Testing an Online Insomnia Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in Insomnia
研究概览
简要总结
The objective of this trial is to determine the effectiveness of an electronic cognitive behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use among heavy drinkers with insomnia. Specifically, it will test the effectiveness of Sleep Healthy Using the Internet (SHUTi), a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. The rationale for this mixed methods proposal is that effective, nonpharmacologic treatments are necessary to stem the highly comorbid public health problems of alcohol use disorder (AUD) and insomnia. If successful, SHUTi will represent a novel and easily accessible intervention for reducing alcohol intake among high-risk heavy drinkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •engage in weekly alcohol binge episodes
- •moderate to severe insomnia
排除标准
- •history of severe alcohol or other substance use disorder
- •obstructive sleep apnea
- •schizophrenia
- •bipolar disorder
- •psychotic spectrum disorder
- •lack of internet access
- •lack of English fluency
- •pregnant or nursing
结局指标
主要结局
Change in Insomnia
时间窗: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Insomnia will be measured using the Insomnia Severity Index (ISI). This survey has 7 questions related to insomnia. Scores range from 0-28, with higher scores indicating increased insomnia.
Change in Sleep Quality
时间窗: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). It measures seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Scores range from 0-indefinite. A score greater than 5 is indicative of poor sleep quality.
Change in Alcohol Use
时间窗: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Alcohol use will be measured using the Timeline Follow Back (TLFB) calendar. Participants will report their drinking over the past 30 days.
次要结局
未报告次要终点
研究者
Jessica Weafer
Assistant Professor
University of Kentucky