Systems, methods and devices for generating and administering 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 priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 047,372, filed July 2, 2020. The disclosure of this prior application is considered part of the disclosure of this application and is incorporated by reference in its entirety herein.

[0002] The present disclosure relates to digital therapeutics, and more particularly to systems, methods and devices for generating and administering placebo and sham digital therapeutics. [Background technology]

[0003] The information provided in this section is intended to provide an overview of the context of the present disclosure. The work of the named inventors and aspects of the present description that may not be prior art at the time of filing this application to the extent described in this section are not admitted, explicitly or implicitly, to be prior art against the present disclosure.

[0004] Drug therapy has played an important role in the treatment of various medical diseases and disorders. Traditional drug therapy involves the administration of pharmaceuticals. Examples of traditional pharmaceuticals include small molecule drugs, which are 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] While drug therapy has proven to be an effective mechanism for treating certain diseases and disorders, it is not without drawbacks. For example, patients undergoing traditional drug therapy may experience unwanted side effects associated with the drugs, administration of traditional drugs can prove difficult, patient adherence to prescribed drug therapy regimens is often difficult to track, and traditional drugs are often quite costly. Thus, digital therapeutics may offer an option as an additional and / or alternative treatment to traditional drug therapy. Summary of the Invention [Problem to be solved by the invention]

[0006] Historically, parameters related to the performance of a digital therapeutic to treat a disease or disorder (e.g., efficacy, safety, patient adherence to a prescribed regimen, reduction in side effects, etc.) have been evaluated relative to traditional drug treatments to treat that disease or disorder. However, traditional systems and methods for comparing treatment options have proven ineffective in evaluating the performance of a digital therapeutic relative to other digital products. [Means for solving the problem]

[0007] One aspect of the present disclosure provides a system for treating a disease or disorder, the system including data processing hardware and memory hardware in communication with the data processing hardware, the memory hardware, when executed on the data processing hardware, causes the data processing hardware to administer a digital therapeutic comprising at least cognitive behavioral therapy content to a first set of one or more users, administer at least one of a sham or placebo digital therapeutic to a second set of one or more users, where the at least one sham or placebo digital therapeutic does not comprise any cognitive behavioral therapy content, and administer a digital therapeutic to a second set of one or more users based on an analysis of the engagement of the first set of one or more users with the digital therapeutic. determining a first efficacy value associated with the digital therapeutic based on an analysis of engagement of the second set of one or more users with the sham or placebo digital therapeutic; determining a second efficacy value associated with the at least one sham or placebo digital therapeutic based on an analysis of engagement of the second set of one or more users with the sham or placebo digital therapeutic; determining a third efficacy value associated with the digital therapeutic based on a comparison of the first efficacy value and the second efficacy value; making modifications to 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 the third set of one or more users.

[0008] Implementations of the present disclosure may include one or more of the following optional features: In some implementations, the third set of one or more users may include some or all users in either the first or second set of users.

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

[0010] Administering the sham digital therapy may include generating text content for display on a display device configured to simulate a conversation with a user of the second set of one or more users. The text content may include at least one of a greeting message, a prompt, a response, or an indication of an end of the simulated conversation.

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

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

[0013] Administering the sham digital treatment may include delivering sham content. Administering the placebo digital treatment may include not delivering content.

[0014] Another aspect of the disclosure is a method of treatment comprising administering, by data processing hardware, a digital therapeutic including at least cognitive behavioral therapy content to a first set of one or more users; administering, by the data processing hardware, at least one of a sham or placebo digital treatment to a second set of one or more users, where the at least one sham or placebo digital treatment does not include any cognitive behavioral therapy content; determining, by the data processing hardware, a first efficacy value associated with the digital treatment based on an analysis of the engagement of the first set of one or more users with the digital treatment; and determining, by the data processing hardware, a first efficacy value associated with the digital treatment based on an analysis of the engagement of the first set of one or more users with the digital treatment. determining, by the data processing hardware, a second efficacy value associated with at least one sham or placebo digital therapeutic based on an analysis of engagement of a second set of one or more users with the sham or placebo digital therapeutic, determining, by the data processing hardware, a third efficacy value associated with the digital therapeutic based on a comparison of the first efficacy value and the second efficacy value, making modifications, by the data processing hardware, to cognitive behavioral therapy content of the digital therapeutic based on the third efficacy value to provide an updated digital therapeutic, and administering, by the data processing hardware, the updated digital therapeutic to the third set of one or more users. This aspect may include one or more of any of the following features.

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

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

[0017] Administering the sham digital therapy may include generating, by the data processing hardware, text content for display on the display device configured to simulate a conversation with a user of the second set of one or more users. The text content may include at least one of a greeting message, a prompt, a response, or an indication of an end of the simulated conversation.

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

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

[0020] Administering the sham digital therapy may include delivering sham content by the data processing hardware. Administering the placebo digital therapy may include delivering no content by the data processing hardware.

