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Engagement Strategies for Digital Mental Health Care
N/A
Recruiting
Led By Michael Pullmann, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 or older and speak English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Study 1: DIY Completion Rate
Study 1: Mental Health America Disengagement
Study 1: Mental Health America Engagement
+7 moreSecondary outcome measures
Study 2: Generalized Anxiety Disorder (GAD-7)
Study 2: Patient Health Questionnaire (PHQ-9)
Other outcome measures
Brief Bipolar Test
CAGE-AID
Duke Social Support Scale
+6 moreTrial Design
12Treatment groups
Experimental Treatment
Group I: Study 2, DIY tool without AIExperimental Treatment1 Intervention
Participants in the DIY tool without 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 DIY tool with 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 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 + Top 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 top resources.
Group V: 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 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 DIY condition, a single question plus the full DIY tool will be embedded within the content page.
Group VII: Study 1, Generic response + Top ResourcesExperimental Treatment2 Interventions
The Generic Response + Top Resources will feature the response-as-usual on MHA's website and the four most frequently visited resource pages on MHA's website.
Participants will be randomized into this condition, and also, participants who do not respond to the demographics survey or the Next Steps survey will be placed in this condition.
Group VIII: Study 1, Generic response + Tailored Resources by Desired ResourcesExperimental Treatment2 Interventions
This condition will feature the response-as-usual on 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 IX: Study 1, Generic response + Tailored Resources by DemographicsExperimental Treatment2 Interventions
This condition will feature the response-as-usual on 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 the most common 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 X: Study 1, Embedded single-question DIYExperimental Treatment1 Intervention
Participants who visit content pages on the MHA website after completing screening will receive stage 2 randomization into one of three content page conditions. In the embedded single-question 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 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 DIY tool.
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,679,275 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
1,740 Previous Clinical Trials
1,837,938 Total Patients Enrolled
3 Trials studying Patient Engagement
342 Patients Enrolled for Patient Engagement
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older, experience significant stress or anxiety, and speak English or Spanish.I am 18 or older and speak English or Spanish.I am under 18, speak English or Spanish, and have low depression or anxiety scores.I am under 14 and do not speak English or Spanish.I am under 18 and do not speak both English and Spanish.I am under 18 and do not speak English or Spanish.I am 14 or older, seeking mental health services, and speak English or Spanish.I am an adult with mental health issues or Tourette Syndrome and speak English or am bilingual in English and Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Study 1, Generic response + Tailored Resources by Demographics
- Group 2: Study 2, Control
- Group 3: Study 1, Embedded full DIY within content page
- Group 4: Study 1, Generic response + Top Resources
- Group 5: Study 1, Tailored Response + Top Resources
- Group 6: Study 1, Tailored Response + Tailored Resources by Desired Resources
- Group 7: Study 1, Embedded single-question DIY
- Group 8: Study 2, DIY tool with AI
- Group 9: Study 1, Single question plus full DIY
- Group 10: Study 1, Content-as-usual
- Group 11: Study 1, Generic response + Tailored Resources by Desired Resources
- Group 12: Study 2, DIY tool without AI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to participate in this experiment?
"Affirmative, information found on the clinicaltrials.gov website points to this study being actively engaged in participant recruitment. Initially posted on October 15th 2021 and recently updated on March 29th 2022, 10000 total patients from 2 different medical sites are needed for inclusion."
Answered by AI
What is the goal of this research endeavor?
"This study, with a baseline evaluation period of approximately X duration, will primarily assess the impact of DMH services on Generalized Anxiety Disorder (GAD-7). Secondary objectives include evaluating consumer's Outcome Expectancies, Task Self-Efficacy, and Action Planning. The former two are measured through single or multiple items based off established guidelines; Action Planning is assessed via questions regarding mental health goals that consumers rate from 1 to 4 in terms of accuracy."
Answered by AI
What is the exact number of participants in this medical research?
"Affirmative. According to information hosted on the clinicaltrials.gov website, recruitment is currently taking place for this medical study which was first advertised on October 15th 2021 and last updated March 29th 2022. A total of 10 000 subjects are needed across 2 facilities."
Answered by AI
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