Actively Recruiting
MBSR Mechanisms in GAD
Led by NYU Langone Health · Updated on 2026-02-06
150
Participants Needed
1
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MBSR Mechanisms in GAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or pre-menopausal female outpatients aged 18 to 50 years
- Primary diagnosis of Generalized Anxiety Disorder confirmed by structured clinical interview
- Clinical anxiety severity of at least mild (CGI-S score of 3 or higher)
- Willingness and ability to consent and follow study procedures
You will not qualify if you...
- History of bipolar disorder, schizophrenia, psychosis, delusional disorders, or recent obsessive-compulsive or eating disorders
- Neurocognitive or communication disorders interfering with therapy or study participation
- Substance or alcohol use disorder (except nicotine) within last 6 months
- Significant suicidal ideation or recent suicidal behavior
- Use of benzodiazepine, antipsychotic, or stimulant medications within 4 weeks before treatment
- Inability to understand study procedures or comply with requirements
- Serious unstable medical illness or conditions likely to require hospitalization within a year
- Pregnant women or women not using medically accepted contraception
- Psychotherapy started within 3 months or ongoing psychotherapy targeting GAD or mindfulness
- Past MBSR or regular meditation practice within past 2 years
- History of head trauma causing loss of consciousness or ongoing cognitive impairment
- Contraindications for MRI such as metal implants or braces
- Left-handed individuals
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 11016
Actively Recruiting
Research Team
L
Leo Almada-Makebish
CONTACT
M
Matthew Irwin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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