Enhancing Engagement With Digital Mental Health Care

NCT04507360 | Completed Results DMC

• 2 other identifiers: STUDY000109581R01MH125179-01
• Study Type: interventional
• Target: 78,390
• Locations: 1 country
• Sites: 3

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.

Conditions

Engagement, Patient

Keywords

Digital Mental Health

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (2)

• Study 2: Patient Health Questionnaire-9 (PHQ-9)

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 8

• Study 2: Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, Week 1, Week 2, Week 3, Week 4, Week 8

Study Arms (11)

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.

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.

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.

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")

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.

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").

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.

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.

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.

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).

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).

Behavioral: Study 1, Next Steps Survey

Interventions

Study 1, Demographics Survey BEHAVIORAL

Participants will be shown a demographics survey (e.g., age range, gender, income).

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 Survey BEHAVIORAL

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, 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 Response BEHAVIORAL

Participants will be provided with the generic/current response to screening.

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 Resources BEHAVIORAL

Participants will be provided with links to a list of 4 generic Mental Health America (MHA) resources.

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 Response BEHAVIORAL

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, Next Steps Survey + Tailored Response + Generic Resources; Study 1, Next Steps Survey + Tailored Response + Tailored Resources by Desired Resources

Study 1, Tailored Resources by Demographics BEHAVIORAL

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, Demographic Survey + Generic Response + Tailored Resources by Demographics

Study 1, Tailored Resources by Desired Resources BEHAVIORAL

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 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, Control BEHAVIORAL

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, Control

Study 2, DIY tool without AI BEHAVIORAL

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 without AI

Study 2, DIY tool with AI BEHAVIORAL

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 2, DIY tool with AI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Mental Health America: collaborator
• Talkspace: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Groop Internet Platform DBA Talkspace

New York, New York, 10023, United States

Location

Mental Health America

Alexandria, Virginia, 22314, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 37099363 DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Tim Althoff
• Organization: University of Washington

althoff@cs.washington.edu

206-543-4243

Study Officials

• Michael Pullmann, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Computer Science and Engineering

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 11, 2020
• Study Start: October 15, 2021
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: August 3, 2025
• Results First Posted: August 3, 2025

Record last verified: 2025-07

Locations

US (3)