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NCT00073632 Clinical Trial

Acceptance-Based Treatment for Generalized Anxiety Disorder

Anxiety Disorders Clinical Trial

Official title:
Developing a New Therapy for GAD: Acceptance-Based CBT

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00073632
Other study ID # R21MH063208
Secondary ID R21MH063208DSIR
Status Completed
Phase Phase 1
First received December 2, 2003
Last updated November 5, 2013
Start date May 2002
Est. completion date August 2006

Study information
Verified date September 2008
Source University of Massachusetts, Boston
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Acceptance Based Behavioral Therapy

Locations
Country Name City State
United States Center for Anxiety and Related Disorders Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
University of Massachusetts, Boston National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Clinician Severity Rating from ADIS for GAD pre, post, 3 mo. f/u, 9 mo. f/u No
Primary Penn State Worry Questionnaire pre-, post-, 3 mo. f/u, 9 mo. f/u No
Primary Depression Anxiety and Stress Scales, anxiety and stress subscales pre-, post-, 3 mo. f/u, 9 mo. f/u No
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