[0021] The details of one or more implementations of the disclosure are set forth in the accompanying drawings and the description below. Other aspects, features, and advantages will become apparent from the description and drawings, and from the claims. [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 is a schematic diagram illustrating an exemplary system including a digital therapeutic placebo / sham application in accordance with the principles of the present disclosure. [Diagram 2] 2 is a flowchart illustrating an example pre-study operation of the digital therapeutic placebo / sham application of FIG. [Figure 3A] 2 is a flowchart illustrating an example start-up operation of the digital therapeutic placebo / sham application of FIG. [Figure 3B] 2 is a flowchart illustrating an example treatment group operation of the digital therapeutic placebo / sham application of FIG. [Figure 3C] 2 is a flowchart illustrating an example placebo / sham group operation of the digital therapeutic placebo application of FIG. [Figure 4] 2 is a flowchart illustrating an example study operation of the digital therapeutic placebo / sham application of FIG. [Diagram 5] 1 is a flowchart illustrating an example therapeutic operation of a genuine digital therapeutic application in accordance with the principles of the present disclosure. [Figure 6A] FIG. 2 illustrates a user device having a first graphical user interface of the digital therapeutic placebo / sham application of FIG. [Figure 6B] FIG. 2 illustrates a user device having a second graphical user interface of the digital therapeutic placebo / sham application of FIG. [Figure 7A] FIG. 1 illustrates a user device having a first graphical user interface of an exemplary authentic digital therapeutic application. [Figure 7B] FIG. 7B illustrates a user device having a second graphical user interface of the example real digital therapeutic application of FIG. 7A. [Figure 8] 1 is a flow chart illustrating a method according to the principles of the present disclosure. [Figure 9] FIG. 1 is a schematic diagram illustrating an example computing device that can be used to implement the systems and methods described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Like reference symbols in the various drawings indicate like elements.

[0024] Exemplary embodiments are presented so that the disclosure is thorough and fully conveys the scope to those skilled in the art. Many specific details are described, such as specific systems, components, devices, and methods, so that the embodiments of the present disclosure can be fully understood. Those skilled in the art will appreciate that specific details may not be employed, that the exemplary embodiments may be embodied in many different forms, and that none of these should be construed as limiting the scope of the present disclosure. In some of the exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0025] As shown and described in more detail below, the present disclosure includes systems, methods, and devices for treating various diseases and disorders. More specifically, the present disclosure includes systems, methods, and devices for generating and administering a digital therapeutic placebo and / or a sham digital therapeutic. The systems described herein may include computing components connected via one or more wired or wireless networks to store the digital therapeutic placebo / sham, transmit the digital therapeutic placebo / sham to a user's computing device (e.g., 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 evaluate the performance of the digital therapeutic by comparing the user's interaction with the digital therapeutic to the corresponding digital therapeutic placebo / sham. The methods described herein may include administering the digital therapeutic placebo / sham to a user, evaluating the performance of the digital therapeutic by comparing the user's interaction with the digital therapeutic to the corresponding digital therapeutic placebo / sham, and making changes to the digital therapeutic and / or the digital therapeutic placebo / sham based on the evaluation of performance. The devices described herein may include a computing device (e.g., a server computer, a smartphone, a tablet, a desktop computer, a laptop computer, or any combination thereof) for storing, transmitting, modifying, and / or executing the patient-facing placebo / sham application. The patient-facing placebo / sham application may constitute a mobile application, a web-based application, or any combination thereof.

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

[0027] Additionally, a second group of users (e.g., participants in a study or clinical trial aimed at evaluating the performance of a digital therapeutic for treating a given disease or disorder) may be administered a digital therapeutic placebo / sham not aimed at treating that particular disease or disorder. For example, the digital therapeutic placebo / sham may be provided to a computing device associated with the second group of users from a host server or the like via a networked system, such as the networked system shown in FIG. 1. This second group of users is referred to as the "placebo / sham" or "control" group.

[0028] According to example implementations described herein, the digital therapeutic placebo may be applied content that visually or audibly resembles the therapeutic content (e.g., cognitive behavioral therapy content) but does not actually apply any therapeutic content that can treat the disease or disorder that the corresponding actual or authentic digital therapeutic is intended to treat. In one example implementation, the digital therapeutic placebo may apply substantially no content (e.g., any textual content) and instead generate a blank screen. In another example implementation, the digital therapeutic placebo may provide a timer or the like that does not deliver any therapeutic content that can treat the disease or disorder that the corresponding actual or authentic digital therapeutic is intended to treat. In another example implementation, a second group of users may be placed on a waitlist that does not receive the digital therapy, and instead, the waitlist group may wait to receive the digital therapy and continue to receive standard treatment (i.e., no use of a digital therapy) for that particular disease or disorder suffered from. At some point in the future, the waitlist group may eventually receive the digital therapy.

