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Completed

NCT Number: NCT00308724

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Center for Quality of Care and Utilization Studies

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavior Therapy

Behavioral

8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period

Other names: CBT

Telephone check-in

Behavioral

Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition

Primary outcomes

  1. Anxiety

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

Secondary outcomes

  1. Functional and health status

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

  2. Quality of life inventory (QOLI)

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

  3. Satisfaction with CBT and general health care

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

  4. Service utilization

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

  5. Depression

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

  6. Sleep quality

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

  7. Use of alcohol and other substances

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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2015
First posted
Mar 30, 2006
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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