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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing a New Therapy for GAD: Acceptance-Based CBT

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Boston:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Lizabeth Roemer, Ph. D., University of Massachusetts Boston
ClinicalTrials.gov Identifier: NCT00073632     History of Changes
Other Study ID Numbers: R21 MH63208, R21MH063208, DSIR AT-AS
Study First Received: December 2, 2003
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014