Trial record 2 of 4 for:    Yoga | Open Studies | Exclude Unknown | NCCAM

Yoga for Generalized Anxiety Disorder

This study is not yet open for participant recruitment.
Verified October 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01912287
First received: July 29, 2013
Last updated: October 23, 2013
Last verified: October 2013
  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
Primary Purpose: Treatment
Official Title: 2/2 Yoga for Generalized Anxiety Disorder

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 Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga Behavioral: Yoga
Other Name: Kundalini Yoga
Active Comparator: Cognitive Behavioral Therapy (CBT) Behavioral: Cognitive Behavioral Therapy
Other Name: CBT
Sham Comparator: Stress Education Behavioral: Stress Education
Other Name: SE

  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01912287

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Allison Campbell    617-726-3508    acampbell7@partners.org   
Principal Investigator: Naomi M Simon, MD, MSc         
Boston University Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Shelley Kind    617-353-9610    slkind@bu.edu   
Principal Investigator: Stefan G Hofmann, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Naomi M Simon, MD, MSc Massachusetts General Hospital
Principal Investigator: Stefan G Hofmann, PhD Boston University
  More Information

No publications provided

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: October 23, 2013
Health Authority: United States: Institutional Review Board

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 April 14, 2014