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

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Behavioral: Cognitive Behavior Therapy; Behavioral: Telephone check-in

• Registration Number: NCT00308724
• Lead Sponsor: Baylor College of Medicine

Brief 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.

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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2006-03-28
• Study First Submitted QC: 2006-03-28
• Study First Posted: 2006-03-30
• Primary Completion: 2008-01
• Study Completion: 2015-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cognitive Behavior Therapy	Cognitive Behavior Therapy
2	Telephone check-in	Usual Care

Primary Outcome Measures

Name	Time	Method
Anxiety	Baseline and 3, 6, 9, 12 and 15 months

Secondary Outcome Measures

Name	Time	Method
Satisfaction with CBT and general health care	Baseline and 3, 6, 9, 12 and 15 months
Depression	Baseline and 3, 6, 9, 12 and 15 months
Quality of life inventory (QOLI)	Baseline and 3, 6, 9, 12 and 15 months
Sleep quality	Baseline and 3, 6, 9, 12 and 15 months
Functional and health status	Baseline and 3, 6, 9, 12 and 15 months
Service utilization	Baseline and 3, 6, 9, 12 and 15 months
Use of alcohol and other substances	Baseline and 3, 6, 9, 12 and 15 months

Trial Locations

Locations (1)

Houston Center for Quality of Care and Utilization Studies; 🇺🇸 Houston, Texas, United States