GATE: Generalized Anxiety - A Treatment Evaluation

Completed · Not applicable

Conditions studied: Generalized Anxiety Disorder

In brief

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.

Key facts

Study ID

NCT01912287

Run by

NYU Langone Health

People needed

226

Starts

2013-12-01

Expected to finish

2019-10-25

Last updated by the study team

2020-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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