N/A
N=78,390
Enhancing Engagement With Digital Mental Health Care
Engagement, Patient
Bottom Line
View on ClinicalTrials.gov: NCT04507360 ↗Enrolled (actual)
78,390
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Study 1: Mental Health America Disengagement (After Stage 1 Randomization) — 574; 566 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Study 1, Demographics Survey (Behavioral); Study 1, Next Steps Survey (Behavioral); Study 1, Generic Response (Behavioral); Study 1, Generic Resources (Behavioral); Study 1, Tailored Response (Behavioral); Study 1, Tailored Resources by Demographics (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)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study 1: Mental Health America Disengagement (After Stage 1 Randomization) |
574; 566 | — |
| PRIMARY Study 1: Mental Health America Engagement, Clicks on Featured Resources (After Stage 2 Randomization) |
2839; 4517; 1272; 1457; 1181; 1507 | — |
| PRIMARY Study 1: Mental Health America Engagement, Number of Webpages Clicked (After Stage 2 Randomization) |
4.32; 5.05; 4.31; 4.43; 4.39; 4.12 | — |
| PRIMARY Study 1: Mental Health America Disengagement (After Stage 2 Randomization) |
9019; 8532; 4107; 4100; 3908; 3891 | — |
| PRIMARY Study 1: DIY Completion Rate (After Stage 2 Randomization) |
131; 173; 55; 54; 63; 69 | — |
| PRIMARY Study 2: Engagement (Dosage) |
2.72; 2.99; 1.98; 2.14; 1.77; 2.14 | — |
| PRIMARY Study 2: Tool Use Helpfulness |
2.00; 1.99; 1.88; 1.95; 1.85; 1.83 | — |
| PRIMARY Study 2: Emotion Mechanisms |
3.66; 3.87; 3.77; 3.62; 3.94; 3.85 | — |
| PRIMARY Study 2: Tool Mechanisms |
4.15; 4.06; 3.93; 3.95; 3.59; 3.68 | — |
| PRIMARY Study 2: Tool Mechanisms (Part 2) |
1.38; 1.42; 1.65; 1.62; 3.03; 3.04 | — |
| PRIMARY Study 2: DIY Skill Use: Competencies of Cognitive Therapy Scale - Self-Report |
3.43; 3.77; 3.68; 3.56; 3.85; 3.86 | — |
| PRIMARY Long-term Adoption of the Intervention |
7.04; 6.82; 6.94; 7.39; 7.17; 7.28 | — |
| PRIMARY Hopefulness |
3.66; 3.87; 3.77; 3.73; 4.03; 3.84 | — |
| SECONDARY Study 2: Patient Health Questionnaire-9 (PHQ-9) |
17.69; 17.66; 17.97; 14.50; 14.88; 15.17 | — |
| SECONDARY Study 2: Generalized Anxiety Disorder-7 (GAD-7) |
14.29; 14.56; 14.38; 12.43; 12.84; 12.69 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04507360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.