Back to resultsAcceptance-Based Treatment for Generalized Anxiety Disorder
Primary Purpose
Anxiety Disorders, Generalized Anxiety Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acceptance Based Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders
Eligibility Criteria
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
Sites / Locations
- Center for Anxiety and Related Disorders
Outcomes
Primary Outcome Measures
Clinician Severity Rating from ADIS for GAD
Penn State Worry Questionnaire
Depression Anxiety and Stress Scales, anxiety and stress subscales
Secondary Outcome Measures
Full Information
NCT ID
NCT00073632
First Posted
December 2, 2003
Last Updated
November 5, 2013
Sponsor
University of Massachusetts, Boston
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00073632
Brief Title
Acceptance-Based Treatment for Generalized Anxiety Disorder
Official Title
Developing a New Therapy for GAD: Acceptance-Based CBT
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Massachusetts, Boston
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will develop and implement an awareness- and acceptance-based for treatment of individuals with generalized anxiety disorder.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Acceptance Based Behavioral Therapy
Primary Outcome Measure Information:
Title
Clinician Severity Rating from ADIS for GAD
Time Frame
pre, post, 3 mo. f/u, 9 mo. f/u
Title
Penn State Worry Questionnaire
Time Frame
pre-, post-, 3 mo. f/u, 9 mo. f/u
Title
Depression Anxiety and Stress Scales, anxiety and stress subscales
Time Frame
pre-, post-, 3 mo. f/u, 9 mo. f/u
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizabeth Roemer, PhD
Organizational Affiliation
University of Massachusetts, Boston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan M Orsillo, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Anxiety and Related Disorders
City
Boston
State/Province
Massachusetts
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17292696
Citation
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. doi: 10.1016/j.beth.2006.04.004. Epub 2006 Oct 24.
Results Reference
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Acceptance-Based Treatment for Generalized Anxiety Disorder
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