Elucidating Neural Mechanisms and Sex Differences in Response to Mindfulness Based Stress Reduction in Generalized Anxiety Disorder
NYU Langone Health
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.
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 i…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or pre-menopausal female outpatients aged 18 to 50 years of age * A primary mental health complaint (designated by the patient as the most important source of current distress and confirmed on structured clinical interview for DSM-5 diagnoses by a certified clinical evaluator) of Generalized Anxiety Disorder (GAD), as defined by DSM-5 criteria. * Overall clinical anxiety severity of at least mild as defined by a CGI-S of at least 3. * Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol. Exclu…
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.
Location
- NYU Langone HealthNew York, New York