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Acceptance-Based Treatment for Generalized Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00073632
Recruitment Status : Completed
First Posted : December 3, 2003
Last Update Posted : November 6, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
University of Massachusetts, Boston

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 Type : Interventional  (Clinical Trial)
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 2002
Primary Completion Date : July 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources




Primary Outcome Measures :
  1. Clinician Severity Rating from ADIS for GAD [ Time Frame: pre, post, 3 mo. f/u, 9 mo. f/u ]
  2. Penn State Worry Questionnaire [ Time Frame: pre-, post-, 3 mo. f/u, 9 mo. f/u ]
  3. Depression Anxiety and Stress Scales, anxiety and stress subscales [ Time Frame: pre-, post-, 3 mo. f/u, 9 mo. f/u ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073632


Locations
United States, Massachusetts
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

Publications:
Responsible Party: Lizabeth Roemer, Ph. D., University of Massachusetts Boston
ClinicalTrials.gov Identifier: NCT00073632     History of Changes
Other Study ID Numbers: R21MH063208 ( U.S. NIH Grant/Contract )
DSIR AT-AS
First Posted: December 3, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: September 2008

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders