Brain and Meditation (BAM) Study

Neurobiological Mechanisms of Perceived Stress and Their Modification Through Behavioral Intervention

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.

Study Overview

• Status: Completed
• Conditions: Stress; Behavior
• Intervention / Treatment: Behavioral: mHealth Meditation

Detailed Description

Participants will be randomized into one of two groups: the intervention group or the waitlist control group. The intervention group will use a mobile health app for four weeks. Participants will complete pre-intervention, weekly, post-intervention, and 3-month follow-up surveys and tasks.

Primary Objective: Test for hypothesized group differences in perceived stress during participation in a 4-week meditation program and at 3-month follow-up.

Secondary Objective: Within the meditation group, determine whether reductions in perceived stress are associated with changes in hippocampal-dependent behavior.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53703
      • Center for Healthy Minds

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Minds Program (HMP); Fully remote, 4-week meditation intervention	Behavioral: mHealth Meditation; 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.; Other Names: mobile health app
No Intervention: Waitlist Control; Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Behavioral Pattern Separation Task	Participants will complete a behavioral pattern separation task . During this task, participants will encode pictures of common objects while performing a basic categorization task. Participants will then label pictures as "Old" (targets, identical objects to those in the encoding phase), "New" (foils, or completely novel objects), or "Similar" (lure items, distinct exemplars of objects seen during encoding). The measure of interest on this task is the "Lure Discrimination Index", which is calculated as the proportion of lures correctly identified as "similar" minus the proportion of foils that are incorrectly identified as "similar". The theoretical range for the pattern separation index is [-1,1], with higher scores indicating better performance.	Baseline, following week 4 of intervention period, and 3 month follow-up
Change in PROMIS Depression Score	The PROMIS Depression Score is a measure of feelings of depression in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale from 1 (never) to 5 (always) with higher scores indicating increased depression. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of depression. A t score >= 59.9 is indicative of moderate depression, a t score >= 65.8 is indicative of moderately severe depression, and a t score >= 71.5 is indicative of severe depression (based on corresponding cutoffs on the Patient Health Questionnaire-9).	Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
Change in PROMIS Anxiety Score	The PROMIS Anxiety Score is a measure of feelings of anxiety in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale from 1 (never) to 5 (always) with higher scores indicating increased anxiety. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of anxiety. A t score >= 62.3 is indicative of moderate anxiety and a t score >= 67.7 is indicative of severe anxiety (based on corresponding cutoffs on the General Anxiety Disorder-7).	Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Posttraumatic Stress Disorder Checklist (PCL-5) Score	The PCL-5 is a 20-item survey scored on a 5 point likert scale from 0 (not at all) to 4 (extremely) for a total possible range of score from 0-80 where higher scores indicate more symptoms of PTSD within the last 30 days.	Baseline, following week 4 of intervention period, and 3 month follow-up
Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score	The FFMQ-A8 is an 8-item survey scored on a 5 point likert scale from 'never, or very rarely true' to 'very often or always true', for a total possible range of scores from 8-40 where higher scores indicate greater mindfulness awareness.	Baseline, following week 4 of intervention period, and 3 month follow-up
Change in Healthy Minds Index (HMI) Score	HMI is a 17-item survey scored on a 5 point likert scale from 0 (never, none, not at all) to 4 (always, every time, to the highest degree) that assesses awareness, connection, insight, and purpose. Higher scores indicate higher sense of awareness, connection, insight, and purpose. Mean score for each subscale will be reported.	Baseline and following week 4 of intervention period
Change in PROMIS Sleep Disturbance Score	The PROMIS Sleep Disturbance Score is a measure of sleep in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale with higher scores indicating increased sleep disturbance. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of sleep disturbances. A t score >= 45.1 is indicative of significant sleep disturbances (based on a corresponding cutoff of >= 5 on the Pittsburgh Sleep Quality Index).	Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
Change in NIH Toolbox Loneliness Score	NIH toolbox Loneliness is a 5-item survey scored on a 5 point likert scale. The average score is taken across items for a total possible range of scores from 1-5, where higher scores indicate increased loneliness.	Baseline, following week 4 of intervention period, and 3 month follow-up
Change in Roaming Entropy	Roaming entropy will be calculated according to the formula in Heller et al. (2020). Using continuous GPS location tracking, the measure takes into account distance traveled and distinct locations visited, with a single resulting value reflecting the diversity of movement through one's lived environment (Measured continuously throughout study participation)	Exploratory analyses will examine linear and nonlinear trajectories of change from baseline through 3-month follow-up

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Dan Grupe, PhD, University of Wisconsin, Madison

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2022
• Primary Completion (Actual): January 9, 2024
• Study Completion (Actual): January 9, 2024

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: mobile health; healthy minds program
• Other Study ID Numbers: 2021-1109; A483000 (Other Identifier: UW Madison); Protocol Version 10/12/2022 (Other Identifier: UW Madison); 5K01MH117222 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The investigators may share coded data with researchers to address future research questions not included in this application, with a complementary study being conducted at the Center for Healthy Minds which is utilizing many of the same survey and behavioral task measures, and/or with journals where open data sharing policies are encouraged or are a requirement for publication. Coded data may be shared as Supplemental Information uploaded to journal websites.

The investigators may share fully de-identified data from the study on data sharing platforms (e.g., OSF, NIMH Data Archive) for use by non-collaborators. Data shared on data sharing platforms will be uploaded via the internet. Confidentiality will be protected by stripping the data of all identifiers, including HIPAA identifiers.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No