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NCT05034159 · ClinicalTrials.gov registry record · NA
CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease
A NA study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT05034159: Completed NA study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT05034159 is a NA study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05034159, a NA study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
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, people 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 researchers want to understand the treatment of sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. This study will use Cognitive Behavioral Therapy for Insomnia (CBT-I) to treat insomnia symptoms. CBT-I is the recommended treatment for insomnia and has been shown to improve sleep problems, pain, and inflammation in other groups of people. If this study is successful, it will contribute to understanding 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.
Primary Outcome
The Insomnia Severity Index (ISI) is a self-report questionnaire designed to measure severity of insomnia. The ISI is made up of 7 items on insomnia symptoms and related impairments and total scores range from 0-28. Higher scores are indicative of greater insomnia symptoms.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-10-22 |
| Est. Completion | 2023-04-19 |
| Phase | NA |
What the finished NCT05034159 record still lists
NCT05034159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Cognitive Behavioral Therapy for Insomnia is the first listed.
NCT05034159 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05034159 about?
NCT05034159 is a clinical study titled "CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease". 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, people with Crohn's disease also report that sleep problems can worsen symptoms of Crohn's disease the next day. In people with other...
What is the current status of trial NCT05034159?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2021-10-22. Estimated completion is 2023-04-19.
What interventions are being tested in trial NCT05034159?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT05034159?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05034159's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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