Engagement, PatientNCT04507360
Enhancing Engagement With Digital Mental Health Care
A study testing Study 1, Demographics Survey, Study 1, Next Steps Survey and Study 1, Generic Response in people with Engagement, Patient, run by University of Washington at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Engagement, Patient
- What is being tested?
- Study 1, Demographics Survey, Study 1, Next Steps Survey and Study 1, Generic Response
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78,390 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Oct 2021to 14 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mental Health America
Alexandria, Virginia, 22314
Groop Internet Platform DBA Talkspace
New York, New York, 10023
University of Washington
Seattle, Washington, 98195
About this study
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.
Read the 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.
- Conditions
- Engagement, Patient
- Being tested
- Study 1, Demographics Survey, Study 1, Next Steps Survey, Study 1, Generic Response, Study 1, Generic Resources, Study 1, Tailored Response
- Keywords
- Digital Mental Health
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study 1, Demographics SurveyBehavioural
Participants will be shown a demographics survey (e.g., age range, gender, income).
Study 1, Next Steps SurveyBehavioural
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.
Study 1, Generic ResponseBehavioural
Participants will be provided with the generic/current response to screening.
Study 1, Generic ResourcesBehavioural
Participants will be provided with links to a list of 4 generic Mental Health America (MHA) resources.
Study 1, Tailored ResponseBehavioural
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).
Study 1, Tailored Resources by DemographicsBehavioural
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.
Study 1, Tailored Resources by Desired ResourcesBehavioural
Participants will be provided with links to Mental Health America (MHA) resources aligned with their expressed interest (e.g., additional screening, self help tools).
Study 2, ControlBehavioural
Participants in the Do-It-Yourself (DIY) control group will receive psychoeducation materials in W0. They will view content as usual (no DIY).
Study 2, DIY tool without AIBehavioural
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.
Study 2, DIY tool with AIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Study 1, Demographic Survey + Generic Response + Generic Resources | Experimental | 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. Receives: Behavioral: Study 1, Demographics Survey; Behavioral: Study 1, Generic Response; Behavioral: Study 1, Generic Resources |
| Study 1, Demographic Survey + Generic Response + Tailored Resources by Demographics | Experimental | 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. Receives: Behavioral: Study 1, Demographics Survey; Behavioral: Study 1, Generic Response; Behavioral: Study 1, Tailored Resources by Demographics |
| Study 1, Next Steps Survey + Generic Response + Generic Resources | Experimental | 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. Receives: Behavioral: Study 1, Next Steps Survey; Behavioral: Study 1, Generic Response; Behavioral: Study 1, Generic Resources |
| Study 1, Next Steps Survey + Generic Response + Tailored Resources by Desired Resources | Experimental | 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") Receives: Behavioral: Study 1, Next Steps Survey; Behavioral: Study 1, Generic Response; Behavioral: Study 1, Tailored Resources by Desired Resources |
| Study 1, Next Steps Survey + Tailored Response + Generic Resources | Experimental | 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. Receives: Behavioral: Study 1, Next Steps Survey; Behavioral: Study 1, Generic Resources; Behavioral: Study 1, Tailored Response |
| Study 1, Next Steps Survey + Tailored Response + Tailored Resources by Desired Resources | Experimental | 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"). Receives: Behavioral: Study 1, Next Steps Survey; Behavioral: Study 1, Tailored Response; Behavioral: Study 1, Tailored Resources by Desired Resources |
| Study 2, Control | Experimental | 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. Receives: Behavioral: Study 2, Control |
| Study 2, DIY tool without AI | Experimental | 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. Receives: Behavioral: Study 2, DIY tool without AI |
| Study 2, DIY tool with AI | Experimental | 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. Receives: Behavioral: Study 2, DIY tool with AI |
| Study 1, Demographic Survey | Experimental | 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). Receives: Behavioral: Study 1, Demographics Survey |
| Study 1, Next Steps Survey | Experimental | 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). Receives: Behavioral: Study 1, Next Steps Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through active web session, an average of 10 minutes
Study 2: Engagement (Dosage)
Number of times using the Do-It-Yourself (DIY) tool
Measured: 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.
Measured: 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?
Measured: 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
Measured: 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?
Measured: 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
Measured: 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.
Measured: 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).
