A platform for dynamic selection of messages to users in real time via decision support tools

Abstract

Provided herein are systems and methods for dynamically providing messages to a user at risk for migraine based on an indication of the condition. A server can maintain in a database an identification of a set of activities for users at risk for migraine, each activity having a set of messages to be presented according to a rule. The server can receive an indication via a user interface identifying a user's condition related to migraine. The server can select an activity to provide to the user for a session based on the user's condition identified in the response. The server can identify a message from the set of messages according to the rule of the activity. The server can cause the message identifying the activity to be presented via the user interface.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 327,662, filed April 5, 2022, U.S. Provisional Application No. 63 / 437,456, filed January 6, 2023, and U.S. Provisional Application No. 63 / 437,466, filed January 6, 2023, each of which is incorporated by reference in its entirety herein. [Background technology]

[0002] Migraine is a type of headache that causes severe pain and often includes other symptoms such as nausea, sensitivity to light and sound, and impaired judgment. Migraine attacks can last from a few hours to several days. Certain people, called "migraineurs," may experience migraines multiple times a month. Migraine headaches are known to interfere with the migraine sufferer's daily activities and responsibilities, impairing their well-being and productivity.

[0003] In pharmaceutical approaches, migraine sufferers may take acute medications to reduce the severity of migraine pain. There are also preventative medications to minimize the chances that a migraine sufferer will experience a migraine. These medications require a prescription, and the migraine sufferer must often decide on their own when the appropriate time to take the medication is, which often involves an analysis of a variety of factors, such as whether the pain is severe enough to justify using a portion of the medication and whether the medication is likely to run out before the prescription can be refilled. These analyses are therefore subjective for each migraine sufferer and are often done while the migraine sufferer is experiencing impaired judgment, one of the symptoms of migraine. Furthermore, many migraine medications are most effective when taken at the right time. For example, certain acute medications are most effective when taken within 1-2 hours of the onset of a migraine headache. Summary of the Invention [Problem to be solved by the invention]

[0004] Administering migraine medications can present various challenges. For example, migraine sufferers may make decisions to take or not take medications that the prescribing physician is unlikely to agree with. However, migraine sufferers are often forced to make such decisions without the assistance of their prescribing physician or other health care provider, for reasons such as difficulty in contacting them during a headache. For example, migraine sufferers are unlikely to be able to schedule and attend appointments while experiencing a migraine, and even if they were able to do so, they would likely exacerbate the migraine sufferer's pain or other symptoms. As a result, migraine sufferers may be even less likely to take acute medications within two hours of the onset of a migraine headache.

[0005] To compound these problems, obtaining prompt help, such as contacting a clinician (e.g., a doctor or nurse), may not be practical, especially if the clinician is not available during a migraine attack, which can be a frustrating experience and thus increase migraine symptoms, and may be better off not contacting them in the first place. Furthermore, when a subject is experiencing a migraine attack, it may be physically difficult for the subject to operate a device to access a digital therapeutic, let alone contact a clinician to receive treatment. [Means for solving the problem]

[0006] To address these and other technical challenges, the service in this disclosure is a decision support tool or digital support tool (DST) to provide timely recommendations for activities to reduce the number of migraines a user experiences or the user's difficulty in managing migraines. The service can utilize the user's condition to select and present messages to provide a digital therapeutic to a given user. The service can select which activity among multiple activities to send to the user. The activity can include different messages to present to the user, such as via the user's mobile device. The purpose of each different activity and corresponding message is to reduce the number of migraines the user experiences or the user's difficulty in managing migraines.

[0007] The service can identify activities to present to the user via the device based on the user's state. The state can include migraine state, emotional state, and other assessed characteristics of the user. The migraine state can be the onset, presence, or absence of a migraine. The emotional state can be the user's calmness, mental stamina, and time availability. The characteristics can be migraine symptoms, vocal biomarkers, mood, or the user's engagement level. The state can include combinations of the above.

[0008] Using the user's condition, the service can select activities and relevant messages for the user. The activities can be classified as calming or energizing activities. The activities can be classified based on a threshold of the user's availability. The activities can be classified based on whether the user is experiencing the onset, presence, or absence of a migraine. The activities can be classified based on a combination of the above. The activities can also provide behavioral therapy, such as cognitive behavioral therapy, biofeedback, and relaxation therapy, which can help treat migraines. The service can also time the delivery or presentation of messages to the user so that the user does not need to actively access a digital therapeutic application on the device while suffering from a migraine. Furthermore, as the service acquires additional data about the user, the service can select activities and messages that are more targeted to the particular user and their condition.

[0009] In this way, the user can easily receive more timely help to alleviate migraines even when suffering from migraines that may inhibit the user from seeking treatment. This can reduce or eliminate barriers for the user to not only physically access the device but also to contact a doctor or healthcare provider to seek help while at risk for a migraine. Furthermore, the service can provide quick and objective advice that the user can rely on instead of the user's own subjective judgment that may be impaired due to a current migraine. By selecting messages sent to the user to correspond to the subject's current condition, the quality of human computer interactions (HCI) between the user and the device can be improved. Furthermore, because the messages are more relevant to the user's condition, unnecessary consumption of computational resources (e.g., processing and memory) and network bandwidth of the service and the user device can be reduced compared to sending ineffective messages. Furthermore, in the context of digital therapeutic applications, such personalized selection of messages can result in the delivery of user-specific interventions to improve the subject's adherence to the treatment. This can result in not only improved adherence to the therapeutic intervention but also improvement in the subject's migraine attacks as described herein.

[0010] An aspect of the disclosure relates to a system for dynamically providing messages. The system may include a computing system having one or more processors coupled with a memory. The computing system may maintain, on a database, an identification of a set of activities for addressing migraines for a user at risk for migraines. Each of the sets of activities may have a set of messages to be presented according to a rule. The computing system may receive, via a user interface, an indication identifying a migraine condition of the user as having one of onset, presence, or absence of a migraine. The computing system may select an activity from the set of activities to provide to the user based on the migraine condition of the user identified in the response. The computing system may identify a message from the set of messages according to the rule of the activity. The computing system may cause the message identifying the activity to be presented via the user interface.

[0011] In some embodiments, the computing system can maintain a timer that identifies an amount of time that has elapsed since the presentation of a previous message via the user interface. In response to the time passing a threshold, the computing system can provide a user interface that prompts an indication of the user's migraine condition. In some embodiments, the computing system can provide a user interface that prompts an indication of the user's migraine condition according to a schedule.

[0012] In some embodiments, the computing system can select an activity from a set of activities based on a user's migraine condition, the set of activities can include (i) a first activity having a set of messages related to preventing the onset of a migraine, (ii) a second activity having a set of messages related to alleviating the presence of a migraine, or (iii) a third activity having a set of messages related to maintaining the absence of a migraine.

[0013] In some embodiments, the computing system can receive, via the user interface, a response identifying an activity performed by the user in response to the presentation of the message for the activity. The computing system can update, in the database, a profile of the user to include the response identifying the activity performed by the user. In some embodiments, the computing system can identify a message from the set of messages for the activity according to a rule based on at least one of: (i) a selection of a second activity in response to a previous message, (ii) a response by the user to the presentation of the previous message, (iii) a number of activities performed by the user, or (iv) a medication taken by the user.

[0014] In some embodiments, the computing system can identify a group of messages to present from the set of messages in time according to a rule. In some embodiments, the computing system can select an activity from the set of activities based on at least one of: (i) a number of migraine occurrences in the user, (ii) a duration of previous occurrences of migraine, or (iii) a medication taken by the user. In some embodiments, the computing system can provide instructions to an application on the user device to present a message to the user associated with the application.

[0015] In some embodiments, the computing system can identify from the instructions a set of emotional states including the user's calmness, time availability, and mental stamina. The computing system can select an activity from the set of activities based on the set of emotional states and the migraine state. In some embodiments, the computing system can identify from the instructions at least one characteristic of the user from a set of characteristics to be evaluated. The set of characteristics can include one or more of migraine symptoms, vocalization biomarkers, mood, and engagement level. The computing system can select an activity from the set of activities based on the at least one characteristic and the migraine state. In some embodiments, the user can receive medication to address the migraine at least partially in parallel with the activity.

[0016] Aspects of the present disclosure relate to a system for dynamically providing messages. The system may include a computing system having one or more processors coupled with a memory. The computing system may maintain, in a database, an identification of a set of activities for addressing migraines for users at risk for migraines. Each of the sets of activities may have a set of messages to be presented according to a rule. The computing system may receive, via a user interface, an instruction identifying at least one in a set of emotional states of the user. The computing system may select an activity to provide to the user from the set of activities based on the instruction. The computing system may identify a message from the set of messages according to the rule of the activity. The computing system may cause the message identifying the activity to be presented via the user interface.

[0017] In some embodiments, the computing system can identify from the instructions a set of emotional states including the user's composure, time availability, and mental stamina. The computing system can select an activity from the set of activities based on the set of emotional states. In some embodiments, the computing system can identify from the instructions at least one in the set of emotional states as a time availability that identifies an amount of time available to the user to perform at least one in the set of activities. The computing system can select an activity from the set of activities based on a comparison of the amount of available time to a threshold time. The set of activities can include (i) a first activity associated with the amount of available time exceeding the threshold time, and (ii) a second activity associated with the amount of available time not exceeding the threshold time.

[0018] In some embodiments, the computing system can identify, from the instructions, a migraine state of the user as having one of a migraine onset, presence or absence. The computing system can select an activity from the set of activities based on the set of migraine state and the emotional state of the user. In some embodiments, the computing system can identify, from the instructions, at least one characteristic of the user from a set of characteristics to be evaluated. The set of characteristics can include one or more of migraine symptoms, vocalization biomarkers, mood and engagement level. The computing system can select an activity from the set of activities based on the at least one characteristic.

[0019] In some embodiments, the computing system can identify from the instructions: (i) at least one characteristic of the user from the set of characteristics to be evaluated; and (ii) a migraine state of the user. The computing system can select an activity based on a combination of the set of emotional states, the at least one characteristic, and the migraine state. In some embodiments, the computing system can identify a group of messages to present in time from the set of messages according to a rule. In some embodiments, the computing system can maintain a timer that identifies an elapsed time since the presentation of a previous message via the user interface. The computing system can provide a user interface that prompts an indication of a set of emotional states of the user in response to the time passing a threshold value.

[0020] In some embodiments, the computing system can provide a user interface that prompts an indication of a set of emotional states of the user according to the schedule. In some embodiments, the computing system can receive a response via the user interface identifying an activity performed by the user in response to the presentation of the activity message. The computing system can update a profile in the database to include the response identifying the activity performed by the user. In some embodiments, the user can receive medication to address the migraine headache at least partially in parallel with the activity.

[0021] An aspect of the disclosure relates to a method for reducing a user's migraine days. The method can include presenting, by a computing device, to a user at risk for migraine at a first time instance, a first message identifying a first activity in a set of activities. The first activity can be selected from the set of activities based on a first indication in the user's first migraine state as one in a set of migraine states. The migraine state can include one or more of onset, presence or absence of migraine. The method can include obtaining, by the computing device, a first metric associated with the user prior to the first activity. The method can include repeating, by the computing device, the presentation, by the computing device, to the user at a second set of time instances, each second message identifying a second activity in the set of activities. The second activity can be selected from the set of activities based on a second indication in the user's second migraine state as one in the set of migraine states. The method can include obtaining, by the computing device, a second metric associated with the user after a second set of time instances. The method may indicate that the user has a reduction in migraine days if the second metric is lower than the first metric from the first time instance.

[0022] In some embodiments, the set of activities may include (i) a first activity having a set of messages related to preventing the onset of migraines, (ii) a second activity having a set of messages related to alleviating the presence of migraines, or (iii) a third activity having a set of messages related to maintaining the absence of migraines. In some embodiments, the first metric at the first time instance may include a first pain catastrophizing scale (PCS) score at baseline. The second metric at the end of the second set of time instances may include a second PCS. In some embodiments, the first metric at the first time instance may include a first PCS score at baseline. The second metric may include a second PCS after at least one of the second set of time instances.

[0023] In some embodiments, the first metric at the first time instance may include a first number of monthly migraine days (MMDs) at baseline. The second metric at the end of the second set of time instances may include a second number of MDDs. In some embodiments, the first metric at the first time instance may include a first number of MDDs at baseline. The second metric may include a second number of MDDs after at least one of the second set of time instances. In some embodiments, the migraine may include at least one of complex migraine, common migraine, subclinical migraine, hemiplegic migraine, or retinal migraine.

[0024] In some embodiments, the user may receive medication to address the migraine headaches at least partially in parallel over at least one of the first time instance or the second set of time instances, The medication may include at least one of a triptan, ibuprofen, ergo, or a calcitonin gene-related peptide (CGRP) inhibitor.

[0025] An aspect of the disclosure relates to a method for reducing a number of migraine days for a user. The method may include presenting, by a computing device, to a user at risk for migraine at a first time instance, a first message identifying a first activity of the set of activities. The first activity may be selected from the set of activities based on a first indication of the first set in the user's first emotional state. The method may include obtaining, by the computing device, a first metric associated with the user prior to the first activity. The method may include repeating, by the computing device, the presentation, by the computing device, to the user at a second set of time instances, each second message identifying a second activity of the set of activities. The second activity may be selected from the set of activities based on a second indication in the second set of the user's emotional state. The method may include obtaining, by the computing device, a second metric associated with the user after the second set of time instances. The user may indicate a reduction in migraine days if the second metric is lower than the first metric from the first time instance.

[0026] In some embodiments, the first set of emotional states and the second set of emotional states may each include the user's composure, mental stamina, and time availability. In some embodiments, at least one of the user's first emotional state and second emotional state may specify the user's time availability. The set of activities may include (i) activities associated with time availability exceeding a threshold and (ii) activities associated with time availability not exceeding a threshold.

[0027] In some embodiments, the first metric at the first time instance may include a first Pain Severity Scale (PCS) score at baseline. The last second metric in the set of second time instances may include a second PCS. In some embodiments, the first metric at the first time instance may include a first PCS score at baseline and the second metric may include a second PCS after at least one of the set of second time instances. In some embodiments, the first metric at the first time instance may include a first monthly migraine days (MDDs) at baseline. The last second metric in the set of second time instances may include a second number of MDDs.

[0028] In some embodiments, the first metric at the first time instance can include a first number of MDD days at baseline, and the second metric can include a second number of MDD days after at least one of the set of second time instances. In some embodiments, the migraine can include at least one of complex migraine, general migraine, subclinical migraine, hemiplegic migraine, or retinal migraine. In some embodiments, the user is taking a medication to address the migraine headaches at least partially in parallel over at least one of the first time instance or the set of second time instances. The medication can include at least one of a triptan, ibuprofen, ergo, or a calcitonin gene-related peptide (CGRP) inhibitor.

[0029] An aspect of the disclosure relates to a method for reducing a number of migraine days for a user. The method may include presenting, by a computing device, to a user at risk for migraine at a first time instance, a first message identifying a first activity of a set of activities. The first activity may be selected from the set of activities based on a first instruction in a first migraine state and a first set of emotional states. The method may include obtaining, by the computing device, a first metric associated with the user prior to the first activity. The method may include repeating the presentation, by the computing device, to the user at a second time instance, of a separate second message identifying a second activity in the grounding of the activity. The second activity may be selected from the set of activities based on a second instruction in a second migraine state and a second set of emotional states. The method may include obtaining, by the computing device, a second metric associated with the user after a second set of time instances. The user may indicate a reduction in migraine days if the second metric is lower than the first metric from the first time instance.

[0030] In some embodiments, the first migraine condition and the second migraine condition can include one or more of onset, presence or absence of migraine. In some embodiments, the first set of emotional states and the second set of emotional states can each include one or more of the user's calmness, mental stamina and time availability. In some embodiments, the first instruction in the second instructions can identify a characteristic of the user from a set of characteristics to be evaluated. The set of characteristics can include one or more of migraine symptoms, vocalization biomarkers, mood and engagement level used to select the first activity or the second activity. In some embodiments, the first metric at the first time instance can include a first Pain Severity Scale (PCS) score at baseline, and the second metric at the end of the second set of time instances can include a second PCS.

[0031] In some embodiments, the first metric at the first time instance can include a first PCS score at baseline and the second metric can include a second PCS score after at least one of the second set of time instances. In some embodiments, the first metric at the first time instance can include a first number of monthly migraine days (MDDs) at baseline and the second metric at the end of the second set of time instances can include a second number of MDDs.

