Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care - Full Text View

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
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00308724

Purpose

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
Generalized Anxiety Disorder	Behavioral: Cognitive Behavior Therapy Behavioral: Telephone check-in	Phase III

MedlinePlus related topics: Anxiety

U.S. FDA Resources

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

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

Primary Outcome Measures:

Anxiety [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional and health status [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Satisfaction with CBT and general health care [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Service utilization [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Depression [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Sleep quality [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
Use of alcohol and other substances [ Time Frame: Baseline and 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]

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
1: Experimental Cognitive Behavior Therapy	Behavioral: Cognitive Behavior Therapy 8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period
2: Active Comparator Usual Care	Behavioral: Telephone check-in Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of Generalized Anxiety Disorder

Exclusion Criteria:

Active suicidal intent
Current psychosis
Current bipolar disorder
Substance abuse within past month
Cognitive impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308724

Locations

United States, Texas
Houston Center for Quality of Care and Utilization Studies
Houston, Texas, United States, 77030

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

Investigators

Principal Investigator:

Melinda A. Stanley, Ph.D.

Baylor College of Medicine

More Information

Publications:

Wetherell JL, Lenze EJ, Stanley MA. Evidence-based treatment of geriatric anxiety disorders. Psychiatr Clin North Am. 2005 Dec;28(4):871-96, ix. Review. No abstract available.

Stanley MA, Kunik ME. Anxiety in primary care: a frontier for mental health services research. Med Care. 2005 Dec;43(12):1161-3. No abstract available.

Stanley MA, Hopko DR, Diefenbach GJ, Bourland SL, Rodriguez H, Wagener P. Cognitive-behavior therapy for late-life generalized anxiety disorder in primary care: preliminary findings. Am J Geriatr Psychiatry. 2003 Jan-Feb;11(1):92-6.

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

Keywords provided by National Institute of Mental Health (NIMH):

Generalized Anxiety Disorder
Geriatric

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009