Systems, methods, and devices for the generation and administration of digital therapeutic placebos and shams.

Abstract

To provide a system for treating a disease or disorder.SOLUTION: A method of treatment via data processing hardware comprises: administering to a first set of one or more users, a digital therapeutic, where the digital therapeutic comprises at least cognitive behavioral therapy content; administering to a second set of one or more users, at least one of sham and placebo digital therapeutics; determining a first efficacy value based on an analysis of engagement of the first set with the digital therapeutic; determining a second efficacy value based on an analysis of engagement of the second set with the sham or placebo digital therapeutic; determining a third efficacy value associated with the digital therapeutic based on a comparison of the first and second efficacy values; altering the cognitive behavioral therapy content of the digital therapeutic based on the third efficacy value to provide an updated digital therapeutic; and administering the updated digital therapeutic to a third set of one or more users.SELECTED DRAWING: Figure 8

Description

Technical Field

[0001] Cross - reference to Related Applications This U.S. patent application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 047,372, filed Jul. 2, 2020. The disclosure of this prior application is considered part of the disclosure of this application and is hereby incorporated by reference in its entirety.

[0002] This disclosure relates to digital therapeutics, and more particularly, to systems, methods, and devices for generating and administering digital therapeutic placebos and shams.

Background Art

[0003] The information presented in this section is intended to outline the context of the present disclosure. The research results of the named inventors up to the extent described in this section, and aspects of this description that may not be prior art as of the filing of this application, are not admitted to be prior art to the present disclosure, either expressly or implicitly.

[0004] Drug therapy has played an important role in the treatment of various medical diseases and disorders. Conventional drug therapy involves the administration of pharmaceutical products. Examples of conventional pharmaceutical products include small - molecule drugs, usually derived from chemical synthesis, and biopharmaceuticals such as recombinant proteins, vaccines, blood products used in therapeutic gene therapy, monoclonal antibodies, and cell therapies.

[0005] Drug therapy has been demonstrated to be an effective mechanism for treating certain diseases and disorders, but it is not without drawbacks. For example, patients receiving conventional drug therapy may experience undesirable side effects associated with the drugs, the administration of conventional drugs may be difficult, it is often difficult to track patient adherence to prescription drug treatment regimens, and conventional drugs are often quite costly. Thus, digital therapy may offer an option as an additional and / or alternative treatment to conventional drug therapy.

Summary of the Invention

[0006] Historically, parameters related to the performance of digital therapies for treating a disease or disorder (e.g., efficacy, safety, patient adherence to prescription regimens, and reduction of side effects) have been evaluated relative to conventional drug therapies for the same disease or disorder. However, traditional systems and methods for comparing treatment options have proven ineffective in evaluating the performance of digital therapies compared to other digital products. [Means for solving the problem]

[0007] One aspect of this disclosure provides a system for treating a disease or disorder. The system includes data processing hardware and memory hardware that communicates with the data processing hardware, and the memory hardware, when executed on the data processing hardware, provides the data processing hardware with the following functions: administering a digital therapy to a first group of one or more users, which includes at least cognitive behavioral therapy content; administering at least one of sham or placebo digital therapies to a second group of one or more users, wherein at least one sham or placebo digital therapy does not include any cognitive behavioral therapy content; and based on an analysis of the engagement of the first group of one or more users with the digital therapy. The system stores instructions to perform actions including: determining a first efficacy value associated with a digital therapy; determining a second efficacy value associated with at least one sham or placebo digital therapy based on an analysis of the involvement of a second group of one or more users with a sham or placebo digital therapy; determining a third efficacy value associated with the digital therapy based on a comparison of the first and second efficacy values; making changes to the cognitive behavioral therapy content of the digital therapy based on the third efficacy value to provide an updated digital therapy; and administering the updated digital therapy to a third group of one or more users.

[0008] Implementations of this disclosure may include one or more of the following optional features. Depending on the implementation, a third set of one or more users may include some or all of the users of either the first set or the second set of users.

[0009] Administering a sham digital therapy may include delivering one or more sentences corresponding to general information relating to at least one of the following: an emotion, illness, disorder, or condition associated with a user in a second set of users of one or more users. The one or more sentences may be delivered in response to the data processing hardware receiving an indication of an emotion, illness, disorder, or condition associated with that user in the second set of users of one or more users.

[0010] Applying a sham digital treatment may include generating text content configured to simulate a conversation with one or more users in a second set of users for display on a display device. The text content may include at least one of the following: a greeting message, a prompt, a response, or a display indicating the end of the simulated conversation.

[0011] Administering a placebo digital treatment may include generating graphic content, including a timer, for display on a display device.

[0012] Administering a placebo digital treatment may include generating a blank screen for display on a display device.

[0013] Providing Siam digital therapy may include distributing Siam content. Providing placebo digital therapy may include not distributing content.

[0014] Another aspect of the present disclosure is a treatment method comprising: administering a digital treatment to a first group of one or more users, including at least cognitive behavioral therapy content, using data processing hardware; administering at least one sham or placebo digital treatment to a second group of one or more users, wherein at least one sham or placebo digital treatment does not include any cognitive behavioral therapy content; and determining a first efficacy value associated with the digital treatment based on an analysis of the engagement of the first group of one or more users with the digital treatment, using data processing hardware The present invention provides a treatment method comprising: determining a second efficacy value associated with at least one sham or placebo digital treatment based on an analysis of the engagement of a second group of one or more users with a sham or placebo digital treatment; determining a third efficacy value associated with the digital treatment based on a comparison of the first and second efficacy values ​​using data processing hardware; modifying the cognitive behavioral therapy content of the digital treatment based on the third efficacy value using data processing hardware to provide an updated digital treatment; and administering the updated digital treatment to a third group of one or more users using data processing hardware. This embodiment may include one or more of the following optional features.

[0015] Depending on the implementation, a third group of one or more users may include some or all of the users in the first or second group of users.

[0016] Administering a sham digital therapy may include, by data processing hardware, delivering one or more sentences corresponding to general information relating to at least one of the emotions, illnesses, disorders, or conditions associated with a user in a second set of one or more users. The one or more sentences may be delivered in response to the data processing hardware receiving an expression of an emotion, illness, disorder, or condition associated with that user in the second set of one or more users from the user in the second set of one or more users.

