activity.

CBT lessons employing BA guidelines may also be configured to deliver one or more different targeted messages that enforce these guidelines. For example, a BA-based CBT lesson may be configured to convey "restart" information, which may introduce the patient with a BA model of depression and help the patient overcome the lack of inertia through small steps. The BA-based CBT lessons may be configured to convey "meaningful activity" moods, which may help patients explore value views and/or schedule activities in meaningful areas of life. The BA-based CBT lesson may be configured to convey the concept of "asleep," which may provide a range of strategies for patients to overcome sleep disorders. The BA-based CBT lessons may be configured to convey a "worry-free" mood that may normalize and provide a strategy to overcome intractable thinking that may exacerbate depression and anxiety. The BA-based CBT lesson may be configured to convey the concept of "overcome avoidance," which may normalize and provide the patient with a strategy to take small steps to overcome avoidance of various types or domains. The BA-based CBT lessons may be configured to convey the concept of "more meaningful activities," which may prompt the patient to revisit the previous BA-based CBT lessons to explore and schedule other meaningful activities of life.

CR guidelines may be used as another therapeutic technique within one or more CBT courses. The patient may be experiencing "automatic thinking" concerning negative views of self, the world and the future. The CR-based CBT lessons can be configured to provide a cognitive tool to the patient to identify and systematically assess the accuracy and effectiveness of these ideas as they appear, and to challenge and reconstruct these ideas to reduce inadaptation. Thus, CR-based CBT lessons can provide a patient with skills to recognize cognitive distortion and/or problematic thinking patterns and adapt thereto.

CBT lessons employing CR principles may also be configured to deliver one or more different targeted messages that enforce these principles. For example, a CR-based CBT lesson may be configured to convey the mental state of "balance your mind," which may introduce a cognitive model of depression and cognitive reconstruction to a patient. The CR-based CBT lesson may be configured to convey the concept of "all or nothing" which may teach the patient to identify and challenge all or nothing to obtain a more balanced mind and emotion. The CR-based CBT lesson may be configured to convey a "overcome self criticism" mood that may assist the patient in handling current self criticism ideas and/or practice-guided self-homonymy exercises. The CR-based CBT lesson may be configured to convey a mental state of "countering negative beliefs," which may provide the patient with skills to identify and countering adverse behavioral impulses associated with negative core beliefs. The CR-based CBT lessons may be configured to convey the mental state of "flexible thinking," which may convey strategies to overcome cognitive stiffness, particularly with respect to pessimistic or passive cognitive bias. The CR-based CBT lesson may be configured to convey the concept of "maintaining your harvest," which may review key strategies in previous CBT lessons and provide advice to the patient to maintain learned knowledge.

Table 1 includes a summary of the CBT courses described above that may be incorporated into therapy content 102.

TABLE 1-

One or more of the CBT courses listed in table 1 may be configured to treat or resolve one or more depressive elements as defined by the montgomery-asberg depression rating scale (MADRS). MADRS is a diagnostic questionnaire employed by HCPs (including psychiatrists) to measure the severity of depressive episodes associated with mood disorders. MADRS may include 10 assessment items that may be used to rate the core symptoms of depression. The 10 assessment items may include apparent sadness, reported sadness, mental stress, reduced sleep, loss of appetite, inattention, tiredness, feeling weakness, pessimistic ideas, and suicidal ideas. In some embodiments, other metrics may be used to identify and/or classify the severity of depressive episodes associated with mood disorders.

Each MADRS item may be scored using a predefined four-level scale (such as 0, 2, 4, and 6 points) and three intermediate levels (such as 1, 3, and 5). For example, a score of 0 item may indicate that there are few or no symptoms, while a score of 6 item may indicate that there are severe or extreme symptoms. Items scored as 2 or 4 may indicate a severity level that is higher than none but lower than extreme. Three intermediate stages may represent symptom exacerbations. The MADRS overall score may range from 0 to 60. A higher MADRS score generally indicates a higher severity of depression. Table 2 includes an exemplary mapping of CBT courses in table 1 to each of the 10 MADRS evaluation items. That is, the patient completing one or more CBT courses in column a may result in a lower score for the corresponding MADRS item, thereby reducing the overall MADRS score for the patient. CBT courses in column B represent a subset of column a. Patient completion of one or more CBT courses in column B may have a more immediate and immediate impact on the corresponding MADRS project.

TABLE 2-

One or more CBT courses listed in table 1 may be configured to treat or address one or more depressive elements defined by the Hamilton Depression Rating Scale (HDRS). HDRS is a depression assessment scale administered by a clinician and is configured to measure the severity of symptoms of depression. HDRS may include 17 assessment items (HAM-D17) such as depressed mood, feelings of guilt, suicide, early insomnia, mid-term insomnia, late insomnia, work and activity, dullness, agitation, mental anxiety, physical symptoms (GI), general physical symptoms, genital symptoms, suspected disorders, weight loss, and/or awareness.

Each item in HAM-D17 may be assessed or scored on a predetermined scale, such as 0 to 2, 0 to 3, or 0 to 4. For example, a score of 0 for an item may indicate that there are few or no symptoms, while a highest score may indicate that there are severe or extreme symptoms. Items with scores between the two may indicate a severity that is higher than none but lower than extreme. The overall score of HAM-D17 may range from 0 to 53, with higher scores generally indicating higher severity of depression. Severity can be assessed according to a predefined range on the HAM-D17 scale. For example, a total score of 0-7 may indicate the absence of depression. Total scores 8-13 may indicate mild depression. Total scores 14-18 may indicate mild to moderate depression. Total scores 19-22 may indicate moderate to major depression. A total score of 23 or more may indicate a very severe degree of depression. Table 3 includes an exemplary mapping of CBT lessons in Table 1 to each of the 17 evaluation items in HAM-D17. That is, the patient completing one or more CBT courses in column a may result in a lower score for the corresponding HAM-D17 item, thereby reducing the overall HAM-D17 score for the patient. CBT courses in column B represent a subset of column a. Patient completion of one or more CBT courses in column B may have a more immediate and immediate impact on the corresponding HAM-D17 project.

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TABLE 3-

Fig. 3A-3C, 4A, 4B, 5A, and 5B depict examples of visual effects and/or features within therapy content 102 of one or more CBT courses in accordance with various embodiments. In some embodiments, as described above, the psychotherapy lesson 106 can include video, such as animated video. Visual effects and features within therapy content 102 for a given CBT lesson may be displayed in frames of an animated video. In some embodiments, the psychotherapy lesson 106 may also include one or more tasks and/or exercises to be performed by the patient. For example, tasks and/or exercises may be provided before, during, or after the video. In some embodiments, video and/or therapy content may be provided to the patient via the patient's computing device. In some embodiments, therapy content may be provided to the patient via a user interface of the mobile application. The mobile application may include computer program instructions that cause the therapy content to be rendered via a computing device of the patient. In some cases, the therapy content may be stored locally in memory on the patient's computing device, but alternatively or additionally, the therapy content may be accessed from a web server that stores some or all of the prescribed therapy content.

As an example, fig. 3A depicts a first frame of video of a psychotherapy session. The first frame may include an icon 310A, which may represent an entity in a visual representation of the surrounding 320A (such as a character in a story). The entity represented by icon 310A may be associated with a symptom of an emotional disorder or an emotional state. In this example, the symptoms of the mood disorder or emotional state may be a sad state and/or an unclonable state, as reflected by the expression 330A of the entity depicted by the icon 310A. As used herein, the term "icon" may refer to a visual representation of a seemingly living entity, such as a humanoid character or a non-humanoid object. When presented in the context of video animation, an entity may have moving features, such as moving arms, moving legs, moving torso, moving facial features, and so forth. The movement of the entity may be adjusted as the video progresses (such as from faster moving features to slower moving features). In some embodiments, the characteristics of the entity may change with the duration of the video or the duration of one or more videos. For example, the color scheme of an entity and/or scene may change from the beginning of the video to the end of the video.

In the example video depicted in fig. 3A-3C, the entity represented by icon 310A is shown transitioning from environment 320A in fig. 3A to environment 320B in fig. 3B, and then to environment 320C in fig. 3C. For example, the entity depicted by icon 310A in fig. 3A has an expression 330A that may correspond to a sad emotional state or an uncluttered emotional state. The entity represented by icon 310A may change emotional state (such as from sad to happy) when transitioning from environment 320A to environment 320C. That is, the expression 330A of the entity represented by the icon 310A in fig. 3A may change to the expression 330C in fig. 3C. In this example, the environment 320A of fig. 3A may be dark and indoor. However, the environment 320C of fig. 3C may be bright and outdoors. The entity depicted by icons 310A, 310B, 310C may transition from environment 320A to environment 320C by using an exit gate depicted within environment 320B. The transition from environment 320A to environment 320C may occur during a predetermined amount of time (such as 5 seconds, 7 seconds, 10 seconds, etc.), which may be configured to alleviate one or more symptoms of MDD. For example, the amount of time that the transition from environment 320A to 320C occurs may be increased or decreased based on the particular treatment provided to the patient, the progress of the patient in the treatment, feedback from the patient (such as explicit feedback, such as responses to questions/cues, and/or implicit feedback captured via one or more sensors, such as biometric feedback, eye tracking, etc.). However, the present disclosure is not limited to these particular environments or this particular transition between environments 320A-320C, and each may be otherwise visually presented to achieve the same meaning conveyed by the transition of an entity from environment 320A to 320C.