Measured: Week 1, Week 2, Week 3, Week 4, Week 8
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start15 Oct 2021
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Engagement, PatientStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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 anticipate enrolling 10,000 Mental Health America consumers in Study 1 (the sequential multiple assignment randomized trial; SMART), with a subset of 250 participating in Study 2, a randomized controlled trial of an Artificial Intelligence (AI)-assisted self-help tool compared to a non-AI self help tool and to psychoeducational materials only control group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78,390 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Mental Health America, Talkspace, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tim Althoff, University of Washington
- Investigators
- Michael Pullmann, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507360
- Sponsor's protocol ID
- STUDY00010958
- Other IDs
- 1R01MH125179-01
- Status last verified
- Jul 2025
- First submitted
- 5 Aug 2020
- Last updated
- 3 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zech JM, Johnson M, Pullmann MD, Hull TD, Althoff T, Munson SA, Fridling N, Litvin B, Wu J, Arean PA. An Integrative Engagement Model of Digital Psychotherapy: Exploratory Focus Group Findings. JMIR Form Res. 2023 Apr 26;7:e41428. doi: 10.2196/41428.
PubMed 37099363
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Engagement With Digital Mental Health Care
- ClinicalTrials.gov ID
- NCT04507360
- Acronym / sponsor ID
- STUDY00010958
- Conditions
- Engagement, Patient
- Keywords
- Digital Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78,390 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Mental Health America, Talkspace, National Institute of Mental Health (NIMH)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Posted 3 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 11
- Model description
- 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 anticipate enrolling 10,000 Mental Health America consumers in Study 1 (the sequential multiple assignment randomized trial; SMART), with a subset of 250 participating in Study 2, a randomized controlled trial of an Artificial Intelligence (AI)-assisted self-help tool compared to a non-AI self help tool and to psychoeducational materials only control group.
| Arm | Type | Receives |
|---|---|---|
| Study 1, Demographic Survey + Generic Response + Generic Resources | Experimental | Behavioral: Study 1, Demographics Survey, Behavioral: Study 1, Generic Response, Behavioral: Study 1, Generic ResourcesThis 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. |
| Study 1, Demographic Survey + Generic Response + Tailored Resources by Demographics | Experimental | Behavioral: Study 1, Demographics Survey, Behavioral: Study 1, Generic Response, Behavioral: Study 1, Tailored Resources by DemographicsThis 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. |
| Study 1, Next Steps Survey + Generic Response + Generic Resources | Experimental | Behavioral: Study 1, Next Steps Survey, Behavioral: Study 1, Generic Response, Behavioral: Study 1, Generic ResourcesThis 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. |
| Study 1, Next Steps Survey + Generic Response + Tailored Resources by Desired Resources | Experimental | Behavioral: Study 1, Next Steps Survey, Behavioral: Study 1, Generic Response, Behavioral: Study 1, Tailored Resources by Desired ResourcesThis 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") |
| Study 1, Next Steps Survey + Tailored Response + Generic Resources | Experimental | Behavioral: Study 1, Next Steps Survey, Behavioral: Study 1, Generic Resources, Behavioral: Study 1, Tailored ResponseThis 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. |
| Study 1, Next Steps Survey + Tailored Response + Tailored Resources by Desired Resources | Experimental | Behavioral: Study 1, Next Steps Survey, Behavioral: Study 1, Tailored Response, Behavioral: Study 1, Tailored Resources by Desired ResourcesThis 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"). |
| Study 2, Control | Experimental | Behavioral: Study 2, ControlParticipants 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. |
| Study 2, DIY tool without AI | Experimental | Behavioral: Study 2, DIY tool without AIParticipants 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. |
| Study 2, DIY tool with AI | Experimental | Behavioral: Study 2, DIY tool with AIParticipants 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. |
| Study 1, Demographic Survey | Experimental | Behavioral: Study 1, Demographics SurveyThis 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). |
| Study 1, Next Steps Survey | Experimental | Behavioral: Study 1, Next Steps SurveyThis 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study 1, Demographics SurveyParticipants will be shown a demographics survey (e.g., age range, gender, income). | Behavioural | Study 1, Demographic Survey, Study 1, Demographic Survey + Generic Response + Generic Resources, Study 1, Demographic Survey + Generic Response + Tailored Resources by Demographics |
| Study 1, Next Steps SurveyParticipants 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. | Behavioural | Study 1, Next Steps Survey, Study 1, Next Steps Survey + Generic Response + Generic Resources, Study 1, Next Steps Survey + Generic Response + Tailored Resources by Desired Resources, Study 1, Next Steps Survey + Tailored Response + Generic Resources, Study 1, Next Steps Survey + Tailored Response + Tailored Resources by Desired Resources |