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

[0030] According to one exemplary embodiment, the digital therapeutic may be configured to treat depressive symptoms associated with one or more diseases or disorders (e.g., multiple sclerosis). According to this embodiment, the sham content generated by the digital therapeutic 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 via the digital therapeutic sham application). Continuing with this embodiment, in a situation in which the user indicates that they are experiencing a state of loneliness, the digital therapeutic sham may generate display data for display on the user's computing device conveying a message such as "isolation impairs immunity, increases the production of stress hormones, is detrimental to sleep, and affects cognitive performance," which message 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. It should be understood that different and / or additional sham content is also contemplated.

[0031] In some implementations, the digital therapeutic placebo / sham delivered to the placebo / sham / control group may include similar functionality and / or content as that included in the corresponding actual digital therapeutic provided to the treatment group. For example, the digital therapeutic placebo / sham may enable the placebo / sham / control group to (i) access and interact with the content via a user's computing device (e.g., the user's mobile device) via a conversational graphical user interface included as part of the digital therapeutic placebo / sham application, (ii) log into 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 the user's computing device that, when selected by the user, launches the digital therapeutic placebo / sham application on the user's computing device. In some implementations, the repetition of a similar conversation scenario may result in the delivery of a copy of the same sham (e.g., psychoeducational) content as in the previous scenario to users in the placebo / sham / control group. That is, the user may not be delivered different sham (e.g., psychoeducational) content over subsequent sessions with the digital therapeutic placebo / sham application.

[0032] In some implementations, the digital placebo / sham application may deliver three daily notifications prompting the user to open the digital placebo / sham application and then display a prescription timer (e.g., a timer clock countdown until the next prescription administration) for the remaining period the application is available (e.g., for the life of the prescription with the treatment diagnosis). The digital placebo / sham application may take into account the non-specific effects of smartphone engagement. However, the digital placebo / sham application may not provide any active coping capabilities (e.g., elements of a psychosocial intervention) and may appear visually similar to the actual digital treatment.

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

[0034] With reference to FIG. 1, in some embodiments, a digital therapeutic placebo / sham system 100 provides a user 101 with access to a digital therapeutic placebo / sham application 120 assigned to the user 101 and monitors events associated with the user's 101 interaction with the digital therapeutic placebo / sham application 120. Although the digital therapeutic placebo / sham application 120 is referred to herein as a "placebo / sham" digital therapeutic, in some implementations, the digital therapeutic placebo / sham application 120 may function similarly to a real digital therapeutic, e.g., a prescription digital therapeutic, such that the user 101 does not know whether he or she is interacting with a real digital therapeutic or a digital therapeutic placebo / sham. A person using or receiving the digital therapeutic placebo / sham may be referred to as a "user." A "user" may include a patient, a user in a placebo / sham or control group, or any other user using or receiving the digital therapeutic placebo / sham application 120.

[0035] Digital therapeutics as used herein may also refer to digital therapeutics configured to provide evidence-based psychosocial intervention techniques to treat patients with a particular disease or disorder and symptoms and / or behaviors associated with the particular disease or disorder. In some implementations, a licensed healthcare provider (HCP) 109 (e.g., a doctor, a nurse, etc.) may oversee the user 101 and assign the user 101 to a digital therapeutic placebo / sham application 120. The HCP 109 may include a doctor, a nurse, a clinician, or other qualified healthcare practitioner. In other implementations, the user 101 may be assigned the digital therapeutic placebo / sham application 120 by any suitable person, such as a person involved in a clinical trial.

[0036] In some embodiments, the system 100 includes a network 106, a user device 102, an optional HCP system 140, and a digital therapeutic placebo / sham application 120. The network 106 provides access to a cloud computing resource 150 (e.g., a distributed system) that executes the placebo / sham application 120 to provide implementation of the service on the remote device. The network 106 may include any type of network that allows for the transmission and reception of communication signals, such as a wireless telecommunications network, a cellular telephone network, a time division multiple access (TDMA) network, a code division multiple access (CDMA) network, a Global System for Mobile Communications (GSM), a third generation (3G) network, a fourth generation (4G) network, a fifth generation (5G) network, a satellite communication network, and other communication networks. The network 106 may include one or more of a wide area network (WAN), a local area network (LAN), and a personal area network (PAN). In some embodiments, the network 106 includes a combination of a data network and a telecommunications network, and a combination of a data and telecommunications network. The user device 102, optional HCP system 140, and placebo / sham application 120 communicate with each other by sending and receiving signals (wired or wireless) over a 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 over the network 106. The term "cloud" services generally refers to services that are not performed locally on a user's device, but are delivered from one or more remote devices accessible over one or more networks 106.

[0037] The user device 102 includes, but is not limited to, a portable electronic device (e.g., a smart phone, a mobile phone, a personal digital assistant, a personal computer, or a wireless tablet device), a desktop computer, or any other electronic device capable of transmitting and receiving information over 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, a mouse, a microphone, and / or a camera that allows a 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, an alarm sound may be output by the speaker to notify the user 101 regarding some time-sensitive event associated with the placebo / sham application 120. In some implementations, the user device 102 executes a user application 103 (or accesses a web-based patient application) for establishing a connection with and accessing the placebo / sham application 120. For example, the user 101 may be able to access the user application 103 during the duration (e.g., three months) of the placebo / sham application 120 assigned to the user 101. Here, the user device 102 may launch the user application 103 by initially providing an access code 104 that enables the user 101 to access content associated with the placebo / sham application 120 when the placebo / sham application 120 is assigned to the user 101.The user application 103, when executed on the data processing hardware 112 of the user device 102, is configured to display various graphical user interfaces (GUIs) on the display 116 of the user device 102 that, among other things, enable the user 101 to interact with the placebo / sham application 120.

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

[0039] The optional HCP system 140 may be located in a hospital, clinic, or facility managed by the HCP 109 and includes data processing hardware 142, memory hardware 145, and a display 146. The memory hardware 144 and the display 146 are in communication with the data processing hardware 142. For example, the data processing hardware 142 may be on a desktop computer or a portable electronic device that allows the HCP 109 to input and retrieve data from the placebo / sham application 120. In some embodiments, the HCP 109 may initially onboard some or all of the user record 105 and / or placebo / sham content 122. In other embodiments, the 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 worker or any other suitable person. The HCP system 140 includes a keyboard 148, a mouse, a microphone, a speaker, and / or a camera. In some implementations, the HCP system 140 (i.e., via data processing hardware 142) executes 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 resources 150 may be a distributed system (e.g., a remote environment) having scalable / elastic resources 152. The resources 152 include computing resources 154 (e.g., data processing hardware) and / or storage resources 156 (e.g., memory hardware). The cloud computing resources 150 execute the placebo / sham application 120 to facilitate communication with the user device 102 and the HCP system 140 and store data in the storage resources 156 in data storage 158. In some embodiments, the data storage 158 is 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 including a set of instructions) executable on the data processing hardware 112 and accessible over the network 106 by the user device 102 upon the user 101 providing a valid access code 104. Similarly, the placebo / sham application 120 may provide the HCP 109 with an HCP application 110 (e.g., a mobile application, a website application, or a downloadable program including a set of instructions) executable on the data processing hardware 142 and accessible by the HCP system 140 via the network 106.

[0041] 2 is a flow chart illustrating a pre-survey operation 200 according to one example implementation of the present disclosure. During the pre-survey operation 200, the system 100 may identify subjects or patients for the study at node 202. The system 100 may then create an allocation list at node 204 that is used in randomizing the subjects or patients at node 206. Patient identification and randomization may be performed by a third party, the party conducting the study, any other suitable party, or any suitable combination of these. During the randomization process, each of the parties may be assigned a unique identifying name or number at node 208.

[0042] 3A-3C are flow charts illustrating application operations 300 according to an exemplary implementation of the present disclosure. Referring to FIG. 3A, a start operation 300 is shown in schematic form. At start operation 310, the system 100 may allow the patient to download a user application 103, for example, via an app store, at node 312. During a login process at node 314, the patient may provide an access code 104 at node 316, which may allow the patient to complete the login process, for example, create a password, create a username, etc., at node 318. At start operation 310, patients in each group (e.g., treatment group and placebo / sham group) may go through a generally similar process such that the patient does not know which group they are in. For example, a patient in the placebo / sham group may not know whether they are in the placebo / sham group or the treatment group.

[0043] 3B, there is shown a schematic of a treatment group operation 320. During the treatment group operation 320, patients in the study group receive treatments, illustrated as a first notifying treatment 324 and a second notifying treatment 326, and check in with the HCP 109 at node 322, by interaction with the user application 103, a face-to-face interview, or any other suitable means.

[0044] 3C, a placebo / sham group operation 330 is shown in schematic form. During the placebo / sham group operation 330, a patient in the placebo / sham group may be presented with a digital therapeutic placebo / sham application 120, for example, via interaction with a user application 103, textual content not demonstrated to treat the disease or disorder that the corresponding actual digital treatment is designed to treat (e.g., textual content shown in Table 1), visual content not demonstrated to treat the disease or disorder that the corresponding actual digital treatment is designed to treat, audio content not demonstrated to treat the disease or disorder that the corresponding actual digital treatment is designed to treat, or any combination thereof. Such content may be part of a sham digital treatment.

[0045] In other implementations, the digital therapeutic placebo / sham application 120 may administer a placebo digital therapeutic that includes the same start operation 310 as the sham digital therapeutic and the real digital therapeutic, but the placebo digital therapeutic presents substantially no content after the start operation 310. As one example, the placebo digital therapeutic may generate and display a blank screen on the display 116. As another example, the placebo digital therapeutic may generate and display a timer, such as a countdown timer, on the display 116.

[0046] In some implementations, the digital therapeutic placebo / sham application 120 may present the patient with a first placebo notification 332 and a second placebo notification 334 (e.g., by displaying 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 (e.g., 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, 338 may include textual statements 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 a first prompt to the patient such as "how are you feeling?". At node 342, the digital therapeutic placebo / sham application 120 may receive an indication of a user emotion from the patient, for example, via the patient's interaction with the user application 103. In some implementations, the digital therapeutic placebo / sham application 120 may present the patient with multiple selectable emotions such as lonely, angry, afraid, sad, stressed, depressed, frustrated, shame, happy, optimistic, proud, motivated, sympathetic, loving, calm, okay, etc., as shown in Table 1. In other implementations, the patient may enter their emotion via a free text input field, speak their emotion, or present their emotion in any suitable manner.

[0047] At nodes 344 and 346, the digital therapeutic placebo / sham application 120 may present a first sentence and a second sentence, respectively, to the user based on the selected emotion. As shown in Table 1, the first and second sentences 344, 346 may include general facts or relatively general information about the selected emotion, the particular disease or disorder being treated, other data, etc. For example, if the patient selects "anger" as their emotion, the digital therapeutic placebo / sham application 120 may display on the display 116, "The total incidence of inappropriate, intense, or poorly controlled anger in the U.S. population is 7.8%," which corresponds to "Sham Anger 1" in Table 1. As shown in Table 1, the digital therapeutic placebo / sham application 120 may present multiple sentences to the patient at nodes 344 and 346 if the patient selects the same emotion multiple times. For example, if the patient selects this emotion as their emotion after already selecting "anger," the digital therapeutic placebo / sham application 120 may display on the display 116 "The increased blood pressure and other physical changes associated with anger can make it harder to think coherently and impair your mental and physical health," which corresponds to "Sham Anger 2" in Table 1. If the patient again selects "anger" as their emotion, in some implementations, the digital therapeutic placebo / sham application 120 will present a sentence that corresponds to "Sham Anger 1." In other implementations, the digital therapeutic placebo / sham application 120 may include several different sentences to present to the patient.

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

[0049] [Table 1] TIFF2024180435000003.tif244155 TIFF2024180435000004.tif51167

[0050] Referring to FIG. 4, the survey operations 400 are shown generally in the form of a flow chart. As mentioned above, the experience of the treatment group patient in downloading the user application 103 and receiving the access code 104 may be substantially similar to the experience of the placebo / sham group patient. That is, at node 402, the user application 103 may be downloaded and the patient may enter their unique access code 104. Based on the access code 104, the digital therapeutic placebo / sham application 120 determines whether the patient belongs to the treatment group or the placebo / sham group. If the digital therapeutic placebo / sham application 120 determines that the patient belongs to the treatment group, then at node 404, the real digital therapeutic performs initial onboarding including username setup, password setup, etc. If the digital therapeutic placebo / sham application 120 determines that the patient belongs to the placebo / sham group, then at node 406, the digital therapeutic placebo / sham application 120 performs the application operations 300 as described above and illustrated in FIGS. 3A-3C. After determining that the patient corresponds to the treatment group, the real digital therapeutic grants the patient access to the treatment version of the user application 103 at node 408. The real digital therapeutic then performs an onboarding process at node 410 to prepare the patient for treatment. The real digital therapeutic then performs treatment for the patient at node 420.

[0051] A patient's treatment may be tailored to the particular disease or disorder the patient is experiencing or suffering from, and in some implementations, the treatment includes at least cognitive behavioral therapy content. By way of example, a treatment 420 is shown and described with reference to FIG. 5 for treating depressive symptoms and disorders associated with multiple sclerosis. At node 422, the patient may check in to the authentic digital therapeutic via user application 103. In some implementations, the patient may check in via one or more application notifications 424 displayed on display 116. Upon checking in, the authentic digital therapeutic may receive an indication of a positive emotion (thus proceeding to the first pathway and node 426) or a negative emotion (thus proceeding to the second pathway and node 428) from the patient. In the first pathway, at node 430, the authentic digital therapeutic may receive an indication of one or more symptoms from the patient. As an example, if the identified symptom is fatigue, the authentic digital therapeutic presents a fatigue check-in at node 432. The real digital therapeutic receives an indication from the patient at node 434 of what type of fatigue they have, and an indication of how severe the fatigue is at node 436, the real digital therapeutic then presents the patient video at node 438 and returns to path 1 at node 440.

[0052] At node 440, the real digital therapeutic receives the status from the patient and then displays a catch-check-change module at node 442. After the real digital therapeutic instructs the patient to create alternative thoughts at node 444, the real digital therapeutic presents a thought journal at node 446, which can be used for data insights 448. In some implementations, the real digital therapeutic may present a mindfulness audio 450 to the patient.

