Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
Not applicable · Testing CBT-I UC · 1 site · Dartmouth-Hitchcock Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing CBT-I UC (a behavioral program) as a possible treatment. Condition(s) listed: Insomnia and Ulcerative Colitis.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Active UC based on PRUCSI
- Insomnia Severity Index score > 8 and SOL or WASO > 30 minutes
- Stability of sleep \& UC meds for > 3 months
Plus 1 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2026-04-17.
- Main results expected around 2026-12-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Retention (Baseline, 8 weeks)
In the researchers’ words
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?
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Insomnia; Ulcerative Colitis |
| Lead sponsor | Dartmouth-Hitchcock Medical Center |
| Enrollment | 20 (estimated) |
| Start date | 2026-04-17 |
| Primary completion (est.) | 2026-12-01 |
| First posted | 2026-02-24 |
| Last updated | 2026-08-28 |
| Official title | Piloting an Insomnia Treatment in Patients With Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT07428629 |
Interventions
- CBT-I UC (Behavioral)
This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * PHQ-9 depression score > 15 * GAD-7 anxiety score > 15 * Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder) * Current alcohol or substance abuse * Current opioid use for pain control * Current systemic corticosteroid use * Current pregnancy or nursing * Ileostomy or colostomy * Diagnosis of seizure disorder * Diagnosis of sleep apnea * Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen * Night shift, rotating shift work, or frequent travel outside of time zone * Residence in a state where we cannot conduct telehealth visits
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.