Other examples of entities that transition between environmental and emotional states are shown in fig. 4A, 4B, 5A, and 5B. For example, fig. 4A depicts frames of video from a psychotherapy lesson and may include an icon 410A representing an entity expressing an expression 430A (such as happy or depressed) in environment 420A. When transitioning to environment 420B, as shown by the frames of video from the psychotherapy lesson of fig. 4B, icon 410B representing the entity transitions to expression 430B (such as happy). Likewise, fig. 5A depicts frames of video from a psychotherapy lesson and may include an icon 510A representing an entity expressing an expression 530A (such as an unpleasant or depressed) in an environment 520A (such as in an underground cave). When transitioning to environment 520B (such as on a mountain rising from a ground in environment 520A to the ground in 520B), as shown by the frames of video from the psychotherapy lesson of fig. 5B, icon 510B representing the entity transitions to expression 530B (such as happy, confident, etc.). Each of these respective transitions may be configured to occur within a predetermined period of time and/or have an accompanying audio effect, which may help alleviate one or more symptoms of MDD.

3A-3C, 4A, 4B, 5A, and 5B may each be part of an animated video that may be displayed during a CBT lesson, alone or with one or more other frames. The animated video may include text content, image content, video content, audio content, or any combination thereof. The animated video may graphically depict entities moving between environments while having associated mental or emotional state changes. These transitions may help train the patient to use cognitive skills, which may enable the patient to make similar emotional transitions in real life. The animated video and its accompanying features and graphics, when viewed by the patient as part of the treatment schedule associated with the DTx 100, may trigger the release of one or more chemicals (such as dopamine, serotonin, endorphins, etc.) in the patient's brain that promote healthier mental and/or emotional states.

Treatment schedule

Fig. 6 depicts an exemplary treatment schedule 600 for delivering therapy content 102 via DTx 100. As shown in fig. 6, the treatment schedule 600 may include a six week treatment period, but the treatment period may be shortened or lengthened depending on the patient's response to the treatment. The treatment schedule 600 may be prescribed (prestoribed) by the patient's HCP or recommended by the provider of the DTx 100. During each week of treatment schedule 600, the patient may complete three (3) memory task exercises (such as EFMT) and three (3) psychological treatment courses (such as CBT). Thus, during a six week treatment period, the patient may complete 18 EFMT exercises and 18 CBT courses. In addition, messages (such as SMS messages) may be delivered during each day of the six-week treatment period. Those of ordinary skill in the art will recognize that the details of the treatment schedule may vary from patient to patient, and that treatment schedule 600 represents one example. Different frequencies of EFMT exercises, CBT lessons, and/or messages may be implemented through the treatment schedule. In some embodiments, the HCP or provider of the DTx 100 may generate a treatment schedule for the patient. In some embodiments, one or more pre-generated treatment schedules may be used as a treatment schedule for a patient (such as using a treatment schedule generated for a patient having similar patient characteristics as another patient), or as a basis for creating a new treatment schedule for a patient (such as by modifying one or more aspects of an existing treatment schedule).

The treatment schedule 600 may be designed to deliver therapy content 102 to a patient via the DTx 100. As shown in fig. 6, the treatment schedule 600 may include six weeks of treatment period, but the treatment period may be shortened or lengthened depending on the patient's response to the treatment. The treatment schedule 600 may be prescribed by the patient's HCP or recommended by the provider of the DTx 100. Furthermore, the treatment schedule may be adjusted as the therapy content is delivered to the patient. For example, one or more additional mental therapy courses may be added to the current treatment schedule, the frequency of providing messages to the patient may be increased or decreased, and so forth. In some embodiments, parameters regarding the therapy content included within the treatment schedule may be adjusted during the duration of the treatment schedule. For example, color schemes, word lists, content types, character movement speed, etc. may be adjusted based on input from the HCP, feedback provided from the patient, performance metrics that measure the effectiveness of the treatment, or based on other measurements or combinations thereof.

During each week of treatment schedule 600, the patient may complete 3 memory task exercises (such as EFMT) and 3 psychotherapy courses (such as CBT). Thus, at the end of the six week treatment period, the patient may complete 18 EFMT exercises and 18 CBT courses. The 18 EFMT exercises are shown in fig. 6 as EFMT 1, EFMT 2, EFMT 3, EFMT 4, EFMT 5, EFMT 6, EFMT 7, EFMT 8, EFMT9, EFMT 10, EFMT 11, EFMT 12, EFMT 13, EFMT 14, EFMT 15, EFMT 16, EFMT 17 and EFMT 18. The 18 CBT courses are reflected in table 1 above and are shown in fig. 6 as CBT 1, CBT 2, CBT 3, CBT 4, CBT 5, CBT 6, CBT 7, CBT 8, CBT 9, CBT 10, CBT 11, CBT 12, CBT 13, CBT 14, CBT 15, CBT 16, CBT 17 and CBT 18. In addition to EFMT exercises and CBT lessons, messages (such as SMS messages) may be delivered during each day of the six week treatment period in treatment schedule 600.

Although not shown in fig. 6, therapy context 102 may be provided as an adjunct by DTx 100, other types of treatment such as antidepressant therapy (ADT), which may include serotonin reuptake inhibitors (SSRI), serotonin and Norepinephrine Reuptake Inhibitors (SNRI), and Norepinephrine and Dopamine Reuptake Inhibitors (NDRI). ADT may be prescribed by the patient's HCP according to a separate treatment schedule.

As shown in the example of treatment schedule 600, EFMT exercises and CBT lessons may be completed on alternate days of the week. For example, CBT lessons may be completed on monday, wednesday and friday, and EFMT exercises may be completed on tuesday, wednesday and friday, but it should be appreciated that the therapy content 102 may be arranged in any suitable order. For example, CBT lessons may be done on monday, thursday and friday, and EFMT exercises may be done on monday, friday and friday. One or more of the EFMT exercises and CBT lessons may also be completed on the same day. Additionally, while the treatment schedule 600 depicted in fig. 6 may not include any EFMT exercises or CBT courses scheduled for the weekdays, it should also be appreciated that such "rest" days may be any day of the week (such as monday through wednesday) while still allowing the EFMT exercises and CBT courses to be completed on alternate days of the week. For example, CBT courses may be completed on tuesday, thursday, and Saturday, and EFMT courses may be completed on tuesday, friday, and sunday, leaving monday as the "rest" day. In other embodiments, the "rest" day may change weekly over the course of a six week treatment period. Still further, some embodiments may include enabling the patient to perform certain exercises and/or courses at various points throughout the treatment schedule. For example, even if different psychological treatment courses are scheduled or no psychological treatment courses occur on that particular day, the patient can access any point in the anchor course and the overall treatment schedule 600.

Each exercise in EFMT 1-18 may have a predetermined duration (such as about 30 minutes). The emoticons displayed in EFMT 1-18 may be the same or may be exercise specific. In addition, the emotional intensity of the emoticons displayed in EFMT 1-18 may be the same or may be different from exercise to exercise. By varying the emotional intensity of the emoticons and/or the displayed emoticons, the difficulty level of the exercise in EFMT 1-18 may be increased or decreased during a six week treatment period. For example, as a patient progresses in treatment and is able to provide a predetermined number of correct responses, exercises in EFMT 1-18 may become progressively more challenging (such as by reducing the emotional intensity of the displayed emoticons). Conversely, if the patient is unable to provide a predetermined number of correct responses during the exercise, the exercise in EFMT 1-18 may become less challenging (such as by increasing the emotional intensity of the displayed emoticons). In other embodiments, the difficulty level may vary (such as increase and decrease) throughout the treatment schedule 600, depending on the patient's performance at any given time during the six week treatment period.

To select a different image to be used in a given EFMT, DTx 100 may filter the image based on an intensity tag indicating the emotional intensity level of the corresponding image. For example, an image marked as being related to a first emotion (such as anger) and having a less than first emotion intensity level (such as less than emotion intensity level 3) may be identified from some or all of the available emoji images. In some embodiments, the HCP may enter a script, enter a value into a database search field, or use another selection mechanism to select emotion and/or emotion intensity levels to be included within a given EFMT. The HCP may be returned a list of results that meet its search criteria, and may select some or all of the images included in the results for use in creating the EFMT. In some embodiments, the EFMT creation process may be automated such that filtering and selection of images from results is performed automatically. In such a scenario, the HCP or other provider of the DTx 100 may be able to subsequently modify and/or curate (curate) the selected image.

Additionally or alternatively, to change the emoticons and their associated emotional intensity, the difficulty level of the exercise in EFMT 1-18 may be adjusted by changing the number of N images back that may require the patient to recall. That is, the difficulty level of exercises in EFMT 1-18 can be increased by increasing the integer N and decreased by decreasing the integer N. Similar to the above-described techniques in which the emotion and/or emotion intensity level of an image may be selected, the value of the integer N may also be selected/modified by the HCP and/or provider of the DTx 100. As with the adjustment of the emotional intensity of the displayed emoticons, the integer N may be adjusted based on the patient's performance during treatment. For example, the integer N may be increased if the number of correct responses of the patient exceeds a predetermined threshold, or the integer N may be decreased if the number of correct responses is below a predetermined threshold. The integer N may be modified by the HCP entering the value of the integer N into a GUI on its computing device, which may generate and transmit instructions to the DTx 100 to set a new value of the integer N. Thus, the integer N may be used to maintain a difficulty level that is best suited for the patient's ability at a given time during the treatment schedule 600.