[0032] In some embodiments, the first metric at the first time instance can include a first number of MDD days at baseline, and the second metric can include a second number of MDD days after at least one of the second time instances. In some embodiments, the migraine can include at least one of complex migraine, subclinical migraine, hemiplegic migraine, or retinal migraine. In some embodiments, the user can receive medication to address the migraine at least partially in parallel across at least one of the first time instance or the set of second time instances. The medication can include at least one of a triptan, ibuprofen, ergo, or a calcitonin gene-related peptide (CGRP) inhibitor. [Brief description of the drawings]

[0033] The above and other objects, aspects, features and advantages of the present disclosure will become more apparent and will be better understood by referring to the following description taken in conjunction with the accompanying drawings. [Figure 1] 1 shows a block diagram of a system for dynamically selecting messages to provide to a user at risk for migraine according to an exemplary embodiment. [Diagram 2] 1 illustrates a block diagram of a process for receiving an indication of a state and selecting an action based on the state in a system for dynamically selecting messages in accordance with an illustrative embodiment. [Diagram 3] 1 illustrates a block diagram of a process for providing messages to activities, receiving responses related to the activities, and updating a profile to include responses of a system that dynamically selects messages according to an exemplary embodiment. [Figure 4A] 1 illustrates a method for presenting a user interface to a user at risk for migraine, according to an exemplary embodiment. [Figure 4B] 1 illustrates a method for presenting a user interface to a user at risk for migraine, according to an exemplary embodiment. [Diagram 5]1 illustrates an example system architecture of a system for presenting a user interface to a user at risk for migraine according to an exemplary embodiment. [Figure 6A] 1 illustrates an example of a user interface presented by a system for presenting a user interface to a user at risk for migraine according to an illustrative embodiment. [Figure 6B] 1 illustrates an example of a user interface presented by a system for presenting a user interface to a user at risk for migraine according to an illustrative embodiment. [Figure 6C] 1 illustrates an example of a user interface presented by a system for presenting a user interface to a user at risk for migraine according to an illustrative embodiment. [Figure 6D] 1 illustrates an example of a user interface presented by a system for presenting a user interface to a user at risk for migraine according to an illustrative embodiment. [Figure 6E] 1 illustrates an example of a user interface presented by a system for presenting a user interface to a user at risk for migraine according to an illustrative embodiment. [Figure 7A] 1 illustrates an example user interface of a system for presenting a user interface to a user at risk for migraine according to an illustrative embodiment. [Figure 7B] 1 illustrates an example user interface of a system for presenting a user interface to a user at risk for migraine according to an illustrative embodiment. [Figure 7C] 1 illustrates an example user interface of a system for presenting a user interface to a user at risk for migraine according to an illustrative embodiment. [Figure 8A] 1 illustrates an example user interface of a system for presenting a user interface to a user at risk for migraine according to an illustrative embodiment. [Figure 8B]1 illustrates an example user interface of a system for presenting a user interface to a user at risk for migraine according to an illustrative embodiment. [Figure 8C] 1 illustrates an example user interface of a system for presenting a user interface to a user at risk for migraine according to an illustrative embodiment. [Figure 9A] 4 illustrates an exemplary user interface for activities performed by a user according to an exemplary embodiment. [Figure 9B] 4 illustrates an exemplary user interface for activities performed by a user according to an exemplary embodiment. [Figure 9C] 4 illustrates an exemplary user interface for activities performed by a user according to an exemplary embodiment. [Figure 10] FIG. 1 is a flow diagram for presenting a user interface to a subject with a migraine headache according to an exemplary embodiment. [Figure 11] FIG. 1 is a flow diagram of a method for reducing the number of migraine days in a user in need thereof, according to an exemplary embodiment. [Figure 12] Timeline of a single-center, exploratory, single-arm, 2-week study in late adolescents and adults with migraine. [Figure 13] FIG. 1 is a timeline of a randomized trial of a digital treatment for episodic migraine prevention. [Figure 14] 2 is a block diagram of a server system and a client computer system according to an exemplary embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] In order to read the following description of the various embodiments, it may be helpful to list each item in this specification and its respective contents below.

[0035] Section A describes systems and methods for presenting a user interface to a subject with migraine.

[0036] Section B describes an example where the efficacy of a digital therapeutic agent was evaluated in subjects at risk for migraine.

[0037] Section C describes network and computing environments useful for practicing the embodiments described herein.

[0038] A. Systems and Methods for Dynamically Providing Messages to Users at Risk for Migraines 1, a block diagram of a system 100 for dynamically selecting messages to provide to a user at risk for migraine is depicted. In overview, the system 100 may include at least one session management service 105 and a set of user devices 110A-N (hereinafter generally referred to as user devices 110 or client devices 110) communicatively coupled to one another via at least one network 115. At least one user device 110 (e.g., a first user device 110A as depicted) may include at least one application 120. The application 120 may include or provide at least one user interface 145 having one or more user interface (UI) elements 150A-N (hereinafter generally referred to as UI elements 150). The session management service 105 may include, among other things, at least one session manager 155, at least one activity selector 160, at least one message selector 165, and at least one response handler 170. Session management service 105 may include or have access to at least one database 175. Database 175 may store, maintain, or otherwise include, among other things, one or more user profiles 180A-N (or user accounts, hereinafter generally referred to as user profiles 180) and one or more activities 185A-N. The functionality of application 120 may be executed in part on session management service 105.

[0039] More specifically, the session management service 105 (sometimes referred to generally herein as a computing system or service) may be any computing device that includes one or more processors coupled with memory and software and is capable of performing various processes and tasks described herein. The session management service 105 may communicate with one or more user devices 110 and a database 175 via a network 115. The session management service 105 is located, collocated, or otherwise associated with at least one server group. A server group may correspond to a data center, a branch office, or a site where one or more servers corresponding to the session management service 105 are located. Within the session management service 105, a session manager 155 may receive, execute, or accept indications of user state associated with a session initiated by a user of an application 120 on an individual user device 110. An activity selector 160 may select an activity 185 to provide to the user device 110 via the session manager. A message selector 165 may select a message according to the rules of the activity 185. The response handler 170 can present a message to the user via the user interface 145 that identifies the activity 185 .

[0040] The user device 110 (sometimes referred to herein as an end-user computing device or client device) may be any computing device that includes one or more processors coupled with memory and software and is capable of performing the various processes and tasks described herein. The user device 110 may communicate with the session management service 105 and the database 175 via the network 115. The user device 110 may be a smartphone, other mobile phone, tablet computer, wearable computing device (e.g., smart watch, glasses), or laptop computer. The user device 110 may be used to access the application 120. In some embodiments, the application 120 may be downloaded (e.g., via a digital distribution platform) and installed on the user device 110. In some embodiments, the application 120 may be a web application having resources accessible via the network 115.

[0041] The application 120 running on the user device 110 may be a digital therapeutic application and may provide a session (sometimes referred to herein as a therapy session) to address the user's migraine headache. The application 120 may be used to present messages prompting the user to perform selected activities based on the user's condition. The condition may relate to the user's emotional state, such as the user's calmness, the user's mental stamina, or the user's available time, among others. The user's mental stamina may refer to the user's fortitude or perceived resilience against an expected or ongoing condition, such as a migraine headache. The user's mental stamina may refer to the user's ability to focus on an activity. The user's available time may refer to the time the user has available to respond or engage in an activity, among others. The user's condition may include a migraine condition, such as, for example, a migraine onset, an ongoing migraine, or the absence of a migraine. The user's condition may include one or more characteristics to be evaluated, such as migraine symptoms, vocalization biomarkers, mood, and engagement level, among others.

[0042] A user of the application 120 may suffer from or be at risk for migraines, such as a typical migraine (also referred to herein as complex migraine) that begins with an aura (e.g., flashing lights, colors, shadows, and other visual effects) that precedes the user's headache, a common migraine without aura and resulting in at least one-sided head pain, an asymptomatic migraine with aura but no pain, a hemiplegic migraine with weakness in parts of the body such as the face, arms, or legs, a retinal migraine (also referred to herein as ocular migraine) that causes vision changes before the headache, etc. The user may suffer from or be at risk for headaches such as ice pick headaches, which are repeated stabbing pains around the user's eyes and temples, or cluster headaches, where the pain occurs in a pattern over a period of time (e.g., a day, a week, a month). The user may be simultaneously taking medication to at least partially address the migraine while being offered a session through the application 120. For example, the user may be taking a triptan (e.g., almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, or zolmitriptan), ibuprofen, aspirin, acetaminophen, dichlorphenazone-acetaminophen, ergotamine (e.g., dihydroergotamine or zolmitriptan), dihydroergotamine or ergotamine tartrate), or a calcitonin gene-related peptide (CGRP) inhibitor (e.g., rimegepant, ubrogepant, or zavegepant), etc.

[0043] The application 120 may include, present, or otherwise provide a user interface 145 including one or more UI elements 150 to a user of the user device 110 according to a configuration on the application 120. The UI elements 150 may correspond to visual components of the user interface 145, such as command buttons, text boxes, checkboxes, radio buttons, menu items, and sliders, among others. In some embodiments, the application 120 may be a digital therapeutic application and may provide sessions (sometimes referred to herein as therapeutic sessions) via the user interface 145, directed toward alleviating or reducing the impact of migraines. For example, the application 120 may receive instructions to present a message to the user. The message may be presented to the user as text, images, videos, or other presentations and may include instructions to have the user perform an activity to alleviate or reduce the impact of migraines. The message may include instructions for the user to reduce the severity of symptoms. For example, the message may include instructions aimed at increasing the user's calmness or mental stamina.

[0044] The database 175 may store and maintain various resources and data related to the session management service 105 and the applications 120. The database 175 may include a database management system (DBMS) for organizing and arranging the data maintained therein. The database 175 may communicate with the session management service 105 and one or more user devices 110 via the network 115. While performing various operations, the session management service 105 and the applications 120 may access the database 175 to retrieve identified data therefrom. The session management service 105 and the applications 120 may also write data to the database 175 from the performance of such operations.

[0045] Such operations may include maintaining a user profile 180. The user profile 180 may include information related to the user's condition, as described herein. For example, the user profile 180 may include information related to the severity of the condition, the occurrence of the condition, medications or treatments the user is taking for the condition, and the like, among other things. The user profile 180 may include information related to the user, such as age, sex, height, weight, location, family, allergies, occupation, income, or education, among other things. The user profile 180 may be updated on a schedule, periodically (e.g., daily, weekly), in response to changes in user information (e.g., entered by the user via the user interface 145 or learned from the user device 110), or in response to a clinician (e.g., a doctor or nurse) addressing the user's condition, among other things. The user profile 180 may enable streamlined communication to the user by presenting messages to the user that are most likely to assist the user in addressing the user's condition, based at least on the user profile 180. Such a direct approach may reduce the need for multiple communications with the user, thereby reducing bandwidth and enhancing the benefits of user-computer interaction.

[0046] User profiles 180 may store and maintain information related to users of application 120 through user device 110. Each user profile 180 (sometimes referred to herein as a subject profile or migraine patient profile) may be associated with or correspond to a respective subject or user of application 120. User profile 180 may identify various information about user 210, such as, among other things, information about sessions performed by user 210, occurrence of a condition (e.g., migraine), duration of the condition, or medications taken by the user. Information about a session may include various parameters of previous sessions performed by user 210, which may initially be null.

[0047] In some embodiments, user profile 180 may identify or include information regarding a treatment regimen undertaken by the user, such as type of treatment (e.g., therapy, pharmacological therapy, or psychotherapy), duration (e.g., day, week, or year), and frequency (e.g., daily, weekly, quarterly, yearly), among others. User profile 180 may be stored and maintained in database 175 using one or more files (e.g., extensible markup language (XML), comma-separated values ​​(CSV), delimited text files, or structured query language (SQL) files). User profile 180 may be iteratively updated as the user provides responses and performs tasks of activities 185. For example, response handler 170 may update user profile 180 based on responses provided by the user.

[0048] Further, the identification of the set of activities 185 can be stored and maintained in database 175. For example, database 175 may maintain the identification of activities 185 using one or more data structures or files (e.g., Extensible Markup Language (XML), Comma Separated Values ​​(CSV) delimited text files, or Structured Query Language (SQL) files). Each of activities 185 can define, specify, or include a message to be provided to a user via application 120 prompting the user to perform the activity via application 120. For example, application 120 may receive an instruction to present a message identifying the activity to be performed. Activity 185 can be providing behavioral therapy including cognitive behavioral therapy, biofeedback, and relaxation therapy.

[0049] In response to the presentation of a message prompting the user to perform a specified activity, the user can use the application 120 to record the performance or completion of the activity. Examples of activities include breathing exercises, mind-body exercises, or hand exercises, among others. The messages can be text-based, image, or video, among other presentation methods. The messages can be presented to the user via a user interface 145 running on the application 120. Each message can identify or include information that is presented via the user interface 145 of the application 120. For example, the information in the message can include a reminder to perform a task of the session or to take an action to relieve a migraine headache. The messages can be delivered periodically, such as daily, weekly, or monthly, among others. The messages may be delivered according to a schedule or in response to receiving instructions from the user. The messages can be derived from a library of pre-generated psychotherapy messages and / or a library of pre-generated engagement (reminder) messages, particularly related to migraine headache relief. The activity 185 messages may include reminders for the subject to take medication, exercise an activity, or perform other actions that may reduce the severity of symptoms or improve the user's migraine. The messages may be personalized based on the user's activity, adherence, or performance related to the regimen. For example, the messages are personalized based on information in the user profile 180 or based on other activities in which the user has participated.

[0050] 2, a block diagram of a process 200 for receiving an indication of a condition and selecting an activity based on the condition in a system for dynamically selecting messages is depicted. The process 200 may include or correspond to operations performed in the system 100 to present a user interface to a user with migraine headaches. Under the process 200, the session manager 155 executing on the session management service 105 may access the database 175 to obtain, fetch, or otherwise identify a user profile 180 of a user 210 (referred to herein as a subject, patient, person, or migraine sufferer) of the application 120 on the user device 110. The user profile 180 may identify or define, among other things, information related to the user 210, the instance of the application 120 on the user device 110, and the user device 110. For example, the user profile 180 may identify that the user 210 is at risk for migraine headaches or suffers from migraine headaches. The user profile 180 may identify, among other things, that the user 210 is taking medication to treat migraines and the frequency of migraine attacks for the user 210.

[0051] Identifying the user profile 180 allows the session manager 155 to determine or identify a session of the user 210 for addressing a migraine headache. A session may correspond to or include at least one activity performed by the user 210 via the application 120. A session may also have a set duration, ranging anywhere between a few minutes (e.g., 3 minutes) to a few months (e.g., 3 months). The user profile 180 may include information about previous sessions, such as previous activities performed by the user 210 in response to previous messages, responses by the user 210 to the presentation of previous messages, the number of activities already performed by the user 210, the taking of medication by the user 210 to address a migraine headache, among others. The user profile 180 may also identify or include information about recorded migraines, such as the number of migraine occurrences, the duration of previous occurrences, and the taking of medication, among others. The user profile 180 may initially lack information about previous sessions and may build information as the user 210 records activities performed via the application 120.

[0052] The session manager 155 can send, provide, or otherwise communicate at least one prompt 205 to the user device 110 for the user 210 to indicate at least one state of the user 210. The prompt 205 may query information related to the migraine of the user 210, such as a migraine state, one or more emotional states, or a characteristic to be evaluated. In some embodiments, the session manager 155 can communicate instructions to the user device 110 that identify the prompt 205. The instructions can be to render, display, or otherwise present the prompt 205 via one or more UI elements 150 of the user interface 145 of the application 120. The instructions can also specify a time or condition for presenting the prompt 205 in the application 120.

[0053] In some embodiments, the session manager 155 may calculate, identify, or otherwise determine the time to send or present a prompt 205 via the user interface 145 of the application 120. In some embodiments, the session manager 155 may maintain a timer that counts the time that has elapsed since the presentation of a previous prompt 205 to indicate the state of the user 210 or a previous message 220 to indicate to the user 210 to perform an activity. The timer may count, among other things, the time that has elapsed since the read receipt of a message, the time that has elapsed since a conveyance message sent from the application 120 as part of a transport protocol, or the time that has elapsed since the conveyance of a message from the session management service 105. In some embodiments, the session manager 155 may maintain a timer that counts the time that has elapsed since the performance of a previous activity.

[0054] Using the timer, the session manager 155 can determine whether the elapsed time exceeds a threshold. The threshold can define, specify, or define an amount of time to provide the prompt 205 for presentation. The threshold can be set or determined by the session manager 155 based on information about the user 210 identified in the user profile 180, such as the number of migraine occurrences, the duration of previous occurrences, and medication use, among others. If the elapsed time exceeds the threshold, the session manager 155 can send a prompt 205 for an indication 215 of the user's 210 condition. The timing of sending the prompt 205 can correlate to when the user 210 is expected to have migraine-related symptoms. Conversely, if the time counted by the timer does not exceed the threshold, the session manager 155 can refrain from sending the prompt 205 and continue to update the time.

[0055] In some implementations, session manager 155 can provide prompt 205 according to a schedule. The schedule can identify or specify the time at which prompt 205 is presented. For example, the schedule can specify presentation of prompt 205 on an hourly, daily, or weekly basis. The schedule can be defined according to a prescription medication schedule or based on historical data of the user, such as the user's 210 history of migraine attacks. When the time of day matches the schedule, session manager 155, via instructions, can provide prompt 205 for display on user interface 145.

[0056] Upon receiving, the application 120 on the user device 110 may render, display, or otherwise present the prompt 205. The prompt 205 may be presented via one or more UI elements 150 of the user interface 145 of the application 120 or as a push notification via the user device 110. The prompt 205 may include a text box, drop-down menu, button, sliding scale, or other UI element 150 and may accept an indication 215 of a state from the user 210.

[0057] In some embodiments, the application 120 can render, display, or otherwise present the prompt 205 independent of the session management service 105. The application 120 may share or have the same functionality as the session manager 155, as described above. For example, the application 120 can maintain a timer to track the time elapsed since the presentation of a previous prompt 205 or message for an activity. The application 120 can compare the elapsed time to a time limit for the message. If the elapsed time exceeds the time limit, the application 120 can determine whether to present the prompt 205. The application 120 can also use a schedule to determine when to present the prompt 205. The application 120 can present the prompt 205 for display through the user interface 145 on the user device 110. The prompt 205 can include a response mechanism, such as a UI element 150.

[0058] The prompt 205 may query the user 210 regarding the migraine-related condition of the user 210. The condition may identify or include a migraine condition, one or more emotional states, and one or more characteristics of the user 210 to be evaluated. The migraine condition may include either the onset, presence, or absence of a migraine headache at the time of presentation of the prompt 205. Onset may correspond to when the user 210 expects a migraine headache to occur soon (e.g., within minutes to hours). Presence may correspond to the user 210 having concurrent or experienced a migraine attack within a time window prior to the presentation of the prompt 205 (e.g., within minutes to hours). Absence may correspond to the user 210 not having symptoms related to a migraine headache at the time of presentation of the prompt 205. For the query about the migraine condition, for example, the prompt 205 may ask the user 210 if they have recently experienced a migraine headache, are experiencing a migraine headache, are expecting a migraine headache, or are not experiencing any migraine symptoms.

[0059] Continuing, the emotional state may include, among others, a state of calmness, mental stamina, and availability of time. Calmness may correspond to a level (or absence or presence) of serenity indicated by the user 210 at the time of presentation of the prompt 205. Mental stamina (or absence or presence) may correspond to a level of focus, mental energy, or emotional well-being at the time of presentation of the prompt 205. Availability of time may indicate an amount of time indicated by the user at the time of presentation of the prompt 205 to perform one or more activities to address the user's condition.

[0060] To query an emotional state, the prompt 205 may further prompt an indication of a state related to the user's emotion. For example, the prompt 205 may query the user 210 for indications related to the user's emotional state, such as the user's calmness, availability of time, the user's mental stamina, among others. The prompt 205 may include instructions via the user interface 145 for the user 210 to display, among others, a push button to indicate a particular response of the state, one or more text boxes (e.g., for describing symptoms) or a sliding scale to indicate the level of the state. For example, the user 210 may enter an amount of available time the user 210 has into a text box or select from a drop-down menu.

