GATE: Generalized Anxiety - A Treatment Evaluation

• ClinicalTrials.gov Identifier: NCT01912287
• Recruitment Status: Completed
• First Posted: July 31, 2013
• Results First Posted: June 22, 2020
• Last Update Posted: June 22, 2020
• Sponsor: NYU Langone Health
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Generalized Anxiety Disorder	Behavioral: Cognitive Behavioral Therapy; Behavioral: Stress Education; Behavioral: Yoga	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 226 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Yoga; 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.	Behavioral: Yoga; 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 [88]. 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

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) [ Time Frame: Weeks 0, 6 , 12 and 6 month follow up ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Boston University

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

NYU Langone Health

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• 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

  Study Documents (Full-Text)

Documents provided by NYU Langone Health:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] July 20, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Simon NM, Hofmann SG, Rosenfield D, Hoeppner SS, Hoge EA, Bui E, Khalsa SBS. Efficacy of Yoga vs Cognitive Behavioral Therapy vs Stress Education for the Treatment of Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Aug 12. doi: 10.1001/jamapsychiatry.2020.2496. [Epub ahead of print]

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01912287
• Obsolete Identifiers: NCT03445143
• Other Study ID Numbers: s17-00526; 1R01AT007258-01A1 ( U.S. NIH Grant/Contract )
• First Posted: July 31, 2013
• Results First Posted: June 22, 2020
• Last Update Posted: June 22, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NYU Langone Health:

Generalized Anxiety Disorder; GAD; Yoga; CBT

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders