Trials / Completed
CompletedNCT04132024
Feasibility of Insomnia Tracking and Treatment in IBD
Feasibility of Insomnia Tracking and Treatment in IBD (FITT)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Dartmouth-Hitchcock Medical Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cognitive Behavioral Therapy for Insomnia (CBT-I) | CBT-I has a specific protocol with behavioral targets that differ significantly from standard CBT. This approach focuses on implementing sleep restriction and stimulus control interventions which are fully deployed during the first session. 5 CBT-I sessions will be delivered over the course of 8 weeks. Key recommendations include: 1) reduce time in bed; 2) get up at the same time every day; 3) do not go to bed unless sleepy; 4) do not stay in bed awake for more than 15 minutes; and 5) avoid napping. Participants are also taught relaxation strategies and cognitive therapy addresses arousal and catastrophizing. |
Timeline
- Start date
- 2019-10-07
- Primary completion
- 2021-04-15
- Completion
- 2021-04-15
- First posted
- 2019-10-18
- Last updated
- 2021-05-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04132024. Inclusion in this directory is not an endorsement.