Behavior, Biology and Well-Being Study

NCT05183867 | Completed Results

• 4 other identifiers: 2021-0991Protocol Version 6/29/2023A4874001U24AT011289-01
• Study Type: interventional
• Target: 1,157
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Psychological Distress

Outcome Measures

Primary Outcomes (1)

• Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score

  The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms.

  Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Secondary Outcomes (22)

• Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score

  Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

• Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score

  Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

• Flourishing Measured by the Flourishing Index Score

  Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

• Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score

  Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

• Connection Measured by NIH Toolbox Loneliness Score

  Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Other Outcomes (20)

• Inflammatory Biomarkers: C-reactive Protein (CRP)

  Baseline and 3 month follow-up

• Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10

  Baseline and 3 month follow-up

• Microbiome Alpha Diversity: Species Richness

  Baseline and 3 month follow-up

Study Arms (3)

Healthy Minds Program (HMP) app

EXPERIMENTAL

Participants will receive access to the 4-week HMP Foundations module. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.

Device: Healthy Minds Program

Psychoeducation app

ACTIVE COMPARATOR

Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.

Device: Healthy Minds Program

Usual Care

NO INTERVENTION

Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.

Interventions

Healthy Minds Program DEVICE

HMP is a 4-week mobile health (mHealth) meditation training program.

Also known as: HMP

Healthy Minds Program (HMP) app; Psychoeducation app

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Hope for Depression Research Foundation: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53703, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Simon Goldberg
• Organization: Center for Healthy Minds

sbgoldberg@wisc.edu

(608) 265-8986

Study Officials

• Simon Goldberg, PhD

  UW-Madison, Center for Healthy Minds

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The groups will be randomized to one of three groups in a 2:2:1 ratio.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: March 24, 2022
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: September 9, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)