[0053] In path 2, if the real digital therapeutic receives an indication that the patient is experiencing positive emotions, the real digital therapeutic receives from the patient a situation at node 452 and a positive reflection at node 454. After the real digital therapeutic instructs the patient to create positive thoughts at node 456, the real digital therapeutic presents a thought journal at node 446, which can be used in data insights 448.

[0054] In some implementations, the digital therapeutic placebo / sham application 120 may provide emotional psychoeducational content in place of clinical content. In some implementations, the same sham content may be presented to the user if the user enters the same conversation scenario and / or responses.

[0055] 6A, a login graphical user interface (GUI) 600 is shown diagrammatically 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. The 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 the 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 element.

[0056] Once the user has entered the above information and selected enter GUI 608, the digital therapeutic placebo / sham application 120 may generate and display a placebo / sham GUI 610 as shown in FIG. 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, a simulated conversation to deliver the sham content, etc.

[0057] Referring to FIG. 7A, a login GUI 650 is shown diagrammatically on the display 116 of the user device 102. The login GUI 650 has the same appearance as the login GUI 600 described above such that the user 101 does not know whether the user 101 is being delivered a real digital treatment or a placebo / sham digital treatment. The login GUI 650 may include a username GUI element 652, a password GUI element 604, and an access code GUI element 606. The user 101 may interact with the username GUI element 652, the password GUI element 654, and the access code GUI element 656 to enter the user's username, password, and access code 104, respectively. The login GUI 650 may be generated by the real digital treatment 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 element.

[0058] Once the user has entered the above information and selected the enter GUI button 658, the authentic digital therapeutic application may generate and display a digital therapeutic GUI 660 as shown in FIG. 7B. Using a digital therapeutic to treat symptoms associated with multiple sclerosis as an example as described above, the digital therapeutic GUI 660 may include a selectable negative emotion GUI element 662 and a selectable positive emotion GUI element 664. For example, the user 101 may select the negative emotion GUI element 662 to begin following a first path as described above and shown in FIG. 5. For example, the user 101 may select the positive emotion GUI element 664 to begin following a second path as described above and shown in FIG. 5. In other implementations, the digital therapeutic GUI 660 may include any suitable cognitive behavioral therapy content, such as those described above by way of example only.

[0059] 8, a treatment method 800 is shown generally in the form of a flow chart. At step 802, the method 800 includes administering a digital treatment to a first set of one or more users, the digital treatment including at least cognitive behavioral therapy content. For example, the first set of one or more users may include a treatment group that receives a digital treatment including cognitive behavioral therapy content, such as treatment 420 for a user diagnosed with multiple sclerosis.

[0060] At step 804, the method 800 includes administering at least one of a sham or placebo digital treatment to a second set of one or more users, where the at least one sham or placebo digital treatment does not include any cognitive behavioral therapy content. For example, the second set of one or more users may include a placebo / sham group. In some implementations, the placebo / sham group may be administered 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. In some implementations, the placebo / sham group may be administered a sham digital treatment in which sham content is delivered, such as the content described in Table 1 and illustrated in FIG. 3C.

[0061] At step 806, the method 800 includes determining a first efficacy value associated with the digital therapeutic based on an analysis of the engagement of the first set of one or more users with the digital therapeutic. For example, the digital therapeutic placebo / sham application 120 may monitor and analyze the extent, duration, frequency, etc. of the therapeutic group's interaction with the user application 103 to determine the first efficacy value. In some implementations, the first efficacy value is a numerical value or score, a percentage, or any suitable type of value. In some implementations, the first efficacy value may be determined by comparing the effect of the actual or real digital therapeutic on the user across one or more parameters (e.g., efficacy, safety, patient adherence to a prescribed regimen, reduction in side effects, etc.) to the effect of a drug on the user across one or more of the same parameters.

[0062] At step 808, the method 800 includes determining a second efficacy value associated with the at least one sham or placebo digital therapeutic based on an analysis of the engagement of the second set of one or more users with the sham or placebo digital therapeutic. For example, the digital therapeutic placebo / sham application 120 may monitor and analyze the extent, duration, frequency, etc. of the placebo / sham group's interaction with the user application 103 to determine the second efficacy value. In some implementations, the second efficacy value is a number or score, a percentage, or any suitable type of value.

[0063] At step 810, the method 800 includes determining a third efficacy value associated with the digital therapeutic based on a comparison of the first efficacy value to the second efficacy value. For example, the digital therapeutic placebo / sham application 120 may compare the first efficacy value to the second efficacy value to determine the third efficacy value. In some implementations, the third efficacy value is a number or score, a percentage, or any suitable type of value. The third efficacy value may provide feedback regarding the efficacy of the digital therapeutic compared to a placebo / sham digital therapeutic, which may serve as a control.

