Enhancing Engagement With Digital Mental Health Care

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.

Study Overview

• Status: Completed
• Conditions: Engagement, Patient
• Intervention / Treatment: Behavioral: Study 1, Generic Response; Behavioral: Study 1, Generic Resources; Behavioral: Study 1, Tailored Resources by Desired Resources; Behavioral: Study 2, Control; Behavioral: Study 2, DIY tool without AI; Behavioral: Study 2, DIY tool with AI; Behavioral: Study 1, Demographics Survey; Behavioral: Study 1, Tailored Resources by Demographics; Behavioral: Study 1, Next Steps Survey; Behavioral: Study 1, Tailored Response

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 trials (SMART) 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 enter the MHA and TS platforms prospectively over 4 years. For aim 1, 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 3a 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.

The purpose of aim 3b is to identify effective engagement strategies tailored to client needs and demographics to increase MHA website engagement, and to better understand how self-help mental health resources can help people overcome negative thinking and support healthier thought processes. The investigators will compare effective engagement strategies tailored to subtypes developed under aim 2 to study the mediated impact of engagement strategies on consumer mental health outcomes. The study team will determine if engagement strategies targeted to consumer engagement subtype will enhance engagement and in turn result in improved clinical outcomes. These will be compared to generic strategies that are not subtype targeted.

All aim 3b activities will occur with MHA, broken down into two parts: (Study 1) a sequential multiple assignment randomized trial (SMART) and (Study 2) a Do-It-Yourself (DIY) tool longitudinal randomized control trial (RCT). Study 1 will use a SMART to examine methods to optimize engagement with MHA's website, and Study 2 will recruit participants for a longitudinal month-long study where they are randomly assigned to a control group, the use of a DIY tool without Artificial Intelligence (AI), or the use of a DIY tool with AI to examine the efficacy of using a digital tool to improve mental health functioning. An AI tool that uses machine learning/Natural Language Processing (NLP)/AI methods was developed to personalize and tailor an intervention to improve engagement and completion outcomes. The study focuses on a specific, popular DIY tool that teaches cognitive restructuring. Pilot work showed that (1) engagement and completion rates on DIY tools can be low, and (2) a pilot AI tool had significantly higher engagement and completion rates. These differences may arise due to AI support, User Interface/User Experience/design differences, other factors, or a combination thereof. Additionally, the efficacy of the digital tool to improve mental health functioning is unknown. Study 2 will recruit participants who will be randomly assigned to one of three groups for a longitudinal month-long study: thrice-weekly DIY tool use with AI, without AI, or a control group.

• Study Type: Interventional
• Enrollment (Actual): 78390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10023
      • Groop Internet Platform DBA Talkspace
  • Virginia
    • Alexandria, Virginia, United States, 22314
      • Mental Health America
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Phase 3b Study 1 (Sequential Multiple Assignment Randomized Trial; SMART): Users of the Mental Health America (MHA) website, engaging from Internet Protocol (IP) addresses in the United States, who have chosen to start the PHQ-9 depression screener in English. Must be those who can read English.
• Phase 3b Study 2 (Do-It-Yourself; DIY): Patient Health Questionnaire (PHQ)-9 or Generalized Anxiety Disorder (GAD)-7 score of 10 or greater, users of MHA website, 18 years of age or older.

Exclusion Criteria:

