Back to resultsRCT of an Acceptance-based Behavior Therapy for GAD
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance based behavioral therapy
Applied relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
Eligibility 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
Sites / Locations
- Center for Anxiety and Related Disorders at Boston University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD
Hamilton Anxiety Rating Scale
Penn State Worry Questionnaire
Secondary Outcome Measures
Beck Depression Inventory - II
Quality of Life Inventory
Full Information
NCT ID
NCT00961493
First Posted
August 18, 2009
Last Updated
June 17, 2013
Sponsor
University of Massachusetts, Boston
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00961493
Brief Title
RCT of an Acceptance-based Behavior Therapy for GAD
Official Title
Randomized Controlled Trial of an Acceptance-based Behavior Therapy for Generalized Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Boston
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Acceptance based behavioral therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Applied relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Hamilton Anxiety Rating Scale
Time Frame
pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Title
Penn State Worry Questionnaire
Time Frame
pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Secondary Outcome Measure Information:
Title
Beck Depression Inventory - II
Time Frame
pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Title
Quality of Life Inventory
Time Frame
pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizabeth Roemer, Ph.D.
Organizational Affiliation
University of Massachusetts, Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Anxiety and Related Disorders at Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
RCT of an Acceptance-based Behavior Therapy for GAD
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