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Sponsors and Collaborators: |
National Institute of Mental Health (NIMH) National Institutes of Health (NIH) The University of Texas Health Science Center, Houston Kelsey Research Foundation Kelsey-Seybold Clinic VA Medical Center, Houston |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00308724 |
The purpose of this study is to determine whether cognitive behavior therapy (CBT) is effective in the treatment of generalized anxiety disorder (GAD) in adults age 60 and older in a primary care setting.
Condition | Intervention | Phase |
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Generalized Anxiety Disorder |
Behavioral: Cognitive Behavior Therapy Behavioral: Telephone check-in |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care |
Enrollment: | 148 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | July 2009 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Cognitive Behavior Therapy
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Behavioral: Cognitive Behavior Therapy
8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period
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2: Active Comparator
Usual Care
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Behavioral: Telephone check-in
Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition
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Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders among older adults. Anxiety in older adults is associated with decreased physical activity, poorer self-perceptions of health, decreased life satisfaction, and increased loneliness. Because many older adults with anxiety seek assistance in a medical setting, treatment has been primarily pharmacological. There is, however, limited evidence of the effectiveness of psychotropic medications. Given the potential difficulties in prescribing psychotropic medications in later life (e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternative or adjuncts.
The treatment phase of this study lasts 10 weeks, during which patients will be randomly assigned to either cognitive behavior therapy (CBT) or usual care. Follow-up will last 12 months after treatment completion, during which time patients will complete telephone assessments.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Houston Center for Quality of Care and Utilization Studies | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Melinda A. Stanley, Ph.D. | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Melinda A. Stanley, Ph.D. ) |
Study ID Numbers: | H15958, R01-MH053932 |
Study First Received: | March 28, 2006 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00308724 |
Health Authority: | United States: Institutional Review Board |
Generalized Anxiety Disorder Geriatric |
Anxiety Disorders Mental Disorders |
Pathologic Processes Disease |