Acceptance-Based Treatment for Generalized Anxiety Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

December 2, 2003

Last Updated Date

September 19, 2008

Start Date ^ICMJE

May 2002

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00073632 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Acceptance-Based Treatment for Generalized Anxiety Disorder

Official Title ^ICMJE

Developing a New Therapy for GAD: Acceptance-Based CBT

Brief Summary

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

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Anxiety Disorders
Generalized Anxiety Disorder

Intervention ^ICMJE

Behavioral: Acceptance Based Behavioral Therapy

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00073632

Responsible Party

Lizabeth Roemer, Ph. D., University of Massachusetts Boston

Study ID Numbers ^ICMJE

R21 MH63208, DSIR AT-AS

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2008

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