The COMParing App Support Strategies Study
Status
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Study type
Funder types
Identifiers
Details and patient eligibility
About
The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.
Full description
Participants will be randomly assigned to various support conditions that vary across three binary factors,
- Introductory coaching session vs introductory information session
- On-demand email support (Yes/No)
- Microsupport messages (Yes/No)
Participants will be screened for eligibility using a web-based screener that assesses inclusion and exclusion criteria. Eligible participants will receive a study overview and will have the option to go through an online consent process. After giving consent, participant will receive a text message to assess their ability to receive text messages and tab on a link embedded in the text message. Those who failed to go through this process will be screened out.
Participants consented will complete a baseline survey consisting of a series of questionnaires and daily check-in assessment sent to their phone. Only those who successfully complete the baseline survey and the first daily check-in survey will advance in the study. Participants will schedule a meeting with our study staff member after completing the baseline survey and first daily check-in survey. They will be assessed through questionnaires at baseline, weekly during the 4-week intervention period, and at 6-month follow-up. They will also complete daily check-in survey twice a day throughout the intervention.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Elevated symptoms of depression and/or anxiety (PHQ-9 greater than or equal to 10, GAD-7 greater than or equal to 10)
- Proficiency in English
- Access to a smartphone and internet
- Ability to receive text messages
Exclusion criteria
- Non-US citizen or legal resident (green card holder)
- History of psychosis or mania
- Suicidal ideation or thoughts of self-harm indicated by PHQ9 item 9 and BDI item 9
- Individuals who do not provide the information required for GUID generation
Trial design
Primary purpose
Allocation
Interventional model
Masking
688 participants in 8 patient groups
Trial contacts and locations
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Central trial contact
Wendy Lau, PhD
Data sourced from clinicaltrials.gov
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