[0061] The prompt 205 may also prompt for additional information in the condition indication 215. For example, the prompt 205 may ask the user for an indication 215 of the user's calmness and migraine symptoms. Similarly, the user 210 may provide multiple conditions in the response. For example, the user 210 may select the level of calmness he or she is experiencing on a sliding scale and may also select the onset of a migraine. In some implementations, the user 210 may textually describe his or her condition in the indication 215, and the session manager 155 may parse the text for keywords related to the user's condition, such as "time," "migraine," "concentration," "feeling," etc., to derive the condition from the indication 215.

[0062] Additionally, the characteristics evaluated may identify or include, among others, migraine symptoms, vocalization biomarkers, engagement level, and mood. Migraine symptoms include, for example, pain intensity, pain location (e.g., head, unilobar, bilobar, occipital, frontal), pain type (e.g., pulsating or constant), indication of whether pain is worsened by physical activity (e.g., walking or climbing), indication of whether physical activity was avoided due to migraine pain, nausea, vomiting, sensitivity to light, sensitivity to sound, visual changes or aura, indication of numbness, response to a migraine disability questionnaire (e.g., the Migraine Disability Index (MIDI) Functional Impairment Questionnaire), etc.

[0063] Vocal biomarkers (e.g., sample voice or speech) may include speech recordings that may be used to identify characteristics correlated with migraine headaches. Engagement levels may identify the level of enthusiasm or positivity of the user 210 for various activities other than those specified by messages presented through the application 120. Mood may identify the type of mood or emotion the user 210 is experiencing at the same time, such as positive moods (e.g., anticipation, joy, trust, or surprise) or negative moods (e.g., fear, sadness, disgust, anger, or anxiety), among others. At least a portion of the information related to the characteristic may be retrieved separately from the prompt 205 or application 120. For example, an assessment may be made by a clinician examining the user 210 with questions (e.g., "Did you take your medicine today?" or "Did you go for a walk?"), and the assessment may be saved and maintained as part of the user profile 180. In conjunction with the presentation of the prompt 205, the application 120 may monitor at least one user interaction with the prompt 205. For example, application 120 may monitor for user interactions or events via an event listener or handler of UI element 150 of user interface 145 that corresponds to prompt 205. The user interaction may identify or indicate a state of user 210 (e.g., a migraine state, an emotional state, or an assessed characteristic, or any combination thereof) in response to presentation of prompt 205. When a user interaction is detected in response to prompt 205, application 120 may process the user interaction to determine or identify a state of user 210 as entered by user 210.

[0064] Upon detection, the application 120 may generate at least one instruction 215 to identify a state of the user 210. In some embodiments, the application 120 may generate the instruction 215 to identify a user interaction on the prompt 205 to determine the state of the user 210. Upon generation, the application 120 may provide, transmit or otherwise communicate the instruction 215 to the session management service 105. The instruction 215 may identify or include a state of the user 210, such as a migraine state, one or more emotional states, or one or more evaluated characteristics, among others. In some embodiments, the instruction 215 may identify a migraine state of the user 210 as either the onset, presence or absence of a migraine. In some embodiments, the instruction 215 may identify a set of emotional states, such as calmness, mental stamina, and time availability, among others. In some embodiments, the instruction 215 may identify one or more of a migraine symptom, vocalization biomarker, engagement level, and mood, among others. Any combination of these states may be identified in the instruction 215.

[0065] Session manager 155 may retrieve, identify, or otherwise receive instructions 215 from user device 110. Upon receipt, session manager 155 may process or analyze instructions 215 to determine, extract, or identify a state of user 210. In some embodiments, application 120 may use user interaction on prompt 205 to determine a state of user 210. The state of user 210 may identify or include, among other things, a migraine state, one or more emotional states, or any combination of one or more evaluated characteristics. Upon this identification, session manager 155 may activate activity selector 160 with the state of user 210.

[0066] The activity selector 160 of the session management service 105 can identify or select at least one activity 185 from the set of activities 185 based on the state of the user 210. In some embodiments, the activity selector 160 can select the activity 185 based on the user profile 180 in association with the state of the user 210 identified in the instructions 215. Each activity 185 can identify or include a set of messages 220A-N and a set of rules 225A-N. In each activity 185, the set of rules 225 (sometimes referred to herein as decision support or migraine support rules) can define, specify or otherwise specify one or more conditions that the state of the user 210 must satisfy in order for the activity 185 to be selected. The rules 225 can be configured to provide an activity 185 to target the underlying causes of the migraine of the user 210 or to alleviate the migraine symptoms in a systematic, objective and therapeutically effective manner. Each activity 185 can also identify, include or be associated with a set of messages 220.

[0067] Each activity 185 may be associated with a state that the user 210 is instructed to by the instructions 215. In some embodiments, the activity 185 may correspond to a migraine of the user 210. For example, the activity 185 may include a routine or activity performed by the user 210 in response to a message 220 related to preventing the onset of a migraine, a message 220 related to mitigating the presence of a migraine, or a message 220 related to maintaining the absence of a migraine. In some embodiments, the activity 185 may correspond to an emotional state of the user 210. For example, the activity 185 may be selected based on the calmness of the user 210 or the mental stamina of the user 210, or a combination thereof. The activity 185 may also include, for example, calming exercises (e.g., progressive muscle relaxation, breathing exercises, self-help, napping) or energizing exercises (e.g., mindfulness exercises, sleep) to induce or assist the user 210 to relax or enter a state of serenity. In some implementations, the activity 185 may be selected based on the time the user 210 is available, including in combination with other factors.

[0068] To make the selection, the activity selector 160 may check or compare the state of the user 210 specified in the instructions 215 with a set of rules 225 for each activity 185. In some embodiments, the activity selector 160 may compare the user profile 180 and the state of the user 210 with a set of rules 225 for each activity 185. The information of the user profile 180 used to compare to the rules 225 may include, for example, previous activities performed by the user 210 in response to previous messages, responses by the user 210 to the presentation of previous messages, the number of activities already performed by the user 210, the taking of medication by the user 210 to deal with migraines, etc. Additionally, the information of the user profile 180 may include, among other things, the number of occurrences of migraines, the duration of previous occurrences, and the taking of medication. The state of the user 210 used to compare to the rules 225 may include, among other things, the state of the migraines, one or more emotional states or evaluated characteristics, or any combination thereof. If the status of the user 210 or the information in the user profile 180 meets the specifications of the rules 225, the activity selector 160 may select the associated activity 185. Otherwise, when the status of the user 210 or the information in the user profile 180 does not meet the specifications of the rules 225, the activity selector 160 may not select the associated activity 185.

[0069] In some embodiments, the activity selector 160 can select an activity 185 based on the migraine status of the user 210. If the migraine status indicates onset, the activity selector 160 can select the activity 185 that includes a set of messages 220 related to preventing the onset of a migraine. If the migraine status indicates presence, the activity selector 160 can select the activity 185 that includes a set of messages 220 related to alleviating the presence of a migraine. If the migraine status indicates absence, the activity selector 160 can select the activity 185 that includes a set of messages 220 related to maintaining the absence of a migraine.

[0070] In some embodiments, the activity selector 160 may select an activity 185 based on a comparison of the availability of time identified in the state of the user 210 to a threshold time specified in at least one rule 225 of the at least one activity 185. The threshold time may define an amount of available time for selecting or deselecting the activity 185. At least one of the activities 185 may be associated with an amount of available time exceeding the threshold time (e.g., as specified by the rule 225). At least one of the activities 185 may be associated with an amount of available time that does not exceed the threshold time (e.g., as specified by the rule 225). If the amount of available time exceeds the threshold time, the activity selector 160 may select the corresponding activity 185. If the amount of available time does not exceed the threshold time, the activity selector 160 may refrain from selecting the corresponding activity 185.

[0071] In some embodiments, the activity selector 160 may select an activity 185 based on one or more combinations of a migraine state, an emotional state, or an evaluated characteristic specified by rules 225 of at least one activity 185. For example, a set of rules 225 of at least one activity 185 may specify the onset of a migraine state to the user 210 being in a non-calm state with low stamina, high anxiety levels, and the user 210 taking medication. When the state of the user 210 matches the specification of the rules 225 for the activity 185, the activity selector 160 may select an activity 185. In some embodiments, the activity selector 160 may select an activity based on one or more combinations of a migraine state, an emotional state, or an evaluated characteristic in addition to information in the user profile 180 specified by rules 225 in at least one of the activities 185. For example, a set of rules 225 of the activity 185 may specify that there is no migraine state, the user 210 is in a calm state with high mental focus, is in a happy mood, and has performed at least five other activities. If the indication of the state and the information in the user profile 180 match, the activity selector 160 may select an activity 185 .

[0072] 3, a block diagram of a process 300 is depicted for providing a message for an activity, receiving a response related to the activity, and updating a profile to include the response of a system presenting a user interface. The process 300 may include or correspond to an operation of presenting a user interface to a user with a migraine headache. Under the process 300, a message selector 165 of the session management service 105 may identify or otherwise select at least one message 220 from a set of messages 220 related to a selected activity 185 according to a rule set 225. In some embodiments, the message selector 165 may select a group of messages 220 to be presented for a set period of time. Each message 220 may prompt the user 210 to perform the activity 185 via the user interface 145 of the application 120 in response to the presentation of the message 220. Each message 220, when presented via the user interface 145, may provide one or more UI elements 150 to enable the user 210 to enter a response (e.g., a completion instruction or a response to a survey).

[0073] The set of rules 225 may also define, specify, or otherwise specify conditions for selecting at least one of the messages 220 for the activity 185. The conditions of the rules 225 may also be based on a state of the user 210, such as a migraine state, an emotional state, or an evaluated characteristic. In some embodiments, the set of messages 220 may be associated with a state of the user 210, such as a migraine state, an emotional state, an evaluated characteristic, among others. For example, at least one activity 185 may include a respective set of messages 220 related to preventing the onset of a migraine. At least one other activity 185 may include a respective set of messages 220 related to alleviating the presence of a migraine. At least one activity 185 may include a respective set of messages 220 related to maintaining a migraine-free state. In a given activity 185, the rules 225 may specify the selection of at least one message based on one or more combinations of a migraine state, an emotional state, or an evaluated characteristic specified by the rules 225 in at least one of the activities 185. For example, the rules 225 of the activity 185 may specify the selection of one message 220 when the state of the user 210 indicates the absence of a migraine condition, the user 210 is in a calm state with high mental focus, and is in a happy mood.

[0074] In some embodiments, the rules 225 may specify the selection of at least one message based on the availability of time identified in the status of the user 210 and a threshold time specified in at least one rule 225 of the selected activity 185. The threshold time may define the amount of available time for selecting or deselecting the messages 220 associated with the activity 185 and may range from a few seconds (e.g., 30 seconds) to a few hours (e.g., 3 hours). The rules 225 may specify to select at least one of the messages 220 when the amount of available time exceeds the threshold time (e.g., as specified by the rules 225). The rules 225 may specify to select at least one of the messages 220 if the amount of available time does not exceed the threshold time (e.g., as specified by the rules 225). If the amount of available time exceeds the threshold time, the message selector 165 may select the corresponding message 220. If the amount of available time does not exceed the threshold time, the message selector 165 may refrain from selecting the message 220 corresponding to the activity.

[0075] The conditions of the rules 225 may also be based on historical data in the user profile 180, such as previous activities performed by the user 210 in response to previous messages, responses by the user 210 to the presentation of previous messages, the number of activities already performed by the user 210, the taking of medication by the user 210 to deal with migraines, etc. In some embodiments, the rules 225 may specify whether to select at least one message 220 based on a response by the user 210 to the presentation of a preceding message. For example, the rules 225 may specify not to select a related message 220 if a previous response by the user 210 to a previously selected message 220 was incorrect.

[0076] Continuing, in some embodiments, the rules 225 can specify that the selection of the at least one message 220 is selected based on the selection of an activity 220 for a previous message. For example, the rules 225 can specify that the message 220 for a water drinking exercise is selected if the previously selected activity 185 was a physical relaxation exercise. In some embodiments, the rules 225 can specify whether to select the at least one message 220 based on the number of activities already performed by the user 210. For example, the rules 225 can specify that the message 220 is selected after performing five activities 185 of the same type. In some embodiments, the rules 225 can specify whether to select the at least one message 220 based on the time of day (e.g., daytime). For example, the rules 225 can prohibit messages encouraging the user 210 to go to bed when it is still daytime, prevent the selection of messages 220 that encourage the user to take medication outside of a prescribed dosing window, or restrict messages that encourage the user to take medication to promote sleep in the morning.

[0077] In some embodiments, the rules 225 may specify the selection of at least one of the messages 220 based on the medication the user takes. For example, the rules 225 may indicate messages related to medication times, pharmacological conflicts in medication, or medication reminders, among others. The rules 225 may relate to the selection of the group of messages 220 to present within the duration of the session. For example, the rules 225 may indicate that the messages of the group should be sent at equal intervals within the duration of the session. Conversely, the rules 225 may indicate that the messages of the group should be sent at various frequencies within the duration of the session. In some embodiments, the rules 225 may indicate that the messages of the group 220 are not sent outside the time duration of the session. For example, if the session is active from 8:00 a.m. to 4:00 p.m. Monday through Friday, the rules 225 may indicate that messages related to weekends or nighttime are not selected by the message selector 165. These examples of rules 225 are intended to be illustrative and non-limiting. There may also be any other rules not depicted herein.

[0078] To make the selection, the message selector 165 can check or compare the state of the user 210 identified in the instructions 215 with a set of rules 225 in the message 220 of the selected activity 185. In some embodiments, the activity selector 160 can compare the user profile 180 and the state of the user 210 with the set of rules 225 in each activity 185. The information of the user profile 180 used to compare to the rules 225 can include, for example, previous activities performed by the user 210 in response to previous messages, responses by the user 210 to the presentation of previous messages, the number of activities already performed by the user 210, the taking of medication by the user 210 to deal with migraines, etc. Additionally, the information of the user profile 180 can include, among other things, the number of occurrences of migraines, the duration of past occurrences, and the taking of medication. The state of the user 210 used to compare to the rules 225 can include, among other things, the state of the migraines, one or more emotional states or evaluated characteristics, or any combination thereof. If the status of the user 210 or the information in the user profile 180 meets the specifications of the rules 225, the activity selector 160 may select the associated message 220. Otherwise, if the status of the user 210 or the information in the user profile 180 does not meet the specifications of the rules 225, the activity selector 160 may not select the associated message 220.

[0079] Upon selection, the message selector 165 can provide, transmit, or otherwise communicate the message 220 to the user device 110. In some embodiments, the message selector 165 can transmit instructions to present the message 220 via the user interface 145 of the application 120 on the user device 110. The instructions can include, for example, a specification of which UI element 150 should be used and can specify content to be displayed on the UI element 150 of the user interface 145. The instructions can include the message 220. The instructions can be code, data packets, or controls to present the message 220 to the user 210 via the application 120 executing on the user device 110. The instructions can include processing instructions for displaying the message 220 on the application 120. The instructions can also include instructions for the user 210 to execute in connection with their session. For example, the instructions can display a message 220 instructing the user to take a medication associated with their session.

[0080] The application 120 on the user device 110 may retrieve, identify, or otherwise receive the message 220 from the session management service 105. Upon receipt, the application 120 may process or parse the message 220. The application 120 may also display, render, or otherwise present the message 220 via the user interface 145. The user interface 145 may display the message 220 as text, images, and videos, among other displays. The UI elements 150 may be arranged according to instructions or according to the application 120 to display the message 220. When presented, the message 220 may prompt the user 210 to perform a selected activity 185 in a particular manner via the application 120. For example, the message 220 may instruct the user 210 to perform a stretching exercise and record the quality of the experience as well as whether the exercise was completed via one or more UI elements 145 displayed on the user interface 145 as part of the message 220.

[0081] The presentation of the message 220 may cause the application 120 to monitor user interaction with the message 220 by the user 210. The message 220 may include or display a prompt, a button, a text box, a link (e.g., a URL), or other means for the user 210 to interact with or engage with the message 220. For example, the application 120 may monitor for user interaction or events via an event listener in a UI element 150 of the user interface 145 that corresponds to the message 220 upon presentation. The user interaction may identify or indicate a response to the message 220 by the user 210 in response to the presentation. When a user interaction is detected in response to the prompt 205, the application 120 may process the user interaction to determine or identify a state of the user 210 entered by the user 210.

[0082] Once detected, the application 120 may generate at least one response 305 in response to the presentation of the message 220 via the user interface 145. In some embodiments, the application 120 may generate the response 305 to identify the user's interaction with the message 220. The response 305 may identify or include information related to the completion of a task by the user, a response by the user 210, the status of the user 210, or general involvement with the message 220 or session. Upon generation, the application 120 may provide, transmit, or otherwise send the response 305 to the session management service 105.

[0083] A response handler 170 executing on the session management service 105 may obtain, identify, or otherwise receive a response 305 from the user device 110. Upon receipt, the response handler 170 may parse the response 305 to extract or identify a state of the user 210. The response handler 170 may record or log data from the response 305 in a database 175. The response handler 170 may store an association between the response 305 and a user profile 180. In some embodiments, the response handler 170 may store and maintain information identifying the state of the user 210 in the database 175. The response handler 170 may store an association between the response 305 and a message 220 of the user 210. For example, the response handler 170 may store information indicating that the presented message 220 elicited an improvement in the user's state from the state of the user prior to the presentation of the message 220.

[0084] The session management service 105 may repeat the above-described functions (e.g., processes 200 and 300) over multiple sessions. The number of sessions may span a set number of days, weeks, or years, or may not have a clear end point. By repeatedly selecting an activity 185 based on the user's condition and providing a message 220 prompting the user 210 to perform the activity 185, the user 210 may receive content that helps alleviate migraine headaches. This may overcome the difficulties faced by the user 210 in accessing such care in a timely manner, even when suffering from a migraine headache, which may prevent the user from seeking treatment or even physically accessing the user device 110. Furthermore, the quality of human-computer interaction (HCI) between the user 210 and the user device 110 may be improved from performing the activity 185 prompted by the message 220 when presented through the user interface 145 of the application 120.