Each course in CBTs 1-18 may have a predetermined duration (such as about 3-5 minutes) and may include animated video. Course content in CBTs 1-18 may vary from course to course during treatment schedule 600, but as discussed further below, the patient may select and/or the patient's HCP may suggest that the patient re-attend the corresponding CBT course one or more times. Although the course content in CBTs 1-18 may be different, the courses in CBTs 1-18 may be grouped into subsets to provide therapeutic intervention according to certain psychotherapy principles, including emotion modulation (ER), behavioural Activation (BA), and Cognitive Reconstruction (CR). For example, as shown in Table 1 and FIG. 6 above, courses in CBT 1-3 and 10-12 may be grouped to provide therapeutic intervention through ER. Courses in CBTs 4-6 and 13-15 may be grouped to provide therapeutic intervention via BA. Courses in CBTs 7-9 and 16-18 may be grouped to provide therapeutic intervention through CR.

In addition to grouping courses in CBTs 1-18 according to ER, BA, and CR, treatment schedule 600 may be configured to deliver courses in CBTs 1-18 in a corresponding order to optimize the manner in which patient receives therapy content 102, resulting in better treatment results. For example, as shown in FIG. 6, the patient may complete a course in CBT 1-3 (ER) during cycle 1. Courses in CBT 4-6 (BA) may be completed during cycle 2. Courses in CBT 7-9 (CR) may be completed during cycle 3. Courses in CBT 10-12 (ER) may be completed during cycle 4. Courses in CBT 13-16 (BA) may be completed during cycle 5. Courses in CBT 16-18 (CR) may be completed during cycle 6. The particular order in which CBT lessons are selected may be related to the particular EFMT exercise selected, with the purpose of the EFMT exercise repairing a particular neural circuit, and the CBT lessons strengthening the repaired neural circuit. While a particular configuration of treatment schedule 600 is described above, alternative arrangements of physiological treatment courses may be used.

Thus, treatment schedule 600 may be configured to introduce the patient's principles of ER during week 1, which may teach the patient how to experience painful emotions, such as sadness, anger, or despair, without being phagocytosed by these emotions and without acting in a deleterious manner. Courses in CBT 1-3 (ER) can provide strategies for patients, including positive ideas and feelings, tolerating difficult emotions, and self-pacifying skills.

During week 2, treatment schedule 600 may be configured to introduce the principles of BA. That is, the lessons in CBT 4-6 (BA) may be directed to patterns in which the patient may avoid or deviate from healthy activity or behavior. The courses in CBT 4-6 (BA) may provide the patient with tasks or "action calls" aimed at helping the patient to re-participate in such activities and behaviors.

During week 3, the treatment schedule 600 may be configured to introduce a principle of CR, which may be directed to the patient's negative perspective on self, world, and/or future. Thus, courses in CBT 7-9 (CR) may provide a cognitive tool for patients to identify and systematically assess the accuracy and effectiveness of such negative ideas. Courses in CBT 7-9 (CR) may help patients challenge and reconstruct ideas to reduce inadaptation.

The sequence of ER, BA and CR courses may be repeated during weeks 4-6 of treatment schedule 600. For example, courses in CBT 10-12 (ER), CBT 13-15 (BA), and CBT 16-18 (CR) may be completed during cycles 4, 5, and 6, respectively. Although the principles of ER, BA and CR may be repeated, the specific content of the courses in CBT 10-12 (ER), CBT 13-15 (BA) and CBT 16-18 (CR) may be different from the content delivered between cycles 1-3. For example, as the patient progresses to weeks 1-3 of treatment schedule 600, the patient may become more adept at practicing the skills and principles associated with ER, BA, and CR. Thus, during weeks 4-6, courses in CBT 10-12 (ER), CBT 13-15 (BA), and CBT 16-18 (CR) may be configured to provide more advanced strategies that enhance previous learning and/or convey additional (such as more complex) mechanisms and skills for alleviating symptoms of depression in patients.

In addition to completing exercises in EFMT 1-18 and/or courses in CBT 1-18, DTx 100 may be configured to provide a menu option to the patient for selecting one or more courses in CBT 1-18 during treatment schedule 600. The menu options may be configured to allow the patient to re-attend the course previously completed in CBT 1-18, which may help strengthen previous learning and/or provide the patient with additional opportunities to master the taught strategies and skills. For example, after completing a course in CBT 1 on monday of the first week, the patient may be able to re-attend the course in CBT 1 at any of the remaining times of treatment schedule 600. However, the menu options may not allow the patient to participate in other courses before the course according to treatment schedule 600 has been completed. Thus, menu options may not provide the patient with an opportunity to access courses in CBT 9 until such time as the course is completed on the fourth week. In some embodiments, the menu options may be presented to the patient via a UI rendered via the patient's computing device.

As part of the treatment schedule 600, messages may be periodically generated and delivered to the patient. Messages may be selected to enhance the principles in the lessons in CBT 1-18 and may be synchronized with the patient's progress. The messaging 108 may facilitate delivery of messages to the patient at any desired interval, such as 0-4 messages per day. The message may also include a reminder to the patient to complete the exercise in EFMT 1-18 and/or the lesson in CBT 1-18. The message may also be configured to acknowledge the difficulty or utility of completing the exercise in EFMT 1-18 and/or the lesson in CBT 1-18 to facilitate patient participation and motivation. The messaging 108 may be personalized based on the patient's activities, compliance, and/or performance during the treatment schedule 600. In some embodiments, the message may be rendered within a UI of a mobile application executing on the patient's computing device. The message may be displayed when the patient invokes a mobile application (such as DTx 100) and or alternatively at specific time intervals. For example, the message may be displayed at one or more particular times of the day. In some cases, a notification (such as a "pop-up window") may be displayed that reflects some or all of the message or a segment/summary of the message.

Exemplary System and computing device

Fig. 7 is a diagram of a system 700 for treating depression via DTx 100, in accordance with various embodiments. The system 700 may include a user device 710, an application server 720, and a network 730. The user device 710 may submit a request 712 for therapy content 102 from the application server 720. The request 712 may include, for example, an indication that the user of the user device 710 accesses a website or portal hosted by the application server 210 (or other server) and requests that therapy content be downloaded to the user device 710. For example, the request 712 may include a MAC identifier, an IP address, a user/patient identifier, or other identifier for identifying the patient (such as the operator of the user device 710). As described herein, user device 710 may be interchangeably referred to as a "computing device". The user device 710 may receive a message, such as an SMS message or an email message, with a hyperlink referencing a network location of the application server 720 for storing the therapy content 102. The user device 710 may receive a selection of a hyperlink from a user. In response to selection of the hyperlink, the user device 710 may transmit a request 712 for downloading therapy content 102 via the network 730.

In response to the request 712, the application server 720 may provide data 722, which may include the therapy content 102. Upon receiving the data 722, the user device 710 may render or display the therapy content 102 according to a treatment schedule configured to alleviate one or more MDD symptoms that the user may be experiencing. In other embodiments, therapy content 102 may be rendered from application server 720 to user device 710 via network 730.

Fig. 8 is a diagram of exemplary system components of a device for treating depression via DTx 100, in accordance with various embodiments. Computing device 800 is intended to represent various forms of digital computers, such as laptops, desktops, workstations, personal digital assistants, servers, blade servers, mainframes, and other appropriate computers. Computing device 650 is intended to represent various forms of mobile devices, such as personal digital assistants, cellular telephones, smartphones, and other similar computing devices. In addition, computing device 800 or 650 may include a Universal Serial Bus (USB) flash drive. The USB flash drive may store an operating system and other applications. The USB flash drive may include an input/output component, such as a wireless transmitter or USB connector that may be plugged into a USB port of another computing device. The components shown here, their connections and relationships, and their functions, are meant to be examples only, and are not meant to limit implementations of the inventions described and/or claimed in this document.

Computing device 800 includes a processor 602, memory 604, storage 606, a high-speed interface 608 connected to memory 604 and high-speed expansion ports 610, and a low-speed interface 612 connected to low-speed expansion ports 614, and storage 606. Each of the components 602, 604, 606, 608, 610, and 612 are interconnected using various buses, and may be mounted on a common motherboard or in other manners as appropriate.

The processor 602 may process instructions for execution within the computing device 800, including instructions stored in the memory 604 or on the storage device 606, to display graphical information for a GUI on an external input/output device, such as a display 616 coupled to the high-speed interface 608. In other embodiments, multiple processors and/or multiple buses, as well as multiple memories and memory types may be used, as appropriate. In addition, multiple instances of computing device 800 may be connected, with each device providing portions of the necessary operations, such as a server bank, a set of blade servers, or a multiprocessor system. In addition, the processor 652 may include multiple instances of a processor or collection of processors.

Memory 604 may store information within computing device 800. In some embodiments, memory 604 is one or more volatile memory units. In another implementation, the memory 604 is one or more non-volatile memory units. Memory 604 may also be another form of computer-readable medium, such as a magnetic or optical disk.

The storage device 606 is capable of providing mass storage for the computing device 800. In some embodiments, storage device 606 may be or contain a computer-readable medium, such as a floppy disk device, a hard disk device, an optical disk device, or a tape device, a flash memory or other similar solid state memory device, or an array of devices, including devices in a storage area network or other configurations. The computer program product may be tangibly embodied in an information carrier. The computer program product may also contain instructions that, when executed, perform one or more methods, such as those described above. The information carrier is a computer-or machine-readable medium, such as the memory 604, the storage device 606, or memory on processor 602.

