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Engagement Strategies for Digital Mental Health Care

N/A
Waitlist Available
Led By Patricia A Arean, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Phase 3a (10,000): TS consumers, 18 years old and older, English or Spanish speaking
Must not have
Phase 3b (250): Younger than 18 years old, Non-English or Non-Spanish speaking, PHQ-9 or GAD-7 of less than 10
Phase 1 (100K) and Phase 2 (50K): Younger than 14 years old; Non-English or Non-Spanish speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Summary

This trial is a partnership between a nonprofit mental health advocacy organization, a for-profit online digital psychotherapy organization, and a university to study the best way to use digital mental health treatments to improve mental health outcomes.

Who is the study for?
This trial is for Mental Health America and Talkspace consumers seeking digital mental health services. Participants must be aged 14 or older, speaking English or Spanish. Adults can join focus groups if bilingual. For later phases, participants need to be over 18 and have certain scores on depression/anxiety questionnaires.
What is being tested?
The study aims to understand how people engage with digital mental health treatments and find personalized ways to boost this engagement. It will track over 100,000 users, use machine learning to analyze engagement patterns, and conduct mini-trials on motivational strategies.
What are the potential side effects?
Since the trial involves non-medical interventions like engagement strategies in a digital environment for mental health treatment, traditional physical side effects are not applicable; however, there may be psychological impacts from increased or altered engagement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and speak English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18, speak English or Spanish, and have low depression or anxiety scores.
Select...
I am under 14 and do not speak English or Spanish.
Select...
I am under 18 and do not speak English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Study 1: DIY Completion Rate
Study 1: Mental Health America Disengagement
Study 1: Mental Health America Engagement
+7 more
Secondary study objectives
Study 2: Generalized Anxiety Disorder (GAD-7)
Study 2: Patient Health Questionnaire (PHQ-9)
Other study objectives
Brief Bipolar Test
CAGE-AID
Duke Social Support Scale
+6 more

Trial Design

12Treatment groups
Experimental Treatment
Group I: Study 2, DIY tool without AIExperimental Treatment1 Intervention
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 W1 to W4 and follow-up surveys in W5 and at the end of W8.
Group II: Study 2, DIY tool with AIExperimental Treatment1 Intervention
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 W1 to W4 and follow-up surveys in W5 and at the end of W8.
Group III: Study 2, ControlExperimental Treatment1 Intervention
Participants in the Do-It-Yourself (DIY) control group will receive psychoeducation materials in W0. They will view content as usual (no DIY) and will receive surveys from W1 to W4 and follow-up surveys in W5 and at the end of W8.
Group IV: Study 1, Tailored Response + Tailored Resources by Desired ResourcesExperimental Treatment2 Interventions
This condition 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 screening").
Group V: Study 1, Tailored Response + Generic ResourcesExperimental Treatment2 Interventions
This condition 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.
Group VI: Study 1, Single question plus full DIYExperimental Treatment1 Intervention
Participants will be randomized into one of three content page conditions. In the single question plus full Do-It-Yourself (DIY) condition, a single question plus the full DIY tool will be embedded within the content page.
Group VII: Study 1, Generic Response + Tailored Resources by Desired ResourcesExperimental Treatment2 Interventions
This condition 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 screening")
Group VIII: Study 1, Generic Response + Tailored Resources by DemographicsExperimental Treatment2 Interventions
This condition 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.
Group IX: Study 1, Generic Response + Generic ResourcesExperimental Treatment2 Interventions
The Generic Response + Generic Resources will feature the response-as-usual on Mental Health America (MHA)'s website and the four generic resource pages on MHA's website. Participants will be randomized into this condition, and participants who do not respond to the demographics survey or the Next Steps survey items will be placed in this condition.
Group X: Study 1, Embedded single-question DIYExperimental Treatment1 Intervention
Participants who visit content pages on the Mental Health America (MHA) website after completing screening will receive stage 2 randomization into one of three content page conditions. In the embedded single-question Do-It-Yourself (DIY) condition, a single DIY question will be embedded within the content page.
Group XI: Study 1, Embedded full DIY within content pageExperimental Treatment1 Intervention
Participants will be randomized into one of three content page conditions. In the embedded full Do-It-Yourself (DIY) condition, the full DIY tool will be embedded within the content page.
Group XII: Study 1, Content-as-usualExperimental Treatment1 Intervention
The content page will not include any embedded Do-It-Yourself (DIY) tool.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,776,966 Total Patients Enrolled
4 Trials studying Patient Engagement
496 Patients Enrolled for Patient Engagement
TalkspaceIndustry Sponsor
4 Previous Clinical Trials
14,436 Total Patients Enrolled
University of WashingtonLead Sponsor
1,791 Previous Clinical Trials
1,904,936 Total Patients Enrolled
3 Trials studying Patient Engagement
342 Patients Enrolled for Patient Engagement

Media Library

Engagement Strategies TBD Clinical Trial Eligibility Overview. Trial Name: NCT04507360 — N/A
Patient Engagement Research Study Groups: Study 1, Generic Response + Generic Resources, Study 2, Control, Study 1, Generic Response + Tailored Resources by Demographics, Study 1, Generic Response + Tailored Resources by Desired Resources, Study 1, Tailored Response + Generic Resources, Study 1, Tailored Response + Tailored Resources by Desired Resources, Study 1, Content-as-usual, Study 2, DIY tool with AI, Study 1, Embedded full DIY within content page, Study 1, Embedded single-question DIY, Study 1, Single question plus full DIY, Study 2, DIY tool without AI
Patient Engagement Clinical Trial 2023: Engagement Strategies TBD Highlights & Side Effects. Trial Name: NCT04507360 — N/A
Engagement Strategies TBD 2023 Treatment Timeline for Medical Study. Trial Name: NCT04507360 — N/A
~146 spots leftby Sep 2025
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