GATE: Generalized Anxiety - A Treatment Evaluation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Massachusetts General Hospital
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01912287
First received: July 29, 2013
Last updated: June 17, 2016
Last verified: June 2016
  Purpose
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 Intervention
Generalized Anxiety Disorder
Behavioral: Cognitive Behavioral Therapy
Behavioral: Stress Education
Behavioral: Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GATE: Generalized Anxiety - A Treatment Evaluation

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Treatment Response as Assessed by the Clinical Global Impression-Improvement (CGI-I of 1 or 2) scale [ Time Frame: Biweekly from weeks 0 through 12, and 6-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) [ Time Frame: Weeks 0, 6 , 12 and 6 month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: December 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912287

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Madelyn Frumkin    617-726-3508    mfrumkin@mgh.harvard.edu   
Principal Investigator: Naomi M Simon, MD, MSc         
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Leigh Andrews    617-353-9610    leighaa@bu.edu   
Principal Investigator: Stefan G Hofmann, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Naomi M Simon, MD, MSc Massachusetts General Hospital
Principal Investigator: Stefan G Hofmann, PhD Boston University
  More Information

Responsible Party: Naomi M. Simon, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01912287     History of Changes
Other Study ID Numbers: 2013P000048  1R01AT007258-01A1 
Study First Received: July 29, 2013
Last Updated: June 17, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Massachusetts General Hospital:
Generalized Anxiety Disorder
GAD
Yoga
CBT

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 23, 2016