[0064] In some implementations, the method 800 may include step 812, which includes making changes to the cognitive behavioral therapy content of the digital therapeutic based on the third efficacy value to provide an updated digital therapeutic. For example, the digital therapeutic placebo / sham application 120 may make changes to the cognitive behavioral therapy content (e.g., text, audio, and / or visual content) delivered to the treatment group based on the feedback received from the third efficacy value, i.e., a comparison of the efficacy of the digital therapeutic to the efficacy of a sham or placebo digital therapeutic.

[0065] In some implementations, method 800 may include step 814, which includes administering the updated digital therapeutic to a third set of one or more users. The third set of one or more users may include some or all users of either the first or second set of users. For example, the updated digital therapeutic may be administered to the same users that formed the basis of the third efficacy value (i.e., a determination of the efficacy of the digital therapeutic), or the updated digital therapeutic may be administered to a set of users that were not involved in the original efficacy analysis.

[0066] 9 is a schematic diagram illustrating an example 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 represent 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 functionality are intended to be exemplary only and are not intended to limit the implementation of the invention described and / or claimed herein.

[0067] The electronic device 900 includes a processor 910, a memory 920, a storage device 930, a high-speed interface / controller 940 that connects to the memory 902 and a high-speed expansion port 950, and a low-speed interface / controller 960 that connects to a low-speed bus 970 and the storage device 930. Each of the components 910, 920, 930, 940, 950, and 960 are interconnected using various buses and may be implemented on a common motherboard or in other manners as appropriate. The processor 910 can process instructions for execution within the electronic device 900, including instructions stored in the memory 920 or the storage device 930, to display graphical 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 memories. Also, multiple electronic devices 900 may be connected (eg, as a server bank, a group of blade servers, or a multi-processor system) with each device providing a portion of the required operations.

[0068] The memory 920 stores information non-transiently in the electronic device 900. The memory 920 may be a computer-readable medium, a volatile memory unit, or a non-volatile memory unit. The 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 (e.g., typically used for firmware such as boot programs), and read-only memory (ROM) / programmable read-only memory (PROM) / erasable programmable read-only memory (EPROM) / electronically erasable programmable read-only memory (EEPROM). 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 disk or tape.

[0069] The storage device 930 can provide mass storage for the electronic device 900. In some implementations, the storage device 930 is a computer-readable medium. In various different implementations, the storage device 930 can be 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 configuration. In other implementations, a computer program product can be tangibly embodied in an information carrier. The computer program product includes instructions that, when executed, perform one or more methods, such as the methods described above. The information carrier is a computer-readable or machine-readable medium, such as the memory 920, the storage device 930, or a memory on the processor 910.

[0070] The high-speed controller 940 manages the bandwidth-intensive operations of the electronic device 900, while the low-speed controller 960 manages the less bandwidth-intensive operations. This functional allocation is merely exemplary. In some implementations, the high-speed controller 940 is coupled to a memory 920, a display 980 (e.g., via a graphics processor or accelerator), and a high-speed expansion port 950 that can accept various expansion cards (not shown).

[0071] The electronic device 900 can be implemented in a number of 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 techniques described herein may be realized in digital electronic and / or optical circuitry, integrated circuits, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and / or combinations thereof. These various implementations may include implementation in one or more computer programs executable and / or interpretable on a programmable system including at least one programmable processor, which may be special purpose or general purpose, coupled to receive data and instructions from and transmit data and instructions to a storage system, at least one input device, and at least one output device.

[0073] These computer programs (also referred to as programs, software, software applications or codes) contain machine instructions for a programmable processor and may be implemented in high-level procedural and / or object-oriented programming languages ​​and / or in assembly / machine language. As used herein, the terms "machine-readable medium" and "computer-readable medium" refer to any computer program product, non-transitory computer-readable medium, apparatus and / or device (e.g., magnetic disk, optical disk, memory, programmable logic device (PLD)) used to provide machine instructions and / or data to a programmable processor, including a machine-readable medium that receives the 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.

[0074] A software application (or software resource) may refer to computer software that causes a computing device to perform a task. In some embodiments, a software application may be referred to as an "application," an "app," or a "program." Examples of applications include, but are not limited to, system diagnostic applications, system management applications, system maintenance applications, word processing applications, spreadsheet applications, messaging applications, media streaming applications, social networking applications, and gaming applications.

[0075] The term "module" as used herein may refer to hardware, software, firmware, or any combination thereof. The processes and logic flows described herein may be performed by one or more programmable processors, also referred to as data processing hardware, that execute one or more computer programs to perform functions by performing operations on input data and generating output. The processes and logic flows may also be performed by special purpose logic circuitry, for example, an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit). Processors suitable for executing computer programs include, for example, both general purpose and special purpose microprocessors, and any one or more processors of any type of digital computer. Generally, a processor receives instructions and data from a read-only memory or a random access memory or both. The 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 example magnetic, magneto-optical, or optical disks, for storing data, or is operatively coupled to receive and / or transfer data from them. However, a computer need not 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 including, for example, semiconductor memory devices, such as EPROM, EEPROM and flash memory devices, magnetic disks, such as internal hard disks or removable disks, magneto-optical disks, CD ROM and DVD-ROM disks. The processor and memory can be supplemented by, or incorporated in, special purpose logic circuitry.

