A Pilot Trial of CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in insomnia symptoms as measured by the Insomnia Severity Index
研究概览
简要总结
People with Crohn's disease often suffer from sleep problems. Long term, sleep problems may lead to more flares of Crohn's disease or other complications. In general, people with Crohn's disease also report that sleep problems can worsen symptoms of Crohn's disease the next day. In people with other medical problems, research has also shown that having sleep problems can make other things worse, such as pain and inflammation. In this study, the researchers want to understand the treatment of sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. This study will use Cognitive Behavioral Therapy for Insomnia (CBT-I) to treat insomnia symptoms. CBT-I is the recommended treatment for insomnia and has been shown to improve sleep problems, pain, and inflammation in other groups of people. If this study is successful, it will contribute to understanding how to treat insomnia in people with Crohn's disease and how sleep impacts pain and inflammation. Long term, this information will be helpful in understanding how best to take care of people with Crohn's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Mild to moderate Crohn's disease (as assessed by PRO-3 score)
- •Insomnia severity index score of 8 or greater
- •Sleep onset latency and/or wake after sleep onset of at least 30 minutes
- •Access to device and internet/cell phone service sufficient for telehealth
排除标准
- •PHQ-9 score of 20 or greater
- •GAD-7 score of 20 or greater
- •Unstable major psychiatric condition
- •Current alcohol or substance abuse
- •Current narcotic use for pain control
- •Current systemic corticosteroid use
- •Current pregnancy or nursing
- •Ileostomy or colostomy
- •Diagnosis of seizure disorder
- •Diagnosis of sleep apnea or positive STOP-Bang screen
- •Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RLSq screen
- •Night shift, rotating shift work, or frequent travel outside of primary time zone
结局指标
主要结局
Change in insomnia symptoms as measured by the Insomnia Severity Index
时间窗: From baseline assessment to 1-month post intervention
The Insomnia Severity Index (ISI) is a self-report questionnaire designed to measure severity of insomnia. The ISI is made up of 7 items on insomnia symptoms and related impairments and total scores range from 0-28. Higher scores are indicative of greater insomnia symptoms.
Change in diary-based wake after sleep onset
时间窗: From baseline assessment to 1-month post intervention
A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary
Change in diary-based sleep onset latency
时间窗: From baseline assessment to 1-month post intervention
A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary
次要结局
- Change in self-reported pain as measured by the Brief Pain Inventory(From baseline assessment to 1-month post intervention)
- Change in self-reported Crohn's disease symptoms as measured by the Patient Reported Outcomes-3(From baseline assessment to 1-month post intervention)
- Change in sleep efficiency based on diary(From baseline assessment to 1-month post intervention)
- Change in diary sleep efficiency based on ambulatory EEG monitoring(From baseline assessment to 1-month post intervention)
- Change in sleep onset latency as measured by ambulatory EEG monitoring(From baseline assessment to 1-month post intervention)
- Change in time spent in slow wave sleep(From baseline assessment to 1-month post intervention)
- Change in C-reactive protein(From baseline assessment to 1-month post intervention)
- Change in sleep efficiency based on actigraphy(From baseline assessment to 1-month post intervention)
- Change in fecal calprotectin(From baseline assessment to 1-month post intervention)
- Change in sleep onset latency as measured by actigraphy(From baseline assessment to 1-month post intervention)
- Change in wake after sleep onset as measured by actigraphy(From baseline assessment to 1-month post intervention)
- Change in wake after sleep onset as measured by ambulatory EEG monitoring(From baseline assessment to 1-month post intervention)
- Change in behaviorally assessed pain tolerance via the Cold Pressor Test(From baseline assessment to 1-month post intervention)
研究者
Jessica.K.Salwen-Deremer
Principal Investigator
Dartmouth-Hitchcock Medical Center