N/A
N=1,157
Behavior, Biology and Well-Being Study
Depression · Psychological Distress
Bottom Line
View on ClinicalTrials.gov: NCT05183867 ↗Enrolled (actual)
1,157
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score — 10.06; 9.85; 9.79; 9.17 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Healthy Minds Program (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score |
10.06; 9.85; 9.79; 9.17; 8.8; 9.45 | — |
| SECONDARY Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score |
8.94; 8.67; 8.37; 8.58; 8.13; 8.04 | — |
| SECONDARY Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score |
57.73; 56.94; 56.9; 56.26; 55.91; 57.12 | — |
| SECONDARY Flourishing Measured by the Flourishing Index Score |
56.26; 56.55; 56.63; 57.19; 57.52; 57.22 | — |
| SECONDARY Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score |
24.11; 24.41; 23.95; 23.61; 24.26; 24.27 | — |
| SECONDARY Connection Measured by NIH Toolbox Loneliness Score |
15.1; 14.74; 15.13; 14.33; 13.97; 14.57 | — |
| SECONDARY Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score |
33.12; 33.22; 33.51; 34.15; 33.92; 33.99 | — |
| SECONDARY Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score |
43.44; 43.09; 43.33; 42.89; 42.59; 41.58 | — |
| SECONDARY Pain Intensity Measured by PROMIS Pain Intensity Score |
3.22; 3.33; 3.42; 2.98; 3.12; 3.5 | — |
| SECONDARY Pain Interference Measured by PROMIS Pain Inference Scale Score |
52.94; 53.6; 53.57; 51.65; 51.66; 53.16 | — |
| SECONDARY Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score |
24.62; 24.35; 23.92; 26.24; 26.32; 25.84 | — |
| SECONDARY Climate Change Anxiety Scale |
21.17; 20.98; 21.22; 20.79; 20.67; 21.01 | — |
| SECONDARY Wellbeing Growth Mindset |
14.27; 14.07; 13.88; 14.61; 14.46; 13.50 | — |
| SECONDARY Healthy Minds Index (HM Index) - Awareness |
9.13; 9.11; 9.01; 9.55; 9.33; 8.72 | — |
| SECONDARY Healthy Minds Index (HM Index) - Connection |
15.67; 15.65; 15.64; 16.03; 16.16; 15.16 | — |
| SECONDARY Healthy Minds Index (HM Index) - Insight |
5.79; 5.76; 6.03; 6.78; 6.71; 6.07 | — |
| SECONDARY Healthy Minds Index (HM Index) - Purpose |
9.07; 8.8; 9.22; 10.19; 10.05; 8.95 | — |
| SECONDARY Life Orientation Test - Revised |
11.78; 11.71; 11.77; 13.42; 13.01; 12.23 | — |
| SECONDARY Perceived Stress Scale |
29.7; 29.51; 29.72; 26.46; 26.90; 29.17 | — |
| SECONDARY Perseverative Thinking Questionnaire |
32.02; 31.14; 31.56; 26.94; 27.08; 30.69 | — |
| SECONDARY Satisfaction With Life Scale |
17.25; 17.27; 17.08; 19.62; 19.40; 17.51 | — |
| SECONDARY Subjective Happiness Scale |
16.45; 16.53; 16.29; 17.91; 17.36; 16.35 | — |
| SECONDARY Problematic and Risky Internet Use Screening Scale (PRIUSS-3) |
4.79; 4.45; 4.42; 3.96; 3.97; 4.94 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Elevated PHQ-8 or PHQ-9 ≥ 5 at screening
- 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 (NCT05183867). 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.