Feasibility of Insomnia Tracking and Treatment in IBD (FITT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inflammatory Bowel Diseases
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Completion of Study Measures- Treatment Study
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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).
Investigators
Jessica.K.Salwen-Deremer
Assistant Professor, Departments of Psychiatry & Medicine, Section of Gastroenterology & Hepatology
Dartmouth-Hitchcock Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Completion of Study Measures- Treatment Study
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Tracking Study: Baseline (Week 1)
Number of participants screened into the study per month will help measure feasibility.
Actigraph Compliance-Treatment Study
Time Frame: 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.
Secondary Outcomes
- 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))