| Study 1, Generic ResponseParticipants will be provided with the generic/current response to screening. | Behavioural | Study 1, Demographic Survey + Generic Response + Generic Resources, Study 1, Demographic Survey + Generic Response + Tailored Resources by Demographics, Study 1, Next Steps Survey + Generic Response + Generic Resources, Study 1, Next Steps Survey + Generic Response + Tailored Resources by Desired Resources |
| Study 1, Generic ResourcesParticipants will be provided with links to a list of 4 generic Mental Health America (MHA) resources. | Behavioural | Study 1, Demographic Survey + Generic Response + Generic Resources, Study 1, Next Steps Survey + Generic Response + Generic Resources, Study 1, Next Steps Survey + Tailored Response + Generic Resources |
| Study 1, Tailored ResponseParticipants 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). | Behavioural | Study 1, Next Steps Survey + Tailored Response + Generic Resources, Study 1, Next Steps Survey + Tailored Response + Tailored Resources by Desired Resources |
| Study 1, Tailored Resources by DemographicsParticipants will be provided with links to Mental Health America (MHA) resources tailored to sexuality (Lesbian, Gay, Bisexual, Transgender, or Queer) status and age range. | Behavioural | Study 1, Demographic Survey + Generic Response + Tailored Resources by Demographics |
| Study 1, Tailored Resources by Desired ResourcesParticipants will be provided with links to Mental Health America (MHA) resources aligned with their expressed interest (e.g., additional screening, self help tools). | Behavioural | Study 1, Next Steps Survey + Generic Response + Tailored Resources by Desired Resources, Study 1, Next Steps Survey + Tailored Response + Tailored Resources by Desired Resources |
| Study 2, ControlParticipants in the Do-It-Yourself (DIY) control group will receive psychoeducation materials in W0. They will view content as usual (no DIY). | Behavioural | Study 2, Control |
| Study 2, DIY tool without AIParticipants in the Do-It-Yourself (DIY) tool without Artificial Intelligence (AI) group will be instructed to use the DIY tool 3 times a week. | Behavioural | Study 2, DIY tool without AI |
| Study 2, DIY tool with AIParticipants 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. | Behavioural | Study 2, DIY tool with AI |
Primary outcome
Study 1: Mental Health America Disengagement (After Stage 1 Randomization)
Time frame: Through active web session, an average of 10 minutes
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.
Study 1: Mental Health America Engagement, Clicks on Featured Resources (After Stage 2 Randomization)
Time frame: Through active web session, an average of 10 minutes
Proportion of users clicking featured resources (i.e., links to webpages on Mental Health America, featured below screening results) from the screening results page.
Study 1: Mental Health America Engagement, Number of Webpages Clicked (After Stage 2 Randomization)
Time frame: Through active web session, an average of 10 minutes
Number of webpages clicked (including links to either featured and non-featured resources) after stage 2 randomization.
Study 1: Mental Health America Disengagement (After Stage 2 Randomization)
Time frame: Through active web session, an average of 10 minutes
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.
Study 1: DIY Completion Rate (After Stage 2 Randomization)
Time frame: Through active web session, an average of 10 minutes
Number of participants who completed the Do-It-Yourself (DIY) tool.
Study 2: Engagement (Dosage)
Time frame: Week 1, Week 2, Week 3, Week 4
Number of times using the Do-It-Yourself (DIY) tool
Study 2: Tool Use Helpfulness
Time frame: Week 1, Week 2, Week 3, Week 4
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.
Study 2: Emotion Mechanisms
Time frame: Week 1, Week 2, Week 3, Week 4, Week 8
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?
Study 2: Tool Mechanisms
Time frame: Week 1, Week 2, Week 3, Week 4
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
Study 2: Tool Mechanisms (Part 2)
Time frame: Week 1, Week 2, Week 3, Week 4
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?
Study 2: DIY Skill Use: Competencies of Cognitive Therapy Scale - Self-Report
Time frame: Week 1, Week 2, Week 3, Week 4, Week 8
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
Long-term Adoption of the Intervention
Time frame: Week 5
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.
Hopefulness
Time frame: Week 1, Week 2, Week 3, Week 4, Week 8
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).
2 secondary outcomes
Study 2: Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8
Study 2: Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37099363Zech JM, Johnson M, Pullmann MD, Hull TD, Althoff T, Munson SA, Fridling N, Litvin B, Wu J, Arean PA. An Integrative Engagement Model of Digital Psychotherapy: Exploratory Focus Group Findings. JMIR Form Res. 2023 Apr 26;7:e41428. doi: 10.2196/41428.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Pullmann, PhD principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study 1, Demographics Survey, Study 1, Next Steps Survey and Study 1, Generic Response in people with Engagement, Patient, run by University of Washington at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study 1: Mental Health America Disengagement (After Stage 1 Randomization) (time frame: Through active web session, an average of 10 minutes). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04507360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.