GATE: Generalized Anxiety - A Treatment Evaluation

Status Not yet recruiting

Clinical Trial Summary

The general purpose of the study is to determine whether yoga is an effective method for treating Generalized Anxiety (GAD), and its relative efficacy compared to a standard psychosocial intervention. This five-year multi-site study will examine the comparative efficacy of yoga, CBT, and stress education, a previously employed control condition, for patients with GAD. Across 2 enrolling centers (BU and MGH) 230 patients will be randomized with GAD to one of three 12 session weekly study treatments: 12-weekly yoga (n=95), CBT (n=95), or stress education (SE: n=40). Independent clinical assessments will occur before the 12-session intervention phase, at mid-treatment, after the intervention, and at 6-month follow-up. All clinician-rated outcomes will be assessed by trained Independent Evaluators (IEs) blind to treatment assignment.

Clinical Trial Description

Investigators hypothesize that Yoga and Cognitive Beahvioral Therapy (CBT) will each be superior to Stress Education (SE) at post-treatment follow up, and Yoga and CBT will not differ based on equivalency analyses. Treatment changes during yoga are mediated via changes in mindfulness and changes in vagal tone, whereas changes in CBT are mediated via changes in maladaptive cognitions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03445143
Study type	Interventional
Source	New York University School of Medicine
Contact	Rebecca Lubin
Phone	646 754 7035
Email	rebecca.lubin@nyumc.org
Status	Not yet recruiting
Phase	N/A
Start date	June 2018
Completion date	June 2021

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