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Clinical Trials/NCT00765219
NCT00765219
Completed
Not Applicable

Treating Late-life GAD in Primary Care: Enhancing Outcomes and Translational Value

Baylor College of Medicine1 site in 1 country222 target enrollmentMay 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Generalized Anxiety Disorder
Sponsor
Baylor College of Medicine
Enrollment
222
Locations
1
Primary Endpoint
Anxiety
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to determine whether cognitive behavior treatment (CBT) can be delivered effectively by providers of different expertise levels 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 in later life. Given the potential difficulties in prescribing psychotropic medications in later life(e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternatives or adjuncts. The treatment phase of this study lasts 6 months, during which patients will be randomly assigned to either cognitive behavior treatment (CBT) with an Anxiety Clinic Specialist (ACS) or Counselor or to Usual Care (UC). All participants will complete telephone assessments at baseline, 1, 2, and 3 months during the treatment phase. During the first 12 weeks, those assigned to CBT will also complete 10-12 weekly sessions, either in person or over the telephone. During the second 12 weeks, CBT patients will receive follow-up telephone booster calls, weekly for the first 4 weeks and biweekly for the last 8 weeks. During the treatment phase, UC participants will receive no treatment from study clinicians but will continue to receive their usual care from their current medical providers. At 6 months, all participants will complete a telephone assessment. CBT patients will enter a one year follow-up period, with telephone assessments at 12 and 18 months. UC participants will be offered the option to receive brief CBT after completion of the 6 month telephone assessment. Those who choose to participate in CBT will complete telephone assessments at 9 and 12 months.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
April 2015
Last Updated
10 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

  • Age 60 and older
  • Principal or Co-principal GAD diagnosis
  • Patient at participating clinic

Exclusion Criteria

  • Active suicidal intent
  • Current psychosis or bipolar disorder
  • Substance abuse within the past month
  • Cognitive impairment according to a Mini Cog screener score of 3 or lower

Outcomes

Primary Outcomes

Anxiety

Time Frame: 18 months

Secondary Outcomes

  • Service utilization(18 months)
  • Use of psychotropic medications(18 months)
  • Use of alcohol(18 months)
  • Functional and health status(18 months)
  • Quality of life(18 months)
  • Sleep quality(18 months)
  • Satisfaction with CBT and general health care(18 months)
  • Depression(18 months)
  • Pain(18 months)

Study Sites (1)

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