Brain and Meditation (BAM) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neurobiological Mechanisms of Perceived Stress and Their Modification Through Behavioral Intervention

Conditions
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Stress, Behavior

Intervention / Treatment
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* Behavioral: mHealth Meditation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Minds Program (HMP)<br>Fully remote, 4-week meditation intervention | Behavioral: mHealth Meditation<br>* 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.<br>* Other names: mobile health app;|
| No Intervention: Waitlist Control<br>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?
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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 pattern separation index is calculated as the proportion of lures correctly differentiated as similar. | 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. | 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. | Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy minds program, mobile health