[0085] Because the messages 220 are more relevant to the user's state (e.g., migraine state, emotional state, and assessed characteristics), the user 210 may be more likely to respond to such messages 220 when presented via the user device 110. This may reduce unnecessary consumption of computational resources (e.g., processing and memory) of the service and the user device 110, and may reduce network bandwidth usage compared to sending otherwise ineffective or irrelevant messages. Furthermore, in the context of digital therapeutic applications, personalized selection of messages 220 utilizing the user's state may deliver user-specific interventions to improve the subject's adherence to treatment. This may result in not only greater adherence to the treatment intervention, but also potential improvement of the subject's migraine attacks, as described in Section B (Examples) herein.

[0086] 4A and 4B, a method 400 for dynamically selecting a message to provide to a user at risk for migraine is depicted. Each figure illustrates operations performed by a client and operations performed by a service. Method 400 can be implemented or performed using any of the components detailed herein, such as session management service 105 and user device 110. Starting with FIG. 4A, under method 400, a service (e.g., session management service 105) may identify (405) a user profile (e.g., user profile 180). A client (e.g., user device 110) may communicate (440) an indication of a status of a user (e.g., user 210). The service may receive (410) the indication from the client. Upon receipt, the service may identify (415) the user's status (e.g., migraine status, emotional state, or evaluated characteristic). The service may select (420) an activity (e.g., activity 185) from a set of activities based on the status. Selection of an activity may cause the service to identify (425) a message (e.g., message 220). The service may communicate (430) the message to the client. The client may present (450) the message to a user of the client.

[0087] Moving to FIG. 4B, the service can check whether time has elapsed (455). In response to presenting a message, the service may check whether time has elapsed (450). In response to not receiving an indication of the status, the service may check whether time has elapsed. If time has not elapsed, the service may continue to present the message (450). If time has elapsed, the service prompts for status input (460). The client may present a prompt (465). The client may or may not communicate an indication (470). If the client communicates an indication, the process returns to (410) where the service receives an indication of the status. If the client does not communicate an indication, the process can return to (455) where a determination is made whether time has elapsed.

[0088] 5, a system architecture of a system for dynamically selecting messages to provide to a user at risk for migraine is depicted in accordance with an exemplary embodiment. The system may include, among other things, a client device 502 (e.g., user device 110), a network 115, and a support platform 504 (e.g., session management service 105). The client device 502 may include a migraine treatment application 506 (e.g., application 120) installed thereon. The migraine treatment application 506 may include, among other things, a support module 507, a support module database 508, and an activity database 509.

[0089] The support platform 504 can be deployed in a cloud computing environment, a file server, an application server, a web server, a proxy server, an appliance, a network appliance, a gateway, a gateway server, a virtualization server, a deployment server, an SSLVPN server, or a firewall and can include a computer readable storage device, an application database 520, one or more microservice modules 524, one or more microservice databases 526, and a migraine treatment API 528. The microservice database 526 can include platform microservices such as authentication services, account services, and messaging services such as SMS and email services. In some embodiments, the support platform 504 can include multiple servers.

[0090] The client device 502 and the support platform 504 can communicate with each other across the network 115, for example, via the migraine treatment API 528. Although FIG. 5 shows the network 115 between the client device 502 and the support platform 504, the client device 502 and the support platform 504 may be on the same network 115. The support platform 504 can update or replace existing data in the activity database and the support module database with new or updated data. Thus, for example, the platform 504 can delete a migraine support lesson and associated digital media content from the activity database for a lesson that the migraine patient has completed. Additionally or alternatively, one or more migraine support lessons and associated digital media content can be added to the activity database for a lesson that the migraine patient has not yet completed. This can avoid storing all migraine support lessons and associated digital media content on the client device 502 and provide more efficient memory storage.

[0091] The application may include a support function, which may also be referred to as a digital support tool or decision support tool or DST. The support function may be used to execute a method of presenting activities to a user via an application executed on a subject's mobile device. The support function may be communicatively coupled to an activity database stored on a storage medium and a support module database also stored on the storage medium. A single database may comprise the activity database and the support module database, or the activity database and the support module database may be maintained separately from one another.

[0092] The activity database may include activity content for (a) a group of migraine support lessons on migraine science topics, migraine treatment topics, and migraine prevention topics, each migraine support lesson in the group of migraine support lessons comprising digital media content, (b) a group of migraine treatment activities, and (c) a group of migraine prevention activities. The activity database may be periodically updated with information received from another database, for example, a corresponding activity database stored in a computer readable storage medium of a remote server computer. The digital media content may include audio files or tracks, video, still images, animated images or videos, tactile information, text information, and combinations thereof.

[0093] The support module database can include a set of queries or prompts, such as a wellness query, a migraine treatment query, a migraine prevention query, and a set of decision support rules for selecting a wellness query from a plurality of queries, for selecting a subsequent query from a plurality of queries after a user responds to a prior query, and for selecting activity content or activities. The wellness queries can be selected from a set of questions based on the set of decision support rules or based on prior question responses (e.g., subject status responses) and are intended to allow the user to determine and communicate how they are currently feeling.

[0094] In this manner, the application allows the user to provide a wellness answer to a wellness query. The wellness response may indicate the subject's current condition and may be selected from a group of response topics consisting of: (1) preventing the onset of a migraine headache, (2) relieving ongoing migraine headaches, and (3) remaining migraine-free. The support module database may be periodically updated with information received from another database, for example, a corresponding support module database stored in a computer-readable storage medium of a remote server computer.

[0095] In the context of digital therapeutic applications, the presented messages can causally influence the user's behavior. For example, a message received from a service to a user device can cause the user to perform a task in an activity offered by the service. To facilitate the user's ease and consistency in participating in an activity, an application running on the device can generate and push prompts or queries that prompt the user to provide a status.

[0096] The message may include a mechanism for responding, such as a link (e.g., a uniform resource locator (URL)) in the message, a text box, or the use of another platform or application related to the application. Based on the response, further inquiries and instructions may be provided to the user based on the decision support rules of the application. Thus, if the response corresponds to the response topic of (2), ongoing migraine relief, the next selected message may be one that asks for relief of headache severity and duration. In this manner, the decision support rules may require the application to provide at least one migraine treatment activity to the subject. For example, the decision support rules may require the application to prompt as to whether the user has taken acute migraine medication since the onset of the current migraine, and if the user responds in the negative, also require the application to advise the user to take medication.

[0097] In this way, the application can provide quick, objective advice on which the user can rely in lieu of the user's own subjective judgment, which may be impaired due to a current migraine. However, the decision support rules can include medication safety rules to ensure that the migraine treatment application does not provide any advice, such as taking a medication when contraindicated, such as when the user is already taking the maximum amount of medication permitted. Alternatively or additionally, in response to (2) condition response, alleviating an ongoing migraine, the decision support rules can also request that the application provide an activity from an activity database. For example, the activity can include pain-accepting mindfulness exercises, such as meditation.

[0098] If the response corresponds to a response state of (1), preventing the onset of a migraine headache, the service can provide messages directed to preventing the onset of a migraine headache, reducing the severity of an onset headache, and minimizing anxiety the user may have. Thus, the decision support rule can require that the migraine treatment application provide the subject with at least one migraine prevention activity from the activity database. For example, the decision support rule can also require that the application queries whether the user has taken a migraine preventative medication since becoming concerned that a migraine may soon occur, and if the user answers in the negative, that the application advises the subject to take the medication via a message presented on the mobile device. Again, the application provides quick and objective advice on which the user can rely in lieu of the user's own subjective judgment, which may be impaired.

[0099] Alternatively or additionally, in response to the response topic in (1), the application can provide migraine prevention activities from an activity database. Migraine prevention activities can include activities such as drinking water, going outside for a walk and getting some fresh air. Other migraine prevention activities can include mindfulness exercises, such as self-compassion mindfulness exercises and curiosity mindfulness exercises.

[0100] Self-compassion exercises include pausing to acknowledge distress as it occurs. Thus, taking a pose of self-compassion can prevent the user from focusing on worries about the impending headache. One example of a self-compassion exercise includes thinking or saying, perhaps repeatedly, "Even though I feel hopeless right now, by practicing relaxation, I am giving myself the best chance of feeling better. It's not easy, but this will support my long-term goal of reducing the number of migraines I get over time." Another example of self-compassion includes thinking or saying, perhaps repeatedly, "Taking my medication will make my brain less sensitive to stress, which will support my long-term goal of reducing the number of migraines I get over time. I hate the side effects of feeling tired, but I'll stick to my medication schedule to stay well."

[0101] Curiosity exercises also help prevent the user from focusing on worries about the impending headache. Curiosity about migraines is an attitude that allows the user to focus on the symptoms of a migraine without trying to change them or wishing they were different. For example, observing physical sensations while calmly breathing is an exercise that enhances curiosity. Furthermore, if an unpleasant physical sensation is felt in the body, imagining breathing into that part of the body and observing how it feels allows further observation and allows the user to be present and focused on the sensation.

[0102] Other migraine prevention activities include mind-body exercises. Mind-body exercises are physical movements that induce beneficial emotions. Beneficial emotions, such as happy emotions, can help prevent migraines. One simple mind-body exercise is smiling. Another mind-body exercise is paced breathing. When people are calm, they generally breathe slower and deeper than when they are anxious. Thus, practicing slow, deep breathing can help calm the mind.

[0103] Another mind-body exercise is Progressive Muscle Relaxation (PMR). PMR is an exercise that reduces stress and anxiety in the body by slowly tensing and relaxing the muscles of the body, one muscle or group of muscles at a time. For example, clenching both hands into fists and relaxing them to a neutral position can be the first step of a PMR exercise. Breathing in slowly while tensing the muscles, breathing out slowly while relaxing, and saying "relax" slowly while breathing out will probably also help reduce stress and anxiety.

[0104] The application, via the support module, can provide self-compassion exercises, curiosity exercises, and mind-body exercises using digital media content such as videos displayed on a display and audio tracks played via an audio output. Self-compassion and curiosity exercises can be provided using audio since they are often performed with eyes closed. Mind-body exercises can be provided using video. For example, in the case of PMR, the video can help focus on which muscle or muscles to tense or relax.

[0105] Migraine prevention activities, such as drinking water or going outside for fresh air, are activities that a user may know to do before beginning to use the application. However, the user may not know how to do other migraine prevention activities, such as practicing mindfulness exercises or mind-body exercises for migraine prevention. Thus, the decision support rules may be configured to not offer any of these exercises to the user until after the migraine treatment application has provided the user with a migraine support lesson that teaches the user about the exercise, and preferably about how to perform at least one example of such an exercise.

[0106] Specifically, the decision support rules may require that a migraine support lesson on mindfulness must be provided to the user before the migraine prevention activity of practicing migraine prevention mindfulness exercises can be selected. Similarly, the decision support rules may require that a migraine support lesson on mind-body connection must be provided to the user before the migraine prevention activity of practicing mind-body exercises can be selected. Thus, the migraine prevention activities that the user can select from the activity database before completing any lesson are drinking water and moving from an indoor location to an outdoor location. Thus, the application may require that the user develop knowledge of migraine science, migraine treatment, and migraine prevention before the migraine treatment application can further assist the user in developing competence in migraine treatment and migraine prevention activities. Developing these competencies may streamline the types of messages and activities provided to the user by the service.

[0107] If the wellness response corresponds to maintaining a migraine-free state, which is the response topic of (3), then the activities and messages identified by the service may correspond to maintaining that feeling or maximizing the amount of time the user maintains that feeling. Additionally, the time during which the user is not experiencing a migraine or is not experiencing a migraine episode may provide an opportunity for the services performed through the application to teach the user about migraine science, migraine treatment, and migraine prevention, and to improve the subject's ability to perform migraine treatment and prevention activities. Such knowledge helps the user better understand his or her condition and further streamlines the messaging process as the user's user profile is updated.

[0108] Thus, upon receiving a wellness response corresponding to the response topic of (3), maintaining the absence of migraine, the decision support rules may require providing at least one of the migraine support lessons on migraine science topics, migraine treatment topics, and migraine prevention topics until at least all of the migraine support lessons in the activity database have been provided. The decision support rules may also require that the activity be followed after any support lesson that introduces a migraine treatment activity or a migraine prevention activity. Thus, for example, if the migraine support lesson teaches about self-compassion, then the migraine support lesson should be followed by a self-compassion exercise.

[0109] Similarly, as described above, the digital support rules may require that no migraine prevention activities be provided by the migraine treatment application until a support lesson teaching about migraine prevention activities has been provided to the user. Thus, for example, the digital support rules may provide that the migraine treatment application will not provide self-compassion exercises until at least one migraine support lesson teaches the concept of self-compassion.

[0110] As the user continues to improve their migraine prevention activity skills, the service can provide more efficient messages. This can save bandwidth and computational resources, which is important when the user is experiencing a migraine. Digital support rules can take advantage of any opportunity the user feels comfortable teaching about migraines and encourage the user to improve their migraine prevention skills. Thus, the migraine prevention activity is preferably at least one of practicing migraine prevention mindfulness exercises and practicing mind-body exercises. These exercises may be the same as some or all of the migraine prevention exercises provided when the user is anticipating a migraine, as described herein.

[0111] The decision support rules may also require the application to provide positive affirmations on the display, such as "hang in there" or "you are living proof that self-compassion is healing", automatically selected from a set of positive affirmations stored in either the activity database or the support module database. The positive affirmations may be accompanied by an audio track or a short animation. The application is designed to be used periodically, e.g., preferably at least once a day, and preferably at approximately the same time each day. Alternatively or additionally, the digital support rules may require the migraine treatment application to automatically provide wellness queries to the user at a predetermined frequency, e.g., at least once a day, and at the same time each day.

[0112] If a predetermined time has elapsed for each period or period corresponding to a predetermined frequency, e.g., by a particular time, e.g., about 2 to about 3 hours or noon, and the user has not accessed the application or answered at least one wellness inquiry, the digital support rules may require the subject to be provided with a reminder, e.g., sent via an SMS text message or notification. Conversely, the user may wish to use the migraine treatment application more frequently than the predetermined frequency. Thus, for example, if the user provides a wellness response (e.g., status) of (2) and then responds affirmatively to a inquiry about whether the user has taken acute migraine medication since the onset of the current migraine, the application will not ask again about the second acute medication during the period.

[0113] In particular, the migraine treatment application operates on the subject's mobile device or at least on a mobile device that is easily and reliably accessible to the subject, for example, according to a predetermined frequency (e.g., once a day), so that the application provides real-time support to the subject. For example, when the migraine treatment application receives a response to a wellness inquiry from the subject, it initiates a migraine support lesson, a migraine treatment activity, or a migraine prevention activity in real time, i.e., at least within a few milliseconds from receiving the wellness inquiry. Thus, for example, if the wellness response corresponds to the response topic of (2), the application can immediately provide the user with objective advice on migraine treatment, including objective advice on taking acute medication. Such prompt guidance cannot be achieved via a face-to-face meeting, phone call, video conference, or text message between the user and a healthcare provider such as a headache specialist. In this way, the application can provide and customize activities for the user based on the user's current condition, which is provided in the response from the user. This increases the usefulness of each message, thereby minimizing overall bandwidth and data communication and creating an iteratively improved service for the user.

[0114] Thus, after the migraine treatment application is installed on the mobile device, the migraine treatment application can be used to perform a migraine treatment method for reducing the number of migraine days experienced by the migraine patient during a current period having a number of days, for example 28 days, compared to a previous period having the same number of days. During the current period, the migraine treatment application first periodically provides a wellness query to the user via the display of the mobile device. Thus, the migraine treatment application can provide the wellness query to the migraine patient at least once a day, at approximately the same time each day, when the migraine treatment application is accessed by the user. Alternatively or additionally, the migraine treatment application can automatically provide the wellness query at a predetermined frequency by automatically displaying the wellness query on the mobile device or by sending the wellness query by text message or through a notification. The wellness query is selected from a plurality of queries included in the support module database according to digital support rules included in the support module database.

[0115] 6A-6E depict example user interfaces (600-660) presented by application 120 upon receiving prompt 205 or message 220 in system 100. UI 600 depicts an example interface of a learning module for user 210 to learn about migraines. UI 605 depicts a questionnaire related to user 210's condition. UI 610 displays questions for user 210 related to the user's medications. In some embodiments, UI 610 can be displayed in response to user 210 indicating that they are experiencing or expecting to experience a migraine. UI 615 displays options for user 210 to engage in activities to reduce migraine symptoms. UI 620 displays a start screen for an activity. UI 625 displays questions related to activities that user 210 may engage in. UI 630 displays a start screen for an activity. UI 635-645 depict interactive activities in progress. Specifically, UIs 635-645 depict an exemplary breathing activity, with each UI 635-645 instructing a controlled breathing pattern for user 210 to perform. UI 650 depicts an activity related to self-compassion meditation. UI 655 depicts an activity related to progressive muscle relaxation. UI 660 depicts an activity related to curiosity mindfulness.

[0116] 7A-7C, a set of example user interfaces (700-710, 740-750, and 770-775) presented by application 120 upon receiving prompt 205 or message 220 in system 100 are depicted. The user interfaces may be related to determining a state of user 210. The depicted examples may be related to prompt 205 provided by session management service 105. In an exemplary embodiment, user device 110 may display an example user interface (UI) 700 via user interface 145. UI 700 may include a question 715 for the user. In some embodiments, question 715 may be related to the composure of user 210. Upon receipt of user response 730, user device 110 may display a second UI 705. UI 705 may be displayed in response to user selection 730. UI 705 may pose a second question 720 to user 210. The second question 720 may be related to the mental stamina of the user 210. The user 210, in some embodiments, may submit a second response 735. The second response 735 may prompt a third UI 710. The third UI 710 may include a third question 725. The third question 725 may be related to the amount of time the user 210 has. In some embodiments, if the user has five minutes or less, the UIs of FIGS. 7B and 7C may be displayed.

[0117] The UI 740 may present the user with a choice of activities to perform in response to the user's answers to the preliminary questions. The user 210 may make a selection 755 of an activity. If the user selects the selection 755, the UI 745 may be displayed. The UI 745 may display instructions, video, text, or other UI elements 150 to indicate the activity to the user 210. The user 210 may indicate completion of the activity through a selection 770. The selection 770 may cause a UI 750 to be displayed indicating completion of the activity. Turning now to FIG. 7C, if the user 210 selects a selection 780 in the UI 740, the system may present a UI 770. The UI 770 may show a different activity than that presented in the UI 745. A selection 785 by the user 210 may cause a UI 775 to be displayed indicating completion.

