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Clinical Trials/NCT05215314
NCT05215314
Completed
Not Applicable

Neurobiological Mechanisms of Perceived Stress and Their Modification Through Behavioral Intervention

University of Wisconsin, Madison1 site in 1 country150 target enrollmentApril 13, 2022
ConditionsStressBehavior

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
University of Wisconsin, Madison
Enrollment
150
Locations
1
Primary Endpoint
Change in Perceived Stress Scale (PSS) Score
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
April 13, 2022
End Date
January 9, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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)

Study Sites (1)

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