N/A
N=300
Behavior, Biology and Well-Being Study
Depression · Psychological Distress
Bottom Line
View on ClinicalTrials.gov: NCT06213701 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS — 89; 29; 98; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Healthy Minds Program (Device); Psychoeducation app (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS |
89; 29; 98; 24; 38; 19 | — |
| PRIMARY Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples |
90; 30; 98; 24; 37; 20 | — |
| SECONDARY Change in Microbiome Alpha Diversity: Species Richness |
261.47; 271.59; 294.22; 257.34; 278.55; 295.67 | — |
| SECONDARY Change in Microbiome Alpha Diversity: Shannon Diversity Index (H') |
4.28; 4.28; 4.35; 4.26; 4.33; 4.40 | — |
| SECONDARY Change in Microbiome Alpha Diversity: Inverse Simpson (1/D) |
62.75; 62.18; 60.73; 62.23; 64.07; 66.58 | — |
| SECONDARY Change in Microbiome Alpha Diversity: Pielou Evenness Index (J) |
0.78; 0.78; 0.78; 0.78; 0.79; 0.79 | — |
| SECONDARY Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D) |
0.03; 0.04; 0.03; 0.04; 0.03; 0.03 | — |
| SECONDARY Change in Inflammatory Biomarkers: C-reactive Protein |
2.26; 2.40; 2.98; 2.62; 3.28; 3.10 | — |
| SECONDARY Change in Inflammatory Biomarkers: TNF-Alpha, IL-6, IL-10 |
2.01; 1.54; 1.66; 1.73; 1.87; 1.98 | — |
| SECONDARY Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score |
9.80; 9.91; 9.45; 9.53; 9.30; 9.35 | — |
| SECONDARY Change in Flourishing Measured by the Flourishing Index Score |
55.61; 56.4; 57.14; 56.31; 56.5; 57.62 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06213701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.