MBSR Mechanisms in GAD

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05064813
Status
Recruiting
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Conditions

  • Generalized Anxiety Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness Based Stress Reduction MBSR Intervention — BEHAVIORAL
    MBSR is an 8-week group-based course developed by Jon Kabat-Zinn (1990) and colleagues at the University of Massachusetts' Center for Mindfulness. Weekly 2.5 hour long classes are given once a week, as well as one day-long weekend class. The classes instruct participants in the theory and practice of several forms of mindfulness meditation, breathing awareness, and mindfulness stretching exercises. Teaching of the theory of mindfulness and experiential practice are both utilized during weekly classes and at-home CD-guided practice sessions.
  • Stress Education Control Condition (SE) — BEHAVIORAL
    Stress Education (SE) was designed to provide an active comparator condition that does not include overlapping active components of mindfulness meditation with MBSR. It will also be delivered over 8-weekly, in-person, 2.5 hour group sessions of the same size (n=4 to 6). In SE, participants receive extensive information about stress and health, but will not receive any MBSR or other mind-body training. Instead, stress relevant psycho-educational information will be taught.

Study Details

The purpose of this study is to understand the neural mechanisms that drive response to MBSR compared to stress education in patients with generalized anxiety disorder (GAD), and to examine the degree to which sex differences in MBSR response are explained by sex differences in these mechanisms. A total of 150 eligible participants with a primary diagnosis of GAD will be randomized to either an 8-week group MBSR or stress education program. The study will include preliminary screening, experimental visits, including fMRI, group intervention visits, and assessments at baseline, endpoint, and 3-month follow-up.

Key Dates

Start date
Nov 18, 2021
Status verified
Feb 2026
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Mindfulness Based Stress Reduction Group
    8 weeks of Mindfulness Based Stress Reduction Group (MBSR).
  • Active Comparator: Stress Education Group
    8 weeks of Stress Education Group (SE).

Primary Outcome Measure

Pre-post changes in fMRI measures of functional activation in the fear extinction network during fear extinction learning [ Time Frame: Experimental Days 1 & 2 (Visit 2 & 3) and Experimental Days 3 & 4 (Visit 9 & 10) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York11016
Leo Almada-Makebish
[email protected]
888-449-6779
Matthew Irwin
[email protected]
212-404-3478
Naomi Simon, MD (PRINCIPAL_INVESTIGATOR)

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NYU Langone Health· New York, NY

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