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

[0077] Although several implementations have been described above, it should be understood that various modifications can be made without departing from the spirit and scope of the present disclosure. Accordingly, other implementations are within the scope of the following claims.

Claims

1. 1. A system for treating a disease or disorder, comprising: Data processing hardware; and memory hardware in communication with the data processing hardware, the memory hardware, when executed on the data processing hardware, administering a digital therapy to a first set of one or more users, the digital therapy including at least cognitive behavioral therapy content; administering to a second set of one or more users at least one of a sham or placebo digital treatment, wherein the 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 therapeutic based on an analysis of the first set of engagement of one or more users with the digital therapeutic; determining a second efficacy value associated with the at least one sham or placebo digital treatment based on an analysis of the second set of engagement of one or more users with the sham or placebo digital treatment; determining a third efficacy value associated with the digital therapeutic based on a comparison of the first efficacy value and the second efficacy value; making changes to the cognitive behavioral therapy content of the digital therapeutic based on the third efficacy value to provide an updated digital therapeutic; and and administering the updated digital therapy to a third set of one or more users.

2. The system of claim 1 , wherein the third set of one or more users may include some or all users in the first or second set of users.

3. administering the sham digital treatment, 2. The system of claim 1, further comprising: delivering one or more sentences corresponding to general information related to at least one of an emotion, a disease, a disorder, or a condition associated with a user of the second set of one or more users.

4. 4. The system of claim 3, wherein the one or more sentences are delivered in response to the data processing hardware receiving, from a user of the second set of one or more users, an indication of an emotion, illness, disorder or condition associated with the user of the second set of one or more users.

5. administering the sham digital treatment, 10. The system of claim 1, further comprising generating textual content for display on a display device configured to simulate a conversation with a user of the second set of one or more users.

6. The system of claim 5 , wherein the textual content includes at least one of a greeting message, a prompt, a response, or an indication of an end of the simulated conversation.

7. administering the placebo digital treatment, The system of claim 1 , further comprising generating graphical content for display on a display device, the graphical content comprising a timer.

8. administering the placebo digital treatment, The system of claim 1 including generating a blank screen for display on a display device.

9. 10. The system of claim 1, wherein administering the sham digital therapy comprises delivering sham content.

10. 10. The system of claim 1, wherein administering the placebo digital treatment comprises not delivering content.

11. 1. A method of treatment comprising: administering, by the data processing hardware, a digital therapy including at least cognitive behavioral therapy content to a first set of one or more users; administering, by the data processing hardware, to a second set of one or more users, at least one of a sham or placebo digital treatment, wherein the at least one sham or placebo digital treatment does not include any cognitive behavioral therapy content; determining, by the data processing hardware, a first efficacy value associated with the digital therapeutic based on an analysis of the first set of engagement of one or more users with the digital therapeutic; determining, by the data processing hardware, a second efficacy value associated with the at least one sham or placebo digital treatment based on an analysis of the second set of one or more users' engagement with the sham or placebo digital treatment; determining, by the data processing hardware, a third efficacy value associated with the digital therapeutic based on a comparison of the first efficacy value and the second efficacy value; modifying, by the data processing hardware, the cognitive behavioral therapy content of the digital therapeutic based on the third efficacy value to provide an updated digital therapeutic; administering, by the data processing hardware, the updated digital therapy to a third set of one or more users.

12. The method of claim 11 , wherein the third set of one or more users may include some or all users in the first or second set of users.

13. administering the sham digital treatment, 12. The method of claim 11, comprising delivering, by the data processing hardware, one or more sentences corresponding to general information related to at least one of an emotion, a disease, a disorder or a condition associated with a user of the second set of one or more users.

14. 14. The method of claim 13, wherein the one or more sentences are delivered in response to the data processing hardware receiving, from a user of the second set of one or more users, an indication of an emotion, illness, disorder or condition associated with the user of the second set of one or more users.

15. administering the sham digital treatment, 12. The method of claim 11, comprising generating, by the data processing hardware, textual content for display on a display device configured to simulate a conversation with a user of the second set of one or more users.

16. The method of claim 15 , wherein the textual content includes at least one of a greeting message, a prompt, a response, or an indication of an end of the simulated conversation.

17. administering the placebo digital treatment, The method of claim 11 , comprising generating, by the data processing hardware, graphical content for display on a display device, the graphical content including a timer.

18. administering the placebo digital treatment, The method of claim 11 , comprising generating, by the data processing hardware, a blank screen for display on a display device.

19. 12. The method of claim 11, wherein administering the sham digital therapy comprises delivering sham content by the data processing hardware.

20. 12. The method of claim 11, wherein administering the placebo digital treatment comprises not delivering content by the data processing hardware.

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