[0118] 8A-8C, a set of example user interfaces (800-850) presented by the application 120 upon receiving a prompt 205 or message 220 in the system 100 are depicted. The depicted examples may relate to activities 185 provided by the session management service 105. In the depicted examples, the user device 110 may display an example UI based on a selected activity via the user interface 145. UI 800 displays an activity related to a half-smile. UI 805 displays instructions related to the half-smile activity of UI 800. UI 810 displays an activity related to a spontaneous hand. UI 815 displays instructions related to the activity related to a spontaneous hand of UI 810. UI 820 displays an activity related to monitoring and acceptance. UI 825 displays instructions related to the monitoring and acceptance activity of UI 820. UI 830 displays an activity related to describing what was seen. UI 835 displays instructions related to the activity related to describing what was seen of UI 830. UI 840 displays a list of alternative activities (e.g., secondary strategies) including opening a window and listening to a favorite song. UI 845 displays an activity related to curiosity mindfulness. UI 850 displays a list of alternative activities (e.g., secondary strategies) including taking a brisk walk and listening to comedy.

[0119] 9A-9C, exemplary user interfaces (900-940) presented by application 120 upon receipt of prompt 205 or message 220 in system 100 are depicted. These activities may be suggested based at least on status indications provided by user 210, or user profile 180, among others. UI 900 depicts an activity related to progressive muscle relaxation. UI 905 depicts an activity related to paced breathing. UI 910 depicts a voluntary hand activity. UI 915 depicts instructions related to the voluntary hand activity depicted in UI 910. UI 920 depicts a list of example alternative activities to be performed. UI 925 depicts an activity related to progressive muscle relaxation. UI 930 depicts an activity related to practicing good sleep habits. UI 935 depicts instructions related to the activity related to practicing good sleep habits depicted in UI 930. UI 940 depicts a list of example alternative activities to be performed.

[0120] 10, a flow diagram is depicted that generally illustrates a method 1000 for providing lesson recommendations based on a user 210. Upon launching the migraine treatment application 506, the migraine treatment application 506 displays a daily check-in interface on the display of the mobile device. This daily check-in interface may include a wellness query. If the migraine sufferer 210 responds to the wellness query with anything other than "feeling good," the support function ("DST") attempts to provide the migraine sufferer 210 with some objective advice regarding migraine treatment or migraine prevention and then provides the migraine sufferer 210 with a lesson. If the migraine sufferer 210 responds with "feeling good," the support function provides the lesson. If the lesson is completed, the support function records this so that another lesson can be provided on another day. If the user wishes to repeat this process again on the same day, the user can request this from the migraine treatment application, and the user is presented with the wellness query again.

[0121] (B. Example) 11, a flow diagram of a method 1100 for reducing migraine days in a user in need thereof is depicted. The method 1100 may be performed by any component or actor described herein, such as the session management service 105, the user device 110, or the user 210, among others. The method 1100 may be used with any combination of the functions or operations described in Sections A or B herein. In brief overview, the method 1100 may include obtaining baseline metrics (1105). The method 1100 may include identifying a user state (1110). The method 1100 may include selecting an activity and a message (1115). The method 1100 may include presenting the message (1120). The method 1100 may include obtaining session metrics (1125). The method 1100 may include determining whether to continue (1130). The method 1100 may include determining whether the session metric is less than the reference metric if the decision is to stop (1135). The method 1100 may include determining that the user indicates a reduction if the session metric is less than the reference metric (1140). The method 1100 may include determining that the user does not indicate a reduction if the session metric is not less than the reference metric (1145).

[0122] More specifically, method 1100 may include determining, measuring, or otherwise obtaining (1105) a baseline metric from a user at risk for migraine. The baseline metric may be obtained (e.g., by a clinician) before a user (e.g., user 210) performs a first activity through a digital therapeutic application (e.g., application 120) (sometimes referred to herein as a CT-132 application or learning app). The baseline metric may be a migraine metric of the user, such as monthly migraine days (MDD) or pain severity scale (PCS) score, among others. In some embodiments, the baseline metric may be, among others, the Difficulties in Emotion Regulation Scale Short Form (DERS-SF), Generalized Anxiety Disorder 7-item (GAD-7), Identify Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6C).

[0123] The migraine may be, for example, a complex migraine, a common migraine, a silent migraine, a hemiplegic migraine, or a retinal migraine. A user may concomitantly take medications such as triptans (e.g., almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, or zolmitriptan), ibuprofen, aspirin, acetaminophen, dichlorphenazone-acetaminophen, ergotamines (e.g., dihydroergotamine, or ergotamine-acetaminophen, dihydroergotamine, or ergotamine tartrate), or calcitonin gene-related peptide (CGRP) inhibitors (e.g., rimegepant, ubrogepant, or zavegepant) to manage the migraine.

[0124] The method 1100 may include receiving, retrieving, or otherwise identifying a user state (1110). A computing device (e.g., the session management service 105 or the user device 110) may receive an indication of at least one state of a user for a time instance. In some embodiments, the state may be one of a set of migraine states, such as the onset, presence, or absence of a migraine in the user. In some embodiments, the state may include one of a set of emotional states, one or more of calmness, mental stamina, or time availability for the time instance. In some embodiments, the state may include one or more characteristics of the user to be evaluated, such as migraine symptoms, vocalization biomarkers, anxiety level, engagement level, mood, etc., among others. The state may include any combination of a migraine state, a set of emotional states, or one or more characteristics.

[0125] Method 1100 may include identifying or selecting (1115) an activity (e.g., activity 185) and a message (e.g., message 220) for the digital therapeutic application. Based on the condition (e.g., migraine condition, emotional state, and evaluated characteristics, or any combination), the computing device may select an activity from a set of activities. Once selected, the computing device may identify at least one message for the selected activity. Selection of the activity and identification of the message are as described above in Section A.

[0126] The method 1100 may include displaying, publishing, or otherwise presenting a message to a user of the digital therapeutic application at a time instance (1120). The message may identify a selected activity to the user. The digital therapeutic application may present the message to the user via a user interface, prompt the user to perform the specified activity, and record a response to the message. The presentation of the message and related functionality may be as described above in Section A.

[0127] The method 1100 may include determining, measuring, or otherwise obtaining (1125) a session metric. The session metric may be obtained (e.g., by a clinician) from a user (e.g., user 210) after performing at least one activity through the digital therapeutic application in response to the presentation of the message. The session metric may be a measure of the user's migraine, such as monthly migraine days (MDD) or pain severity scale (PCS) score, among others. In some embodiments, the session metric may be a short form of the Difficulties in Emotion Regulation Scale (DERS-SF), 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-88 (PHQ-8), or 6-item Self-Efficacy Scale for Managing Chronic Diseases (SES6C), among others.

[0128] The method may include identifying or determining whether to continue providing additional messages (1130). The determination may be based on a set length of trial (e.g., a day, a week, or a year) or a set number of sessions provided to the user. If the amount of time since acquisition of the baseline metric or the first activity has not exceeded the set length, the decision may be to continue and repeat from (1110). Presentation of the message identifying the selected activity may be repeated until a decision is made to stop. Otherwise, when the amount of time since acquisition of the baseline metric or the first activity exceeds the set length, the decision may be to stop.

[0129] The method 1100 may include, if the decision is to stop, determining whether the session metric is less than the reference metric (1135). In some embodiments, the decision may be performed independently of the decision to stop the trial. The reference metric obtained from one time instance (e.g., before the first activity) may be compared to the session metric obtained from another time instance. In some embodiments, the compared session metric may be from the last of the time instances of the repeated presentation of the message (e.g., after the decision to stop). In some embodiments, the compared session metric may be from at least one of the time instances of the repeated presentation of the message (e.g., independent of the decision to continue or stop).

[0130] The method 1100 may include determining that the user exhibits a reduction if the session metric is less than the reference metric (1140). The reduction may be a reduction in the number of migraine days for the user if the session metric is less than the reference metric. The type of metric may be, among others, a PCS score or MDD. In some embodiments, the reduction may be a reduction in the number of migraine days for the user if the session metric is an improvement over the reference metric. The type of metric may be, among others, a short form of the Difficulties in Emotion Regulation Scale (DERS-SF), 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-88 (PHQ-8), or 6-item Self-Efficacy Scale for Managing Chronic Diseases (SES6C). Alternatively, the method 1100 may include determining that the user does not exhibit a reduction in migraine days if the session metric is not less than the reference metric (1145). In some embodiments, the user may not exhibit a reduction in migraine days if the session metric is not an improvement over the reference metric.

[0131] Example 1 - A single-center, exploratory, single-arm, 2-week study to evaluate the effective establishment of a digital working alliance in late adolescents and adults with migraine (use of migraine state for digital treatment to address migraine)

[0132] (overview) Research purpose: -Study the feasibility and acceptability of the application. -Assess migraine symptoms and medication use patterns while using the application. -Measure application engagement. · Investigate compliance of the application's day-to-day engagement. - To investigate self-efficacy in managing chronic illness, stress, symptoms of depression and symptoms of anxiety before and after two weeks of use of the application (e.g., application 120).

[0133] Main criteria for diagnosis and inclusion: Self-reported and physician-diagnosed migraine · Answered affirmatively to the question, "Have you ever been diagnosed by a doctor as having migraine headaches?" -Reported having had at least four migraines in the past 28 days. -Age is between 18 and 64. - One or more acute treatments and / or prophylactic medications were prescribed to concurrently manage migraine headaches.

[0134] Test product, dose, method of administration and duration of treatment: The application was used daily by study participants on their smartphones for approximately two weeks.

[0135] Evaluation criteria: Pain Severity Scale (PCS) Migraine diary · Mobile Application Rating Scale (MARS)

[0136] Exploratory Endpoints: Feasibility and acceptability of learning apps, defined as follows: The level of engagement of participants with the learning app, as measured by participant usage data captured within the app a. The number of lessons completed on a given day out of all lessons scheduled on that day b. Daily retention rate c. Number of times each user uses the decision support tool d. Number of times they reported practicing skills recommended by a learning app Participant feedback obtained through follow-up participant qualitative interviews Participants' self-reported symptoms and medication use patterns Change in self-efficacy for managing a chronic disease from baseline to week 2 as measured by the SES6C Change in stress perception from baseline to week 2 as measured by the PSS Change in depressive symptoms from baseline to week 2 as measured by the PHQ-8 Change in anxiety symptoms from baseline to week 2 as measured by the GAD-7

[0137] Exploratory endpoints and associated statistical analyses were performed according to SAP.

[0138] One-sample Mest or Wilcoxon signed-rank tests were used for changes from baseline in questionnaire scores, including SES6C, DERS-SF, PCS, PHQ-8, and GAD-7, among others.

[0139] Post hoc exploratory analyses of change in MMD over time (baseline [BL] to end of study [EOS]) were performed using paired t-tests. Engagement metrics were reported using summary statistics (number of nonmissing observations, mean, standard deviation, median, quantiles, minimum, maximum).

[0140] A post-hoc analysis of medication adherence was performed for the 34 participants who reported daily medication adherence in the past 14 days at BL and EOS. The mean number of days of medication adherence in the 14 days before BL was 8.1 days (± 6 days) (median 10 days) and the mean number of days of medication adherence in the 14 days during the study was 6.6 days (± 5.8 days) (median 3.5 days). Because the data were not normally distributed, the significance of the change from BL to EOS was assessed using medians, but this difference was not statistically significant (p value = 0.22).

[0141] The data collection methodology was programmed to avoid any missing data (e.g., an answer must be given to proceed to the next assessment question). The only data input was the number of lessons completed. This was done in cases where a more advanced lesson was completed but some of the previous lessons were missing. This situation could occur in limited circumstances where a user goes offline for an extended period of time and completion of a previous lesson is not recorded (the exam app is programmed to only allow access to a lesson if the previous lesson has been completed).

[0142] Study participants:

[0143] Sixty patients were enrolled and there were no withdrawals.

[0144] result:

[0145] Results of the engagement analysis were as follows: The number of lessons completed ranged from 6 to 15, with an average of 13 lessons. Participants accessed the DST an average of four or more times during the intervention phase and practiced an average of nearly four skills from the DST. Participants also practiced therapeutic skills an average of 3.4 times outside of daily lessons during the intervention phase.

[0146] The statistically significant mean difference in PCS scores between BL and EOS was -2.7 (p-value=0.012), indicating an improvement in pain severity. The PSS was considered to be a low reliability measure (Cronbach's BLa=0.029, EOSa=0.17).

[0147] Post hoc exploratory analyses showed sufficient evidence to conclude that the mean monthly migraine days (MMDs) for BL were statistically significantly different from the mean MMDs for EOS (tdf=51=-2.47, p-value=0.01686) after doubling the MMDs for EOS to compare with BL and taking into account the difference in reporting period (28 vs. 14 days). The sample mean difference was -2.2 MMDs, 95% CI [-3.94; -0.41].

[0148] Safety Results:

[0149] No AEs or SAEs were reported during the study. The study app poses minimal risk to users.

[0150] Overall conclusion:

[0151] Results from this exploratory study indicate that participants formed a positive association with the study app, adhered to the daily lesson content, and engaged with the available therapeutic skills and DST. Participants also reported statistically significantly improved pain severity, and exploratory analyses suggested pre-post reductions in MMDs. Collectively, these findings constitute an early signal of promising clinical efficacy for CT-132.

[0152] (CT-132 Application) CT-132 (e.g., application 120) is a digital treatment designed to target the reduction of MMDs in migraine sufferers. CT-132 is a smartphone application that provides therapeutic content and support throughout a 12-week treatment experience, presenting messages such as those depicted in Figures 6A-6E.

[0153] CT-132 is intended to provide an interactive, software-based intervention for the prevention of migraine headaches in late adolescents and adults ages 18 to 64. This preventive treatment will be delivered over a 12-week period in the manner laid out in Figure 12.

[0154] Treatment was delivered in the form of daily lessons, treatment skills, and decision support tools (DSTs). On specific days during the 14-day trial app experience, participants were delivered SMS text messages to reinforce the lessons.

[0155] (Objectives and Endpoints) (exploratory purpose) The secondary exploratory study objectives were to: To explore the feasibility and acceptability of abbreviated treatment using the test app To assess migraine symptoms and medication use patterns during use of the study app - To explore the level of engagement with the testing app Explore compliance with daily use of the test app engagement Explore self-efficacy in managing chronic illness, stress, depression and anxiety symptoms before and after two weeks of using the study app.

[0156] This study was exploratory and was not intended to evaluate any specific hypotheses. Exploratory endpoints were identified. Study endpoints are shown in Table 2.

[0157] [Table 1]

[0158] (Research participants) At BL, most participants (73.3%) met criteria for episodic migraine as assessed by the ID-CM. On average, participants reported severe migraine-related disability, with a mean MIDAS score of 39.4 (± 35.2), and 10.3 (± 8) migraines in the past 30 days at BL. Participants reported moderate anxiety with a mean score of 11.7 (± 3.8), moderate depression with a mean score of 13.7 (± 3.9), subclinical level of pain severity with a mean score of 17.5 (± 7.9), difficulty with emotion regulation with a mean score of 36.5 (± 7.4), and self-efficacy for disease management with a mean score of 5.9 (± 1.7). Finally, participants reported high digital literacy, as assessed by the MDPQ, with the majority reporting that they could perform the 46 listed tasks very easily.

[0159] [Table 2-1] [Table 2-2] [Table 2-3]

[0160] DERS-SF=Difficulties in Emotion Regulation Scale Short Form, GAD-7=7-item Generalized Anxiety Disorder, ID-CM=Identifying Chronic Migraine, Max=Maximum, Min=Minimum, PCS=Pain Severity Scale, PHQ-8=Patient Health Questionnaire-8, SD=Standard deviation, SES6C=Self-Efficacy for Managing Chronic Illness 6-item Scale

[0161] (Individual patient data results and tables) (analysis) (Endpoint) (Feasibility and acceptability of the test app) The endpoint was to examine participants' engagement with the study app as measured by lesson completion rates, DST usage, and engagement with the available skill content. A total of 14 daily lessons were available, and participants could engage with the DST and skill content as often as they wanted. The DST also suggested specific skills to practice depending on participants' input. Therefore, participants' engagement with the skill content was analyzed for both skills practiced from the study app's skills tab and skills practiced from the DST suggestions.

[0162] Most participants completed all 14 lessons, with a median of 14 and an average of 13.2 lessons. Retention rates were high (see Table 4). No participants discontinued or dropped out.

[0163] [Table 3]

[0164] DST=decision support tool, SD=standard deviation Skills tab a Skills are contrasted with the practice of skills, which may be part of daily lessons.

[0165] The skills most commonly completed by participants were paced breathing and self-compassion meditation (see Table 5).

[0166] [Table 4]

[0167] (Quality of mobile health apps) The quality of the study apps was assessed using the MARS and is summarized in Table 6. This 23-item scale rates the quality of mobile health apps on a scale of 1–5, with 1 indicating poor and 5 indicating excellent. Participants reported a mean app quality score of 4.1 (±0.5) and a mean subjective quality of 4.7 (±0.8).

[0168] [Table 5]

[0169] (Migraine Diary) Participants' reports from the migraine diaries are summarized in Table 7.

[0170] [Table 6]

[0171] (Symptoms and medication patterns) Table 8 describes the symptoms reported by participants during a migraine attack. The most commonly reported symptoms were sensitivity to light (16.3%), sensitivity to sound (14.9%), fatigue (14.0%), and nausea (13.4%).

[0172] [Table 7]

[0173] (Endpoint) The improvement in mean PCS of -2.7 was statistically significant (p-value=0.012), indicating a reduction in reported pain severity.

[0174] [Table 8]

[0175] Δμ = mean difference, BL = baseline, EOS = end of study, SD = standard deviation, tdf = t score with df as the degrees of freedom

[0176] (Post-mortem analysis) (Number of migraine days per month) Monthly migraine days were assessed as a post-hoc exploratory analysis. BLMMDs were assessed by asking participants to report MMDs over the past month, but note that the MMD assessment period in this study was only 2 weeks. Therefore, EOSMMDs were doubled to compare with BLMMDs (see Table 10). Participants with fewer than 14 daily migraine surveys were excluded from statistical testing (n=52).

[0177] [Table 9]

[0178] BL = baseline, EOS = end of study, tdf = t score with df being the degrees of freedom

[0179] In this post hoc exploratory pre-post comparison, paired data with two observations were analyzed. The mean difference in MMDs from BL to EOS was -2.2, indicating a statistically significant improvement (tdf=51=-2.47, p-value=0.017, 95% CI[-2.9;-0.4]).

