The purpose of this randomized study is to examine the comparative efficacy of yoga, cognitive behavioral therapy, and stress education, a previously employed control condition, for patients with Generalized Anxiety Disorder.
We are currently conducting a treatment study to reduce stress and anxiety in people with generalized anxiety disorder (GAD). This study will not use a medication, but instead will involve weekly stress reduction classes that use different strategies to reduce anxiety. The study involves having a formal psychiatric interview, filling out questionnaires, ECGs, saliva samples, a urine test for drugs of abuse, and study visits over 12 weeks. Each study visit will take a few hours. Qualified participants will be compensated for time and travel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
226
CBT focused on Generalized Anxiety Disorder (12 sessions)
Active control group (12 sessions)
12 sessions, mindfulness components
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston University
Boston, Massachusetts, United States
Proportion of Participants With Treatment Response
Treatment response is a dichotomous outcome coded 0=no treatment response, 1= treatment response. This treatment response coding was derived from the Clinical Global Impression-Improvement (CGI-I) measure. The CGI-I is a clinician administered instrument that assesses level of symptom change across the course of treatment. The CGI-I ranges from 1 to 7, with lower scores indicating greater improvement. Our treatment response outcome variable was coded 0 if CGI-I was 3 or more. Treatment response was coded 1 if CGI-I was rated 1 (very much improved) or 2 (much improved).
Time frame: Biweekly from weeks 0 through 12
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)
Time frame: Weeks 0, 6 , 12 and 6 month follow up
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