Acceptance-Based Treatment for Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Massachusetts, Boston
ClinicalTrials.gov Identifier:
NCT00073632
First received: December 2, 2003
Last updated: November 5, 2013
Last verified: September 2008

December 2, 2003
November 5, 2013
May 2002
July 2006   (final data collection date for primary outcome measure)
  • Clinician Severity Rating from ADIS for GAD [ Time Frame: pre, post, 3 mo. f/u, 9 mo. f/u ] [ Designated as safety issue: No ]
  • Penn State Worry Questionnaire [ Time Frame: pre-, post-, 3 mo. f/u, 9 mo. f/u ] [ Designated as safety issue: No ]
  • Depression Anxiety and Stress Scales, anxiety and stress subscales [ Time Frame: pre-, post-, 3 mo. f/u, 9 mo. f/u ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00073632 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Acceptance-Based Treatment for Generalized Anxiety Disorder
Developing a New Therapy for GAD: Acceptance-Based CBT

This study will develop and implement an awareness- and acceptance-based for treatment of individuals with generalized anxiety disorder.

Participants in this study are recruited from intakes at the Center for Anxiety and Related Disorders at Boston University. Participants will be randomly assigned to receive either acceptance and mindfulness-based strategies plus cognitive behavioral therapy or no treatment for 16 weeks. The treatment will involve daily practice of mindfulness techniques to help draw attention to and accept various emotional states. Interviews, questionnaires, and depression and anxiety scales will be used to assess participants. Assessments will be conducted post-treatment and at 3- and 9-month follow-up visits.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Anxiety Disorders
  • Generalized Anxiety Disorder
Behavioral: Acceptance Based Behavioral Therapy
Not Provided
Roemer L, Orsillo SM. An open trial of an acceptance-based behavior therapy for generalized anxiety disorder. Behav Ther. 2007 Mar;38(1):72-85. Epub 2006 Oct 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2006
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Generalized Anxiety Disorder (GAD)
  • Willing to maintain medication levels and refrain from any additional psychosocial treatment during the course of the study

Exclusion Criteria:

  • Bipolar disorder, psychotic disorder, or substance dependence
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00073632
R21 MH63208, R21MH063208, DSIR AT-AS
No
Lizabeth Roemer, Ph. D., University of Massachusetts Boston
University of Massachusetts, Boston
National Institute of Mental Health (NIMH)
Principal Investigator: Lizabeth Roemer, PhD University of Massachusetts, Boston
Principal Investigator: Susan M Orsillo, PhD Boston University
University of Massachusetts, Boston
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP