Enhancing Engagement With Digital Mental Health Care

Study Overview
=================
Brief Summary
-----------------
This proposal is a partnership between Mental Health America (MHA), a nonprofit mental health advocacy and resource organization, Talkspace (TS), a for-profit, online digital psychotherapy organization, and the University of Washington's Schools of Medicine and Computer Science Engineering (UW). The purpose of this partnership is to create a digital mental health research platform leveraging MHA and TS's marketing platforms and consumer base to describe the characteristics of optimal engagement with digital mental health treatment, and to identify effective, personalized methods to enhance motivation to engage in digital mental health treatment in order to improve mental health outcomes. These aims will be met by identifying and following at least 100,000 MHA and TS consumers over the next 4 years, apply machine learning approaches to characterizing client engagement subtypes, and apply micro-randomized trials to study the effectiveness of motivational enhancement strategies and response to digital mental health treatment.

Detailed Description
-----------------
Digital mental health (DMH) is the use of technology to improve population well-being through rapid disease detection, outcome measurement, and care. Although several randomized clinical trials have demonstrated that digital mental health tools are highly effective, most consumers do not sustain their use of these tools. The field currently lacks an understanding of DMH tool engagement, how engagement is associated with well-being, and what practices are effective at sustaining engagement. In this partnership between Mental Health America (MHA), Talkspace (TS) and the University of Washington (UW), the investigators propose a naturalistic and experimental, theory-driven program of research, with the aim of understanding 1) how consumer engagement in self-help and clinician assisted DMH varies and what engagement patterns exist, 2) the association between patterns of engagement and important consumer outcomes, and 3) the effectiveness of personalized strategies for optimal engagement with DMH treatment. This study will prospectively follow a large, naturalistic sample of MHA and TS consumers, and will apply machine learning, user-centered design strategies, and micro randomized and sequential multiple assignment randomized (SMART) trials to address these aims. As is usual practice for both platforms, consumers will complete online mental health screening and assessment, and the investigators will be able to classify participants by disease status and symptom severity. The sample that the investigators will be working with will not be limited by diagnosis or co-morbidities. Participants will be 10 years old and older and enter the MHA and TS platforms prospectively over 4 years. In order to test the first aim, the investigators will identify a minimum of 100,000 consumers who have accessed MHA and TS platforms in the past. Participant data will be analyzed statistically to reveal differences in engagement and dropout across groups based on demographics, symptoms and platform activity. For aim 2, the investigators will use supervised machine learning techniques to identify subtypes based on consumer demographics, engagement patterns with DMH, reasons for disengagement, success of existing MHA and TS engagement strategies, and satisfaction with the DMH tools, that are predictive of future engagement patterns. Finally, based on the outcomes from aim 2, in aim 3 the investigators will conduct focus groups applying user centered design strategies to identify and co-build potentially effective engagement strategies for particular client subtypes. The investigators will then conduct a series of micro-randomized and SMART trials to determine which theory-driven engagement strategies, co-designed with users, have the greatest fit with subtypes developed under aim 2. The investigators will test the effectiveness of these strategies to 1) prevent disengagement from those who are more likely to have poor outcomes after disengagement, 2) improve movement from motivation to volition and, 3) enhance optimal dose of DMH engagement and consequently improve mental health outcomes. These data will be analyzed using longitudinal mixed effects models with effect coding to estimate the effectiveness of each strategy on client engagement behavior and mental health outcomes.

Official Title
-----------------
Enhancing Engagement With Digital Mental Health Care

Conditions
-----------------
Engagement, Patient

Intervention / Treatment
-----------------
* Behavioral: Engagement Strategies TBD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phase 1 (100K) and Phase 2 (50K): MHA and TS consumers who are naturalistically seeking services; Aged 14 and older; English or Spanish speaking Focus Groups: Adult MHA and TS consumers, English speaking or bilingual English & Spanish speakers Phase 3a (10,000): TS consumers, 18 years old and older, English or Spanish speaking Phase 3b (250): TS consumers, 18 years old and older, PHQ-9 or GAD-7 of 10 or greater, English or Spanish speaking Exclusion Criteria: Phase 1 (100K) and Phase 2 (50K): Younger than 14 years old; Non-English or Non-Spanish speaking Focus Groups: Younger than 18 years old; Non-English speaking or Non-bilingual (English & Spanish) Phase 3a (10,000): Younger than 18 years old, Non-English or Non-Spanish speaking Phase 3b (250): Younger than 18 years old, Non-English or Non-Spanish speaking, PHQ-9 or GAD-7 of less than 10