[0017] Implementing a sham digital therapy may include using data processing hardware to generate text content configured to simulate a conversation with one or more users in a second set for display on a display device. The text content may include at least one of the following: a greeting message, a prompt, a response, or a display indicating the end of the simulated conversation.

[0018] Administering a placebo digital treatment may include generating graphic content, including a timer, for display on a display device using data processing hardware.

[0019] Administering a placebo digital treatment may include generating a blank screen for display on a display device using data processing hardware.

[0020] Administering a Siam digital therapy may include delivering Siam content using data processing hardware. Administering a placebo digital therapy may include not delivering content using data processing hardware.

[0021] Details of one or more implementations of this disclosure are described in the accompanying drawings and the following description. Other embodiments, features, and advantages will become apparent from the description and drawings and from the claims.

Brief Description of the Drawings

[0022] [Figure 1] A schematic diagram showing an exemplary system including a digital therapeutic placebo / sham application according to the principles of the present disclosure. [Figure 2] A flowchart showing an exemplary pre - investigation operation of the digital therapeutic placebo / sham application of FIG. 1. [Figure 3A] A flowchart showing an exemplary start operation of the digital therapeutic placebo / sham application of FIG. 1. [Figure 3B] A flowchart showing an exemplary treatment group operation of the digital therapeutic placebo / sham application of FIG. 1. [Figure 3C] A flowchart showing an exemplary placebo / sham group operation of the digital therapeutic placebo application of FIG. 1. [Figure 4] A flowchart showing an exemplary investigation operation of the digital therapeutic placebo / sham application of FIG. 1. [Figure 5] A flowchart showing an exemplary treatment operation of an authentic digital therapeutic application according to the principles of the present disclosure. [Figure 6A] A diagram showing a user device having a first graphical user interface of the digital therapeutic placebo / sham application of FIG. 1. [Figure 6B] A diagram showing a user device having a second graphical user interface of the digital therapeutic placebo / sham application of FIG. 1. [Figure 7A] A diagram showing a user device having a first graphical user interface of an exemplary authentic digital therapeutic application. [Figure 7B] A diagram showing a user device having a second graphical user interface of the exemplary authentic digital therapeutic application of FIG. 7A. [Figure 8] A flowchart showing a method according to the principles of the present disclosure. [Figure 9] This is a schematic diagram showing exemplary computing devices that can be used to implement the systems and methods described herein. [Modes for carrying out the invention]

[0023] Similar reference numerals in various drawings indicate the same elements.

[0024] Exemplary embodiments are provided to ensure that the disclosure is sufficient and that the scope is fully conveyed to those skilled in the art. Many specific details, such as particular systems, components, devices and methods, are described so that the embodiments of the disclosure can be fully understood. Those skilled in the art will see that specific details do not have to be adopted, that the exemplary embodiments may be embodied in many different forms, and that none of them should be construed as limiting the scope of the disclosure. Some of the exemplary embodiments do not describe in detail well-known processes, well-known device structures and well-known techniques.

[0025] As will be shown and described in more detail below, this disclosure includes systems, methods, and devices for treating various diseases and disorders. More specifically, this disclosure includes systems, methods, and devices for generating and administering digital therapeutic placebos and / or digital therapeutic shams. The systems described herein may include one or more computing components connected via a wired or wireless network for storing digital therapeutic placebos / shams, transmitting the digital therapeutic placebos / shams to a user's computing device (for example, a computing device associated with a participant in a study or clinical trial designed to evaluate the performance of a digital therapeutic for treating a given disease or disorder), and evaluating the performance of the digital therapeutic by comparing the user interaction with the digital therapeutic with the corresponding digital therapeutic placebo / sham. The methods described herein may include a method for administering a digital therapeutic placebo / sham to a user, a method for evaluating the performance of the digital therapeutic by comparing the user interaction with the digital therapeutic with the corresponding digital therapeutic placebo / sham, and a method for making changes to the digital therapeutic and / or digital therapeutic placebo / sham based on the performance evaluation. The devices described herein may include computing devices (e.g., server computers, smartphones, tablets, desktop computers, laptop computers, or any combination thereof) for storing, transmitting, modifying, and / or running patient-in-person placebo / sham applications. Patient-in-person placebo / sham applications may constitute mobile applications, web-based applications, or any combination thereof.

[0026] Digital therapy may provide the patient with therapeutic content in the form of text and / or audio / visual content delivered via a computer application executable on a computing device. A digital therapy placebo / sham can be implemented to evaluate the performance of digital therapy relative to non-pharmacological therapy (e.g., compared to digital therapy) across performance parameters such as efficacy, safety, patient adherence to prescription regimens, or any other performance parameters for medical therapy known in the art. According to one embodiment, a digital therapy intended to treat a specific disease or disorder may be administered to a first group of users (e.g., participants in a study or clinical trial aimed at evaluating the performance of digital therapy for treating a given disease or disorder). For example, the digital therapy may be delivered from a host server, etc., to computing devices associated with the first group of users via a network system, such as the network system shown in Figure 1. This first group of users may be referred to as the “therapy group.”

[0027] Furthermore, a second group of users (for example, participants in a study or clinical trial aimed at evaluating the performance of digital therapies for treating a given disease or disorder) may be given a digital therapy placebo / sham that is not intended to treat that particular disease or disorder. For example, the digital therapy placebo / sham may be delivered from a host server or similar device to the computing devices associated with the second group of users via a network system, such as the networked system shown in Figure 1. This second group of users is referred to as the “placebo / sham” or “control” group.

[0028] According to the exemplary implementations described herein, a digital therapeutic placebo may be therapeutic content that is visually or audibly similar to therapeutic content (e.g., cognitive behavioral therapy content) but does not actually deliver any therapeutic content that could treat the disease or disorder that the corresponding actual or genuine digital therapy is intended to treat. In one exemplary implementation, the digital therapeutic placebo may deliver substantially no content (e.g., no text content) and instead generate a blank screen. In another exemplary implementation, the digital therapeutic placebo may provide a timer or the like, without delivering any therapeutic content that could treat the disease or disorder that the corresponding actual or genuine digital therapy is intended to treat. In another exemplary implementation, a second group of users may be placed on a waiting list and not receive digital therapy. Instead, the waiting list group may wait to receive digital therapy and continue to receive standard treatment (i.e., without the use of digital therapy) for the specific disease or disorder they are suffering from. At some point in the future, the waiting list group may eventually receive digital therapy.