[0180] (Strict adherence to preventive medication) Thirty-four participants reported daily medication adherence during the past 14 days during BL and EOS. The mean number of days of medication adherence 14 days before BL was 8.1 days (± 6 days) (median 10 days) and during the 14-day study was 6.6 days (± 5.8 days) (median 3.5 days).

[0181] (statistical / analytical problems) Baseline MMDs were assessed by asking about the number of migraine days in the previous month, but the MMD assessment period was only 2 weeks. Therefore, end-of-study MMDs were doubled to allow comparison with baseline MMDs. MMDs data were collected in the daily migraine survey as a Yes / No response to the question "Have you had a migraine attack in the past 24 hours?" Participants who recorded fewer than 14 events per day in this survey were excluded from statistical testing. Pre-post comparisons were only performed for paired data with two observations.

[0182] No adjustment for multiplicity was made in any statistical tests.

[0183] Cronbach's alpha was used to explore the reliability of the assessments used in this study. Assessments with α ≥ 0.6 were considered reliable. The PSS assessment was judged to be unreliable based on Cronbach's alpha results (BLα = 0.029, EOSα = 0.17), so the results are not reported.

[0184] (Conclusion) Participants also engaged with the study app consistently throughout the intervention phase. Most participants completed all available lessons, with the median number of lessons completed being 14 of 14. Promising utilization of study app features was also observed, with participants who accessed the DST doing so an average of 4 or more times during the intervention period, and participants who practiced DST skills practicing the skills an average of nearly 4 times. Participants also practiced available treatment skills an average of 3.4 times during the intervention period outside of daily lessons.

[0185] Exploratory analyses also observed trends of improvement in other metrics. A statistically significant reduction in pain severity was observed when comparing BL with EOS, with a mean reduction in PCS score of -2.7, 95% CI [-4.8; -0.6] (p=0.012). Post-hoc analyses also found a statistically significant difference in mean MMDs between BL and EOS of -2.2 (p=0.017), indicating that participants experienced a reduction in the number of migraine days per month. However, this pre-post comparison relied on EOS MMDs, which were doubled compared with BL, to account for the difference in reporting period (28 vs. 14 days). Post-hoc analyses did not detect any improvement in preventive medication adherence.

[0186] These results indicate that participants developed a positive relationship with the study app, adhered to the daily lesson content, and engaged with the available therapeutic skills and DST. Participants also reported significant improvements in pain severity, and exploratory analyses suggested pre-post reductions in MMDs. Taken together, these findings provide promising early signals of clinical efficacy for CT-132.

[0187] (Safety Assessment) Adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the end of the follow-up period. No AEs were reported during the study. The study app presents minimal risk to users.

[0188] Example 2 – Randomized trial of digital therapeutics for episodic migraine prevention

[0189] (overview) Indication: CT-132 is an investigational prescription digital therapeutic (PDT) indicated for the preventive treatment of episodic migraine in late adolescents and adults 18 years of age or older.

[0190] Rationale for the study: CT-132 is a PDT being developed by Click Therapeutics. CT-132 is a mobile application that provides an interactive software-based intervention for the preventive treatment of episodic migraine in late adolescents and adults. Examples of messages delivered to users are shown in Figures 7A-9C.

[0191] The aim of this study is to evaluate the efficacy and safety of CT-132 versus digital control in a sufficiently sized randomized controlled trial of participants diagnosed with episodic migraine. If proven effective, CT-132 would provide an important addition to currently available treatment options.

[0192] Objective: To evaluate the efficacy and safety of CT-132 compared with digital control in reducing monthly migraine days (MMDs) in late adolescent and adult patients with episodic migraine.

[0193] Evaluation Criteria: All efficacy endpoints will be evaluated comparing treatment and control groups.

[0194] Participants' baseline MMD and MHD were defined as the sum of the number of migraine days recorded during the 28-day run-in period. Week 12 MMD and MHD were defined as the sum of the number of migraine days recorded during the previous 28 days (weeks 9–12).

[0195] Primary efficacy endpoint Change from baseline in MMD counts at week 12

[0196] Secondary Efficacy Endpoints Percentage of participants who achieved at least a 50% reduction in mean MMD count from baseline at week 12 Change from baseline in number of MMDs recorded in the past 28 days for weeks 4 and 8 Reduction from baseline in average MMD count over 12 weeks Change in mean headache severity from run-in period to weeks 9-12 Change from baseline in the Migraine-Specific Quality Questionnaire v2.1 (MSQ) at weeks 4, 8, and 12 Change from baseline in Migraine Disability Assessment (MIDAS) at weeks 4, 8, and 12 Changes in acute migraine medication use (frequency, dose, type) from the run-in period to weeks 9-12

[0197] Exploratory Endpoints Key engagement metrics Participant-reported information, including data such as: Healthcare utilization will be assessed by change from baseline at weeks 4, 8, and 12 via the Custom Healthcare Utilization Method (CHUM). Anxiety and depression will be assessed by change from baseline at weeks 4, 8, and 12 via the GAD-7 and PHQ-8, respectively. To assess the frequency of acute medication use at weeks 4 and 8 compared to the run-in period. Change from baseline in preventive medication adherence assessed by the Voils DOSE-Nonadherence Measure at Week 12 Monthly headache days (MHDs) Change in number of MHDs from baseline at 12 weeks Percentage of participants who achieved at least a 50% reduction in mean MHDs from baseline at week 12 Change from baseline in the number of MHDs recorded in the past 28 days for weeks 4 and 8 Reduction from baseline in mean number of MHDs over 12 weeks

[0198] Safety Endpoints Frequency and severity of AEs, serious AEs, and study discontinuations due to AEs - Frequency and severity of AEs associated with migraine exacerbation

[0199] Study Design: This is a randomized, double-blind, digitally controlled, parallel-group, virtual trial evaluating the efficacy and safety of CT-132 compared to digital control for migraine prophylaxis in late adolescents and adults.

[0200] As shown in Figure 13, this study consists of a screening period of up to 14 days, a run-in period of 28 days, a double-blind intervention period of 12 weeks, and a follow-up period of up to 1 week for safety evaluation.

[0201] Screening period (days -42 to -29)

[0202] All participants will enter a screening period of up to 14 days to determine eligibility. Eligible participants must report having at least 4 and no more than 14 migraine days per month (a month is defined as 28 days) during the 3 months prior to the screening visit.

[0203] Prior to entering the screening period, participants will be asked to download the ObvioHealth app (separate from the study app) to consent to the study and complete study assessments, including self-management scales.

[0204] Break-in period (-28th day to -1st day)

[0205] After completing start-up activities, eligible participants will be contacted to schedule a remote video call to verify identity and migraine medication prescription. Once review and authentication is complete, participants will deploy the study app by downloading and installing the application on their personal iPhone or Android smartphone. Only the eDiary element of the study app will be enabled.

[0206] Participants then enter a 28-day run-in period to establish baseline MMDs and enter daily headache information into the study app to determine adherence to and performance with the study app. Adherence to entry requirements will be assessed by the investigator prior to randomization at the baseline visit.

[0207] Baseline virtual visit (Day 1)

[0208] After the 28-day run-in period, participants will be contacted for a baseline visit to review and confirm eligibility. Participants will be deemed eligible for the study based on all of the following criteria: Continue to meet all other inclusion and exclusion criteria based on the investigator's assessment. Understand and adhere to the start requirements and test app (adherence rate of 80% or higher). During the 28-day run-in period, you will report between 4 and 14 (inclusive) migraine days in the study app. ·Agree to honestly complete the 12-week study intervention at the baseline virtual visit.

[0209] Eligible participants will then be randomized in a 1:1 ratio to activate the assigned full treatment app (CT-132: digital control). Assessments and activities during this period will be performed remotely via telehealth technology visits in accordance with the SoA (section 1.2).

[0210] Double-blind intervention period (12 weeks)

[0211] During the 12-week intervention period, the study app will deliver either the CT-132 or the digital control. Participants will be able to use their prescribed medications to treat episodic migraine headaches as needed (including medication or dose changes) while continuing to use the study app on their usual schedule. Assessments and activities during this period will be conducted remotely according to the Schedule of Activities and Assessments (Section 1.2).

[0212] Follow-up period (up to 1 week)

[0213] Following the end of the 12-week intervention period or within one week of study discontinuation, participants will complete follow-up activities according to the Schedule of Activities and Assessments (section 1.2).

[0214] Planned Number of Participants: Approximately 558 participants will be randomized in this study.

[0215] Study Centers: This will be a fully virtual study. Participants residing in the United States will be enrolled and followed through telehealth visits.

[0216] Study participation criteria: Inclusion criteria

[0217] Participants are eligible to participate in this study if they meet all of the following criteria: 1. Willing and able to provide written informed consent to participate in the study, attend study visits, and comply with requirements and evaluations related to the study. 2. Living in the United States 3. Adults aged 18 years or older or late adolescents at the time of informed consent 4. Fluent in written and spoken English, and able to read and understand the informed consent form 5. The following will be subject to physician review: Participant will have a history of migraine headaches (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, for ≥1 year. -Migraine headaches occur before age 50. · If left untreated, migraine attacks last an average of 4 to 72 hours. Participant-reported 4 to 14 migraine days per month (a month is defined as 28 days) in the past 3 months prior to the screening visit Number of migraine days between 4 and 14 during the run-in period 6. Currently managing migraines with one or more prescription acute medications and / or prescription first or second line preventive medications as assessed by a physician. 7. Have an iPhone with iOS 14 or later operating system or an Android smartphone with OS 11 or later operating system alone and are willing to download and use the test app required by the protocol. 8. Able and willing to receive SMS text messages and push messages on your smartphone. 9. You have an email address and have regular access to it. 10. Have regular access to the internet via a cellular data plan and / or wifi.

[0218] Exclusion criteria

[0219] Participants were ineligible to participate in the study if they met any physician-reviewed criteria. 1. History of basilar or hemiplegic migraine. 2. Active chronic pain syndromes such as fibromyalgia, chronic pelvic pain, and complex regional pain syndrome (CRPS). 3. Other pain syndromes (including trigeminal neuralgia), psychiatric illness (e.g. major depressive episode, bipolar disorder, major depressive disorder, schizophrenia), dementia or any significant neurological disease (except migraine) that in the investigator's opinion would interfere with the study evaluations. 4. Have a history of, or evidence of, alcohol or drug abuse within the past 12 months (48 weeks), or have met DSM-V criteria for any major substance use disorder within the past 12 months (48 weeks) from the date of the screening visit. 5. History of use of analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs] or acetaminophen, including opioids) or butalbital ≥ 15 days per month in the 3 months (12 weeks) prior to the screening visit or during the run-in period. 6.Currently taking anti-calcitonin gene-related peptide (CGRP) medication prescribed for episodic or chronic migraine headaches. 7. Post-traumatic headache, persistent post-traumatic headache or post-concussion syndrome. 8. Any other significant episodic or chronic medical condition that the investigator believes may confound the interpretation of findings informing PDT development. 9. Failure to comply or complete the Study App entry and initiation activities during the Run-In Period. Participants who do not comply during the Run-In Period will not be eligible to participate in the Study. 10. Previous participation in any pilot or pivotal study of a digital therapeutic for the indication of migraine. 11. Participation in any other investigational clinical trial while participating in this study.

[0220] Study Product and Administration: Eligible participants will download and install the required study app onto their smartphone at the start of the run-in period. Participants will complete the initiation requirements during the run-in period and will be randomized to either CT-132 or digital control at the baseline visit (Day 1).

[0221] Study Duration: Study participation will last approximately 19 weeks. Screening period: up to 2 weeks Break-in period: 4 weeks Intervention period: 12 weeks Follow-up period: up to 1 week

[0222] Sample size: Approximately 558 people will be randomized in this study.

[0223] Statistical analysis: The change from baseline in MMD in the CT-132 group and the digital control group is μ1 and μ2, respectively. The null hypothesis for the primary endpoint is that they are equal, and the alternative hypothesis is that they are different.

[0224] To test this hypothesis, an analysis of covariance (ANCOVA) model was used, with the dependent variable being the change in MMD for each participant from baseline to week 12. A participant's baseline MMD was the sum of the number of migraine days recorded during the 28-day run-in period. The MMD at week 12 was the sum of the number of migraine days recorded over the previous 28 days (weeks 9-12).

[0225] Models are adjusted for the following covariates: treatment arm, baseline MMD, and sex. Analyses include a modified intention-to-treat (mITT) analysis set. Multiple imputation with missing at random is used to account for early termination.

[0226] (Objectives and Endpoints) The objective of this study was to evaluate the efficacy and safety of CT-132 compared to a digital control in reducing the number of MMDs in late adolescents and adults with migraine headaches.

[0227] Study endpoints supporting these objectives are shown in Table 1.

[0228] Participants' baseline MMD and MHD were the sum of the number of migraine days recorded during the 28-day run-in period. Week 12 MMD and MHD were the sum of the number of migraine days recorded during the previous 28 days (weeks 9–12).

[0229] [Table 10]

[0230] (Test evaluation) The study will use the following efficacy measures at the times described in the SoA (Section 1.2). A description of all endpoint measures and their respective scoring algorithms will be provided in the Statistical Analysis Plan (SAP).

[0231] (Migraine Patient Journey Questionnaire) The Migraineur Travel Questionnaire is a four-item click-generated self-report questionnaire to characterize migraine history.

[0232] (Monthly migraine days (MMD)) Participants will record the number of days per month (defined as 28 days) that they experienced a migraine event within the study app.

[0233] (Identification of chronic migraine (ID-CM)) The ID-CM is a 12-item self-report standardized assessment designed to assess the presence or absence of a self-reported migraine diagnosis and subsequently classify respondents as meeting diagnostic criteria for either episodic or chronic migraine.

[0234] (Migraine-Specific Quality of Life (MSQ)) The Migraine Specific Quality of Life Questionnaire v2.1 (MSQ) is a 14-item questionnaire that measures the impact of migraine on three important aspects of a patient's health-related quality of life over the past 4 weeks.

[0235] (Migraine Disability Assessment Scale (MIDAS)) The Migraine Disability Assessment Scale (MIDAS) is a brief, self-report, seven-item questionnaire designed to quantify headache-related disability over a 3-month period.

[0236] (Patient Health Questionnaire-8 (PHQ-8)) The Patient Health Questionnaire-8 (PHQ-8) is an eight-item self-report questionnaire designed to assess the severity of depressive symptoms as well as to confirm the diagnosis of a depressive disorder.

[0237] (7-item generalized anxiety disorder (GAD-7)) The 7-item Generalized Anxiety Disorder (GAD-7) is a valid and efficient 7-item self-report instrument for screening generalized anxiety disorder and assessing its severity in clinical and research settings.

[0238] (Custom Healthcare Usage Method (CHUM)) The Custom Healthcare Utilization (CHUM) is an 8-item click-generated self-report questionnaire that captures migraine-related health care visits across multiple settings in the past 4 weeks.

[0239] (Voils DOSE-Non-Adherence Measure) The Voils DOSE-Non-Adherence Scale is a two-domain measure designed to assess how many doses have been missed and the reasons for non-taking, allowing the measurement of various possibilities for patient non-adherence (missed doses, unfilled prescriptions, etc.).

[0240] (Patient Global Impression of Change (PGI-C)) The Patient Global Change (PGI-C) is a self-reported, 7-point scale that indicates the patient's overall degree of improvement. The PGI-C has been validated in many other episodic disorders against established measures of pain intensity, pain interference with daily life, and treatment efficacy.

[0241] (Test app engagement evaluation) Measure key engagement metrics. Number of daily lessons completed out of the total number of daily lessons scheduled Number of days participants opened the test app and engaged with it beyond the eDiary Here, "engagement beyond the eDiary" means any of the following activities that took place after a participant opened their eDiary for that day, regardless of completion: opening a lesson, opening a decision support tool or opening a skill. Number of times users opened the decision support tool Number of times a user accessed skill practice from the Skills tab Average number of times the test app was opened per day

[0242] (Primary endpoint) The primary analysis will include the mITT set.

[0243] The primary endpoint is the change from baseline in MMD count at week 12. The primary endpoint is analyzed using an ANCOVA model, with the dependent variable being the change from baseline to week 12 in MMD for each participant. A participant's baseline MMD is the sum of the number of migraine days recorded during the 28-day run-in period. MMD at week 12 is the sum of the number of migraine days recorded over the previous 28 days (weeks 9-12). The model is adjusted for the following covariates: treatment arm, baseline MMD, and sex. Multiple imputation with missing at random is used to account for early termination. Least Squares Means (LSMEANS) of the difference from baseline between the two treatment arms are presented with associated 95% confidence intervals and two-sided p-values ​​to test the null hypothesis of no difference. A two-sided p-value ≤ 0.05 will be considered successful.

[0244] (Sensitivity analysis of the primary endpoint) The primary analysis will be repeated in the ITT and PP analysis sets.

[0245] SAP defines additional analyses to assess the impact of missing data.

[0246] (Subgroup) The main model was repeated at each of the following subgroup levels: However, the study may not have been powered to show statistical significance for each of the subgroups. ·Gender (male, female) Age group (18-21, 22-35, 36-64, 65+) Number of MMDs at baseline (reported using run-in period) (<8 ​​days, ?8 days) Subjects' currently prescribed migraine medications at baseline (acute medications only, prophylactic L1 with or without acute medications, prophylactic L2 with or without acute medications)

[0247] (Secondary endpoint) The mITT set will be included in the analysis of secondary endpoints. The proportion of participants who achieved at least a 50% reduction from baseline in mean MMD counts at week 12 will be analyzed using logistic regression. Changes from baseline in the number of MMDs recorded in the previous 28 days through weeks 4 and 8 will be analyzed in the same manner as the primary endpoint. The reduction from baseline in mean MMD counts over 12 weeks will be analysed in the same way as the primary endpoint, but comparing the mean MMD counts during the study to the MMD counts recorded during the 28-day run-in period. Change from baseline in headache severity over 12 weeks will be analyzed in the same way as the primary endpoint, but comparing the mean headache severity from weeks 9-12 to the mean headache severity during the run-in period. Changes from baseline in the Migraine Specific Quality of Life Questionnaire v2.1 (MSQ) at weeks 4, 8, and 12 will be analyzed using ANCOVA. Changes from baseline in migraine disability assessment at weeks 4, 8, and 12 will be analyzed using ANCOVA. Change from baseline in frequency of acute migraine medication use during weeks 9–12

[0248] The SAP will detail the analyses of other endpoints, covariates, and handling of missing data.

[0249] Example 3 - Use of calmness, concentration and time availability assessments for digital therapeutics to address migraines

[0250] In one embodiment, the CT-132 mobile app (e.g., application 120) is given (e.g., in a manner as described above in Example 2) to an individual who has 4-14 migraine days per month and is taking migraine medication. Treatment is for 12 weeks. The decision support tool is an on-the-spot interactive method that recommends to the individual strategies to help them feel better or how to act around a migraine headache they may be experiencing to help them decide what activities to undertake related to migraine treatment. The decision support tool described herein asks the individual questions about their level of calmness, difficulty concentrating, and immediate time availability. Based on the individual's reported levels of these three variables, the mobile app recommends different energizing and calming strategies. Users are expected to show a reduction (or improvement) in average monthly migraine days (MDD), Pain Severity Scale (PCS) scores, Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy Scale for Managing Chronic Illness 6-item (SES6C) during use of the CT-132 mobile app.

[0251] Example 4 - Using calmness assessment, concentration assessment and time availability assessment in conjunction with migraine status in a digital intervention to address migraine

[0252] In one embodiment, the CT-132 mobile app (e.g., application 120) is given (e.g., in a manner as described above in Example 2) to an individual who has migraine days per month and is taking migraine medication. The decision support tool is an on-the-spot interactive method that recommends skills practices and strategies to the individual that will help them feel better and act around any migraines they may be experiencing to help them decide what activities to undertake related to treating their migraine. The decision support tool described herein asks the individual questions about their migraine condition, as well as their level of calmness, difficulty concentrating, and immediate time availability. Based on the individual's reported levels of these four variables, the mobile app recommends different skill practices. Users can collect data such as the average number of migraine days per month (MDD), the Pain Severity Scale (PCS) score, the Delayed Emotion Regulation Scale Short Form (DERS-SF), the 7-item Generalized Anxiety Disorder (GAD-7), the Identifying Chronic Migraine (ID-CM), the Patient Health Questionnaire-8 (PHQ-8), or the Self-Efficacy for Managing Chronic Illness 6-item Scale (SES6C). It is expected that patients will demonstrate a decrease (or improvement) during the period of use of the CT-132 mobile app.

[0253] Example 5 - Use of evaluated properties of digital therapeutics to address migraines

[0254] In one embodiment, the CT-132 mobile app (e.g., application 120) is given (e.g., in a manner as described above in Example 2) to an individual who has 4-14 migraine days per month and is taking migraine medication. Treatment is for 12 weeks. The decision support tool is an on-the-spot interactive method that recommends to the individual strategies to help them feel better or how to act around the migraines they may be experiencing to help them decide what activities to undertake related to treating their migraines. The decision support tool described herein asks the individual questions about various characteristics to be assessed, such as migraine symptoms, vocalization biomarkers, anxiety levels, engagement levels, and mood. Based on the individual's characteristics, the mobile app recommends various strategies. Users are expected to show a reduction (or improvement) in average monthly migraine days (MDD), Pain Severity Scale (PCS) scores, Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy Scale for Managing Chronic Illness 6-item (SES6C) during use of the CT-132 mobile app.

[0255] Example 6 - Use of assessed traits in combination with migraine condition in a digital therapeutic to address migraine.

[0256] In one embodiment, the CT-132 mobile app (e.g., application 120) is given (e.g., in a manner as described above in Example 2) to an individual who has 4-14 migraine days per month and is taking migraine medication. Treatment is for 12 weeks. The decision support tool is an on-the-spot interactive method that recommends to the individual strategies to help them feel better or how to act around the migraines they may be experiencing to help them decide what activities to undertake related to treating their migraines. The decision support tool described herein asks the individual questions about various characteristics to be assessed, such as migraine symptoms, vocalization biomarkers, anxiety levels, engagement levels, and mood. The decision support tool also asks questions about the user's migraine status. Based on the individual's characteristics and migraine status, the mobile app recommends various strategies. Users are expected to show a reduction (or improvement) in average monthly migraine days (MDD), Pain Severity Scale (PCS) scores, Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy Scale for Managing Chronic Illness 6-item (SES6C) during use of the CT-132 mobile app.

[0257] Example 7 - Use of assessed characteristics in combination with migraine state and calmness assessment, concentration assessment, and time availability assessment in a digital treatment to address migraine headaches

[0258] In one embodiment, the CT-132 mobile app (e.g., application 120) is given (e.g., in a manner as described above in Example 2) to an individual who has 4-14 migraine days per month and is taking migraine medication. Treatment is for 12 weeks. The decision support tool is an on-the-spot interactive method that recommends to the individual strategies to help them feel better or how to act around the migraine headaches they may be experiencing to help them decide what activities to engage in related to migraine treatment. The decision support tool described herein asks the individual questions about various characteristics to be assessed, such as migraine symptoms, vocalization biomarkers, anxiety levels, engagement levels, and mood. The decision support tool described herein asks the individual questions about their level of calmness, difficulty concentrating, and immediate time availability in addition to their migraine status. Based on the individual's characteristics, migraine status, calmness, difficulty concentrating, and time availability, the mobile app recommends various strategies. Users are expected to show a reduction in average monthly migraine days (MDD), Pain Severity Scale (PCS) scores, Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy Scale for Managing Chronic Disease 6-item (SES6C) during use of the CT-132 mobile app.

[0259] Example 8 - Use of assessed characteristics in combination with calmness, concentration and time availability assessments in a digital treatment to address migraines

[0260] In one embodiment, the CT-132 mobile app (e.g., application 120) is given (e.g., in a manner as described above in Example 2) to an individual who has 4-14 migraine days per month and is taking migraine medication. Treatment is for 12 weeks. The decision support tool is an on-the-spot interactive method that recommends to the individual strategies to help them feel better or how to act around a migraine headache they may be experiencing to help them decide what activities to engage in related to migraine treatment. The decision support tool described herein asks the individual questions about various characteristics to be assessed, such as migraine symptoms, vocalization biomarkers, anxiety levels, engagement levels, and mood. The decision support tool described herein asks the individual questions about their level of calmness, difficulty concentrating, and immediate time availability. Based on the individual's characteristics, calmness, difficulty concentrating, and time availability, the mobile app recommends various strategies. Users are expected to show a reduction (or improvement) in average monthly migraine days (MDD), Pain Severity Scale (PCS) scores, Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy Scale for Managing Chronic Illness 6-item (SES6C) during use of the CT-132 mobile app.

[0261] Example 9 - Using calmness, concentration and time availability assessments in a digital therapeutic to address migraines in medicated users

[0262] In one embodiment, the CT-132 mobile app (e.g., application 120) is given (e.g., in a manner as described above in Example 2) to an individual who has 4-14 migraine days per month. Treatment is for 12 weeks. The decision support tool is an on-the-spot interactive method that recommends to the individual strategies that will help them feel better or how to act around a migraine headache that they may be experiencing to help them decide what activities they should undertake related to the treatment of their migraine. The decision support tool described herein asks the individual questions about their level of calmness, difficulty concentrating, and immediate availability of time. Based on the individual's reported levels of these three variables, the mobile app recommends different energizing and calming strategies. Users are expected to show a reduction in average monthly migraine days (MDD), Pain Severity Scale (PCS) scores, Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy Scale for Managing Chronic Disease 6-item (SES6C) during use of the CT-132 mobile app.

[0263] Example 10 - Use of calmness assessment, concentration assessment, and time availability assessment in combination with migraine condition in a digital therapeutic to address migraine in medicated users

[0264] In one embodiment, the CT-132 mobile app (e.g., application 120) is administered to an individual (e.g., in a manner as described above in Example 2) who has a certain number of migraine days per month. The decision support tool is an on-the-spot interactive method that recommends behavioral practices and strategies to the individual to help them decide what activities to undertake related to treating their migraine to feel better or around the migraine headaches they may be experiencing. The decision support tool described herein asks the individual questions about their migraine condition, as well as their level of calmness, difficulty concentrating, and immediate time availability. Based on the individual's reported levels of these four variables, the mobile app recommends the practice of various skills. Users are expected to show a reduction (or improvement) in average monthly migraine days (MDD), Pain Severity Scale (PCS) scores, Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy Scale for Managing Chronic Illness 6-item (SES6C) during use of the CT-132 mobile app.

[0265] Example 11 - Use of evaluated properties of digital therapeutics to address migraines in medicated users

[0266] In one embodiment, the CT-132 mobile app (e.g., application 120) is given (e.g., in a manner as described above in Example 2) to an individual who has 4-14 migraine days per month. Treatment is for 12 weeks. The decision support tool is an on-the-spot interactive method that recommends to the individual strategies to help them feel better or how to act around the migraines they may be experiencing to help them decide what activities to undertake related to the treatment of migraines. The decision support tool described herein asks the individual questions about various characteristics to be assessed, such as migraine symptoms, vocal biomarkers, anxiety levels, engagement levels, and mood. Based on the individual's characteristics, the mobile app recommends various strategies. Users are expected to show a reduction (or improvement) in average monthly migraine days (MDD), Pain Severity Scale (PCS) scores, Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy Scale for Managing Chronic Illness 6-item (SES6C) during use of the CT-132 mobile app.

[0267] Example 12 - Use of evaluated traits in combination with migraine condition for a digital therapeutic to address migraine in medicated users

[0268] In one embodiment, the CT-132 mobile app (e.g., application 120) is given (e.g., in a manner as described above in Example 2) to an individual who has 4-14 migraine days per month. Treatment is for 12 weeks. The decision support tool is an on-the-spot interactive method that recommends to the individual strategies to help them feel better or how to act around the migraine headaches they may be experiencing to help them decide what activities to undertake related to the treatment of migraine. The decision support tool described herein asks the individual questions about various characteristics to be assessed, such as migraine symptoms, vocalization biomarkers, anxiety levels, engagement levels, and mood. The decision support tool also asks questions about the user's migraine status. Based on the individual's characteristics and migraine status, the mobile app recommends various strategies. Users are expected to show a reduction (or improvement) in average monthly migraine days (MDD), Pain Severity Scale (PCS) scores, Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy Scale for Managing Chronic Illness 6-item (SES6C) during use of the CT-132 mobile app.

[0269] Example 13 - Use of assessed characteristics in combination with migraine state, calmness assessment, concentration assessment, and time availability assessment in a digital treatment to address migraine in unmedicated users

[0270] In one embodiment, the CT-132 mobile app (e.g., application 120) is given (e.g., in a manner as described above in Example 2) to an individual who has 4-14 migraine days per month. Treatment is for 12 weeks. The decision support tool is an on-the-spot interactive method that recommends to the individual strategies to help them feel better or how to act around the migraine headaches they may be experiencing to help them decide what activities to undertake related to migraine treatment. The decision support tool described herein asks the individual questions about various characteristics to be assessed, such as migraine symptoms, vocalization biomarkers, anxiety levels, engagement levels, and mood. In addition to migraine status, the decision support tool described herein asks the individual questions about their level of calmness, difficulty concentrating, and immediate time availability. Based on the individual's characteristics, migraine status, calmness, difficulty concentrating, and time availability, the mobile app recommends various strategies. Users are expected to show a reduction (or improvement) in average monthly migraine days (MDD), Pain Severity Scale (PCS) scores, Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy Scale for Managing Chronic Illness 6-item (SES6C) during use of the CT-132 mobile app.

[0271] Example 14 - Use of assessed characteristics in combination with migraine state, calmness assessment, concentration assessment, and time availability assessment in a digital treatment to address migraine in medicated users

[0272] In one embodiment, the CT-132 mobile app (e.g., application 120) is given (e.g., in a manner as described above in Example 2) to an individual who has 4-14 migraine days per month. Treatment is for 12 weeks. The decision support tool is an on-the-spot interactive method that recommends to the individual strategies to help them feel better or how to act around the migraine headaches they may be experiencing to help them decide what activities to undertake related to migraine treatment. The decision support tool described herein asks the individual questions about various characteristics to be assessed, such as migraine symptoms, vocal biomarkers, anxiety levels, engagement levels, and mood. The decision support tool described herein asks the individual questions about their level of calmness, difficulty concentrating, and immediate time availability. Based on the individual's characteristics, calmness, difficulty concentrating, and time availability, the mobile app recommends various strategies. Users are expected to show a reduction (or improvement) in average monthly migraine days (MDD), Pain Severity Scale (PCS) scores, Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) 7-item Generalized Anxiety Disorder (GAD-7), Identifying Chronic Migraine (ID-CM), Patient Health Questionnaire-8 (PHQ-8), or Self-Efficacy Scale for Managing Chronic Illness 6-item (SES6C) during use of the CT-132 mobile app.

[0273] (C. Network and Computing Environment) Various operations described herein may be implemented on a computer system. FIG. 14 shows a simplified block diagram of a representative server system 1400, a client computer system 1414, and a network 1426 that may be used to implement certain embodiments of the present disclosure. In various embodiments, the server system 1400 or a similar system may implement the services or servers described herein or portions thereof. The client computer system 1414 or a similar system may implement the clients described herein. The system 100 described herein may be similar to the server system 1400. The server system 1400 may have a modular design incorporating multiple modules 1402 (e.g., blades in a blade server embodiment), and although two modules 1402 are shown, any number may be provided. Each module 1402 may include a processing unit 1404 and local storage 1406.

[0274] The processing unit 1404 may include a single processor or multiple processors, which may have one or more cores. In some embodiments, the processing unit 1404 may include a general-purpose primary processor as well as one or more special-purpose co-processors, such as graphics processors, digital signal processors, etc. In some embodiments, some or all of the processing units 1404 may be implemented using customized circuitry, such as application specific integrated circuits (ASICs) or field programmable gate arrays (FPGAs). In some embodiments, such integrated circuits execute instructions stored in the circuitry itself. In other embodiments, the processing unit 1404 may execute instructions stored in local storage 1406. Any combination of any type of processor may be included in the processing unit 1404.

[0275] The local storage 1406 may include volatile storage media (e.g., DRAM, SRAM, SDRAM, etc.) and / or non-volatile storage media (e.g., magnetic or optical disks, flash memory, etc.). The storage media incorporated in the local storage 1406 may be fixed, removable, or upgradeable, as desired. The local storage 1406 may be physically or logically divided into various sub-units, such as a system memory, a read-only memory (ROM), and a permanent storage device. The system memory may be a volatile read-write memory, such as a read-write memory device or a dynamic random access memory. The system memory may store some or all of the instructions and data that the processing unit 1404 needs at run time. The ROM may store static data and instructions that the processing unit 1404 needs. The permanent storage device may be a non-volatile read-write memory device that can store instructions and data even when the module 1402 is powered down. As used herein, the term "storage medium" includes any medium that can store data indefinitely (subject to overwriting, electrical disturbance, power loss, etc.), and does not include carrier waves and ephemeral electronic signals propagated over wireless or wired connections.

[0276] In some embodiments, local storage 1406 may store one or more software programs executed by processing unit 1404, such as an operating system and / or programs that implement various server functions, such as functions of system 100 or any other system described herein, or any other server associated with system 100 or any other system described herein.

[0277] "Software" generally refers to a sequence of instructions that, when executed by the processing unit 1404, causes the server system 1400 (or portions thereof) to perform various operations, thus executing the operations of the software program to define one or more specific machine embodiments that operate. The instructions may be stored as firmware resident in a read-only memory and / or as program code stored in a non-volatile storage medium that can be read into a volatile working memory for execution by the processing unit 1404. The software may be implemented as a single program or a collection of separate programs or program modules that interact as desired. From the local storage 1406 (or non-local storage, described below), the processing unit 1404 may retrieve program instructions to execute and data to process in order to perform the various operations described above.

[0278] In some server systems 1400, multiple modules 1402 may be interconnected via a bus or other interconnect 1408 to form a local area network that supports communication between the modules 1402 and other components of the server system 1400. The interconnect 1408 may be implemented using a variety of technologies, such as server racks, hubs, routers, etc.

[0279] A wide area network (WAN) interface 1410 may provide data communication capabilities between a local area network (e.g., through interconnect 1408) and a network 1426, such as the Internet. The server system may be communicatively coupled to the network 1426 using other technologies, including wired technologies (e.g., Ethernet, IEEE 802.3 standard) and / or wireless technologies (e.g., Wi-Fi, IEEE 802.11 standard).

[0280] In some embodiments, the local storage 1406 is intended to provide working memory for the processing unit 1404, providing fast access to programs and / or data being processed while reducing traffic on the interconnect 1408. Storage for larger amounts of data may be provided over a local area network by one or more mass storage subsystems 1412, which may be connected to the interconnect 1408. The mass storage subsystems 1412 may be based on magnetic, optical, semiconductor or other data storage media. Direct attached storage, storage area networks, network attached storage, etc. may be used. Any data store or other collection of data described herein as generated, consumed or maintained by a service or server may be stored in the mass storage subsystem 1412. In some embodiments, additional data storage resources may be accessible via the WAN interface 1410 (potentially increasing latency).

[0281] The server system 1400 can operate in response to requests received via the WAN interface 1410. For example, one of the modules 1402 can implement a monitoring function and assign individual tasks to other modules 1402 in response to received requests. Work allocation techniques can be used. Once a request is processed, results can be returned to the requester via the WAN interface 1410. Such operations can generally be automated. Furthermore, in some embodiments, the WAN interface 1410 can connect multiple server systems 1400 together, providing a scalable system capable of managing large volumes of activity. Other techniques for managing server systems and server farms (collections of cooperating server systems) can be used, including dynamic resource allocation and reallocation.

[0282] The server system 1400 can interact with a variety of user-owned or user-operated devices over a wide area network such as the Internet. One example of a user-operated device is shown in Figure 14 as client computing system 1414. The client computing system 1414 can be implemented as a consumer device, such as, for example, a smartphone, other mobile phone, tablet computer, wearable computing device (e.g., smart watch, glasses), desktop computer, laptop computer, etc.

[0283] For example, client computing system 1414 may communicate via WAN interface 1410. Client computing system 1414 may include computer components such as a processing unit 1416, a storage device 1418, a network interface 1420, user input devices 1422, and user output devices 1424. Client computing system 1414 may be computing devices implemented in a variety of form factors, such as desktop computers, laptop computers, tablet computers, smartphones, other mobile computing devices, wearable computing devices, etc.

