Acceptance-Based Treatment for Generalized Anxiety Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00073632

Purpose

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

Condition	Intervention	Phase
Anxiety Disorders Generalized Anxiety Disorder	Behavioral: Acceptance Based Behavioral Therapy	Phase I

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Developing a New Therapy for GAD: Acceptance-Based CBT

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 ]

Enrollment:	50
Study Start Date:	May 2002
Study Completion Date:	August 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073632

Locations

United States, Massachusetts
Center for Anxiety and Related Disorders
Boston, Massachusetts, United States

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Lizabeth Roemer, PhD	University of Massachusetts Boston
Principal Investigator:	Susan M Orsillo, PhD	Boston University

More Information

Publications:

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.

Responsible Party:	University of Massachusetts Boston ( Lizabeth Roemer, Ph. D. )
Study ID Numbers:	R21 MH63208, DSIR AT-AS
Study First Received:	December 2, 2003
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00073632
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 15, 2009