[0029] In another example of implementation, a digital therapy sham may include “sham” content such as general or psychoeducational content specifically designed to avoid therapeutic content (e.g., cognitive behavioral therapy content) intended to treat a disease or disorder for which the corresponding actual digital therapy is intended to treat. Other non-limiting examples of sham content may include text content that has not been demonstrated to treat a disease or disorder for which the corresponding actual digital therapy is intended to treat (e.g., the text content shown in Table 1), visual content that has not been demonstrated to treat a disease or disorder for which the corresponding actual digital therapy is intended to treat, audio content that has not been demonstrated to treat a disease or disorder for which the corresponding actual digital therapy is intended to treat, or any combination thereof.

[0030] In one exemplary embodiment, the digital therapy may be configured to treat depressive symptoms associated with one or more diseases or disorders (e.g., multiple sclerosis). In this embodiment, the sham content generated by the digital therapy sham may include text, audio, and / or visual content that targets the emotional state the user is experiencing (e.g., based on input information provided by the user through the digital therapy sham application). Continuing this embodiment, in a situation indicating that the user is experiencing a state of loneliness, the digital therapy sham may generate display data to be shown on the user's computing device, conveying a message such as "Isolation impairs the immune system, increases the production of stress hormones, is detrimental to sleep, and affects cognitive abilities," which has been demonstrated to have no therapeutic effect in reducing or eliminating depressive symptoms associated with one or more diseases or disorders. Other exemplary sham content is shown in Table 1. Please understand that different and / or additional sham content is also intended.

[0031] Depending on the implementation, the digital therapeutic placebo / sham delivered to the placebo / sham / control group may include features and / or content similar to those included in the corresponding actual digital therapy provided to the therapy group. For example, the digital therapeutic placebo / sham may allow the placebo / sham / control group to (i) access and interact with the content via their computing device (e.g., their mobile device) through a conversational graphical user interface included as part of the digital therapeutic placebo / sham application, (ii) log in to the digital therapeutic placebo / sham application via a login interface (e.g., by the user entering a unique ID and access code), and (iii) receive a local notification on their computing device to start the digital therapeutic placebo / sham application on their computing device when selected by the user. Depending on the implementation, as a result of repeating similar conversational scenarios, copies of the same sham (e.g., psychoeducational) content as in previous scenarios may be delivered to users within the placebo / sham / control group. In other words, the user does not need to be delivered different sham (e.g., psychoeducational) content across subsequent sessions with the digital therapeutic placebo / sham application.

[0032] Depending on the implementation, a digital placebo / sham application may deliver three daily notifications prompting the user to open the application, and then display a prescription timer (e.g., a timer clock countdown to the next prescription administration) for the remaining period the application is available (e.g., the duration of a prescription based on a treatment diagnosis). The digital placebo / sham application may take into account the nonspecific effects of smartphone involvement. However, the digital placebo / sham application does not need to provide any proactive coping capabilities (e.g., elements of psychosocial intervention) and may appear visually similar to actual digital treatment.

[0033] The systems, methods, and devices described herein may be used to evaluate the effectiveness of actual digital therapies aimed at treating diseases and disorders, including but not limited to substance use disorders, opioid use disorders, schizophrenia, post-traumatic stress disorder, general anxiety disorder, insomnia, traumatic brain injury, attention deficit hyperactivity disorder, multiple sclerosis, and major depressive disorder.

[0034] Referring to Figure 1, in some embodiments, the digital therapeutic placebo / sham system 100 provides user 101 with access to a digital therapeutic placebo / sham application 120 assigned to user 101 and monitors events associated with user 101's interaction with the digital therapeutic placebo / sham application 120. While the digital therapeutic placebo / sham application 120 is referred to herein as the “placebo / sham” digital therapeutic, depending on the implementation, the digital therapeutic placebo / sham application 120 may function similarly to a real digital therapeutic, such as a prescription digital therapeutic, so that user 101 does not know whether they are interacting with a real digital therapeutic or a digital therapeutic placebo / sham. A person using or receiving a digital therapeutic placebo / sham may be referred to as a “user.” “User” may include a patient, a user in the placebo / sham or control group, or any other user using or receiving the digital therapeutic placebo / sham application 120.

[0035] As used herein, digital therapy may also refer to digital therapy configured to provide evidence-based psychosocial intervention techniques for treating patients with a specific disease or disorder, and symptoms and / or behaviors associated with that disease or disorder. Depending on the implementation, an authorized healthcare provider (HCP) 109 (e.g., a physician, nurse, etc.) may supervise and assign the digital therapy placebo / sham application 120 to the user 101. The HCP 109 may include a physician, nurse, clinician, or other qualified healthcare professional. In other implementations, the user 101 may be assigned the digital therapy placebo / sham application 120 by any appropriate person, such as a person involved in a clinical trial.

[0036] In some embodiments, system 100 includes a network 106, a user device 102, an optional HCP system 140, and a digital therapeutic placebo / sham application 120. Network 106 provides access to cloud computing resources 150 (e.g., a distributed system) running the placebo / sham application 120 to provide the execution of services on the remote device. Network 106 may include any type of network that enables the transmission and reception of communication signals, such as wireless telecommunications networks, cellular networks, time division multiple access (TDMA) networks, code division multiple access (CDMA) networks, Global Systems for Mobile Communications (GSM), third-generation (3G) networks, fourth-generation (4G) networks, fifth-generation (5G) networks, satellite communication networks, and other communication networks. Network 106 may include one or more of wide area networks (WANs), local area networks (LANs), and personal area networks (PANs). In some embodiments, network 106 includes combinations of data networks and telecommunications networks, and combinations of data and telecommunications networks. The user device 102, an optional HCP system 140, and a placebo / sham application 120 communicate with each other by sending and receiving signals (wired or wireless) via the network 106. In some embodiments, the network 106 provides access to cloud computing resources, which may be elastic / on-demand computing and / or storage resources 156, available via the network 106. The term “cloud” service generally refers to services that are not performed locally on the user’s device but are delivered from one or more remote devices accessible via one or more networks 106.