[0284] The processing unit 1416 and storage device 1418 may be similar to the processing unit 1404 and local storage 1406 described above. Appropriate devices may be selected based on the requirements placed on the client computing system 1414. For example, the client computing system 1414 may be implemented as a "thin" client having limited processing capabilities or as a high-powered computing device. The client computing system 1414 may comprise program code executable by the processing unit 1416 to enable various interactions with the server system 1400.

[0285] The network interface 1420 may provide a connection to a network 1426, such as a wide area network (e.g., the Internet), to which the WAN interface 1410 of the server system 1400 is also connected. In various embodiments, the network interface 1420 may include a wired interface (e.g., Ethernet) and / or a wireless interface implementing various RF data communication standards, such as Wi-Fi, Bluetooth, or cellular data network standards (e.g., 3G, 4G, LTE, etc.).

[0286] User input device 1422 may include any device (or devices) by which a user can provide signals to client computing system 1414, which can interpret the signals as indicating a particular user request or information. In various embodiments, user input device 1422 may include any or all of a keyboard, a touchpad, a touchscreen, a mouse or other pointing device, a scroll wheel, a click wheel, a dial, a button, a switch, a keypad, a microphone, etc.

[0287] The user output devices 1424 may include any device by which the client computing system 1414 can provide information to a user. For example, the user output devices 1424 may include inter-display images generated or delivered by the client computing system 1414. Displays may incorporate a variety of image generating technologies, e.g., liquid crystal display (LCD), light-emitting diode (LED) displays including organic light-emitting diodes (OLED), projection systems, cathode ray tubes (CRT), etc., along with supporting electronics (e.g., digital-to-analog or analog-to-digital converters, signal processors, etc.). Some embodiments may include devices such as touch screens that function as both input and output devices. In some embodiments, other user output devices 1424 may be provided in addition to or instead of a display. Examples include indicator lights, speakers, tactile "display" devices, printers, etc.

[0288] Some embodiments include electronic components such as a microprocessor, storage, and memory that store computer program instructions on a computer-readable storage medium. Many of the features described herein can be implemented as a process specified as a set of program instructions encoded on a computer-readable storage medium. These program instructions, when executed by one or more processing units, cause the processing units to perform various operations indicated in the program instructions. Examples of program instructions or computer code include machine code, such as produced by a compiler, and files containing high-level code that is executed by a computer, electronic component, or microprocessor using an interpreter. Through appropriate programming, the processing units 1404 and 1416 can provide various functionalities for the server system 1400 and the client computing system 1414, including any functionality or other functionality described herein as being performed by a server or client.

[0289] It will be understood that the server system 1400 and the client computing system 1414 are exemplary and that variations and modifications are possible. Computer systems used in connection with embodiments of the present disclosure may have other capabilities not specifically described herein. Additionally, while the server system 1400 and the client computing system 1414 are described with reference to certain blocks, it should be understood that these blocks are defined for convenience of description and are not intended to imply a particular physical arrangement of component parts. For example, different blocks may, but need not, be located in the same facility, in the same server rack, or on the same motherboard. Additionally, the blocks need not correspond to physically distinct components. The blocks may be configured to perform various operations, for example, by programming a processor or providing appropriate control circuitry, and the various blocks may or may not be reconfigurable depending on how the initial configuration is obtained. The embodiments of the present disclosure may be realized in a variety of apparatuses, including electronic devices implemented using any combination of circuitry and software.

[0290] Although the present disclosure has been described with respect to specific embodiments, those skilled in the art will recognize that many variations are possible. The embodiments of the present disclosure can be implemented using various computer systems and communication technologies, including but not limited to the specific examples described herein. The embodiments of the present disclosure can be implemented using any combination of dedicated components and / or programmable processors and / or other programmable devices. The various processes described herein can be implemented on the same processor or different processors, in any combination. Where components are described as being configured to perform certain operations, such configuration can be achieved, for example, by designing electronic circuitry to perform the operations, by programming programmable electronic circuitry (such as a microprocessor) to perform the operations, or by any combination thereof. Furthermore, while the embodiments described above may refer to specific hardware and software components, those skilled in the art will recognize that different combinations of hardware and / or software components can also be used, and that certain operations described as being implemented in hardware can also be implemented in software, or vice versa.

[0291] A computer program incorporating various features of the present disclosure may be encoded and stored on various computer readable storage media. Suitable media include magnetic disks or tapes, optical storage media such as compact disks (CDs) or digital versatile disks (DVDs), flash memory and other non-transitory media. A computer readable medium on which the program code is encoded may be packaged with a compatible electronic device, or the program code may be provided separately from the electronic device (e.g., via internet download or as a separately packaged computer readable storage medium).

[0292] Thus, although the disclosure has been described in terms of specific embodiments, it will be understood that the disclosure is intended to cover all modifications and equivalents falling within the scope of the following claims.

Claims

1. 1. A system for dynamically providing messages, comprising: a computing system having one or more processors coupled to a memory, the computing system comprising: maintaining in a database an identification of a plurality of activities for managing migraines or headaches for a user at risk of the migraines or headaches, each of the plurality of activities having a plurality of messages to be presented according to rules; receiving, via a user interface, an indication identifying the user's migraine or headache condition as one of an onset, presence, or absence of a migraine or headache; selecting an activity to offer to the user from the plurality of activities based on the migraine or headache condition of the user identified in a response; identifying a message from the plurality of messages according to the rules regarding the activity; and causing the message identifying the activity to be presented via the user interface; 2. A system configured to:

2. 10. The system of claim 1, wherein the computing system further comprises: maintaining a timer that identifies the amount of time that has elapsed since the presentation of a previous message via the user interface; and In response to the time passing a threshold, the user interface provides a prompt to indicate the user's migraine or headache condition; a system configured to:

3. 10. The system of claim 1, wherein the computing system is further configured to provide the user interface prompting the user for the indication of the migraine or headache condition according to a schedule.

4. 10. The system of claim 1, wherein the computing system is further configured to select the activity from the plurality of activities based on the migraine state of the user, the plurality of activities including: (i) a first activity having the plurality of messages related to preventing the migraine or the onset of the headache, (ii) a second activity having the plurality of messages related to alleviating the presence of the migraine, or (iii) a third activity having the plurality of messages related to maintaining the absence of the migraine.

5. 10. The system of claim 1, wherein the computing system further comprises: receiving, via the user interface, a response identifying an activity performed by the user in response to presentation of the message of the activity; and updating a profile of the user on the database to include the response identifying the activity performed by the user; A system that is configured to:

6. 10. The system of claim 1, wherein the computing system is further configured to identify the message from the plurality of messages for the activity in accordance with the rule based on at least one of: (i) a selection of a second activity for a preceding message; (ii) a response by the user to presentation of the preceding message; (iii) a number of activities performed by the user; or (iv) a medication taken by the user.

7. 2. The system of claim 1, wherein the computing system is further configured to identify a group of messages from the plurality of messages to present within a time period in accordance with the rules.

8. 2. The system of claim 1, wherein the computing system is further configured to select the activity from the plurality of activities based on at least one of: (i) a number of occurrences of the migraine or headache in the user; (ii) a duration of previous occurrences of the migraine or headache; or (iii) medication taken by the user.

9. 10. The system of claim 1, wherein the computing system is further configured to provide instructions to an application on a user device for presenting the message to the user associated with the application.

10. 10. The system of claim 1, wherein the computing system further comprises: identifying a plurality of emotional states of the user from the instructions, including calmness, time availability, and mental stamina; and selecting the activity from the plurality of activities based on the plurality of emotional states and the migraine or headache state; A system that is configured to:

11. 10. The system of claim 1, wherein the computing system further comprises: Identifying from the instructions at least one characteristic of the user from a plurality of characteristics to be assessed, the plurality of characteristics comprising one or more of migraine or headache symptoms, vocal biomarkers, mood, and engagement level; and selecting the activity from the plurality of activities based on the at least one characteristic and the migraine or headache condition; A system that is configured to:

12. 10. The system of claim 1, wherein the user is taking medication to manage the migraine or headache at least in part in conjunction with the activity.

13. 1. A method for dynamically providing messages, comprising: maintaining, by a computing system, in a database, an identification of a plurality of activities for managing migraines or headaches for a user at risk of the migraines or headaches, each of the plurality of activities having a plurality of messages to be presented according to rules; receiving, by the computing system via a user interface, an indication identifying the user's migraine or headache condition as one of an onset, presence, or absence of a migraine or headache; selecting, by the computing system, an activity to offer to the user from the plurality of activities based on the migraine or headache condition of the user identified in the instructions; identifying, by the computing system, a message from the plurality of messages according to the rules; and presenting, by the computing system, via the user interface, the message for the activity selected from the plurality of activities; A method for dynamically providing messages, comprising:

14. 14. The method of claim 13, further comprising: maintaining, by the computing system, a timer that identifies the amount of time that has elapsed since the presentation of a previous message via the user interface; and providing, by the computing system, in response to the time period passing the threshold, a prompt on the user interface to indicate the user's migraine or headache condition; A method comprising:

15. 14. The method of claim 13, further comprising the step of providing, by the computing system, the user interface prompting the user for the indication of the migraine or headache condition according to a schedule.

16. 14. The method of claim 13, wherein selecting the activity further comprises selecting the activity from the plurality of activities based on the migraine or headache condition of the user, the plurality of activities including: (i) a first activity having the plurality of messages related to preventing the onset of the migraine or headache, (ii) a second activity having the plurality of messages related to alleviating the presence of the migraine, or (iii) a third activity having the plurality of messages related to maintaining the absence of the migraine or headache.

17. 14. The method of claim 13, further comprising: receiving, by the computing system, a response via the user interface identifying an activity performed by the user in response to presentation of the message of the activity; and updating, by the computing system, on the database, a profile of the user to include the response identifying the activity performed by the user; A method for providing

18. 14. The method of claim 13, wherein the identifying step further comprises identifying a message from the plurality of messages for the activity in accordance with the rule based on at least one of: (i) a selection of a second activity in response to a previous message; (ii) a response by the user to presentation of the previous message; (iii) a number of activities performed by the user; or (iv) a medication taken by the user.

19. 14. The method of claim 13, wherein identifying further comprises identifying a subset of messages from the plurality of messages for presentation within a time period according to the rules.

20. 14. The method of claim 13, wherein selecting further comprises selecting the activity from the plurality of activities based on at least one of: (i) a number of occurrences of the migraine or headache in the user; (ii) a duration of previous occurrences of the migraine or headache; or (iii) medication taken by the user.

21. 14. The method of claim 13, further comprising providing, by the computing system, instructions to an application on a user device for presenting the message to the user associated with the application.

22. 14. The method of claim 13, further comprising the step of: determining, by the computing system, a plurality of emotional states of the user from the instructions, the emotional states including calmness, time availability, and mental stamina; and The method, wherein selecting the activity further comprises selecting the activity from the plurality of activities based on the plurality of emotional states and the migraine or headache state.

23. The method of claim 13 further comprising: Identifying, by the computing system, at least one characteristic of the user from a plurality of characteristics to be evaluated, the plurality of characteristics comprising one or more of migraine or headache symptoms, vocal biomarkers, mood, and engagement level; and The method, wherein selecting the activity further comprises selecting the activity from the plurality of activities based on the plurality of characteristics and the migraine or headache condition.

24. 14. The method of claim 13, wherein the user is taking medication to manage the migraine or headache at least partially concurrently with the activity.

25. 1. A system for dynamically providing messages, comprising: a computing system having one or more processors coupled to a memory, the computing system comprising: maintaining in a database an identification of a plurality of activities for managing migraines or headaches for a user at risk of the migraines or headaches, each of the plurality of activities having a plurality of messages to be presented according to rules; receiving, via a user interface, an indication identifying at least one of a plurality of emotional states of the user; selecting an activity to provide to the user from the plurality of activities based on the instruction; identifying a message from the plurality of messages according to the rules of the activity; and causing the message identifying the activity to be presented via the user interface; 2. A system configured to:

26. 26. The system of claim 25, wherein the computing system further comprises: identifying the plurality of emotional states, including calmness, time availability, and mental stamina, of the user from the instructions; and selecting the activity from the plurality of activities based on the plurality of emotional states.

27. 26. The system of claim 25, wherein the computing system further comprises: identifying at least one of the plurality of emotional states from the instructions as a time availability that specifies an amount of time available for the user to perform at least one of the plurality of activities; and selecting the activity from the plurality of activities based on a comparison of the amount of available time to a threshold time, the plurality of activities including (i) a first activity associated with the amount of available time exceeding the threshold time, and (ii) a second activity associated with the amount of available time not exceeding the threshold time; 2. A system configured to:

28. 26. The system of claim 25, wherein the computing system further comprises identifying the user's migraine or headache condition from the indication as having one of an onset, presence, or absence of a migraine or headache; and selecting the activity from the plurality of activities based on the migraine or headache state and the plurality of emotional states of the user; 2. A system configured to:

29. 26. The system of claim 25, wherein the computing system further comprises: Identifying from the instructions at least one characteristic of the user from a plurality of characteristics to be assessed, the plurality of characteristics including one or more of migraine or headache symptoms, vocal biomarkers, mood, and engagement level; and selecting the activity from the plurality of activities based on the at least one characteristic; 2. A system configured to:

30. 26. The system of claim 25, wherein the computing system further comprises: and identifying from the instructions (i) at least one characteristic of the user from a plurality of characteristics to be evaluated, and (ii) a migraine or headache condition of the user; and selecting the activity based on a combination of the plurality of emotional states, the at least one characteristic, and the migraine or headache state; 2. A system configured to:

31. 26. The system of claim 25, wherein the computing system is further configured to identify a group of messages from the plurality of messages to present within a time period according to the rules.

32. 26. The system of claim 25, wherein the computing system further comprises: maintaining a timer that identifies the time that has elapsed since the presentation of a previous message via the user interface; and providing the user interface prompting the indication of the plurality of emotional states of the user in response to the time passing a threshold; 2. A system configured to:

33. 26. The system of claim 25, wherein the computing system is further configured to provide the user interface prompting the indication of the plurality of emotional states of the user according to a schedule.

34. 26. The system of claim 25, wherein the computing system further comprises: receiving, via the user interface, a response identifying an activity performed by the user in response to presentation of the message of the activity; and updating, on the database, a profile to include the response identifying the activity performed by the user; 2. A system configured to:

35. 26. The system of claim 25, wherein the user is taking medication to address the migraine or headache at least in part in conjunction with the activity.

36. 1. A method for dynamically providing messages, comprising: maintaining, by the computing system, in a database, an identification of a plurality of activities for managing a migraine or headache for a user at risk for the migraine or headache for a session, each of the plurality of activities having a plurality of messages to be presented according to rules; receiving, by the computing system, via a user interface, an indication identifying at least one of a plurality of emotional states of the user; selecting, by the computing system, an activity to provide to the user from the plurality of activities based on the instruction; identifying, by the computing system, a message from the plurality of messages according to the rule of the activity; presenting, by the computing system, via the user interface, the message for the activity selected from the plurality of activities; A method comprising:

37. 37. The method of claim 36, further comprising the step of: determining, by the computing system, from the instructions, the plurality of emotional states comprising calmness, time availability, and mental stamina of the user; and The method, wherein selecting the activity comprises selecting the activity from the plurality of activities based on the plurality of emotional states.

38. 37. The method of claim 36, further comprising identifying, by the computing system, from the instructions, at least one of the plurality of emotional states as a time availability that identifies an amount of time the user has available to perform at least one of the plurality of activities; and The method, wherein the step of selecting an activity further includes selecting the activity from the plurality of activities based on a comparison between the amount of available time and a threshold time, the plurality of activities including (i) a first activity associated with the amount of available time exceeding the threshold time, and (ii) a second activity associated with the amount of available time not exceeding the threshold time.

39. 37. The method of claim 36, further comprising identifying, by the computing system, from the indications, at least one migraine or headache condition of the user as having one of an onset, a presence, or an absence of a migraine or headache; and The method, wherein selecting an activity further comprises selecting based on the migraine or headache condition and the plurality of emotional states of the user.

40. 37. The method of claim 36, further comprising identifying, by the computing system, from the instructions, at least one characteristic of the user from a plurality of characteristics to be assessed, the plurality of characteristics comprising one or more of migraine or headache symptoms, vocal biomarkers, mood, and engagement level; The method, wherein selecting the activity further comprises selecting the activity based on the at least one characteristic.

41. 37. The method of claim 36, further comprising identifying, by the computing system, from the instructions: (i) at least one characteristic of the user from a plurality of characteristics to be evaluated; and (ii) a migraine or headache condition of the user; and The method, wherein selecting the activity further comprises selecting the activity based on a combination of the plurality of emotional states, the at least one characteristic, and the migraine and headache states.

42. 37. The method of claim 36, further comprising identifying, by the computing system, a group of messages from the plurality of messages to present within a time period according to the rules.

43. 37. The method of claim 36, further comprising: maintaining, by the computing system, a timer that identifies the amount of time that has elapsed since the presentation of a previous message via the user interface; and providing, by the computing system, in response to the time passing a threshold, a prompt on the user interface to indicate the plurality of emotional states of the user; A method comprising:

44. 37. The method of claim 36, further comprising the step of providing, by the computing system, the user interface prompting the indication of the emotional state of the user according to a schedule.

45. 37. The method of claim 36 further comprising: receiving, by the computing system, a response via the user interface identifying an activity performed by the user in response to presentation of the message of the activity; updating, by the computing system, a profile on the database to include the response identifying the activity performed by the user.

46. 37. The method of claim 36, wherein the user is taking medication to treat migraines or headaches at least in part concurrently with the activity.

47. The system of claim 1, wherein the computing system is further configured to perform the step of receiving, via a wearable device configured to be worn by the user, an identification of the user's migraine or headache condition as having one of the onset, presence or absence of the migraine or headache.

48. The method of claim 13, further comprising the step of receiving, by the computing system, via a wearable device configured to be worn by the user, sensor data identifying the user's migraine or headache condition as having one of the onset, presence or absence of the migraine or headache.

49. The system of claim 25, wherein the computing system is further configured to perform the step of receiving sensor data identifying at least one of a plurality of emotional states of the user via a wearable device configured to be worn by the user.

50. The method of claim 36, further comprising a step of receiving, by the computing system, sensor data identifying at least one of a plurality of emotional states of the user via a wearable device configured to be worn by the user.

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