• Phase 3b Study 1 (SMART): None
• Phase 3b Study 2 (DIY): Younger than 18 years old, Non-English or Non-Spanish speaking, PHQ-9 less than 10, outside of US, have more than a little familiarity with the concept of cognitive reframing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study 1, Demographic Survey + Generic Response + Generic Resources; This arm included participants who completed the Demographics Survey (stage 1 randomization). The Generic Response + Generic Resources condition (stage 2 randomization) will feature the response-as-usual on Mental Health America (MHA)'s website and the four generic resource pages on MHA's website.	Behavioral: Study 1, Generic Response; Participants will be provided with the generic/current response to screening.; Behavioral: Study 1, Generic Resources; Participants will be provided with links to a list of 4 generic Mental Health America (MHA) resources.; Behavioral: Study 1, Demographics Survey; Participants will be shown a demographics survey (e.g., age range, gender, income).
Experimental: Study 1, Demographic Survey + Generic Response + Tailored Resources by Demographics; This arm included participants who completed the Demographics Survey (stage 1 randomization). The Generic Response + Tailored Resources by Demographics condition (stage 2 randomization) will feature the response-as-usual on Mental Health America (MHA)'s website and resources tailored to two demographics. People who endorse being Lesbian, Gay, Bisexual, Transgender, or Queer (LGBTQ) will receive 4 resources associated with LGBTQ issues. People who endorse being 8-17, 18-24, 25-44, or 45+ years of age will receive 4 resources used by people in those age groups. If someone enters both age and LGBTQ status, they will be provided with 2 resources tailored to age and 2 resources tailored to LGBTQ status, randomly chosen.	Behavioral: Study 1, Generic Response; Participants will be provided with the generic/current response to screening.; Behavioral: Study 1, Demographics Survey; Participants will be shown a demographics survey (e.g., age range, gender, income).; Behavioral: Study 1, Tailored Resources by Demographics; Participants will be provided with links to Mental Health America (MHA) resources tailored to sexuality (Lesbian, Gay, Bisexual, Transgender, or Queer) status and age range.
Experimental: Study 1, Next Steps Survey + Generic Response + Generic Resources; This arm included participants who completed the Next Steps Survey (stage 1 randomization). The Generic Response + Generic Resources condition (stage 2 randomization) will feature the response-as-usual on Mental Health America (MHA)'s website and the four generic resource pages on MHA's website.	Behavioral: Study 1, Generic Response; Participants will be provided with the generic/current response to screening.; Behavioral: Study 1, Generic Resources; Participants will be provided with links to a list of 4 generic Mental Health America (MHA) resources.; Behavioral: Study 1, Next Steps Survey; Participants will be shown the Next Steps Survey, which includes 2 items assessing intended next steps on the Mental Health America (MHA) website (e.g., take another mental health test, find a treatment provider near you) and perceived need (yes, no, or I don't know) in addition to the Demographics Survey items.
Experimental: Study 1, Next Steps Survey + Generic Response + Tailored Resources by Desired Resources; This arm included participants who completed the Next Steps Survey (stage 1 randomization). The Generic Response + Tailored Resources by Desired Resources condition (stage 2 randomization) will feature the response-as-usual on Mental Health America (MHA)'s website and 4 resources tailored to a survey question that asks participants what they would like to do next on the website after screening is complete (e.g., "Learn more about depression", "Take another mental health test")	Behavioral: Study 1, Generic Response; Participants will be provided with the generic/current response to screening.; Behavioral: Study 1, Tailored Resources by Desired Resources; Participants will be provided with links to Mental Health America (MHA) resources aligned with their expressed interest (e.g., additional screening, self help tools).; Behavioral: Study 1, Next Steps Survey; Participants will be shown the Next Steps Survey, which includes 2 items assessing intended next steps on the Mental Health America (MHA) website (e.g., take another mental health test, find a treatment provider near you) and perceived need (yes, no, or I don't know) in addition to the Demographics Survey items.