[0037] The user device 102 includes, but is not limited to, a portable electronic device (e.g., a smartphone, mobile phone, personal digital assistant, personal computer, or wireless tablet device), a desktop computer, or any other electronic device capable of sending and receiving information via the network 106. The user device 102 includes data processing hardware 112 (a computing device that executes instructions), memory hardware 114, and a display 116 that communicates with the data processing hardware 112. In some embodiments, the user device 102 includes a keyboard, mouse, microphone, and / or camera that enable the user to input data. In addition to, or instead of, the display 116, the user device 102 may include one or more speakers that output audio data to the user 101. For example, the speakers may output an alarm sound to notify the user 101 about some time-constrained event associated with the placebo / sham application 120. Depending on the implementation, the user device 102 runs a user application 103 (or accesses a web-based patient application) to establish a connection with and access the placebo / sham application 120. For example, user 101 may have access to user application 103 during the duration (e.g., 3 months) of the placebo / sham application 120 assigned to user 101. Here, user device 102 may launch user application 103 by first providing an access code 104 that allows user 101 to access the content associated with the placebo / sham application 120 when the placebo / sham application 120 is assigned to user 101.When the user application 103 is run on the data processing hardware 112 of the user device 102, it is configured to display various graphical user interfaces (GUIs) on the display 116 of the user device 102, in particular, allowing the user 101 to interact with the placebo / sham application 120.

[0038] The storage resource 156 may provide data storage 158 for storing user records 105 and placebo / sham content 122. User records 105 may be encrypted while stored in data storage 158 so as to anonymize any information identifying user 101, but may be decryptable later when user 101 or the supervising HCP 109 or clinical trial personnel request user records 105 (provided the requester is authorized / authenticated to access user records 105). All data transmitted between the user device 102 and the cloud computing system 150 via network 106 may be encrypted and transmitted via a secure communication channel.

[0039] An optional HCP system 140 may be located in a hospital, clinic, or facility managed by HCP 109 and includes data processing hardware 142, memory hardware 145, and a display 146. The memory hardware 144 and the display 146 communicate with the data processing hardware 142. For example, the data processing hardware 142 may be on a desktop computer or portable electronic device that allows HCP 109 to input and retrieve data to and from the placebo / sham application 120. In some embodiments, HCP 109 may initially onboard some or all of the user record 105 and / or placebo / sham content 122. In other embodiments, user 101 may onboard some or all of the user record 105, and the placebo / sham application content 122 may be created by a clinical trial participant or any other suitable person. The HCP system 140 includes a keyboard 148, a mouse, a microphone, a speaker, and / or a camera. Depending on the implementation, the HCP system 140 (i.e., by the data processing hardware 142) runs the HCP application 110 (or accesses a web-based patient application) to establish a connection with the placebo / sham application 120 to input and retrieve data.

[0040] The cloud computing resource 150 may be a distributed system (e.g., a remote environment) having scalable / elastic resources 152. Resource 152 includes computing resources 154 (e.g., data processing hardware) and / or storage resources 156 (e.g., memory hardware). The cloud computing resource 150 runs a placebo / sham application 120 to facilitate communication with the user device 102 and the HCP system 140 and to store data in the storage resources 156 within the data storage 158. In some embodiments, the data storage 158 is located on a standalone computing device. The placebo / sham application 120 may provide the user 101 with a user application 103 (e.g., a mobile application, a website application, or a downloadable program containing a set of instructions) which is executable on the data processing hardware 112 and accessible by the user device 102 via the network 106 when the user 101 provides a valid access code 104. Similarly, the placebo / sham application 120 may provide the HCP 109 with an HCP application 110 (for example, a mobile application, a website application, or a downloadable program containing a set of instructions) that is executable on the data processing hardware 142 and accessible by the HCP system 140 via the network 106.

[0041] Figure 2 is a flowchart illustrating a preliminary survey operation 200 in one exemplary implementation of the present disclosure. During the preliminary survey operation 200, the system 100 may identify the survey subjects or patients at node 202. The system 100 may then create an allocation list at node 204, which will be used for randomizing the subjects or patients at node 206. Patient identification and randomization may be performed by a third party, the party conducting the survey, any other appropriate party, or any appropriate combination thereof. During the randomization process, each party may be assigned a unique identifier name or number at node 208.

[0042] Figures 3A to 3C are flowcharts of an application operation 300 according to one exemplary implementation of the present disclosure. Referring to Figure 3A, the start operation 300 is schematically shown. During the start operation 310, the system 100 may enable the patient to download a user application 103 at node 312, for example, via an app store. During the login process at node 314, the patient may provide an access code 104 at node 316, which may enable the patient to complete the login process and create a password, username, etc., at node 318, for example. During the start operation 310, patients in each group (e.g., a treatment group and a placebo / sham group) may go through a substantially similar process so that the patient does not know which group they belong to. For example, a patient in the placebo / sham group does not need to know whether they belong to the placebo / sham group or the treatment group.

[0043] Referring to Figure 3B, treatment group operation 320 is schematically shown. During treatment group operation 320, the patients in the investigation group receive the treatments illustrated as the first notification treatment 324 and the second notification treatment 326, and check in with HCP 109 at node 322 by interaction with user application 103, direct interview, or any other appropriate means.

[0044] Referring to Figure 3C, the placebo / sham group operation 330 is schematically shown. During the placebo / sham group operation 330, the digital treatment placebo / sham application 120 may be presented to the patient in the placebo / sham group through interaction with, for example, a user application 103, text content that has not been proven to treat a disease or disorder for which the corresponding actual digital treatment is intended to treat (e.g., the text content shown in Table 1), visual content that has not been proven to treat a disease or disorder for which the corresponding actual digital treatment is intended to treat, audio content that has not been proven to treat a disease or disorder for which the corresponding actual digital treatment is intended to treat, or any combination thereof. Such content may be part of the sham digital treatment.

