Behavioral Insomnia Therapy in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective (actigraphic) and subjective (sleep log) sleep measures at 6 weeks and 6 months
研究概览
简要总结
Insomnia reduces quality of life, increases risks for other illnesses, and enhances health care costs/utilization. Several efficacy studies have shown that Cognitive-Behavioral Therapy (CBT) for insomnia improves sleep and diurnal complaints among highly screened samples; however, its effectiveness among �real-world� primary care patients is yet to be tested. This project is highly relevant to the VA health care mission, given the high prevalence of insomnia in middle-aged and older adults. Pilot data from this VA suggest that 40% of primary care patients report trouble sleeping.
详细描述
Background:
Insomnia reduces quality of life, increases risks for other illnesses, and enhances health care costs/utilization. Several efficacy studies have shown that Cognitive-Behavioral Therapy (CBT) for insomnia improves sleep and diurnal complaints among highly screened samples; however, its effectiveness among �real-world� primary care patients is yet to be tested. This project is highly relevant to the VA health care mission, given the high prevalence of insomnia in middle-aged and older adults. Pilot data from this VA suggest that 40% of primary care patients report trouble sleeping.
Objectives:
This project tests the incremental benefits of adding CBT to usual primary care for reducing sleep disturbance, diurnal dysfunction, quality of life concerns and health care utilization among veterans enrolled in the DVAMC Primary Care Clinics. Study hypotheses predict that patients who receive CBT along with usual care will show greater improvements in sleep, mood, and quality of life, as well as larger reductions in health care utilization than will those who receive usual care alone.
Methods:
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran enrolled in primary care at Durham VAMC
- •Insomnia complaint for > 1 month
- •Meet structured interview criteria for at least one DSM-IV insomnia subtype
- •Mean total wake time > 60 minutes per night
- •Provide informed consent
- •Concurrence for enrollment from primary care provider
排除标准
- •Terminal illness
- •Acute or unstable psychiatric condition
- •Acute pain or poorly managed chronic pain
- •Not mentally competent
- •Evidence of clinically significant sleep apnea or periodic limb movement disorder
- •Refuse to provide informed consent
- •In the opinion of their MD provider, have an unstable psychiatric or medical condition that makes participation unadvisable
研究组 & 干预措施
Arm 1
干预措施: Cognitive-Behavioral Therapy (Behavioral)
结局指标
主要结局
Objective (actigraphic) and subjective (sleep log) sleep measures at 6 weeks and 6 months
次要结局
- Mood and quality of life at 6 weeks and 6 months; healthcare utilization at 6 months