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Clinical Trials/NCT00308724
NCT00308724
Completed
Not Applicable

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

Baylor College of Medicine1 site in 1 country148 target enrollmentMarch 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Generalized Anxiety Disorder
Sponsor
Baylor College of Medicine
Enrollment
148
Locations
1
Primary Endpoint
Anxiety
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2004
End Date
April 2015
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Melinda Stanley

Professor

Baylor College of Medicine

Eligibility 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

Outcomes

Primary Outcomes

Anxiety

Time Frame: Baseline and 3, 6, 9, 12 and 15 months

Secondary Outcomes

  • 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)
  • Use of alcohol and other substances(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)

Study Sites (1)

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