Status:
COMPLETED
Behavior, Biology and Well-Being Study
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Hope for Depression Research Foundation
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Depression
Psychological Distress
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The central aim of this pilot study is to compare markers of inflammation and gut microbial diversity with users of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being....
Detailed Description
Depression is highly prevalent and associated with extreme personal and societal costs. Meditation training reduces depression symptoms and psychological distress, but access to in-person programs is ...
Eligibility Criteria
Inclusion
- Elevated PHQ-8 or PHQ-9 ≥ 5 at screening and pre-baseline interview
- Proficient in English
- Able to provide informed consent
- Have access to a smartphone that can download apps from Google Play or the Apple App Store
- For payment purposes, must be a US citizen or a permanent US resident
Exclusion
- Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
- Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
- \- Previous use of Healthy Minds Program app
- Current suicidal intent and/or high self-injury risk (determined from the interview)
- Self-reported history of psychosis
- Self-reported history of mania
- Current psychopathology that interferes with study participation as assessed by interview
- Living or traveling outside the US during the whole study participation period (trips outside US after the interview phase is not an exclusion)
- Alcohol Use Disorders Identification Test (AUDIT) score ≥ 13 for women and AUDIT score ≥ 15 for men
- Drug Use Disorders Identification Test (DUDIT) score ≥ 8 for women and men
Key Trial Info
Start Date :
June 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06213701
Start Date
June 16 2022
End Date
July 15 2023
Last Update
July 30 2025
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53703