GATE: Generalized Anxiety - A Treatment Evaluation

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Male or female outpatients > 18 years of age with a primary psychiatric diagnosis of generalized anxiety disorder
Clinical Global Impression-Severity scale (CGI-S) score of 4 or higher
Off concurrent psychotropic medication for at least 2 weeks prior to initiation of randomized treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
Willingness and ability to perform the yoga intervention and to comply with the requirements of the study protocol.
For women of childbearing potential, willingness to use a reliable form of birth control

Exclusion Criteria

Patients unable to understand study procedures and participate in the informed consent process.
Pregnancy as assessed by pregnancy test at screen or lack of use approved methods birth control for women of childbearing age
Women who are planning to become pregnant
Serious medical illness or instability for which hospitalization may be likely within the next year
Significant current suicidal ideation or suicidal behaviors within the past 6 months (assessed with the Beck Depression Inventory-II [BDI-II])
History of head trauma causing loss of consciousness, or seizure disorder resulting in ongoing cognitive impairment
Posttraumatic stress disorder, substance use disorder, eating disorder, or organic mental disorder within the past 6 months
Lifetime history of psychotic disorder, bipolar disorder, or developmental disorder
Significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview)
Prior experience with (more than 5 Yoga classes or CBT sessions within the last 3 years) and/or current practice of mindbody techniques (e.g., yoga, meditation, Tai-Chi, etc) or cognitive behavioral therapy (CBT)
Concomitant therapy for generalized anxiety disorder (GAD) (any therapy)
Physical conditions that might cause injury from yoga (pregnancy, physical injuries and musculoskeletal problems)
Cognitive impairment (MOCA<21)

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Treatment Response	Biweekly from weeks 0 through 12	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).

Secondary Outcome Measures

Name	Time	Method
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)	Weeks 0, 6 , 12 and 6 month follow up

Locations (2): Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Boston University
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States