RCT of an Acceptance-based Behavior Therapy for GAD

June 17, 2013 updated by: Lizabeth Roemer, University of Massachusetts, Boston

Randomized Controlled Trial of an Acceptance-based Behavior Therapy for Generalized Anxiety Disorder

The purpose of this study is to determine whether acceptance-based behavior therapy for GAD results in greater symptom reduction and increased quality of life than applied relaxation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

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, 02215
        • Center for Anxiety and Related Disorders at Boston University

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:

  • principal diagnosis of GAD
  • at least moderate (4 on a scale from 0 to 8) on the ADIS Severity Scale for GAD symptoms
  • willing to maintain current psychotropic medication levels (and have been stabilized on any current medications for at least three months) and refrain from other psychosocial treatments for anxiety or mood problems during the course of therapy
  • fluent in English
  • 18 years or older

Exclusion Criteria:

  • bipolar disorder
  • psychotic disorders
  • substance dependence
  • active suicidal intent
  • if anxious symptomatology is due to a medical/physical condition

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Behavioral: Acceptance based behavioral therapy
16 individual psychotherapy sessions focused on psychoeducation about anxiety, anxious responding, the function of emotions, mindfulness, and problems with efforts to constrict one's emotional experience; training in mindfulness skills; practice applying mindfulness skills in daily life, including acceptance of, rather than efforts to control, internal experience; and identification of values in areas of life and practice engaging in chosen actions.
Active Comparator: 2
Behavioral: Applied relaxation
16 sessions of individual psychotherapy focused on psychoeducation about anxiety and anxious responding; training in multiple forms of relaxation; early cue detection; and practice applying relaxation in daily life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD
Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Hamilton Anxiety Rating Scale
Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Penn State Worry Questionnaire
Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Depression Inventory - II
Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Quality of Life Inventory
Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up

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, Ph.D., University of Massachusetts, Boston

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

March 1, 2007

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

August 18, 2009

First Submitted That Met QC Criteria

August 18, 2009

First Posted (Estimate)

August 19, 2009

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH074589 (U.S. NIH Grant/Contract)
  • NIH MH074589
  • DSIR 83-ATAS2

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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