Experimental: Study 1, Next Steps Survey + Tailored Response + Generic Resources; This arm included participants who completed the Next Steps Survey (stage 1 randomization). The Tailored Response + Generic Resources condition (stage 2 randomization) will feature a response tailored to screening status (above or below criteria for depression) and expressed need for mental health support (e.g., "We're so glad to hear you're open to exploring how to improve your mental health. People who score with minimum or mild depression often notice that symptoms can get worse in the weeks after taking a Depression test.") They will also receive the 4 generic resources.	Behavioral: Study 1, Generic Resources; Participants will be provided with links to a list of 4 generic Mental Health America (MHA) resources.; Behavioral: Study 1, Next Steps Survey; Participants will be shown the Next Steps Survey, which includes 2 items assessing intended next steps on the Mental Health America (MHA) website (e.g., take another mental health test, find a treatment provider near you) and perceived need (yes, no, or I don't know) in addition to the Demographics Survey items.; Behavioral: Study 1, Tailored Response; Participants will be provided with a response to screening that is tailored to the match between screening score (above or below depression criteria) and expressed need for mental health support (yes, no, or I don't know).
Experimental: Study 1, Next Steps Survey + Tailored Response + Tailored Resources by Desired Resources; This arm included participants who completed the Next Steps Survey (stage 1 randomization). The Tailored Response + Tailored Resources by Desired Resources condition (stage 2 randomization) will feature a response tailored to screening status (above or below criteria for depression) and expressed need for mental health support, and will receive resources tailored to a survey question that asks participants what they would like to do next on the website after screening is complete (e.g., "Learn more about depression", "Take another mental health test").	Behavioral: Study 1, Tailored Resources by Desired Resources; Participants will be provided with links to Mental Health America (MHA) resources aligned with their expressed interest (e.g., additional screening, self help tools).; Behavioral: Study 1, Next Steps Survey; Participants will be shown the Next Steps Survey, which includes 2 items assessing intended next steps on the Mental Health America (MHA) website (e.g., take another mental health test, find a treatment provider near you) and perceived need (yes, no, or I don't know) in addition to the Demographics Survey items.; Behavioral: Study 1, Tailored Response; Participants will be provided with a response to screening that is tailored to the match between screening score (above or below depression criteria) and expressed need for mental health support (yes, no, or I don't know).
Experimental: Study 2, Control; Participants in the Do-It-Yourself (DIY) control group will receive psychoeducation materials in week 0. They will view content as usual (no DIY) and will receive surveys from week 1 to week 4 and follow-up surveys in week 5 and at the end of week 8.	Behavioral: Study 2, Control; Participants in the Do-It-Yourself (DIY) control group will receive psychoeducation materials in W0. They will view content as usual (no DIY).
Experimental: Study 2, DIY tool without AI; Participants in the Do-It-Yourself (DIY) tool without Artificial Intelligence (AI) group will be instructed to use the DIY tool 3 times a week. They will receive surveys from week 1 to week 4 and follow-up surveys in week 5 and at the end of week 8.	Behavioral: Study 2, DIY tool without AI; Participants in the Do-It-Yourself (DIY) tool without Artificial Intelligence (AI) group will be instructed to use the DIY tool 3 times a week.
Experimental: Study 2, DIY tool with AI; Participants in the Do-It-Yourself (DIY) tool with Artificial Intelligence (AI) group will be instructed to use the DIY tool with AI 3 times a week. They will receive surveys from week 1 to week 4 and follow-up surveys in week 5 and at the end of week 8.	Behavioral: Study 2, DIY tool with AI; Participants in the Do-It-Yourself (DIY) tool with Artificial Intelligence (AI) group will be instructed to use the DIY tool with AI 3 times a week.
Experimental: Study 1, Demographic Survey; This arm included participants who were randomized to the Demographics Survey (stage 1 randomization) and were not randomized to a stage 2 condition (i.e., did not view screening results page on which stage 2 randomization occurred).	Behavioral: Study 1, Demographics Survey; Participants will be shown a demographics survey (e.g., age range, gender, income).
Experimental: Study 1, Next Steps Survey; This arm included participants who were randomized to the Next Steps Survey (stage 1 randomization) and were not randomized to a stage 2 condition (i.e., did not view screening results page on which stage 2 randomization occurred).	Behavioral: Study 1, Next Steps Survey; Participants will be shown the Next Steps Survey, which includes 2 items assessing intended next steps on the Mental Health America (MHA) website (e.g., take another mental health test, find a treatment provider near you) and perceived need (yes, no, or I don't know) in addition to the Demographics Survey items.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study 1: Mental Health America Disengagement (After Stage 1 Randomization)	Proportion of users disengaging (i.e., by leaving the website; in contrast to clicking to view the screening results page or clicking another Mental Health America [MHA] link) after stage 1 randomization.	Through active web session, an average of 10 minutes
Study 1: Mental Health America Engagement, Clicks on Featured Resources (After Stage 2 Randomization)	Proportion of users clicking featured resources (i.e., links to webpages on Mental Health America, featured below screening results) from the screening results page.	Through active web session, an average of 10 minutes
Study 1: Mental Health America Engagement, Number of Webpages Clicked (After Stage 2 Randomization)	Number of webpages clicked (including links to either featured and non-featured resources) after stage 2 randomization.	Through active web session, an average of 10 minutes
Study 1: Mental Health America Disengagement (After Stage 2 Randomization)	Proportion of users disengaging (i.e., by leaving the website; in contrast to clicking a link to a Mental Health America [MHA] webpage) after stage 2 randomization.	Through active web session, an average of 10 minutes
Study 1: DIY Completion Rate (After Stage 2 Randomization)	Number of participants who completed the Do-It-Yourself (DIY) tool.	Through active web session, an average of 10 minutes
Study 2: Engagement (Dosage)	Number of times using the Do-It-Yourself (DIY) tool	Week 1, Week 2, Week 3, Week 4
Study 2: Tool Use Helpfulness	Tool Use Helpfulness is measured using one item (Using the tool has been helpful to me in dealing with my negative thoughts and emotions) on a scale of 0 (strongly disagree) to 3 (strongly agree). Higher scores indicate better outcomes (helpfulness of the tool). Scores will be assessed using mean item-level scores. Note: includes 5 qualitative questions, not included here.	Week 1, Week 2, Week 3, Week 4
Study 2: Emotion Mechanisms	Emotion mechanisms are measured using a 7-item scale. Each item is scored from 1 to 7. Total scores range from 7 to 49. Higher scores indicate better emotion mechanisms. Participants are asked about their emotions (e.g., hopefulness, worry, confidence, motivation) about their ability to address negative thoughts. Scores will be assessed using mean item-level and total scores. Item 1: How hopeful do you feel about the future? Item 2: How hopeful do you feel about managing negative thoughts? Item 3: How worried do you feel about managing negative thoughts? (reverse-coded) Item 4: How motivated are you to keep working on managing negative thinking? Item 5: How confident are you in your ability to identify thinking traps? Item 6: How confident are you in your ability to reframe negative thoughts? Item 7: How likely are you to recommend it to a friend?	Week 1, Week 2, Week 3, Week 4, Week 8
Study 2: Tool Mechanisms	Tool Mechanisms is measured using 4 items about reframing. The items measure relatability/believability, helpfulness, memorability, and learnability on a scale of 1 (strongly disagree) to 5 (strongly agree). Total scores range from 4 to 20, with higher scores indicating better outcomes after using a Do-It-Yourself (DIY) tool. Scores will be assessed using mean item-level and total scores. Item 1: I believe in the reframe I came up with; Item 2: The reframe helped me deal with the thought I was struggling with; Item 3: I will remember this reframe the next time I experience this thought; Item 4: By doing this activity, I learned how I can deal with future negative thoughts	Week 1, Week 2, Week 3, Week 4
Study 2: Tool Mechanisms (Part 2)	Tool Mechanisms (Part 2) is measured using 2 items about belief change and emotion change on a scale of -7 to 7. Total scores range from -14 to 14, with higher scores indicating stronger beliefs and emotions after completing a DIY tool. Note: this also includes 1 qualitative question; not included here. Scores will be assessed using mean item-level and total scores. Item 1: After doing this activity, how strongly do you believe in your original thought? Item 2: After doing this activity, how strong is your emotion?	Week 1, Week 2, Week 3, Week 4
Study 2: DIY Skill Use: Competencies of Cognitive Therapy Scale - Self-Report	The Competencies of Cognitive Therapy Scale will be used to ask participants about how much they have used specific strategies to cope with negative moods, primarily negative automatic thoughts, in the last 4 weeks. The current study will use items 20, 28, 21, 6, 24, and 11. Items are rated from 1 (not at all) to 7 (completely). Total scores range from 6 to 42. Higher scores indicate better outcomes. Scores will be assessed using mean item-level and total scores. Note: also includes 3 qualitative questions; not included here. Themes: Item 20: re-evaluating the situation; Item 28: taking time to step back and considering that negative thoughts might be inaccurate; Item 21: actively working to develop more rational views; Item 6: having a specific action plan of things they could do to cope; Item 24: taking time to consider other factors that may have been involved; Item 11: taking note of what they were thinking and working to develop a more balanced view	Week 1, Week 2, Week 3, Week 4, Week 8
