Clinical trial NCT05215314: Brain and Meditation (BAM) Study
Official title: Neurobiological Mechanisms of Perceived Stress and Their Modification Through Behavioral Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Behavior
Keywords: healthy minds program
mobile health
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-01-31
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Perceived Stress Scale (PSS) Score
timeFrame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
Secondary outcomes:
measure: Change in Behavioral Pattern Separation Task
timeFrame: Baseline, following week 4 of intervention period, and 3 month follow-up
measure: Change in PROMIS Depression Score
timeFrame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
measure: Change in PROMIS Anxiety Score
timeFrame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
Other outcomes:
measure: Change in Posttraumatic Stress Disorder Checklist (PCL-5) Score
timeFrame: Baseline, following week 4 of intervention period, and 3 month follow-up
measure: Change in PROMIS Sleep Disturbance Score
timeFrame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
measure: Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score
timeFrame: Baseline, following week 4 of intervention period, and 3 month follow-up
measure: Change in NIH Toolbox Loneliness Score
timeFrame: Baseline, following week 4 of intervention period, and 3 month follow-up
measure: Change in Healthy Minds Index (HMI) Score
timeFrame: Baseline and following week 4 of intervention period
measure: Change in Roaming Entropy
timeFrame: Exploratory analyses will examine linear and nonlinear trajectories of change from baseline through 3-month follow-up
Locations:
city: Madison
country: United States
facility: Center for Healthy Minds
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Dan Grupe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.