The high-speed interface 608 may manage bandwidth-intensive operations of the computing device 800, while the low-speed interface 612 may manage lower bandwidth-intensive operations. This allocation of functions is merely an example. In some embodiments, the high-speed interface 608 may be coupled to the memory 604, the display 616, such as through a graphics processor or accelerator, and to a high-speed expansion port 610 that may accept various expansion cards (not shown). In some embodiments, low-speed interface 612 may be coupled to storage 606 and low-speed expansion port 614. The low-speed expansion port 614, which may include various communication ports, such as USB, bluetooth, ethernet, and/or wireless ethernet, may be coupled to one or more input/output devices, such as a keyboard, a pointing device, a microphone/speaker pair, a scanner, and/or a networking device, such as a switch or router, for example, through a network adapter. Computing device 800 may be implemented in a number of different forms, as shown in the figures. For example, computing device 800 may be implemented as standard server 620, or multiple times in a group of such servers. Computing device 800 may also be implemented as part of a rack application server 624. Furthermore, computing device 800 may be implemented in a personal computer such as a laptop computer 622. Alternatively, components from computing device 800 may be combined with other components in a mobile device (not shown), such as device 650. Each of such devices may contain one or more of computing device 800, 650, and the entire system may be made up of multiple computing devices 800, 650 communicating with each other.

Computing device 800 may be implemented in a number of different forms, as shown in the figures. For example, computing device 800 may be implemented as standard server 620, or multiple times in a group of such servers. Computing device 800 may also be implemented as part of a rack application server 624. In addition, the computing device 800 may be implemented in a personal computer such as a laptop computer 622. Alternatively, components from computing device 800 may be combined with other components in a mobile device (not shown), such as device 650. Each of such devices may contain one or more of computing device 800, 650, and the entire system may be made up of multiple computing devices 800, 650 communicating with each other.

Computing device 650 may include a processor 652, a memory 664, and input/output devices, such as a display 654, a communication interface 666, and a transceiver 668, among other components. The computing device 650 may also be equipped with a storage device, such as a microdrive or other device, to provide additional storage. Each of the components 650, 652, 664, 654, 666, and 668, can be interconnected using various buses, and several of the components can be mounted on a common motherboard or in other manners as appropriate. As described herein, a single instance of certain components of computing devices 800, 650 may be depicted in fig. 8, but it should be understood that additional instances of such components may be implemented and that the use of a single instance of a component is merely to ensure that the components are not confused.

The processor 652 may execute instructions within the computing device 650, including instructions stored in the memory 664. Processor 652 may be implemented as a chipset that includes separate multiple analog and digital processors. In addition, processor 652 may be implemented using any of a variety of architectures. For example, the processor 652 may be a CISC (complex instruction set computer) processor, a RISC (reduced instruction set computer) processor, or a MISC (minimum instruction set computer) processor. Processor 652 may provide, for example, for coordination of the other components of device 650, such as control of user interfaces, applications run by device 650, and wireless communication by device 650. In addition, the processor 652 may include multiple instances of a processor or collection of processors.

The processor 652 may communicate with a user through a control interface 658 and a display interface 656 coupled to a display 654. The display 654 may be, for example, a TFT (thin film transistor liquid crystal display) display or an OLED (organic light emitting diode) display or other suitable display technology. The display interface 656 may include appropriate circuitry for driving the display 654 to present graphics and other information to a user, such as a UI for rendering a mobile application including the therapy content 102 of the DTx 100. The control interface 658 may receive commands from a user and convert them for submission to the processor 652. Further, an external interface 662 may be provided in communication with the processor 652 to enable near area communication of the computing device 650 with other devices. External interface 662 may provide, for example, for wired communication in some embodiments, or for wireless communication in other embodiments, and multiple interfaces may also be used.

The memory 664 can store information within the computing device 650. The memory 664 may be implemented as one or more of one or more computer-readable media, one or more volatile memory units, or one or more non-volatile memory units. Expansion memory 674 may also be provided and connected to computing device 650 via expansion interface 672, which expansion interface 672 may include, for example, a SIMM (Single in line memory Module) card interface. Such expansion memory 674 may provide additional storage space for computing device 650 or may also store applications or other information for computing device 650. Specifically, expansion memory 674 may include instructions for performing or supplementing the processes described above, and may include secure information. Thus, for example, expansion memory 674 may be provided as a security module for computing device 650, and may be programmed with instructions that allow secure use of computing device 650. Further, secure applications may be provided via the SIMM card, as well as additional information, such as placing identifying information on the SIMM card in an indestructible manner.

The memory may include, for example, flash memory and/or NVRAM memory, as discussed below. In some embodiments, the computer program product is tangibly embodied in an information carrier. The computer program product contains instructions that, when executed, perform one or more methods, such as those described above. The information carrier is a computer-or machine-readable medium, such as the memory 664, expansion memory 674, or memory on processor 652, which may be received by transceiver 668 or external interface 662.

Computing device 650 may communicate wirelessly through communication interface 666, which communication interface 666 may include digital signal processing circuitry as necessary. Communication interface 666 may provide for communication under various modes or protocols, such as GSM voice calls, SMS, EMS, or MMS messaging, CDMA, TDMA, PDC, WCDMA, CDMA2000, or GPRS, among others. Such communication may occur, for example, through radio frequency transceiver 668. In addition, short-range communications may be performed, such as using Bluetooth, wi-Fi, or other such transceivers (not shown). In addition, a GPS (Global positioning System) receiver module 670 may provide additional navigation-and location-related wireless data to computing device 650, which may be used as appropriate by applications running on computing device 650.

The computing device 650 may also communicate audibly using an audio codec 660, the audio codec 660 may receive voice information from a user and convert it to usable digital information. The audio codec 660 may likewise generate audible sound for a user, such as through a speaker in a handset of the computing device 650. Such sound may include sound from voice telephone calls, may include recorded sound such as voice messages, music files, and the like, and may also include sound generated by applications operating on computing device 650.

The computing device 650 may be implemented in a number of different forms, as shown in the figures. For example, it may be implemented as a cellular telephone 680. It may also be implemented as part of a smart phone 682, personal digital assistant, or other similar mobile device.

Various implementations of the systems and methods described herein may be implemented in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations of such implementations. These various embodiments may include embodiments in one or more computer programs executable and/or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.

These computer programs (also known as programs, software applications or code) include machine instructions for a programmable processor, and may be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language. As used herein, the terms "machine-readable medium," computer-readable medium "and/or" computer program product, apparatus and/or device, such as magnetic disks, optical disks, memory, programmable Logic Devices (PLDs), used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term "machine-readable signal" refers to any signal used to provide machine instructions and/or data to a programmable processor.

To provide for interaction with a user, the systems and techniques described here can be implemented on a computer having a display device such as a CRT (cathode ray tube) or LCD (liquid crystal display) monitor for displaying information to the user and a keyboard and a pointing device such as a mouse or a trackball by which the user can provide input to the computer. Other types of devices may also be used to provide for interaction with a user; for example, feedback provided to the user may be any form of sensory feedback, such as visual feedback, auditory feedback, or tactile feedback; input from the user may be received in any form, including acoustic, speech, or tactile input.

The systems and techniques described here can be implemented in a computing system that includes a back-end component, such as a data server, or that includes a middleware component, such as an application server, or that includes a front-end component, such as a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the systems and techniques described here, or any combination of such back-end, middleware, or front-end components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network ("LAN"), a wide area network ("WAN"), and the Internet.

The computing system may include clients and servers. The client and server are typically remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.

Example 1

Protocol header

A multicenter, randomized, control trial aimed at assessing the effectiveness of digital therapy (CT-152) as an adjunct therapy to adult subjects diagnosed with Major Depressive Disorder (MDD).

CT-152

CT-152 is a digital therapy that provides interactive, software-based, cognitive, affective and behavioral therapies. Components of CT-152 include Emotion Facial Memory Task (EFMT), cognitive Behavioral Therapy (CBT) based psychotherapy lessons, and Short Message Service (SMS) text messaging. EFMT and psychotherapy courses will be completed 3 times per week within 6 weeks. A text message was sent during the 6 week treatment period.

Reasons for the test

One test aimed at testing CT-152 against sham in a randomized control test of sufficient sample size of subjects diagnosed with MDD and undergoing anti-depressant therapy (ADT) monotherapy. The trial will provide data on the efficacy and safety of the software therapy.

Test targets and endpoints

The main object is: CT-152 was compared to sham for effectiveness in adult subjects diagnosed with MDD and undergoing ADT monotherapy.

The main curative effect end point: the Montgomery-Arabidopsis depression rating scale (MADRS) total score varies from baseline to week 6. The persistence of the effect will include 3 MADRS assessments at weeks 6, 8 and 10. In addition to the least clinically significant difference (MCID) group differences of 1.6 to 1.9, which demonstrated statistical significance at week 6, persistence will also be demonstrated by estimating points of baseline variation differences above 1.6 at weeks 8 and 10 when comparing CT-152 with sham groups.

Key adjuvant efficacy endpoint: general anxiety disorder-7 (GAD-7) score varied from baseline to week 6. Based on the persistence of GAD-7, which will include 3 assessments at weeks 6, 8 and 10, a greater improvement in the point estimate of the difference in total GAD-7 score from baseline change at weeks 8 and 10 in CT-152 compared to the sham group was demonstrated.