[0045] In other implementations, the digital therapy placebo / sham application 120 may administer a placebo digital therapy that includes the same initiation action 310 as the sham digital therapy and the real digital therapy, but after the initiation action 310, the placebo digital therapy does not substantially present any content. In one embodiment, the placebo digital therapy may generate a blank screen and display it on the display 116. In another embodiment, the placebo digital therapy may generate a timer, such as a countdown timer, and display it on the display 116.

[0046] Depending on the implementation, the digital therapeutic placebo / sham application 120 may present the patient with a first placebo notification 332 and a second placebo notification 334 (for example, by displaying them on the display 116). The first and second placebo notifications 332, 334 may be push notifications or other similar notifications that remind the patient to use the user application 103. When the patient opens the digital therapeutic placebo / sham application 120 (for example, by interacting with the user application 103), the digital therapeutic placebo / sham application 120 may simulate a conversation with the user 101. For example, the digital therapeutic placebo / sham application 120 may present the patient with a first greeting at node 336. The digital therapeutic placebo / sham application 120 may then present the patient with a second greeting at node 338. The first and second greetings 336 and 338 may include text phrases such as "Hello" and "Welcome back to the app," as shown in Table 1 below. At node 340, the digital therapeutic placebo / sham application 120 may present the patient with a first prompt, such as "How are you feeling?" At node 342, the digital therapeutic placebo / sham application 120 may receive a display of the user's emotions from the patient, for example, through the patient's interaction with the user application 103. Depending on the implementation, the digital therapeutic placebo / sham application 120 may present the patient with a selection of emotions, such as loneliness, anger, fear, sadness, stress, depression, frustration, shame, happiness, optimism, pride, motivation, sympathy, affection, calmness, fairness, etc., as shown in Table 1. In other implementations, the patient may enter their emotions via a free-text input field, utter their emotions, or present their emotions in any appropriate manner.

[0047] At nodes 344 and 346, the digital therapeutic placebo / sham application 120 may present the user with a first and second sentence, respectively, based on the selected emotion. As shown in Table 1, the first and second sentences 344 and 346 may contain general facts or relatively general information about the selected emotion, the specific disease or disorder being treated, or other data. For example, if the patient selects "anger" as their emotion, the digital therapeutic placebo / sham application 120 may display on display 116 the following, corresponding to "Sham Anger 1" in Table 1: "The overall prevalence of inappropriate, intense, or poorly controlled anger in the U.S. population is 7.8%." As shown in Table 1, if the patient selects the same emotion multiple times, the digital therapeutic placebo / sham application 120 may present the patient with multiple sentences at nodes 344 and 346. For example, if a patient selects "anger" as their emotion after having already selected it, the digital therapeutic placebo / sham application 120 may display on the display 116 the following statement corresponding to "Sham Anger 2" in Table 1: "The rise in blood pressure and other physical changes associated with anger can make it difficult to think rationally and may impair mental and physical health." If the patient again selects "anger" as their emotion, depending on the implementation, the digital therapeutic placebo / sham application 120 will present the statement corresponding to "Sham Anger 1." In other implementations, the digital therapeutic placebo / sham application 120 may include several different statements to present to the patient.

[0048] At node 348, the digital therapeutic placebo / sham application 120 may present the patient with a second prompt, such as "Do you feel better now?". At node 350, the digital therapeutic placebo / sham application 120 may end the conversation or interaction with the patient by displaying, for example, "Finished" or "Complete" on display 116.

[0049] [Table 1] TIFF0007832274000002.tif244155 TIFF0007832274000003.tif51167

[0050] Referring to Figure 4, the investigation operation 400 is schematically shown in the form of a flowchart. As described above, the experience of a patient in the treatment group who downloads the user application 103 and receives an access code 104 may be similar to that of a patient in the placebo / sham group. That is, at node 402, the user application 103 may be downloaded, and the patient may enter their own unique access code 104. Based on the access code 104, the digital treatment placebo / sham application 120 determines whether the patient belongs to the treatment group or the placebo / sham group. If the digital treatment placebo / sham application 120 determines that the patient belongs to the treatment group, at node 404, the real digital treatment performs initial onboarding, including username setting, password setting, etc. If the digital treatment placebo / sham application 120 determines that the patient belongs to the placebo / sham group, at node 406, the digital treatment placebo / sham application 120 performs application operation 300 as described above and shown in Figures 3A to 3C. After determining that the patient is suitable for the treatment group, the Real Digital Therapy grants the patient access to the treatment version of user application 103 at node 408. The Real Digital Therapy then performs an onboarding process at node 410 to prepare the patient for treatment. Next, at node 420, the Real Digital Therapy performs the patient's treatment.

[0051] Patient treatment may be tailored to the specific disease or disorder the patient is experiencing or suffering from, and depending on the implementation, the treatment may include at least cognitive behavioral therapy content. As an example, with reference to Figure 5, treatment 420 is shown and described for the treatment of depressive symptoms and disorders associated with multiple sclerosis. At node 422, the patient may check in to the authentic digital treatment via user application 103. Depending on the implementation, the patient may check in via one or more application notifications 424 displayed on display 116. Upon check-in, the authentic digital treatment may receive a display from the patient indicating either positive emotions (and thus proceeding to the first path and node 426) or negative emotions (and thus proceeding to the second path and node 428). In the first path, at node 430, the authentic digital treatment may receive a display from the patient indicating one or more symptoms. For example, if the identified symptom is fatigue, the authentic digital treatment presents a fatigue check-in at node 432. The real digital therapy receives an indication from the patient at node 434 of what kind of fatigue it is, and an indication at node 436 of how severe the fatigue is, then the real digital therapy presents a video of the patient at node 438, and returns to route 1 at node 440.

[0052] At node 440, the Real Digital Therapy receives the situation from the patient, and then at node 442, it displays the Catch-Check-Change module. After the Real Digital Therapy instructs the patient to create alternative thoughts at node 444, the Real Digital Therapy presents a thought journal at node 446, which can be used for data insights 448. Depending on the implementation, the Real Digital Therapy may present the patient with mindfulness audio 450.

