NCT07428629Recruiting
Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 19 Feb 2026
- Start date
- 17 Apr 2026
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Diseases
- Ulcerative colitis
- NCT number
- NCT07428629
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 17 Apr 2026 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current systemic corticosteroid use
Other illness
- Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)
- Diagnosis of seizure disorder
- Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen
Other
- PHQ-9 depression score \> 15
- GAD-7 anxiety score \> 15
- Current alcohol or substance abuse
- Current opioid use for pain control
- Current pregnancy or nursing
- Ileostomy or colostomy
- Diagnosis of sleep apnea
- Night shift, rotating shift work, or frequent travel outside of time zone
- Residence in a state where we cannot conduct telehealth visits
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.