NCT05183867

Behavior, Biology and Well-Being Study

Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,157 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The central aim of this study is to test the efficacy 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 1100 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.

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 limited due to associated cost and lack of available services. Research on neurocognitive and biological mechanisms of meditation training in alleviating depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on retrospective self-report measures, which are vulnerable to a host of biases. This project will use gold-standard behavioral measures and explore novel measures of relevant neurocognitive and behavioral processes, namely pattern separation, self-referential thought, and video-based assessment of emotional well-being. Furthermore, the project will investigate effects on the gut microbiome (with fecal samples) and inflammation (with dried blood spots), which reflect biological systems hypothesized to be mechanistically related to benefits of meditation and well-being training.

Conditions

• Depression
• Psychological Distress

Interventions

Type	Name	Description
DEVICE	Healthy Minds Program	HMP is a 4-week mobile health (mHealth) meditation training program.

Timeline

• Start date: 2022-03-24
• Primary completion: 2024-07-15
• Completion: 2024-07-15
• First posted: 2022-01-11
• Last updated: 2025-09-09
• Results posted: 2025-08-01

Locations

1 site across 1 country: United States