[0053] In Path 2, if the Real Digital Therapy receives an indication that the patient is experiencing positive emotions, the Real Digital Therapy receives the situation from the patient at node 452 and positive introspection at node 454. After the Real Digital Therapy instructs the patient to create positive thoughts at node 456, the Real Digital Therapy presents a thought journal at node 446, which can be used in data insight 448.

[0054] Depending on the implementation, the digital therapeutic placebo / sham application 120 may provide psychoeducational content related to emotions instead of clinical content. Depending on the implementation, the same sham content may be presented to the user if the user inputs the same conversation scenario and / or responses.

[0055] Referring to Figure 6A, a login graphical user interface (GUI) 600 is schematically shown on the display 116 of the user device 102. The login GUI 600 may include a username GUI element 602, a password GUI element 604, and an access code GUI element 606. User 101 may interact with the username GUI element 602, the password GUI element 604, and the access code GUI element 606 to enter the user's username, password, and access code 104, respectively. The login GUI 600 may be generated by a digital therapeutic placebo / sham application 120 and displayed via the user application 103. The login GUI 600 may include a selectable enter GUI button 608 or other similar selectable GUI elements.

[0056] When the user enters the above information and selects the Enter GUI 608, the digital therapeutic placebo / sham application 120 may generate and display a placebo / sham GUI 610 as shown in Figure 6B. As described above, the placebo / sham GUI 610 may include a timer GUI element 612. In other implementations, the placebo / sham GUI 610 may include a blank screen, sham content, simulated conversations for delivering the sham content, etc.

[0057] Referring to Figure 7A, the login GUI 650 on the display 116 of the user device 102 is schematically shown. The login GUI 650 has the same appearance as the login GUI 600 described above so that user 101 does not know whether they are being delivered a real digital therapy or a placebo / sham digital therapy. The login GUI 650 may include a username GUI element 652, a password GUI element 604, and an access code GUI element 606. User 101 may interact with the username GUI element 652, the password GUI element 654, and the access code GUI element 656 to enter their username, password, and access code 104, respectively. The login GUI 650 may be generated by a real digital therapy application and displayed via the user application 103. The login GUI 650 may include a selectable enter GUI button 658 or other similar selectable GUI elements.

[0058] When the user enters the above information and selects the Enter GUI button 658, the actual digital therapy application may generate and display a digital therapy GUI 660 as shown in Figure 7B. If the digital therapy is used as an example to treat symptoms associated with multiple sclerosis as described above, the digital therapy GUI 660 may include a selectable negative emotion GUI element 662 and a selectable positive emotion GUI element 664. For example, user 101 may select the negative emotion GUI element 662 and begin following the first path described above and shown in Figure 5. For example, user 101 may select the positive emotion GUI element 664 and begin following the second path described above and shown in Figure 5. In other implementations, the digital therapy GUI 660 may include any appropriate cognitive behavioral therapy content, such as those described above, for illustrative purposes only.

[0059] Referring to Figure 8, treatment method 800 is schematically shown in the form of a flowchart. In step 802, method 800 comprises administering a digital therapy to a first group of one or more users, the digital therapy comprising at least cognitive behavioral therapy content. For example, the first group of one or more users may include a therapy group receiving a digital therapy that includes cognitive behavioral therapy content, such as therapy 420 in the case of a user diagnosed with multiple sclerosis.

[0060] In step 804, method 800 includes administering at least one of sham or placebo digital treatments to a second group of one or more users, the at least one of which does not include any cognitive behavioral therapy content. For example, the second group of one or more users may include a placebo / sham group. Depending on the implementation, the placebo / sham group may be given a placebo digital treatment in which no therapeutic content is delivered. For example, such a placebo digital treatment may include a timer or a blank screen. Depending on the implementation, the placebo / sham group may be given a sham digital treatment in which sham content is delivered, such as the content listed in Table 1 and shown in Figure 3C.

[0061] In step 806, method 800 includes determining a first efficacy value associated with the digital therapy based on an analysis of the engagement of a first set of one or more users with the digital therapy. For example, the digital therapy placebo / sham application 120 may monitor and analyze the degree, duration, frequency, etc., of interaction between the therapy group and the user application 103 in order to determine the first efficacy value. Depending on the implementation, the first efficacy value may be a numerical value or score, a percentage, or any appropriate type of value. Depending on the implementation, the first efficacy value may be determined by comparing the effect that a real or genuine digital therapy has on a user across one or more parameters (e.g., efficacy, safety, patient adherence to a prescription regimen, reduction of side effects, etc.) with the effect that a drug has on a user across one or more of the same parameters.

[0062] In step 808, method 800 includes determining a second efficacy value associated with at least one sham or placebo digital treatment based on an analysis of the engagement of a second set of one or more users with the sham or placebo digital treatment. For example, the digital treatment placebo / sham application 120 may monitor and analyze the degree, duration, frequency, etc., of interaction between the placebo / sham group and the user application 103 in order to determine the second efficacy value. Depending on the implementation, the second efficacy value may be a numerical value or score, a percentage, or any appropriate type of value.

[0063] In step 810, method 800 includes determining a third efficacy value associated with the digital treatment based on a comparison of a first efficacy value and a second efficacy value. For example, the digital treatment placebo / sham application 120 may compare the first efficacy value to the second efficacy value in order to determine the third efficacy value. Depending on the implementation, the third efficacy value may be a numerical value or score, a percentage, or any appropriate type of value. The third efficacy value may provide feedback on the effectiveness of the digital treatment compared to a placebo / sham digital treatment, which can serve as a control.

[0064] Depending on the implementation, Method 800 may include step 812, which includes modifying the cognitive behavioral therapy content of the digital therapy based on a third efficacy value in order to provide an updated digital therapy. For example, the digital therapy placebo / sham application 120 may modify the cognitive behavioral therapy content (e.g., text, audio, and / or visual content) delivered to the therapy group based on feedback received from a third efficacy value, i.e., a comparison of the efficacy of the digital therapy with the efficacy of the sham or placebo digital therapy.

