Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05064813
Study type Interventional
Source NYU Langone Health
Contact Emma Jennings
Phone 1-888-449-6779
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 2021
Completion date June 2026

See also
  Status Clinical Trial Phase
Terminated NCT03420456 - Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study N/A
Not yet recruiting NCT04931134 - Treatment of Anxiety Disorders With Trigeminal Nerve Stimulation N/A
Withdrawn NCT02382224 - Worry Exposure for Generalized Anxiety Disorder N/A
Completed NCT02256566 - Cognitive Training for Mood and Anxiety Disorders N/A
Completed NCT02306356 - Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting N/A
Completed NCT01958788 - Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder N/A
Completed NCT01681329 - Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder N/A
Completed NCT01342120 - PHARMO Institute Seroquel Safety Study N/A
Completed NCT01337713 - Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD) N/A
Completed NCT01201967 - A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients Phase 4
Completed NCT00961298 - An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder Phase 4
Completed NCT01971203 - Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat N/A
Completed NCT01203293 - Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector Phase 1
Terminated NCT01244711 - Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines Phase 4
Completed NCT00744627 - Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults. Phase 3
Completed NCT00711737 - Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months N/A
Completed NCT00537615 - An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers Phase 1
Completed NCT00515242 - Therapeutic Massage for Generalized Anxiety Disorder Phase 1/Phase 2
Completed NCT00525226 - Evaluating the Effects of Stress in Pregnancy N/A
Completed NCT00620776 - Combined Treatment for Generalized Anxiety Disorder (GAD) Phase 2