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临床试验/NCT00765219
NCT00765219已完成不适用

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

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
222
试验地点
2
主要终点
Anxiety

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Anxiety

时间窗: 18 months

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melinda Stanley

Professor

Baylor College of Medicine

研究点 (2)

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