[0065] Depending on the implementation, method 800 may include step 814, which includes administering the updated digital treatment to a third group of one or more users. The third group of one or more users may include some or all of the users from either the first or second group of users. For example, the updated digital treatment may be administered to the same users who formed the basis for the third efficacy value (i.e., the determination of the effectiveness of the digital treatment), or the updated digital treatment may be administered to a group of users who were not involved in the original efficacy analysis.

[0066] Figure 9 is a schematic diagram showing an exemplary electronic device 900 (e.g., a computing device) that can be used to implement the systems and methods described herein. The electronic device 900 is intended to correspond to various forms of digital computers, such as laptops, desktops, workstations, personal digital assistants, servers, blade servers, mainframes, and other suitable computers. The components illustrated herein, their connections and relationships, and their functions are intended to be illustrative only and are not intended to limit the implementations of the invention described and / or claimed herein.

[0067] The electronic device 900 includes a processor 910, memory 920, storage device 930, a high-speed interface / controller 940 connected to memory 902 and a high-speed expansion port 950, and a low-speed interface / controller 960 connected to a low-speed bus 970 and storage device 930. Each of the components 910, 920, 930, 940, 950, and 960 is interconnected using various buses and may be implemented on a common motherboard or in other ways as appropriate. The processor 910 can process instructions for execution within the electronic device 900, including instructions stored in memory 920 or storage device 930 for displaying graphic information for a graphical user interface (GUI) on an external input / output device such as a display 980 coupled to the high-speed interface 940. In other implementations, multiple processors and / or buses may be used as appropriate, along with multiple memories and multiple types of memory. Furthermore, multiple electronic devices 900 that provide some of the necessary functions for each device may be connected (for example, as a server bank, a group of blade servers, or a multiprocessor system).

[0068] Memory 920 stores information non-transiently in the electronic device 900. Memory 920 may be a computer-readable medium, a volatile memory unit, or a non-volatile memory unit. Non-transient memory 920 may be a physical device used to temporarily or permanently store programs (e.g., sequences of instructions) or data (e.g., program state information) for use by the electronic device 900. Examples of non-volatile memory include, but are not limited to, flash memory and read-only memory (ROM) / programmable read-only memory (PROM) / erasable programmable read-only memory (EPROM) / electronically erasable program read-only memory (EEPROM), (typically used for firmware such as boot programs). Examples of volatile memory include, but are not limited to, random access memory (RAM), dynamic random access memory (DRAM), static random access memory (SRAM), phase-change memory (PCM), and disks or tapes.

[0069] The storage device 930 can provide large-capacity storage to the electronic device 900. Depending on the implementation, the storage device 930 is a computer-readable medium. In various different implementations, the storage device 930 may be a floppy disk device, a hard disk device, an optical disk device, or a tape device, flash memory or other similar solid-state memory device, or an array of devices including devices in a storage area network or other configuration. In other implementations, a computer program product may be tangibly embodied in an information carrier. The computer program product includes instructions that, when executed, perform one or more methods, such as those described above. The information carrier is a computer-readable medium or machine-readable medium, such as memory 920, the storage device 930, or memory on the processor 910.

[0070] The high-speed controller 940 manages the bandwidth-heavy operation of the electronic device 900, while the low-speed controller 960 manages the less bandwidth-heavy operation. This function assignment is merely illustrative. Depending on the implementation, the high-speed controller 940 may be coupled to memory 920, a display 980 (for example, via a graphics processor or accelerator), and a high-speed expansion port 950 capable of accepting various expansion cards (not shown).

[0071] The electronic device 900 can be implemented in several different forms, as shown in Figure 9. For example, it may be implemented as a standard server 900a or multiple times in a group of such servers 900a, as a laptop computer 900b, as part of a rack server system 900c, as a smartphone 900d, and / or as a tablet computer 900e.

[0072] Various implementations of the systems and technologies described herein can be realized in digital electronic and / or optical circuits, integrated circuits, specially designed ASICs (application-specific integrated circuits), computer hardware, firmware, software, and / or combinations thereof. These various implementations may include implementations in one or more computer programs executable and / or interpretable on a programmable system, which includes at least one programmable processor that can be dedicated or general-purpose, coupled to receive and transmit data and instructions from a storage system, at least one input device, and at least one output device.

[0073] These computer programs (also called programs, software, software applications, or code) contain machine instructions for programmable processors and can be implemented in high-level procedural and / or object-oriented programming languages ​​and / or assembly / machine language. As used herein, the terms “machine-readable medium” and “computer-readable medium” refer to any computer program product, non-transient computer-readable medium, apparatus and / or device (e.g., magnetic disks, optical disks, memory, programmable logic devices (PLDs)) used to provide machine instructions and / or data to a programmable processor, including machine-readable medium that receives machine instructions as machine-readable signals. The term “machine-readable signal” refers to any signal used to provide machine instructions and / or data to a programmable processor.

[0074] A software application (i.e., a software resource) can refer to computer software that causes a computing device to perform a task. In some examples, a software application may be called an “application,” “app,” or “program.” Examples of applications include, but are not limited to, system diagnostic applications, system administration applications, system maintenance applications, word processing applications, spreadsheet applications, messaging applications, media streaming applications, social networking applications, and game applications.

[0075] As used herein, the term “module” may refer to hardware, software, firmware, or any combination thereof. The processes and logic flows described herein can be performed by one or more programmable processors, also called data processing hardware, which execute one or more computer programs to perform functions by performing operations on input data and producing outputs. Processes and logic flows can also be executed by dedicated logic circuits, such as FPGAs (Field-Programmable Gate Arrays) or ASICs (Special Purpose Integrated Circuits). Processors suitable for executing computer programs include, for example, both general-purpose and dedicated microprocessors, and any one or more processors in any type of digital computer. Generally, processors receive instructions and data from read-only memory or random-access memory or both. Essential elements of a computer are a processor for executing instructions and one or more memory devices for storing instructions and data. Generally, a computer also includes one or more mass storage devices for storing data, such as magnetic, magneto-optical disks, or optical disks, or is operably coupled to them for receiving or transferring data from or both. However, a computer does not have to include such devices. Computer-readable media suitable for storing computer program instructions and data include all forms of non-volatile memory, media, and memory devices, such as semiconductor memory devices (e.g., EPROM, EEPROM, and flash memory devices), magnetic disks (e.g., internal hard disks or removable disks), magneto-optical disks, CD-ROMs, and DVD-ROM disks). Processors and memory may be complemented by or integrated into dedicated logic circuits.

