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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

No Placebo-Only Group

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:

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I am under 18, speak English or Spanish, and have low depression or anxiety scores.

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I am under 14 and do not speak English or Spanish.

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I am under 18 and do not speak English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met