Behavior, Biology and Well-Being Study
NCT06213701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2025-07-30
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. The investigators plan to conduct a randomized controlled trial (RCT) involving 300 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation \[HMP without meditation practice\]), and a waitlist control in a sample of United States adults with elevated depression symptoms.
Conditions
- Depression
- Psychological Distress
Interventions
- DEVICE
-
Healthy Minds Program
HMP is a 4-week mobile health (mHealth) meditation training program.
- OTHER
-
Psychoeducation app
Psychoeducation app
Sponsors & Collaborators
-
Hope for Depression Research Foundation
collaborator OTHER -
National Center for Complementary and Integrative Health (NCCIH)
collaborator NIH -
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Simon Goldberg, PhD · UW-Madison, Center for Healthy Minds
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-16
- Primary Completion
- 2023-07-15
- Completion
- 2023-07-15
Countries
- United States
Study Locations
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