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Micro-Randomized (MRT) and Sequential Multiple Assignment Randomized (SMART) Trials offer methodological tools that can harness the sheer volume of DMH clients and interactions in order to optimize and test personalize engagement strategies. For aim 3, the investigators will conduct focus groups applying user-centered design strategies to identify and co-build potentially effective engagement strategies for particular client subtypes. The investigators will then conduct a series of micro-randomized and sequential multiple assignment randomized (SMART) trials to determine which theory-driven engagement strategies, co-designed with users, have the greatest fit with subtypes developed under aim 2. The investigators anticipate enrolling 10,000 Talkspace consumers in the SMART trial, with a subset of 250 participating in a survey after they discontinue treatment. The number of arms will be based on learnings re: engagement strategies from previous phases.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Engagement Strategy - 1<br>Engagement strategies that will be tested in Aim 3 in Y04 will be developed based on learnings from Aims 1 and 2 in Y01-Y03 of the project. | Behavioral: Engagement Strategies TBD<br>* Engagement strategies that will be tested in Aim 3 in Y04 will be developed based on learnings from Aims 1 and 2 in Y01-Y03 of the project.<br>|
| Experimental: Engagement Strategy - 2<br>Engagement strategies that will be tested in Aim 3 in Y04 will be developed based on learnings from Aims 1 and 2 in Y01-Y03 of the project. | Behavioral: Engagement Strategies TBD<br>* Engagement strategies that will be tested in Aim 3 in Y04 will be developed based on learnings from Aims 1 and 2 in Y01-Y03 of the project.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health America Engagement | Increased time spent on webpages | 2 months | 
| Mental Health America Engagement | Number of article(s) read on topics indicative of ambivalence | 2 months | 
| Mental Health America Engagement | Number of mental health screens taken | 2 months | 
| Mental Health America Engagement | Clicks to outside service provider page (including Talkspace) | 2 months | 
| Mental Health America Engagement | Use of outside services (e.g. therapeutic video games, communities, and online therapy services including Talkspace) | 2 months | 
| Mental Health America Engagement | Return to MHA website after screening and reading materials | 2 months | 
| Mental Health America Engagement | Length of time until next MHA website visit | 2 months | 
| Mental Health America Engagement | Length of time until website visits end for two months | 2 months | 
| Talkspace Engagement | Increased time on website | 2 months | 
| Talkspace Engagement | Visit to app install page | 2 months | 
| Talkspace Engagement | Download app | 2 months | 
| Talkspace Engagement | Enrollment and completion of intake assessment | 2 months | 
| Talkspace Engagement | Texts sent to therapist - occurrence | 2 months | 
| Talkspace Engagement | Texts sent to therapist - number of texts | 2 months | 
| Talkspace Engagement | Texts sent to therapist - length of texts | 2 months | 
| Talkspace Engagement | Texts sent to therapist - frequency | 2 months | 
| Talkspace Engagement | Completion of outcome measures | Every 3 weeks for 2 months | 
| Talkspace Engagement | Length of time until communication with providers ends | 2 months | 
| Patient Health Questionnaire (PHQ-9) | The PHQ-9 consists of 9 depression items and one disability item. Each time is associated with a DMS symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time. Used for screening and will be used as a moderator. | Baseline | 
| Generalized Anxiety Disorder (GAD-7) | A 7- item screener for generalized anxiety. It consists of items related to GAD. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks. The scale is a valid screener for GAD.Used for screening and will be used as a moderator. | Baseline | 
| Neuro-QoL Short Form - Ability to Participate in Social Roles and Activities | A measure of disability/functional status that assesses the ability to participate in social roles and activities across neurological conditions visual-spatial, numeric and verbal anchors. The scale has been validated in medical and psychiatric populations with a variety of psychiatric diagnoses. Used for screening and will be used as a moderator. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Working Alliance Inventory, Short Form | The WAI is a 12-item measure of therapeutic alliance (relationship between the consumer and therapist or coach). It is a reliable measure of alliance, with alpha = .92. | From start of treatment, every 3 weeks until and at treatment completion (up to 9 weeks for majority of Talkspace consumers) | 
| Task Self-Efficacy | Single item based on McAuley and Mihalko's guidelines for measuring task self-efficacy. Consumers rate how confident they are in their ability to engage in DMH services if they were motivated enough to do so. | Baseline | 
| Perceived Needs/Risks | Single item that consumers will be asked to rate about the chance of their symptoms becoming worse if they do not act, on a 4-point scale from not high to very high. | Baseline | 
| Outcome expectancies | Three items: What do you think will be the consequences for yourself if you begin DMH treatment? Consumers will rank these choice options (a) I will be healthier, (b) I will feel better mentally, (c) It will improve my quality of life (1=not true; 4=exactly true). | Baseline | 
| Behavioral Intention | Two items commonly used in the behavioral medicine and recommended by Azjen et al. Consumers will be asked to rate how true the statement: I will try to review information about mental health services over the next week is for them (1 = definitely false; 4 = definitely true); and to what extent is the statement: I intend to send some time learning about my treatment options over the next week likely for them (1 = not likely; 4 = extremely likely). | Baseline | 
| Action Planning | Existing questions about goals for visiting MHA and TS websites, with one item that asks consumers will rate (1 = not true; 4 = extremely true) whether they had made detailed plans regarding their mental health goals: (a) where; (b) when; (c) what types of activities they will do; (d) how often; and (e) how long they will engage in DMH. | Baseline | 
| Maintenance Self-efficacy | This question asks consumers to rate their confidence in their ability to text their therapist over the next week even if they had to overcome these barriers: no immediate positive effects, technical problems, perceived difficulties, and lack of motivation. All items will be rated on a seven-point scale (1 = not confident at all; 4 = completely confident). | Week 1 | 
| Reasons for disengagement | Four items to determine if the service just used met their needs | Disengagement (up to 9 weeks from treatment engagement for majority of Talkspace consumers) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digital Mental Health