Other efficacy endpoints: total MADRS score change from baseline to week 2 and week 4; change in GAD-7 total score from baseline to week 2 and week 4; MADRS response rate at weeks 2, 4 and 6 (> 50% decrease from baseline); clinical global impression-severity (CGI-S) score change from baseline to weeks 2, 4 and 6; change from baseline to week 6 in world health organization disability assessment table (WHODAS) 2.0 total score; patient health questionnaire-9 (PHQ-9) total score changed from screening to week 4 and week 6; partial MADRS response at weeks 2, 4 and 6 (MADRS score decrease from baseline by > 30% and < 50%); MADRS response rate at week 8 and week 10 (all or part, defined as a decrease in MADRS total score of > 30% from baseline).

Exploratory endpoint: remission rates at weeks 2, 4 and 6 (MADRS score. Ltoreq.10 and MADRS decrease. Gtoreq.50% from baseline); satisfaction measured by subject and Health Care Professional (HCP) satisfaction metrics; health status as measured by EuroQol 5-dimensional, 5-level (EQ-5D-5L).

Security objective: CT-152 was evaluated for safety in adult subjects diagnosed with MDD and undergoing ADT monotherapy.

Safety endpoint: frequency and severity of Adverse Events (AEs), severe AEs, and test aborts due to AEs.

Test design

A multicenter, randomized, control trial aimed at assessing the effectiveness of CT-152 in adult subjects diagnosed with MDD and being treated for depression with ADT monotherapy. The subjects will participate in the trial for up to 13 weeks. The trial will include a screening period of up to 3 weeks, a treatment period of 6 weeks and an extension period of 4 weeks. Eligible subjects will be randomly assigned to 1 of the 2 digital mobile applications (CT-152 or sham) on the first day.

To alleviate the subject's expectations, the subject in the trial will be blinded to the efficacy hypothesis. The test site staff will inform the eligible subjects: a) They will take part in a trial for up to 13 weeks and will receive one of two digital therapy treatments at random; and b) the purpose of the test is to compare the effectiveness of two digital therapy treatments when used in combination with ADT. Both treatments would be considered likely to contribute to the improvement of MDD. No CT-152 or sham group is mentioned for the subject. At the end of the subject participation trial, and after completion of all final visit procedures, the trial site staff will inform the subject of the trial hypothesis, in other words, assuming that a digital therapy is more beneficial for improving symptoms of depression, but needs to be confirmed by the trial. A situation reporting guideline will be provided to the test site staff to assist in this discussion with the subject.

The test site personnel will implement the program on each visit by telephone or by remote access via telemedicine techniques. The screening visit may be performed at the discretion of the researcher. If security issues/concerns need to be assessed, the test site may be accessed by itself or remotely at any time.

Remote access will be made using a sponsor-specified telemedicine platform using a portal accessible to test site staff, and the subject will be required to download a mobile application (separate from the research digital mobile application) in order to agree to the test and complete the test evaluation, including a self-administered scale.

Prior to downloading the mobile application for telemedicine access, the subject is required to agree to participate in the registration and agree to the terms of service required for his privacy policy and for collecting subject information (including identity verification) within the telemedicine platform. The subject will need to remotely complete the identity verification process before he can electronically sign the test consent to comply with the 21 federal regulation (CFR) part 11 electronic signature requirements. See site operation manual for details.

The screening period was started after informed consent was obtained. A subject meeting the admission criteria in a screening visit will download the digital mobile application on his smart phone and gain access to the job entry (onboard) software module. The call center may assist in downloading digital mobile applications. During the screening period, the subject will be familiar with the software. The subject's understanding and interest in the trial will be demonstrated by adequate compliance with the job-in requirements. The investigator will evaluate this by confirmation with the subject and task completion of the subject over a span of 7 consecutive days during the designated 3 week screening window.

After a screening visit, the subjects will be considered eligible based on: (1) Subject compliance and performance of the on-duty software module (defined as 3 example sessions completed during 7 consecutive days of the 3 week screening period, and difficulty level of achieving cognitive control tasks in the third session ≡2). (2) All inclusion and non-exclusion criteria based on the investigator evaluation were continued to be met.

On the first day, eligible subjects will be randomly assigned (CT-152 or sham) at a 1:1 ratio at approximately 50 test sites. The upper sample size limit for any single test site was about 15% of the total number of subjects randomly enrolled in the test. Randomization will be layered by test site.

During the treatment period (day 1 [ baseline ] to week 6), subjects will have remote access at weeks 2, 4 and 6 and will be contacted by telephone at weeks 1, 3 and 5 through the test site. It is expected that the subject should adhere to his digital mobile application exercises during the treatment period.

After week 6, the subject will continue to participate in the trial during an extended period (weeks 7 to 10). During the extension period, each group will still install a digital mobile application. The subject will receive a brief Short Message Service (SMS) message prompting the subject to previously complete the CT-152 or sham course of treatment (see the "trial treatment" section below for more details) and will continue their ADT. The subjects will have remote access at weeks 8 and 10 and the test site will be contacted with the subjects by telephone at weeks 7 and 9.

The experiment will end at week 10.

During the treatment and extended periods, blind independent expert clinical evaluators from centralized suppliers, who would not otherwise interact with the subject, would remotely rate and record the montgomery-asberg depression rating scale (MADRS) by telephone while still remaining blinded to treatment assignments and other clinical information. This may be done separately from the remote test site access, but must be performed within the window described in the evaluation schedule.

The clinical global impression-severity (CGI-S) scale will be completed by designated test site personnel upon remote access during the treatment session. Other evaluations performed during the trial included generalized anxiety disorder-7 (GAD-7), world health organization disability assessment Table (WHODAS) 2.0, patient health questionnaire-9 (PHQ-9), subject and Health Care Professional (HCP) satisfaction scales, and EuroQol 5-dimension, 5-grade (EQ-5D-5L).

During the trial, the trial site staff will also administer the columbia suicide severity rating scale (C-SSRS), review the subject's compliance with the course of treatment during the treatment period, confirm the subject's compliance with the current ADT, and evaluate Adverse Events (AEs) and concomitant medications.

Test crowd

The trial will recruit male or female subjects aged 22 to 64 years with informed consent, who are currently initially diagnosed as MDD based on criteria in the "manual for diagnosis and statistics of mental diseases" fifth edition (DSM-5), single or recurrent episodes, without psychotic features and do not meet MDD criteria with mixed feature subtypes, and are receiving ADT monotherapy. If other allowable psychiatric diagnoses are present, they cannot be considered as primary diagnoses (more painful or damaging than MDD).

Critical inclusion/exclusion criteria

In addition to the criteria mentioned in the above test population, key inclusion criteria are as follows:

the subject must currently be in major depressive episode as defined by the DSM-5 standard and confirmed by a small international neuropsychiatric interview (MINI) and adequate clinical psychiatric assessment.

The Hamiltonian depression scale 17 item (HAM-D17) score at screening and baseline visit (day 1) was ≡18.

The subject must have a history of reported current episodes of inadequate response to their current monotherapy ADT. Current ADT treatment must have sufficient dose and duration to be defined as the lowest therapy dose (or higher dose) for at least 6 weeks according to the total hospital antidepressant therapy response questionnaire (MGH-ATRQ) in ma, which is performed at screening. Insufficient response was defined as a <50% reduction in severity of depressive symptoms according to MGH-ATRQ. In addition, subjects must receive a stable dose of their current monotherapy ADT at least 4 weeks prior to baseline (day 1).

Subjects willing to maintain a current dose of ADT treatment during their participation in the trial.

As the only user of an iPhone with an IPhone Operating System (iOS) 13.0 or higher capability or a smartphone with an Android Operating System (OS) 9.0 or higher capability, and agree to the subject to download and use the digital mobile application as required by the protocol.

Researchers believe that no additional drug intervention is required in subjects during the course of the depression treatment trial.

Subjects who successfully completed the incumbent software module in the digital mobile application during the screening period.

Subjects who underwent participation in the trial and were judged to understand the use of the digital mobile application at baseline visit (day 1) continued.

The key exclusion criteria were as follows:

subjects with inadequate response to >1 full ADT trial with current onset are reported. According to MGH-ATRQ, a sufficient trial is defined as the minimum therapeutic dose (or higher dose) for at least 6 weeks. Insufficient response was defined as a <50% reduction in severity of depressive symptoms according to MGH-ATRQ.

Subjects who have received psychotropic drug potentiation therapy (such as lithium, triiodothyronine or antipsychotics added to ADT, multiple ADT) for depression in the past or at the time of their current onset. If the clinical opinion of the researcher deems that the subjects did not receive adequate trials for the enhanced agent, then the inclusion of these subjects may be considered after discussion and approval by the medical monitor.

Subjects currently undergoing psychotherapy or who received psychotherapy within 90 days prior to screening.

Subjects who failed to respond to sufficient course of cognitive behavioral therapy (8 weeks or more) at any time in the past.

Suicide propensity assessment: subjects who responded "yes" to C-SSRS suicide item 4 (active suicide with some intent of action, no specific plan) within the last 12 months before screening or at baseline visit (day 1), subjects who responded "yes" to C-SSRS suicide item 5 (active suicide with specific plan and intent) within the last 12 months before screening or at baseline visit (day 1), or subjects who responded "yes" to any of the 5C-SSRS suicide items (actual attempt, discontinued attempt, preparatory action or suicide) within the last 24 months before screening or at baseline visit (day 1), or subjects who the researcher believes there is a serious suicide risk.

