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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308724
• Other study ID #: H15958
• Secondary ID: R01MH053932
• Status: Completed
• Phase: N/A
• Start date: March 2004
• Est. completion date: April 2015

Study information

• Verified date: March 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00081393

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: April 2015
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Houston Center for Quality of Care and Utilization Studies	Houston	Texas

Sponsors (7)

Lead Sponsor	Collaborator
Baylor College of Medicine	Kelsey Research Foundation, Kelsey-Seybold Clinic, Michael E. DeBakey VA Medical Center, National Institute of Mental Health (NIMH), National Institutes of Health (NIH), The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Stanley MA, Kunik ME. Anxiety in primary care: a frontier for mental health services research. Med Care. 2005 Dec;43(12):1161-3. doi: 10.1097/01.mlr.0000190923.04095.80. No abstract available. — View Citation

Wetherell JL, Lenze EJ, Stanley MA. Evidence-based treatment of geriatric anxiety disorders. Psychiatr Clin North Am. 2005 Dec;28(4):871-96, ix. doi: 10.1016/j.psc.2005.09.006. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety		Baseline and 3, 6, 9, 12 and 15 months
Secondary	Functional and health status		Baseline and 3, 6, 9, 12 and 15 months
Secondary	Quality of life inventory (QOLI)		Baseline and 3, 6, 9, 12 and 15 months
Secondary	Satisfaction with CBT and general health care		Baseline and 3, 6, 9, 12 and 15 months
Secondary	Service utilization		Baseline and 3, 6, 9, 12 and 15 months
Secondary	Depression		Baseline and 3, 6, 9, 12 and 15 months
Secondary	Sleep quality		Baseline and 3, 6, 9, 12 and 15 months
Secondary	Use of alcohol and other substances		Baseline and 3, 6, 9, 12 and 15 months