Improving Sleep for Healthy Hearts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change from baseline Insomnia Severity Index score at 6 weeks
研究概览
简要总结
This is a pilot study randomizing patients with insomnia and coronary heart disease to either general sleep hygiene counseling and web-based cognitive behavioral therapy for insomnia versus general sleep hygiene counseling alone (followed by the cognitive behavioral therapy at a later date).
详细描述
For this pilot study, the investigators will recruit up to 30 participants with insomnia and coronary heart disease. Another 30 patients will be recruited from another institution. Patients will be screened with a modified version of the Insomnia Severity Index (ISI), a brief self-report instrument validated for identifying insomnia. The investigators will modify the ISI to include exclusionary criteria. The investigators will randomize participants to 6 weeks of access to web based cognitive behavioral therapy for insomnia (wCBT-I) using an internet based CBT-I program plus education provided through access to the Harvard Sleep Education web site (which provides general sleep education information only) compared to 6 weeks of access to the Harvard Sleep Education web site, followed by access to the web-CBT program (a wait list control group). The investigators will test the hypothesis that use of wCBT-I improves sleep quality and sleep duration as measured by sleep diaries and the ISI. A secondary goal of the study is to assess the recruitment yields, retention and adherence rates.
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
- None
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
- •meet criteria for at least mild insomnia based on the Insomnia Severity Index questionnaire results
- •have established coronary disease defined by: a) prior myocardial infarction or a coronary artery revascularization procedure; b) angiographically documented stenosis (>70%) of a major coronary artery; or c) prior ischemic stroke without major functional impairment.
- •minimum age of 18 years old.
排除标准
- •no daily access to a computer with an internet connection
- •visual impairment preventing use of a computer
- •inability to read English
- •severe uncontrolled medical or psychiatric problems
- •heart failure with reduced ejection fraction <35%
- •high depressive symptoms (PHQ > 15)
- •drowsy driving
- •>3 days per week use of hypnotic medications
- •known untreated sleep disordered breathing, narcolepsy, or restless leg syndrome
- •shift-workers
- •prior exposure to CBT-I treatment
- •dialysis patient
结局指标
主要结局
Change from baseline Insomnia Severity Index score at 6 weeks
时间窗: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
It is a 7 item, validated questionnaire to determine severity of insomnia symptoms.
次要结局
- Change in sleep duration from baseline to 6 weeks(At baseline, at 6 weeks, and in the treatment arm at 12 weeks.)
- Change in mood assessed using the Patient Health Questionnaire-8 from baseline to 6 weeks(At baseline, at 6 weeks, and in the treatment arm at 12 weeks.)
- Change in sleepiness assessed using the Epworth Sleepiness Questionnaire from baseline to 6 weeks(At baseline, at 6 weeks, and in the treatment arm at 12 weeks.)
- Change in blood pressure from baseline to 6 weeks(At baseline and at 6 weeks)
- Change in heart rate from baseline to 6 weeks(At baseline and at 6 weeks)
- Change in Quality of life at baseline and 6 weeks(At baseline, at 6 weeks, and in the treatment arm at 12 weeks.)
研究者
Susan Redline
Senior Physician, Division of Sleep and Circadian Disorders
Brigham and Women's Hospital