Subjects who have been treated for depression at any time in the past with electroconvulsive therapy or neuromodulation devices (transcranial magnetic stimulation, vagal stimulation, or transcranial direct current stimulation, etc.).

Subjects who have received ketamine, esketamine, or alcaline for treatment of depression have been treated at any time in the past.

Computer, web or smartphone software-based applications or equivalent applications are currently being used to treat subjects with mental health or depression. Subjects who agree to discontinue use at the time of screening will be allowed to enter the trial.

Subjects currently diagnosed with substance or alcohol usage disorders (excluding nicotine) according to DSM-5 within 6 months prior to screening visit.

Subjects with current major depressive episodes lasting for more than 2 years.

Subjects considered resistant/refractory to treatment were judged by medical history and researchers.

As assessed by m.i.n.i., for lifetime diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorder or bipolar I/II disorder, or presently post-traumatic stress disorder, panic disorder or obsessive-compulsive disorder.

Currently assessed by m.i.n.i. and considered primary (more painful or damaging than MDD) generalized anxiety disorder or social anxiety disorder.

Subjects diagnosed with any DSM-5 personality disorder during mental assessment and/or based on medical record assessment by the researcher.

Depression due to general health or neurological diseases.

A history of epilepsy other than a fully resolved single childhood febrile convulsion.

Subjects who may require concomitant therapy for inhibition during the trial.

Trial treatment, duration of treatment, mode of administration

Subjects who meet all initial inclusion criteria and do not meet any exclusion criteria at the time of screening will download the digital mobile application and install it on their own smart phone device that they will use for testing. A specialized call center may facilitate the initial download and access of digital mobile applications. Researchers will confirm the subject's understanding and interest in the trial by fully following the break-in job requirements in the job software module over a span of 7 consecutive days during the 3-week screening period (day 21 to day 1).

The incumbent software module will provide an example cognitive control task session. The content of these example sessions would not include therapy content in order to minimize bias after subjects were randomly assigned to 1 of the 2 groups (CT-152 or sham groups).

At baseline access (first day), successful use of the incumbent software module will be confirmed. CT-152 or dummy group will be activated in the digital mobile application during baseline access using the access code.

CT-152 delivers software-based interactive interventions including cognitive emotion training, psychotherapy lessons, psychotherapy messages, and participation messages. Each treatment session will include Emotion Facial Memory Task (EFMT) exercises and psychological treatment courses. The sham group will be used as a control.

The sham group will provide a cognitive training exercise designed to maintain the interests of the user while minimizing any effects of the therapy. Each treatment session will include a Shape Memory Task (SMT) exercise. It will present a similar structure to the user matching the time and attention of the cognitive emotion training exercises in CT-152. In order to preserve the expected placebo properties of the sham group, it does not contain EFMT or psychotherapy content.

The subjects will participate in the trial for up to 13 weeks. This includes screening periods of up to 3 weeks; at least 7 consecutive days are required for screening due to job compliance requirements. If desired by the researcher, the screening period may be permitted to be extended after discussion and approval by the medical monitor.

Once the baseline visit is completed, the intervention will begin on the same day as the baseline visit. The subjects will complete a treatment schedule of 18 sessions (about 30-45 minutes) at a rate of 3 sessions per week over a 6 week treatment period (day 1 [ baseline ] to week 6).

After week 6, the subject will continue to participate in the trial during an extended period (weeks 7 to 10). During the extension period, each group will still install digital mobile applications, EFMT and SMT are no longer available. The previously provided psychotherapy content was still available for selective reference by the CT-152 group, but no new therapy content was introduced, nor was there a desired treatment schedule. Both groups will receive a brief SMS message over an extended period of time reminding the subject of the previously completed CT-152 and sham course of treatment.

A specialized call center may provide support for subjects and experimental sites over any technical issues related to the digital mobile application throughout the experiment, as well as initial download and access of the digital mobile application.

In the case of any technical problem with digital mobile applications, the subject must contact the call center under the direction of the researcher. All telephones placed to the call center will be recorded and processed. The basic user technical problem is to be solved by a call center.

If the subject contacts the call center for AE, the call center will record the call and immediately provide this information to the test site and sponsor or sponsor's designated personnel for subsequent processing.

If the subject contacts the call center for a possible or suspected Product Quality Complaint (PQC), the call center will record the call. All call records (tickets) captured by the call center will be provided to the Click Therapeutics quality team for PQC analysis, tracking and resolution.

If the subject reports a possible or suspected PQC to a researcher or prescribing personnel during remote access or telephone contact, the researcher or prescribing personnel should immediately contact a call center, which will record the call and immediately provide information to the Click Therapeutics quality team.

In addition to call tracking, calls may also be recorded for quality purposes with respect to a call center. Call center contact information and procedures are detailed in the site operating manual.

Test evaluation

Efficacy evaluation: MADRS, GAD-7, CGI-S, WHODAS 2.0.0 and PHQ-9.

Security assessment: AE (including AEs associated with worsening of depressive symptoms) and C-SSRS.

Screening/other: subject and HCP satisfaction scales, EQ-5D-5L, m.i.n.i., HAM-D17, antidepressant therapy response questionnaire, DSM-5MDD diagnosis, urine abuse drug screening, pregnancy test, and compliance check.

Statistical method

The initial sample size was calculated to detect a 3-unit difference in the change in total MADRS score from baseline between CT-152+adt and sham+adt, with 85% efficacy at the 2-sided α=0.05 level, assuming a common standard deviation of 9. Results the sample size was a total of 324 evaluable subjects (162 subjects per group). To compensate for subjects failing to make an evaluable assessment of the total MADRS score in the complete analysis set (FAS) sample (estimated to be up to 10% of all subjects), a total of 360 subjects (180 subjects per group) will be randomly assigned in the trial.

Due to the limitations of applying assumptions on the magnitude of the therapeutic effect, and to ensure that the test has sufficient efficacy, DMC will be subjected to a non-blind metaphase analysis. The final sample size can be increased to 540 subjects (270 subjects per group) according to DMC recommendations. An O' Brien-Fleming payout function was used, for which a significance level of 0.003 (side 2) was assigned to the metaphase analysis. The corresponding final significance level was 0.049 (side 2).

Based on the primary efficacy endpoint, the null hypothesis of the statistical test comparing CT-152+ADT and sham+ADT is that the change in MADRS with CT-152+ADT is equal to the change in MADRS with sham+ADT.

The primary analysis will be based on FAS samples adjusted for baseline MADRS total score, with changes in MADRS total score from baseline to final treatment assessment (week 6).

The minimum clinically significant difference (MCID) range for MADRS is believed to be between 1.6 and 1.9. In this trial, we plan to detect a 3-point difference in the primary efficacy endpoint between treatment groups. The 3-point treatment difference was above the MCID range. A test is considered positive if it stops at the mid-term efficacy analysis or if the p-value based on a statistical comparison of the final primary efficacy endpoints is < 0.049.

The primary analysis would utilize Mixed Model Repeat Measurements (MMRM), with treatments, visits to interactive treatments and sites as fixed effects to assess heterogeneity of treatment effects. Key adjuvant efficacy endpoints and other efficacy endpoints will be analyzed based on the FAS described for primary analysis.

Based on the key adjuvant efficacy endpoint, the null hypothesis of the statistical test comparing CT-152+ADT and sham+ADT is that the change in GAD-7 total score from baseline to week 6 with CT-152+ADT is equal to the change in GAD-7 total score from baseline to week 6 with sham+ADT.

The same method (MMRM) as in the primary analysis will be used to analyze the key adjuvant efficacy endpoint and replace the accessed interaction terms with the baseline GAD-7 total score as the covariate.

The persistence of CT-152 effect will be assessed based on MADRS total score and GAD-7 total score at weeks 6, 8 and 10. The change from baseline to weeks 8 and 10 in the above assessment will be analyzed using MMRM as described in the main analysis.

Non-blind interim efficacy data analysis will be performed on approximately the first 180 randomized subjects. When these subjects completed the 6 th week visit or stopped visiting prior to week 6, a non-blind metaphase analysis would be performed.

Differences between CT-152 and sham groups based on primary efficacy endpoints will be tested in a non-blind metaphase analysis. The sample size is re-estimated based on conditional efficacy determined only by the interim analysis. The adaptive design methods published by Chen, detes and Lan will be used to increase the sample size based on a temporary estimate of the magnitude of the treatment effect, possibly in combination with other external information, without exaggerating type I errors.

Examples of the various enumerated embodiments include: 1. a method for treating depression, the method comprising: providing a memory task exercise according to a first schedule, wherein providing the memory task exercise comprises: sequentially displaying a first plurality of emoji images to a patient receiving treatment for depression, wherein each of the first plurality of emoji images is configured to convey a respective emotion; prompting a patient to provide input indicating whether a respective emotion of a first expression image of the first plurality of expression images matches a respective emotion of a second expression image of the first plurality of expression images; and receiving a patient response indicating whether respective emotions of a first expression image and a second expression image of the first plurality of expression images match each other; providing a psychotherapy lesson according to a second schedule, wherein providing the psychotherapy lesson comprises displaying an animated video to the patient configured to provide therapeutic intervention through at least one of affective modulation, behavioral activation, and cognitive reconstruction, wherein the first schedule and the second schedule define a six-week treatment period.

