Study Results
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View full resultsBasic Information
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COMPLETED
NA
78390 participants
INTERVENTIONAL
2021-10-15
2024-05-14
Brief Summary
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Detailed Description
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This study will prospectively follow a large, naturalistic sample of MHA and TS consumers, and will apply machine learning, user-centered design strategies, and micro randomized and sequential multiple assignment randomized trials (SMART) to address these aims. As is usual practice for both platforms, consumers will complete online mental health screening and assessment, and the investigators will be able to classify participants by disease status and symptom severity. The sample that the investigators will be working with will not be limited by diagnosis or co-morbidities. Participants will enter the MHA and TS platforms prospectively over 4 years. For aim 1, participant data will be analyzed statistically to reveal differences in engagement and dropout across groups based on demographics, symptoms and platform activity. For aim 2, the investigators will use supervised machine learning techniques to identify subtypes based on consumer demographics, engagement patterns with DMH, reasons for disengagement, success of existing MHA and TS engagement strategies, and satisfaction with the DMH tools, that are predictive of future engagement patterns. Finally, based on the outcomes from aim 2, in aim 3a 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 will then conduct a series of micro-randomized and SMART trials to determine which theory-driven engagement strategies, co-designed with users, have the greatest fit with subtypes developed under aim 2. The investigators will test the effectiveness of these strategies to 1) prevent disengagement from those who are more likely to have poor outcomes after disengagement, 2) improve movement from motivation to volition and, 3) enhance optimal dose of DMH engagement and consequently improve mental health outcomes. These data will be analyzed using longitudinal mixed effects models with effect coding to estimate the effectiveness of each strategy on client engagement behavior and mental health outcomes.
The purpose of aim 3b is to identify effective engagement strategies tailored to client needs and demographics to increase MHA website engagement, and to better understand how self-help mental health resources can help people overcome negative thinking and support healthier thought processes. The investigators will compare effective engagement strategies tailored to subtypes developed under aim 2 to study the mediated impact of engagement strategies on consumer mental health outcomes. The study team will determine if engagement strategies targeted to consumer engagement subtype will enhance engagement and in turn result in improved clinical outcomes. These will be compared to generic strategies that are not subtype targeted.
All aim 3b activities will occur with MHA, broken down into two parts: (Study 1) a sequential multiple assignment randomized trial (SMART) and (Study 2) a Do-It-Yourself (DIY) tool longitudinal randomized control trial (RCT). Study 1 will use a SMART to examine methods to optimize engagement with MHA's website, and Study 2 will recruit participants for a longitudinal month-long study where they are randomly assigned to a control group, the use of a DIY tool without Artificial Intelligence (AI), or the use of a DIY tool with AI to examine the efficacy of using a digital tool to improve mental health functioning. An AI tool that uses machine learning/Natural Language Processing (NLP)/AI methods was developed to personalize and tailor an intervention to improve engagement and completion outcomes. The study focuses on a specific, popular DIY tool that teaches cognitive restructuring. Pilot work showed that (1) engagement and completion rates on DIY tools can be low, and (2) a pilot AI tool had significantly higher engagement and completion rates. These differences may arise due to AI support, User Interface/User Experience/design differences, other factors, or a combination thereof. Additionally, the efficacy of the digital tool to improve mental health functioning is unknown. Study 2 will recruit participants who will be randomly assigned to one of three groups for a longitudinal month-long study: thrice-weekly DIY tool use with AI, without AI, or a control group.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Study 1, Demographic Survey + Generic Response + Generic Resources
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.
Study 1, Demographics Survey
Participants will be shown a demographics survey (e.g., age range, gender, income).
Study 1, Generic Response
Participants will be provided with the generic/current response to screening.
Study 1, Generic Resources
Participants will be provided with links to a list of 4 generic Mental Health America (MHA) resources.
Study 1, Demographic Survey + Generic Response + Tailored Resources by Demographics
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.
Study 1, Demographics Survey
Participants will be shown a demographics survey (e.g., age range, gender, income).
Study 1, Generic Response
Participants will be provided with the generic/current response to screening.
Study 1, Tailored Resources by Demographics
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, Next Steps Survey + Generic Response + Generic Resources
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.
Study 1, Next Steps Survey
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, Generic Response
Participants will be provided with the generic/current response to screening.
Study 1, Generic Resources
Participants will be provided with links to a list of 4 generic Mental Health America (MHA) resources.
Study 1, Next Steps Survey + Generic Response + Tailored Resources by Desired Resources
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")
Study 1, Next Steps Survey
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, Generic Response
Participants will be provided with the generic/current response to screening.
Study 1, Tailored Resources by Desired Resources
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 + Tailored Response + Generic Resources
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.
Study 1, Next Steps Survey
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, Generic Resources
Participants will be provided with links to a list of 4 generic Mental Health America (MHA) resources.
Study 1, Tailored Response
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 + Tailored Resources by Desired Resources
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").
Study 1, Next Steps Survey
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, Tailored Response
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, Tailored Resources by Desired Resources
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 2, Control
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.
Study 2, Control
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, DIY tool without AI
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.
Study 2, DIY tool without AI
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 with AI
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.
Study 2, DIY tool with AI
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 1, Demographic Survey
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).
Study 1, Demographics Survey
Participants will be shown a demographics survey (e.g., age range, gender, income).
Study 1, Next Steps Survey
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).
Study 1, Next Steps Survey
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.
Interventions
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Study 1, Demographics Survey
Participants will be shown a demographics survey (e.g., age range, gender, income).
Study 1, Next Steps Survey
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, Generic Response
Participants will be provided with the generic/current response to screening.
Study 1, Generic Resources
Participants will be provided with links to a list of 4 generic Mental Health America (MHA) resources.
Study 1, Tailored Response
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, Tailored Resources by Demographics
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, Tailored Resources by Desired Resources
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 2, Control
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, DIY tool without AI
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 with AI
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
ALL
Yes
Sponsors
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Mental Health America
OTHER
Talkspace
INDUSTRY
National Institute of Mental Health (NIMH)
NIH
University of Washington
OTHER
Responsible Party
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Tim Althoff
Assistant Professor, Computer Science and Engineering
Principal Investigators
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Michael Pullmann, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Groop Internet Platform DBA Talkspace
New York, New York, United States
Mental Health America
Alexandria, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY00010958
Identifier Type: -
Identifier Source: org_study_id
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