Long-term Adoption of the Intervention	We measure long-term adoption of the Intervention using an 8-item scale assessing attitudes and behaviors related to engaging with and adopting a mental health intervention focused on reframing negative thoughts. Each item is scored on a scale from 1 to 10. Higher scores indicate greater comfort, likelihood, willingness, excitement, or impact, depending on the item. Specifically, the items assess comfort with attending therapy (Item 1), working with a therapist on reframing (Item 2), and discussing negative thoughts (Item 3); likelihood of seeking mental health information (Item 4); willingness to commit to practicing reframing (Item 5); excitement about learning a new mental health skill (Item 6); the impact of negative thoughts on life (Item 7); and likelihood of recommending the intervention to a friend (Item 8). Scores will be assessed using mean item-level scores. No statistical analysis conducted.	Week 5
Hopefulness	Hopefulness is measured using a single item (How hopeful do you feel about the future?). Scores will be assessed using mean item-level scores. Scores range from 1 to 7, with higher scores indicating better outcomes (more hopefulness). No statistical analysis (this item was merged with emotion mechanisms).	Week 1, Week 2, Week 3, Week 4, Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study 2: Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire-9 (PHQ-9) consists of 9 depression items. Each item is associated with a Diagnostic and Statistical Manual (DSM) symptom of depression. Participants rate whether or not they have experienced the symptom over the last two weeks, with severity ratings of 0 to 3. Total scores range from 0 to 27, with higher scores indicating greater severity of depression symptoms. 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.	Baseline, Week 1, Week 2, Week 3, Week 4, Week 8
Study 2: Generalized Anxiety Disorder-7 (GAD-7)	The Generalized Anxiety Disorder-7 (GAD-7) is a 7- item screener for generalized anxiety. It consists of items related to Generalized Anxiety Disorder (GAD). Participants rate how much anxiety they have experienced in the last two weeks on a scale of 0 to 3. Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety symptoms. The scale is a valid screener for GAD.	Baseline, Week 1, Week 2, Week 3, Week 4, Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with Talkspace	Satisfaction with Talkspace clinical services, measure created by TS and asks whether goals were met	Treatment completion (up to 9 weeks from treatment engagement for majority of Talkspace consumers)
Satisfaction with outside services	Satisfaction with outside services (administered to MHA consumers)	Treatment completion (an average of 2-4 weeks from treatment engagement)
Prodromal Questionnaire - Brief Version	A validated measure of symptoms indicating risk for psychosis. 21 dichotomous response items. Used for screening and will be used as a moderator.	Baseline
Brief Bipolar Test	A brief, validated self-report instrument designed to indicate bipolar symptoms. Used for screening and will be used as a moderator.	Baseline
Stanford-Washington University Eating Disorder (SWED) Screen	A brief, 11-item validated self-report instrument designed to indicate eating disorders. Used for screening and will be used as a moderator.	Baseline
Primary Care - Post Traumatic Stress Disorder Screen (PC-PTSD)	A brief, 4 item screen for PTSD for the primary care population. Used for screening and will be used as a moderator.	Baseline
CAGE-AID	A brief, 4-item screen for alcohol addiction. Used for screening and will be used as a moderator.	Baseline
Healthy Workplace Survey	A brief measure created by MHA to examine workplace mental health, examining the psychological safety, fairness, and healthiness of work environment. Will be used as a moderator.	Baseline
Duke Social Support Scale	A validated, brief, 11 item self-report measure of the amount of social support a person feels. Will be used as a moderator.	Baseline

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); Mental Health America; Talkspace
• Investigators: Principal Investigator: Michael Pullmann, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): May 14, 2024
• Study Completion (Actual): May 14, 2024

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Digital Mental Health
• Other Study ID Numbers: STUDY00010958; 1R01MH125179-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No