Feasibility of Insomnia Tracking and Treatment in IBD (FITT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Completion of Study Measures- Treatment Study
研究概览
简要总结
This study is a longitudinal clinical trial designed to characterize sleep patterns in individuals with Inflammatory Bowel Disease (IBD) as well as to assess the feasibility of sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in individuals with both insomnia and Inflammatory Bowel Disease (IBD).
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Completion of Study Measures- Treatment Study
时间窗: Follow Up (week 15)
The average percentage of study measures (daily diaries and CBT-I sessions) that are completed across participants will help determine feasibility.
ActiGraph Use-Treatment Study
时间窗: Follow Up (week 15)
The average percentage of days spent wearing the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility.
Actigraph Compliance-Tracking Study
时间窗: Baseline (Week 1)
The average percentage of hours of wear per day of the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility.
ActiGraph Use-Tracking Study
时间窗: Baseline (Week 1)
The average percentage of days spent wearing the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility.
Completion of Study Measures-Tracking Study
时间窗: Baseline (average of weeks 1 & 2)
The average percentage of study measures (daily diaries and CBT-I sessions) that are completed across participants will help determine feasibility.
Change in sleep continuity
时间窗: Tracking Study: Baseline (average of weeks 1 & 2), Treatment Study: Follow Up (change from baseline to week 15)
Sleep continuity will be measured by sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE), based on ActiGraph data and daily diary data. Sleep parameters measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer. Measured in minutes of sleep per night. Higher number indicating longer sleep duration.
Recruitment Rate
时间窗: Tracking Study: Baseline (Week 1)
Number of participants screened into the study per month will help measure feasibility.
Actigraph Compliance-Treatment Study
时间窗: Follow up (Week 15)
The average percentage of hours of wear per day of the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility.
次要结局
- Treatment liking(Treatment Study: Visit 1 (Week 3) and Follow up (Week 15))
- Change in Sleepiness(Tracking Study: Baseline (Week 1) and Follow up (Week 15))
- Change in general fatigue(Tracking Study: Baseline (Week 1), Treatment Study: Follow up (Week 15))
- Change in general sleep quality(Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15))
- Change in overall health and quality of life(Tracking Study: Baseline (Week 1), Treatment Study: Follow up (week 15))
- Change in beliefs and attitudes about sleep(Tracking Study: Baseline (Week 1), Treatment Study: Visit 5 (Week 11), Follow up (Week 15))
- Change in pain related disability(Tracking Study: Baseline (Week 1), Follow up (Week 15))
- Change in severity of depression symptoms(Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Follow up (week 15))
- Change in Insomnia Severity(Tracking Study: Baseline (Week1), Treatment Study: Visit 1 (Week 3), Visit 5 (Week 11) Follow up (Week 15))
- Change in behaviors that can interfere with sleep.(Tracking Study: Baseline (Week 1), Treatment Study: Visit 5 (Week 11), Follow up (week 15))
- Change in pain(Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Visit 5 (week 11), Follow up(week 15))
- Change in individual's beliefs about IBD symptoms(Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15))
- Restless Leg Syndrome(Tracking Study: Baseline (Week 1))
- Circadian Rhythms(Tracking Study: Baseline (Week 1))
- Sleep Apnea(Tracking Study: Baseline (Week 1))
- Change in beliefs about pain(Tracking: Baseline (Week 1), Follow up (week 15))
- Change in severity of anxiety symptoms(Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Follow up (week 15))
- Change in IBD severity(Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15))
- Change in IBD symptom severity(Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15))
- Change in stress(Tracking Study: Baseline (Week 1), Treatment Study: Follow up (week 15))
研究者
Jessica.K.Salwen-Deremer
Assistant Professor, Departments of Psychiatry & Medicine, Section of Gastroenterology & Hepatology
Dartmouth-Hitchcock Medical Center