RCT of an Acceptance-based Behavior Therapy for GAD - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00961493

Purpose

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.

Condition	Intervention
Generalized Anxiety Disorder	Behavioral: Acceptance based behavioral therapy Behavioral: Applied relaxation

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial of an Acceptance-based Behavior Therapy for Generalized Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Hamilton Anxiety Rating Scale [ Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up ] [ Designated as safety issue: No ]
Penn State Worry Questionnaire [ Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Beck Depression Inventory - II [ Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up ] [ Designated as safety issue: No ]
Quality of Life Inventory [ Time Frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	126
Study Start Date:	March 2007
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Active Comparator	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.

Arms

Assigned Interventions

1: Experimental

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.

2: Active Comparator

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961493

Contacts

Contact: Lizabeth Roemer, Ph.D.	617-287-6358	lizabeth.roemer@umb.edu
Contact: Susan M Orsillo, Ph.D.	617-353-9610	sorsillo@suffolk.edu

Locations

United States, Massachusetts
Center for Anxiety and Related Disorders at Boston University	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Susan M Orsillo, Ph.D. 617-353-9610 sorsillo@suffolk.edu
Principal Investigator: Susan M Orsillo, Ph.D.

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Lizabeth Roemer, Ph.D.

University of Massachusetts Boston

More Information

No publications provided

Responsible Party:	University of Massachusetts Boston ( Lizabeth Roemer )
Study ID Numbers:	R01 MH074589, NIH MH074589, DSIR 83-ATAS2
Study First Received:	August 18, 2009
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00961493 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2009