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RECRUITING
NCT05064813
NA

MBSR Mechanisms in GAD

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

Summary

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.

Official title: Elucidating Neural Mechanisms and Sex Differences in Response to Mindfulness Based Stress Reduction in Generalized Anxiety Disorder

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-11-18

Completion Date

2026-06-30

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

BEHAVIORAL

Mindfulness Based Stress Reduction MBSR Intervention

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.

BEHAVIORAL

Stress Education Control Condition (SE)

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.

Locations (1)

NYU Langone Health

New York, New York, United States