Brain and Meditation (BAM) Study

NCT05215314 | Completed Results

• 4 other identifiers: 2021-1109Protocol Version 10/12/2022A4830005K01MH117222
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial to test the impact of an app-based meditation program on perceived stress and behavioral correlates of stress with known neurobiological correlates. Healthy adult participants between the ages of 25-65 will be enrolled in the study for about 4-5 months.

Conditions

Stress; Behavior

Keywords

healthy minds program; mobile health

Outcome Measures

Primary Outcomes (1)

• Change in Perceived Stress Scale (PSS) Score

  PSS is a 10-item survey scored on a 5 point likert scale from 0 = never to 4 = very often, for a total possible range of scores from 0-40 where higher scores indicate higher perceived stress.

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

Secondary Outcomes (3)

• Change in Behavioral Pattern Separation Task

  Baseline, following week 4 of intervention period, and 3 month follow-up

• Change in PROMIS Depression Score

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

• Change in PROMIS Anxiety Score

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

Other Outcomes (6)

• Change in Posttraumatic Stress Disorder Checklist (PCL-5) Score

  Baseline, following week 4 of intervention period, and 3 month follow-up

• Change in PROMIS Sleep Disturbance Score

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

• Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score

  Baseline, following week 4 of intervention period, and 3 month follow-up

Study Arms (2)

Healthy Minds Program (HMP)

EXPERIMENTAL

Fully remote, 4-week meditation intervention

Behavioral: mHealth Meditation

Waitlist Control

NO INTERVENTION

Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study

Interventions

mHealth Meditation BEHAVIORAL

Participants will receive access to the 4-week Healthy Minds Program (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.

Also known as: mobile health app

Healthy Minds Program (HMP)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual can read, write, speak, and understand English
• Able to provide informed consent
• Willing and able to complete all study procedures, including the Healthy Minds Program
• Has access to a smartphone that can download apps from Google Play or the Apple App Store
• US citizen or a permanent US resident (green card holder)

You may not qualify if:

• Extensive experience in meditation practice (e.g., regular daily meditation practice for the past 6 months or regular weekly meditation practice for the past 12 months), experience in substantively similar meditation training programs (e.g., attended a meditation retreat or a yoga/body practice retreat with a significant mediation component), or substantial previous use of the Healthy Minds Program app
• Individuals will be excluded if they previously participated in substantively similar research at our Center at the discretion of the investigator due to similar tasks being used in certain studies
• History of psychosis
• History of mania
• Current psychopathology that interferes with study participation

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Healthy Minds

Madison, Wisconsin, 53703, United States

Location

Related Publications (1)

• Heller AS, Shi TC, Ezie CEC, Reneau TR, Baez LM, Gibbons CJ, Hartley CA. Association between real-world experiential diversity and positive affect relates to hippocampal-striatal functional connectivity. Nat Neurosci. 2020 Jul;23(7):800-804. doi: 10.1038/s41593-020-0636-4. Epub 2020 May 18.

  PMID: 32424287 BACKGROUND

MeSH Terms

Conditions

Behavior

Results Point of Contact

• Title: Daniel Grupe
• Organization: University of Wisconsin-Madison

grupe@wisc.edu

608-263-7572

Study Officials

• Dan Grupe, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: April 13, 2022
• Primary Completion: January 9, 2024
• Study Completion: January 9, 2024
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)