Neurobiological Mechanisms of Perceived Stress and Their Modification Through Behavioral Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in Perceived Stress Scale (PSS) Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Waitlist Control
Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Healthy Minds Program (HMP)
Fully remote, 4-week meditation intervention
Intervention: mHealth Meditation (Behavioral)
Outcomes
Primary Outcomes
Change in Perceived Stress Scale (PSS) Score
Time Frame: 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 Outcomes
- 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)