RecruitingNot ApplicableNCT05064813

MBSR Mechanisms in GAD

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

Sponsor

NYU Langone Health

Enrollment

150 participants

Start Date

Nov 18, 2021

Study Type

INTERVENTIONAL

Conditions

Generalized Anxiety Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study examines how mindfulness-based stress reduction (MBSR) — an 8-week program of guided meditation and stress management — works to reduce anxiety in people with generalized anxiety disorder (GAD). Researchers will use brain imaging and other measurements to understand the biological changes that explain its benefits. **You may be eligible if...** - You are aged 18–50 and have a primary diagnosis of Generalized Anxiety Disorder (GAD) - You are not currently on psychiatric medications, or have been on a stable dose - Your anxiety is at least mild in severity **You may NOT be eligible if...** - You have a history of bipolar disorder, schizophrenia, or psychosis - You have an eating disorder or OCD in the past 12 months - You have substance or alcohol use disorder in the past 6 months - You have significant suicidal thoughts or cognitive difficulties Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMindfulness 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.

BEHAVIORALStress 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

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NCT05064813

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