Acceptance-Based Treatment for Generalized Anxiety Disorder

November 5, 2013 updated by: University of Massachusetts, Boston

Developing a New Therapy for GAD: Acceptance-Based CBT

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States
        • Center for Anxiety and Related Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Boston

Collaborators

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

December 2, 2003

First Submitted That Met QC Criteria

December 2, 2003

First Posted (Estimate)

December 3, 2003

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21MH063208 (U.S. NIH Grant/Contract)
  • DSIR AT-AS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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