Behavior, Biology and Well-Being Study

NCT06213701 | Completed Results

• 4 other identifiers: 2021-0991: PilotProtocol Version 6/29/2023A4874001U24AT011289-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

inflammation; microbiota; alpha diversity

Outcome Measures

Primary Outcomes (2)

• Feasibility of DBS Collection as Measured by Number of Participants Who Provide DBS

  Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.

  Baseline and 3 month follow-up

• Feasibility of Fecal Sample Collection as Measured by Number of Participants Who Provide Fecal Samples

  Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.

  Baseline and 3 month follow-up

Secondary Outcomes (9)

• Change in Microbiome Alpha Diversity: Species Richness

  Baseline and 3 month follow-up

• Change in Microbiome Alpha Diversity: Shannon Diversity Index (H')

  Baseline and 3 month follow-up

• Change in Microbiome Alpha Diversity: Inverse Simpson (1/D)

  Baseline and 3 month follow-up

• Change in Microbiome Alpha Diversity: Pielou Evenness Index (J)

  Baseline and 3 month follow-up

• Change in Microbiome Alpha Diversity: Simpson's Dominance Index (D)

  Baseline and 3 month follow-up

Other Outcomes (1)

• Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline

  Baseline, week 1, week 2, week 3, week 4 (of intervention period), 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.

Other: Psychoeducation app

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 OTHER

Psychoeducation 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 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

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

Related Links

• FULL Behavior, Biology and Well-Being Study

MeSH Terms

Conditions

Depression; Inflammation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: January 9, 2024
• First Posted: January 19, 2024
• Study Start: June 16, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: July 30, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)