GATE: Generalized Anxiety - A Treatment Evaluation
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|ClinicalTrials.gov Identifier: NCT01912287|
Recruitment Status : Completed
First Posted : July 31, 2013
Results First Posted : June 22, 2020
Last Update Posted : June 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder||Behavioral: Cognitive Behavioral Therapy Behavioral: Stress Education Behavioral: Yoga||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||GATE: Generalized Anxiety - A Treatment Evaluation|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||April 29, 2019|
|Actual Study Completion Date :||October 25, 2019|
The yoga intervention will apply Kundalini Yoga practices as taught by Yogi Bhajan. This is a well-known, accessible style of practice in the U.S. that incorporates all of the traditional components of yoga including physical postures and exercises, breathing techniques, relaxation exercises and meditation practices. It is a safe style of yoga that is registered with the Yoga Alliance that is readily and routinely adapted for therapeutic purposes. The 12-week yoga intervention will consist of 12 group classes and assigned daily home practice led by qualified and certified yoga instructors. Each group yoga session will include physical postures/exercises, breathing techniques, meditation and deep relaxation practice that are all easy to learn and do not require extensive practice or athletic ability to perform.
12 sessions, mindfulness components
Other Name: Kundalini Yoga
Active Comparator: Cognitive Behavioral Therapy (CBT)
The 12 session CBT treatment will be based on the standardized protocol developed at one of our centers (CARD) and widely available . This protocol is comprised of four primary treatment modules including cognitive restructuring, progressive muscle relaxation, worry exposures, and in vivo exposure exercises. The initial sessions describe the cognitive behavioral model of worry and GAD. Each session consists of a different "lesson." These lessons initially cover basic information about the nature of the anxiety and worry, the possible function and negative consequences of worrying, the maladaptive and paradoxical effects of attempting to control and suppress one's thoughts, the basic cognitive errors of probability overestimation and catastrophic thinking, adaptive strategies to deal with worries, such as problem solving, worry exposure, which may involve exploring and exposing the patient to negative images and scenarios that might be behind some of the worrisome thoughts.
Behavioral: Cognitive Behavioral Therapy
CBT focused on Generalized Anxiety Disorder (12 sessions)
Other Name: CBT
Sham Comparator: Stress Education
SE will also include 12 weeks of group and home practice sessions. SE will control for attention from instructors, expectancy effects, and group support effects, Stress Education (SE) will be employed as an active control intervention. SE is currently used in NIH-funded protocols at the Benson-Henry Institute for Mind-Body Medicine at MGH. In this condition, participants will be provided with detailed and extensive information about stress and health, but will not receive any CBT, yoga, or other mind-body training techniques.
Behavioral: Stress Education
Active control group (12 sessions)
Other Name: SE
- Proportion of Participants With Treatment Response [ Time Frame: 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).
- Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) [ Time Frame: Weeks 0, 6 , 12 and 6 month follow up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912287
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Naomi M Simon, MD, MSc||NYU Langone Health|
|Principal Investigator:||Stefan G Hofmann, PhD||Boston University|
|Principal Investigator:||Eric Bui, MD, PhD||Massachusetts General Hospital|