Brain and Meditation (BAM) Study

Not Applicable

Completed

Conditions: Behavior
Stress

Registration Number: NCT05215314

Lead Sponsor: University of Wisconsin, Madison

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 150

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Perceived Stress Scale (PSS) Score	Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Change in Behavioral Pattern Separation Task	Baseline, following week 4 of intervention period, and 3 month follow-up	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.
Change in PROMIS Depression Score	Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up	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).
Change in PROMIS Anxiety Score	Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up	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).