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Completed

NCT Number: NCT00765219

Cognitive Behavior Treatment of Older Adults With Generalized Anxiety Disorder in Primary Care

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.

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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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CBT

Behavioral

10-12 weekly sessions of CBT in person or over the telephone.

Other names: Cognitive Behavior Treatment, Cognitive Behavior Therapy

Usual Care

Other

Treatment as usual provided by participants' physician(s)

Other names: Treatment as Usual

Primary outcomes

  1. Anxiety

    Time frame: 18 months

Secondary outcomes

  1. Depression

    Time frame: 18 months

  2. Sleep quality

    Time frame: 18 months

  3. Use of alcohol

    Time frame: 18 months

  4. Functional and health status

    Time frame: 18 months

  5. Quality of life

    Time frame: 18 months

  6. Pain

    Time frame: 18 months

  7. Satisfaction with CBT and general health care

    Time frame: 18 months

  8. Service utilization

    Time frame: 18 months

  9. Use of psychotropic medications

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2015
First posted
Oct 2, 2008
Registry last updated
Jul 23, 2015

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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