[0076] To provide user interaction, one or more aspects of the present disclosure can be implemented on a computer having a display device for displaying information to the user, such as a CRT (cathode ray tube), LCD (liquid crystal display) monitor, or touchscreen, and optionally a keyboard and pointing device, such as a mouse or trackball, by which the user can provide input to the computer. Other types of devices can also be used to provide user interaction. For example, the feedback provided to the user may be any form of sensory feedback, such as visual feedback, auditory feedback, or tactile feedback, and input from the user may be received in any form, including acoustic, verbal, or tactile input. Furthermore, the computer may interact with the user by sending documents to and receiving documents from a device used by the user, for example, by sending a web page to a web browser on the user's client device in response to a request received from a web browser.

[0077] Several implementation forms have been described above. However, it should be understood that various modifications can be made without departing from the concept and scope of this disclosure. Therefore, other implementation forms are also included in the following claims.

Claims

1. It is a method, The data processing system will (i) assign the user's test set to a test group receiving a condition-related digital treatment, and (ii) assign the user's control set to a control group receiving a digital placebo. The data processing system provides at least one of (i) an access code for a digital treatment for the user in the user's test set, and (ii) an access code for a digital placebo for the user in the user's control set. The data processing system performs (i) administering the digital treatment to the user test set in the test group, and (ii) administering a digital placebo to the user control set in the control group. The data processing system receives (i) trial involvement data of the user's trial set using the digital treatment, and (ii) control involvement data of the user's control set using the digital placebo. The data processing system determines (i) the test value for the digital treatment based on the trial involvement data, and (ii) the control value for the digital placebo based on the control involvement data. The data processing system determines a comparative value based on the test value and the control value, The data processing system stores the test value, the control value, and the comparison value for the digital treatment. Methods that include...

2. The method according to claim 1, further comprising providing the data processing system with (i) access to the user's test set of the digital treatment for a defined period, and (ii) access to the user's control set of the digital placebo for a defined period.

3. The method according to claim 1, further comprising the data processing system providing (i) another access code for the digital treatment to another user in the user's test set, and (ii) another access code for the digital placebo to another user in the user's control set.

4. The data processing system modifies the digital treatment based on the comparison value and provides the updated digital treatment. The data processing system provides the updated digital treatment to one or more users, The method according to claim 1, further comprising:

5. The method according to claim 1, wherein providing the digital therapy to the user's test set further comprises providing the user's test set with a digital therapy including cognitive behavioral therapy content.

6. The method according to claim 1, wherein administering the digital treatment to the user test set further comprises administering the digital treatment to at least one of the user test set members based on the severity index level of the symptoms related to the condition in at least one of the users.

7. The method according to claim 1, wherein administering the digital placebo to the user's control set further comprises administering a digital placebo containing information about the state to be addressed.

8. The method according to claim 1, further comprising receiving the trial involvement data and the control involvement data, (i) monitoring one or more interactions of the user's trial set with the digital treatment, and (ii) monitoring one or more interactions of the user's control set with the digital placebo.

9. The method according to claim 1, further comprising determining the test value and the control value, (i) the test value indicating the ability of the digital treatment to address the condition, and (ii) the control value indicating the ability of the digital placebo to address the condition.

10. The method according to claim 1, further comprising determining the comparative value, providing feedback that identifies the ability of the digital treatment to the digital placebo based on a comparison of the test value and the control value.

11. It is a system, A data processing system having one or more processors coupled to memory, the data processing system (i) Assign the user's test set to the trial group that will receive a condition-related digital treatment, and (ii) Assign the user's control set to the control group that will receive a digital placebo. (i) an access code for a digital treatment for the user in the user's test set, and (ii) at least one of an access code for a digital placebo for the user in the user's control set. (i) administer the digital treatment to the test set of the user in the test group, and (ii) administer the digital placebo to the control set of the user in the control group. (i) receive trial involvement data from the user's trial set using the digital treatment, and (ii) receive control involvement data from the user's control set using the digital placebo. (i) Determine the test value for the digital treatment based on the trial involvement data, and (ii) determine the control value for the digital placebo based on the control involvement data. The comparative value based on the aforementioned test value and the aforementioned control value is determined, The digital treatment is configured to store the test value, the control value, and the comparison value. system.

12. The system according to claim 11, wherein the data processing system is further configured to provide (i) access to the user's test set of the digital treatment for a defined period, and (ii) access to the user's control set of the digital placebo for a defined period.

13. The system according to claim 11, wherein the data processing system is further configured to (i) provide a trial access code for the digital treatment to another user in the user's trial set, and (ii) provide a control access code for the digital placebo to another user in the user's control set.

14. The data processing system modifies the digital treatment based on the comparison value and provides the updated digital treatment. The system according to claim 11, further configured to administer the updated digital treatment to one or more users using the data processing system.

15. The system according to claim 11, wherein the data processing system is further configured to apply digital therapy, including cognitive behavioral therapy content, to the user's test set.

16. The system according to claim 11, wherein the data processing system is further configured to administer the digital treatment to at least one person in a test set of users based on the severity index level of symptoms related to the condition in at least one user.

17. The system according to claim 11, wherein the data processing system is further configured to apply a digital placebo containing information about the state to be addressed.

18. The system according to claim 11, wherein the data processing system is further configured to monitor (i) one or more interactions of the user's test set with the digital treatment, and (ii) one or more interactions of the user's control set with the digital placebo.

19. The system according to claim 11, wherein the data processing system is further configured to determine (i) the test value indicating the ability of the digital treatment to address the condition, and (ii) the control value indicating the ability of the digital placebo to address the condition.

20. The system according to claim 11, wherein the data processing system is further configured to provide feedback identifying the ability of the digital treatment to the digital placebo based on a comparison of the test value and the control value.

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