2. The method of embodiment 1, wherein: the first schedule and the second schedule include providing a memory task exercise and a psychotherapy session for at least three days per week, respectively, and the memory task exercise and the psychotherapy session are provided on alternate days of the week.

3. The method of any of embodiments 1-2, wherein the psychotherapy lessons include cognitive behavioral therapy lessons, each lesson having a duration of about 3-5 minutes.

4. The method of any one of embodiments 1-3, wherein one or more of the psychotherapy courses includes an activity or task to be completed by the patient.

5. The method of any of embodiments 1-4, wherein providing the psychological treatment course according to the second schedule comprises: rendering a first plurality of animated videos configured to provide therapeutic intervention by emotion modulation during a first week of a six-week treatment period; rendering a second plurality of animated videos configured to provide therapeutic intervention by behavioral activation during a second period of the six-week treatment period; rendering a third plurality of animated videos configured to provide therapeutic intervention by cognitive reconstruction during a third period of the six-week treatment period; rendering a fourth plurality of animated videos configured to provide therapeutic intervention by affective modulation during a fourth week of the six week treatment period; rendering a fifth plurality of animated videos configured to provide therapeutic intervention by behavioral activation during a fifth one of the six-week treatment periods; and rendering a sixth plurality of animated videos configured to provide therapeutic intervention by cognitive reconstruction during a sixth period of the six-week treatment period.

6. The method of any of embodiments 1-5, wherein at least one of the psychotherapy courses is configured to reduce the severity of depression measured by a montgomery-asberg depression rating scale or a hamilton depression rating scale.

7. The method of any one of embodiments 1-6, wherein: the first plurality of emoji images includes facial expressions, and each of the respective emotions of the first plurality of emoji images is configured to represent at least one of: happiness, worry, anger, sadness, surprise or aversion.

8. The method of any of embodiments 1-7, wherein providing a memory task exercise according to the first schedule further comprises: the score is determined based at least in part on whether the patient response is correct.

9. The method of embodiment 8, wherein providing the memory task exercise according to the first schedule further comprises: sequentially displaying a second plurality of emoji images to the patient, wherein each of the second plurality of emoji images is configured to convey a respective emotion; and prompting the patient to provide an input indicating whether a respective emotion of a first of the second plurality of images matches a respective emotion of a second of the second plurality of images, wherein the second of the second plurality of images is a countback N images from the first of the second plurality of images.

10. The method of embodiment 9, wherein the value of N is an integer configured to be adjusted based at least in part on whether patient responses to the first plurality of emoji images are correct.

11. The method of any of embodiments 9-10, wherein the first and second images of the second plurality of images of expression each include a respective emotional intensity configured to be adjusted based at least in part on whether patient responses to the first plurality of images of expression are correct.

12. A non-transitory computer-readable medium storing computer program instructions that, when executed by one or more processors of a computing device, implement operations comprising any one of embodiments 1-11.

13. A medical device, comprising: a memory storing computer program instructions; and one or more processors configured to execute the computer program instructions to implement operations comprising any of embodiments 1-11.

14. A medical system, comprising: a memory storing computer program instructions; and one or more processors configured to execute the computer program instructions to implement operations comprising any of embodiments 1-11.

15. The medical system of embodiment 14, further comprising: a plurality of user devices, wherein a user device is one of the plurality of user devices.

16. A treatment apparatus for treating mood disorders via digital therapy including a plurality of memory task exercises and a plurality of psychotherapy courses, the treatment apparatus comprising: a processor programmed to access a treatment schedule defining a duration and timing of administration of the digital therapy; identifying, from the plurality of memory task exercises, a first memory task exercise to be administered on a first day of a treatment schedule; accessing a first plurality of emoji images associated with a first memory task exercise, wherein each of the first plurality of emoji images is configured to convey a respective emotion; sequentially displaying the first plurality of emoji images via a display device to a patient receiving treatment of an mood disorder; displaying to the patient a prompt providing input as to whether a respective emotion of a first expression image of the first plurality of expression images matches a respective emotion of a second expression image of the first plurality of expression images; receiving a patient response indicating whether respective emotions of a first and second expression image of the first plurality of expression images match each other; identifying, from the plurality of psychotherapy courses, a psychotherapy course to be administered on a second day of the treatment schedule; and displaying the psychotherapy lesson with the option of repeating one or more previous psychotherapy lessons. The treatment schedule may be accessed from local memory or may be transmitted from an application server.

17. The therapeutic apparatus of embodiment 16, wherein the treatment schedule includes a first treatment schedule for the plurality of memory task exercises and a second treatment schedule for the psychological treatment lesson.

18. The treatment device of embodiment 16, wherein the second day immediately follows the first day.

19. The treatment apparatus of embodiment 16, wherein the treatment schedule defines a treatment period of at least six weeks.

20. The treatment apparatus of embodiment 16 wherein the treatment schedule defines alternating dates of memory task exercises and psychological treatment sessions throughout the duration of the treatment session.

In the block diagrams, the components shown are depicted as discrete functional blocks, but the embodiments are not limited to systems in which the functions described herein are organized as shown. The functionality provided by each component may be provided by a different software or hardware module than the presently depicted organization, e.g., such software or hardware may be mixed, combined, replicated, split, distributed (such as within a data center or geographically distributed), or otherwise organized differently. The functions described herein may be provided by one or more processors of one or more computers executing code stored on a tangible, non-transitory, machine-readable medium. In some cases, although the singular term "medium" is used, the instructions may be distributed across different storage devices associated with different computing devices, e.g., each computing device has a different subset of instructions, an implementation consistent with the use of the singular term "medium" herein. In some cases, the third party content delivery network may host some or all of the information communicated through the network, in which case the information may be provided by sending instructions to retrieve the information from the content delivery network insofar as it is referred to as provisioning or otherwise providing the information, such as content.

The reader should appreciate that the present application describes several techniques that are independently useful. The applicant does not divide these technologies into a plurality of isolated patent applications, but groups them into a single document, as their related subject matter helps to save the application process. The unique advantages and aspects of these techniques should not be taken together. In some cases, embodiments address all of the drawbacks noted herein, but it should be understood that these techniques are independently useful, and that some embodiments address only a subset of such issues or provide other non-mentioned benefits that will be apparent to one of ordinary skill in the art upon review of the present disclosure. Some of the techniques disclosed herein may not be presently claimed due to cost limitations and may be claimed in later applications, such as in a continued application or by revising the present claims. Similarly, neither the abstract nor the summary of the application should be considered to contain a comprehensive list of all such techniques, or all aspects of such techniques, due to space limitations.

It should be understood that the description and drawings are not intended to limit the technology to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the technology as defined by the appended claims. Further modifications and alternative embodiments of various aspects of the technology will be apparent to those skilled in the art in view of this description. Accordingly, the description and drawings are to be construed as illustrative only and are for the purpose of teaching those skilled in the art the general manner of carrying out the technology. It is to be understood that the forms of the technology shown and described herein are to be taken as examples of embodiments. Elements and materials may be substituted for those illustrated and described herein, parts and processes may be reversed or omitted, and certain features of the present technology may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of this description of the technology. Changes may be made in the elements described herein without departing from the spirit and scope of the present technology as described in the following claims. The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description.

As used throughout this disclosure, the word "may" is used in a permissive sense (in other words, meaning having the potential to), rather than the mandatory sense (in other words, meaning must). The words "include", "including" and "comprising" mean including but not limited to. As used throughout this disclosure, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to "an element" or "an element" includes a combination of two or more elements, although other terms and phrases may be used to refer to one or more elements, such as "one or more". The term "or" is non-exclusive, in other words, encompasses both "and" or "unless otherwise indicated. Terms describing conditional relationships, such as "in response to X, Y", "at X, Y", "if X, Y", "when X, Y", etc., encompass causal relationships in which the antecedent is a necessary causal condition, the antecedent is a sufficient causal condition, or the antecedent is a contributing causal condition of the result, such as "state X occurs" generally "X occurs only when Y is obtained" and "X occurs when Y and Z". Such a conditional relationship is not limited to only the results that occur immediately after the leading word is obtained, since some of the results may be delayed, and in the conditional statement, the leading word is related to its successor, such as the likelihood that the leading word is related to the successor. Unless otherwise indicated, a statement in which multiple attributes or functions are mapped to multiple objects (such as one or more processors performing steps A, B, C and D) encompasses all such attributes or functions mapped to all such objects and a subset of attributes or functions mapped to a subset of attributes or functions (such as all processors each performing steps a-D, and the case in which processor 1 performs step a, processor 2 performs a portion of steps B and C, and processor 3 performs a portion of step C and step D). Further, unless otherwise indicated, recitation of one value or action "based on" another condition or value encompasses instances in which that condition or value is the only factor, as well as instances in which that condition or value is one of multiple factors. Unless otherwise indicated, the statement that "each" instance of a certain set has a certain attribute should not be read as excluding the case that some other identical or similar members of a larger set do not have that attribute, in other words, each does not necessarily mean each and every. No limitation concerning the order of the recited steps should be read into the claims unless explicitly specified, such as by using an explicit language like "after X is performed" as opposed to a statement that may be improperly demonstrated as implying an order limitation (e.g., "X is performed on items, Y is performed on items that are X") that is used for the purpose of making the claims easier to read than specifying an order. References to "at least Z out of A, B and C," etc. (such as "A, B or at least Z out of C") refer to at least Z out of the listed categories (A, B and C), and do not require at least Z units in each category. Unless specifically stated otherwise, as apparent from the discussion, it is appreciated that throughout the description, terms such as "processing," "computing," "calculating," "determining," or the like, refer to actions or processes of a particular apparatus (such as a special purpose computer or similar special purpose electronic processing/computing device). Features described with reference to geometric configurations, such as "parallel", "perpendicular/orthogonal", "square", "cylindrical", and the like, should be construed to cover items that substantially implement the nature of geometric configurations, such as reference to "parallel" surfaces covering substantially parallel surfaces. The allowable ranges of deviation of these geometric configurations from the bragg ideal will be determined with reference to the ranges in the specification, and without specifying such ranges, with reference to industry specifications in the field of use, and without defining such ranges, with reference to industry specifications in the field of manufacture of the specified features, and without defining such ranges, features that substantially implement geometric configurations should be interpreted as including those features that are within 15% of the defined attributes of the geometric configuration. The terms "first," "second," "third," "given," and the like, if used in the claims, are used for distinguishing or otherwise identifying, and not for showing a sequential or numerical limitation. As is commonly used in the art, the data structures and formats described with reference to use for human significance need not be presented in a human-understandable format to constitute the described data structures or formats, such as need not be rendered in Unicode or ASCII or even encoded text to constitute text; the image, map and data visualizations need not be displayed or decoded to make up the image, map and data visualizations, respectively; speech, music, and other audio need not be emitted or decoded separately through speakers to make up speech, music, or other audio.

