Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this clinical trial is to learn if telehealth-based Cognitive Behavioral Therapy for Insomnia (CBT-I) adapted for Ulcerative Colitis (UC) works to treat insomnia in adults with UC. The main questions it aims to answer are:
- Is telehealth-based CBT-I adapted for UC feasible and acceptable to participants?
- Does CBT-I for UC impact insomnia severity and sleep continuity?
Participants will:
- Answer questionnaires online before and after treatment
- Complete an online daily sleep diary before, during, and after treatment
- Participate in 5 telehealth treatment visits over 7-8 weeks
- Participate in 5-10-minute phone calls between treatment visits
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Active UC based on PRUCSI
- •Insomnia Severity Index score > 8 and SOL or WASO > 30 minutes
- •Stability of sleep & UC 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
- •Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen
- •Night shift, rotating shift work, or frequent travel outside of time zone
- •Residence in a state where we cannot conduct telehealth visits
研究组 & 干预措施
CBT-I UC Treatment
All participants entered into the study will receive telehealth CBT-I for UC.
干预措施: CBT-I UC (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: From study initiation until we are no longer actively recruiting (approximately 3 months)
Recruitment rate will be based on the average number of participants who are enrolled into the trial per month.
Acceptability
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.
Retention
时间窗: Baseline, 8 weeks
Measured based on the percentage of participants who complete the full study.
次要结局
- Change in insomnia symptoms as measured by the Insomnia Severity Index(Baseline, 8 weeks)
- Change in diary-based sleep onset latency(Baseline, 8 weeks)
- Change in diary-based wake after sleep onset(Baseline, 8 weeks)
- Change in diary-based sleep efficiency(Baseline, 8 weeks)
研究者
Jessica.K.Salwen-Deremer
Assistant Professor of Psychiatry
Dartmouth-Hitchcock Medical Center