Brief Behavioral Treatment for Sleep Problems in Irritable Bowel Syndrome: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Irritable Bowel Syndrome Severity Scoring System
研究概览
简要总结
Patients with Irritable Bowel Syndrome (IBS) often report more fatigue and sleep disturbances compared to their healthy counterparts and compared to patients with other GI disorders. This pilot study will evaluate the feasibility of a Brief Behavioral Treatment for Insomnia (BBT-I) in Irritable Bowel Syndrome. 40 participants will be recruited; 20 will receive 4 weeks of BBT and 20 will be assigned to a wait list control group (WLC). The primary aim of the current project is to assess feasibility of administering BBT-I to a sample of patients with IBS. Because behavioral sleep treatment has not yet been studied in IBS or any other GI population, this project will provide information about treatment adherence, recruitment, and effect sizes. Secondary aims include evaluating the impact of BBT-I on sleep quality and IBS symptom severity.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-50
- •Meet diagnostic criteria for IBS
- •Stable medication for IBS for at least 1 month
- •Stable medication for sleep for at least 1 month
- •ISI cutoff score of 10 or higher
- •Completes at least 5 out of 7 days of daily symptom and sleep diary during 1 week baseline
排除标准
- •Medical history of significant head injury or other neurological disorder
- •Pregnancy (self-reported)
- •Post-menopause
- •Major concomitant medical conditions
- •Major psychiatric diagnosis with comorbid sleep problems
- •Taking medications that might interfere with sleep
- •Confirmed or suspected other untreated sleep disorder
- •Active illicit drug use
结局指标
主要结局
Change in Irritable Bowel Syndrome Severity Scoring System
时间窗: 5 weeks
A measure of IBS symptom severity
次要结局
- Change in Insomnia Severity Index(5 weeks)
- Change in Pittsburgh Sleep Quality Index(5 weeks)
研究者
Anthony Lembo
Associate Professor of Medicine
Beth Israel Deaconess Medical Center