NCT05064813

MBSR Mechanisms in GAD

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Mindfulness-Based Stress Reduction (MBSR) has demonstrated efficacy for Generalized Anxiety Disorder (GAD), yet there remains a major knowledge gap about its neural mechanisms. This study will examine functional activation of brain regions associated with the fear extinction network (ventromedial prefrontal cortex (vmPFC), hippocampus, and amygdala) as a specific probe of the 'instinctual' type of emotion regulation as well as large-scale functional connectivity as a marker of neural plasticity changes. Sex differences in MBSR-induced neural changes and their relationship to sex differences in clinical GAD response will be examined. Finally, a novel statistical approach will be used to explore whether baseline neural measures can predict neural changes and clinical symptom reduction to identify likely MBSR responders. The unique combination of a focus on GAD, an anxiety condition with established emotion regulation difficulties implicating target neural circuits, previously demonstrated MBSR efficacy, and sex differences with rigorous fMRI behavioral probes with novel analytic approaches ought to provide major new insights about MBSR versus stress education mechanisms and sex considerations, moving towards precision medicine that could guide future treatment development research. Eligible participants with Generalized Anxiety Disorder will be 2:1 randomized to group intervention with MBSR or stress education classes. They will participate for 13-14 weeks plus one 3 month follow up assessment (23-24 weeks from screening). Full participation includes screening, baseline, endpoint and 3 month follow up assessments, two sets of experimental days 12 weeks apart which include fMRI scans, and 8 weeks of the assigned group intervention (either MBSR or stress education).

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-18
• Primary completion: 2026-03-31
• Completion: 2026-06-30
• First posted: 2021-10-01
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States