Those skilled in the art will recognize that various modifications and/or enhancements may be made to the present teachings. For example, while the implementation of the various components described above may be implemented in a hardware device, it may also be implemented as a purely software solution, such as installed on an existing server. In addition, the dialog management techniques disclosed herein may be implemented as firmware, a firmware/software combination, a firmware/hardware combination, or a hardware/firmware/software combination.

While the foregoing has described what are considered to constitute the present teachings and/or other examples, it is to be understood that various modifications may be made thereto and that the subject matter disclosed herein may be implemented in various forms and examples, and that these teachings may be applied in a variety of applications, only some of which are described herein. It is intended by the appended claims to claim any and all applications, modifications, and variations that fall within the true scope of the present teachings.

Claims

1. A treatment apparatus for treating mood disorders via digital therapy including a plurality of memory task exercises and a plurality of psychotherapy courses, the treatment apparatus comprising:

a processor programmed to:

accessing a treatment schedule defining a duration and timing of administration of the digital therapy;

Identifying, from the plurality of memory task exercises, a first memory task exercise to be administered on a first day of a treatment schedule;

accessing a first plurality of emoji images associated with a first memory task exercise, wherein each of the first plurality of emoji images is configured to convey a respective emotion;

sequentially displaying the first plurality of emoji images via a display device to a patient receiving treatment of an mood disorder;

displaying to the patient a prompt providing input as to whether a respective emotion of a first expression image of the first plurality of expression images matches a respective emotion of a second expression image of the first plurality of expression images;

receiving a patient response indicating whether respective emotions of a first and second expression image of the first plurality of expression images match each other;

identifying, from the plurality of psychotherapy courses, a psychotherapy course to be administered on a second day of the treatment schedule; and

the psychological treatment lesson is displayed with the option of repeating one or more previous psychological treatment lessons.

2. The therapeutic device of claim 1, wherein a treatment schedule comprises a first treatment schedule for the plurality of memory task exercises and a second treatment schedule for the psychological treatment lesson.

3. The therapeutic apparatus of claim 1, wherein the second day immediately follows the first day.

4. The therapeutic apparatus of claim 1, wherein the second day immediately precedes the first day.

5. The therapeutic device of claim 1, wherein the treatment schedule defines a treatment period of at least six weeks.

6. The therapeutic apparatus of claim 1, wherein the treatment schedule defines alternating dates of memory task exercises and psychological treatment sessions throughout the duration of the treatment session.

7. A method of treating depression, the method comprising:

providing a memory task exercise according to a first schedule, wherein providing the memory task exercise comprises:

sequentially displaying a first plurality of emoji images to a patient receiving treatment for depression, wherein each of the first plurality of emoji images is configured to convey a respective emotion;

prompting a patient to provide input indicating whether a respective emotion of a first expression image of the first plurality of expression images matches a respective emotion of a second expression image of the first plurality of expression images; and

receiving a patient response indicating whether respective emotions of a first and second expression image of the first plurality of expression images match each other; and

Providing a psychotherapy lesson according to the second schedule, wherein providing the psychotherapy lesson comprises displaying an animated video to the patient, the animated video configured to provide therapeutic intervention through at least one of affective modulation, behavioral activation, and cognitive reconstruction.

8. The method of claim 7, wherein:

the first schedule and the second schedule include providing a memory task exercise and a psychotherapy session for at least three days per week, respectively, and

memory task exercises and psychotherapy courses are provided on alternate days of the week.

9. The method of claim 7, wherein the psychological treatment session comprises cognitive behavioral treatment sessions, each session having a duration of about 3-5 minutes.

10. The method of claim 7, wherein one or more of the psychotherapy courses includes an activity or task to be completed by the patient.

11. The method of claim 7, wherein providing the psychological treatment course according to the second schedule comprises:

rendering a first plurality of animated videos configured to provide therapeutic intervention by emotion modulation during a first week of a six-week treatment period;

rendering a second plurality of animated videos configured to provide therapeutic intervention by behavioral activation during a second period of the six-week treatment period;

Rendering a third plurality of animated videos configured to provide therapeutic intervention by cognitive reconstruction during a third period of the six-week treatment period;

rendering a fourth plurality of animated videos configured to provide therapeutic intervention by affective modulation during a fourth week of the six week treatment period;

rendering a fifth plurality of animated videos configured to provide therapeutic intervention by behavioral activation during a fifth one of the six-week treatment periods; and

rendering a sixth plurality of animated videos configured to provide therapeutic intervention by cognitive reconstruction during a sixth period of the six-week treatment period.

12. The method of claim 7, wherein at least one of the psychotherapy courses is configured to reduce the severity of depression as measured by a montgomery-arabic depression rating scale or a hamilton depression rating scale.

13. The method of claim 7, wherein:

the first plurality of emoji images includes facial expressions, and

each of the respective emotions of the first plurality of emoji images is configured to represent at least one of: happiness, worry, anger, sadness, surprise or aversion.

14. The method of claim 7, wherein providing the memory task exercise according to the first schedule further comprises:

The score is determined based at least in part on whether the patient response is correct.

15. The method of claim 14, wherein providing the memory task exercise according to the first schedule further comprises:

sequentially displaying a second plurality of emoji images to the patient, wherein each of the second plurality of emoji images is configured to convey a respective emotion; and

prompting the patient to provide an input indicating whether a respective emotion of a first expression image of the second plurality of expression images matches a respective emotion of a second expression image of the second plurality of expression images,

wherein the second expression image of the second plurality of expression images is N images back from the first expression image of the second plurality of expression images.

16. The method of claim 15, wherein the value of N is an integer configured to be adjusted based at least in part on whether patient responses to the first plurality of emoji images are correct.

17. The method of claim 15, wherein the first and second images of the second plurality of images each include a respective emotional intensity configured to be adjusted based at least in part on whether a patient response to the first plurality of images is correct.

18. The method of claim 7, wherein the first schedule and the second schedule define a six week treatment period.

19. A computer-readable medium for storing instructions for rendering therapy content for treating depression, the instructions being executable by one or more processing devices to perform operations comprising:

20. The computer readable medium of claim 19, wherein:

the first schedule and the second schedule each include providing memory task exercises and psychotherapy courses, respectively, three days a week, and

21. The computer readable medium of claim 19, wherein the psychological treatment session comprises cognitive behavioral therapy, each session having a duration of about 3-5 minutes.

22. The computer readable medium of claim 19, wherein one or more of the psychotherapy courses includes an activity or task to be completed by the patient.

23. The computer readable medium of claim 19, wherein providing the psychological treatment course according to the second schedule comprises:

24. The computer readable medium of claim 19, wherein at least one of the psychotherapy courses is configured to reduce the severity of depression as measured by a montgomery-asberg depression rating scale or a hamilton depression rating scale.

25. The computer readable medium of claim 19, wherein:

the first plurality of emoji images includes facial expressions, and

each of the respective emotions of the first plurality of emoji images is configured to represent one of happiness, fear, anger, sadness, surprise, and disgust.

26. The computer readable medium of claim 19, wherein providing the memory task exercise according to the first schedule further comprises determining a score based at least in part on whether the patient response is correct.

27. The computer readable medium of claim 19, wherein providing the memory task exercise according to the first schedule further comprises:

wherein the second expression image of the second plurality of expression images is the first expression image of the second plurality of expression images N images back.

28. The computer readable medium of claim 27, wherein the value of N is an integer configured to be adjusted based at least in part on whether patient responses to the first plurality of emoji images are correct.

29. The computer-readable medium of claim 27, wherein a first and a second expression image of the second plurality of expression images each include a respective emotional intensity configured to be adjusted based at least in part on whether a patient response to the first plurality of expression images is correct.

30. The computer readable medium of claim 19, wherein the first schedule and the second schedule define a six week treatment period.