Acceptance-Based Treatment for Generalized Anxiety Disorder

• Sponsor: University of Massachusetts, Boston (Other)
• Overall Status: Completed
• CT.gov ID: NCT00073632
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 50
• Location: 1
• Duration (Months): 51
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders; Generalized Anxiety Disorder	Behavioral: Acceptance Based Behavioral Therapy	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Developing a New Therapy for GAD: Acceptance-Based CBT
• Study Start Date: May 1, 2002
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Outcome Measures

Primary Outcome Measures

1. Clinician Severity Rating from ADIS for GAD [pre, post, 3 mo. f/u, 9 mo. f/u]

2. Penn State Worry Questionnaire [pre-, post-, 3 mo. f/u, 9 mo. f/u]

3. Depression Anxiety and Stress Scales, anxiety and stress subscales [pre-, post-, 3 mo. f/u, 9 mo. f/u]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Center for Anxiety and Related Disorders	Boston	Massachusetts	United States

Sponsors and Collaborators

• University of Massachusetts, Boston
• National Institute of Mental Health (NIMH)

Investigators

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

Study Documents (Full-Text)

None provided.

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.

• ClinicalTrials.gov Identifier: NCT00073632
• Other Study ID Numbers: R21MH063208; R21MH063208; DSIR AT-AS
• First Posted: Dec 3, 2003
• Last Update Posted: Nov 6, 2013
• Last Verified: Sep 1, 2008

• Additional relevant MeSH terms: Disease; Anxiety Disorders

Study Results

No Results Posted as of Nov 6, 2013