RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention as measured by assessment completion at multiple time points
研究概览
简要总结
The purpose of this study is to assess whether the investigators can treat insomnia in people with Crohn's disease, and if insomnia treatment can make other things better, like pain or inflammation.
详细描述
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, patients 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 investigators want to understand if they can treat sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. If this study is successful, it will help the investigators understand more about 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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 CD based on PRO-3 & 50% with objective evidence of active disease
- •Insomnia Severity Index score ≥ 8 and SOL or WASO ≥ 30 minutes
- •Stability of sleep & CD meds for ≥ 3 months
- •Access to internet or cell phone service sufficient for telehealth
排除标准
- •PHQ-9 depression score ≥ 15
- •GAD-7 anxiety score ≥ 15
- •Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)
- •Current alcohol or substance abuse
- •Current opioid 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 WatchPAT screen
- •Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen
- •Night shift, rotating shift work, or frequent travel outside of time zone
研究组 & 干预措施
Behavioral Treatment
干预措施: Behavioral Treatment (Behavioral)
Sleep Education Treatment
干预措施: Sleep Education Treatment (Behavioral)
结局指标
主要结局
Feasibility of the intervention as measured by assessment completion at multiple time points
时间窗: Baseline, 8 weeks, 21 weeks, and 34 weeks
Assessment completion rate will be based on the percentage of participants who complete all the required questionnaires and tasks at each time point.
Feasibility of the intervention as measured by attrition rate over time
时间窗: Baseline, 8 weeks, 21 weeks, and 34 weeks
Attrition rate will be based on the percentage of participants who have dropped out of the trial at different time points.
Feasibility of the intervention as measured by recruitment rate over time
时间窗: From study initiation until we are no longer actively recruiting (approximately 24 months)
Recruitment rate will be based on the number of participants who are recruited into the trial per month.
Feasibility of the intervention as measured by qualitative interviews
时间窗: 8 weeks and 34 weeks
Feasibility will be based on interview-derived themes related to barriers and facilitators to study engagement. Data will be collected at two time points to ensure completeness of themes.
Acceptability of the intervention as measured by visit completion
时间窗: 8 weeks
Visit completion will be based the number of visits (out of 5) completed by each participant.
Treatment acceptability questionnaire score
时间窗: 1 week
The Treatment Acceptability Questionnaire is a 4-item self-report questionnaire designed to assess the overall acceptability of an intervention. Scores range from 1 to 4 and higher scores are indicative of greater acceptability.
Acceptability of the intervention as measured by qualitative interviews
时间窗: 8 weeks
Acceptability will be based on interview-derived themes related to aspects of the intervention that participants found helpful and unhelpful.
次要结局
- Change in insomnia symptoms as measured by the Insomnia Severity Index(Baseline, 8 weeks, 21 weeks, and 34 weeks)
- Change in diary-based sleep onset latency(Baseline, 8 weeks, 21 weeks, and 34 weeks)
- Change in Crohn's disease symptoms as measured by the Patient Reported Outcomes 3(Baseline, 8 weeks, 21 weeks, and 34 weeks)
- Change in diary-based wake after sleep onset(Baseline, 8 weeks, 21 weeks, and 34 weeks)
研究者
Jessica.K.Salwen-Deremer
Assistant Professor of Psychiatry & Medicine
Dartmouth-Hitchcock Medical Center