GATE: Generalized Anxiety - A Treatment Evaluation
2 other identifiers
interventional
226
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2013
CompletedFirst Posted
Study publicly available on registry
July 31, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2019
CompletedResults Posted
Study results publicly available
June 22, 2020
CompletedJune 22, 2020
June 1, 2020
5.4 years
July 29, 2013
April 30, 2020
June 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Biweekly from weeks 0 through 12
Secondary Outcomes (1)
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)
Weeks 0, 6 , 12 and 6 month follow up
Study Arms (3)
Yoga
EXPERIMENTALThe 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.
Cognitive Behavioral Therapy (CBT)
ACTIVE COMPARATORThe 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.
Stress Education
SHAM COMPARATORSE 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.
Interventions
CBT focused on Generalized Anxiety Disorder (12 sessions)
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston University
Boston, Massachusetts, 02215, United States
Related Publications (4)
Keltz S, Quintana L, Szuhany KL, Adhikari S, Twi-Yeboah A, Baker AW, Khalsa SBS, Hoge E, Bui E, Hoeppner SS, Rosenfield D, Hofmann SG, Simon NM. Impact of homework engagement on treatment response to group cognitive-behavioral therapy, yoga, and stress education for generalized anxiety disorder. Cogn Behav Ther. 2025 Nov 18:1-12. doi: 10.1080/16506073.2025.2589392. Online ahead of print.
PMID: 41252645DERIVEDHoge EA, Simon NM, Szuhany K, Feldman B, Rosenfield D, Hoeppner S, Jennings E, Khalsa SB, Hofmann SG. Comparing Kundalini Yoga, cognitive behavioral therapy, and stress education for generalized anxiety disorder: Anxiety and depression symptom outcomes. Psychiatry Res. 2023 Sep;327:115362. doi: 10.1016/j.psychres.2023.115362. Epub 2023 Aug 6.
PMID: 37598625DERIVEDSzuhany KL, Adhikari S, Chen A, Lubin RE, Jennings E, Rassaby M, Eakley R, Brown ML, Suzuki R, Barthel AL, Rosenfield D, Hoeppner SS, Khalsa SB, Bui E, Hofmann SG, Simon NM. Impact of preference for yoga or cognitive behavioral therapy in patients with generalized anxiety disorder on treatment outcomes and engagement. J Psychiatr Res. 2022 Sep;153:109-115. doi: 10.1016/j.jpsychires.2022.07.008. Epub 2022 Jul 5.
PMID: 35810600DERIVEDSimon 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. 2021 Jan 1;78(1):13-20. doi: 10.1001/jamapsychiatry.2020.2496.
PMID: 32805013DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Naomi Simon
- Organization
- NYU Langone Health
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2013
First Posted
July 31, 2013
Study Start
December 1, 2013
Primary Completion
April 29, 2019
Study Completion
October 25, 2019
Last Updated
June 22, 2020
Results First Posted
June 22, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share