Telehealth CBT for insomnia tailored to ulcerative colitis
Official title: Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
Run by Dartmouth-Hitchcock Medical Center · NCT07428629 · Data updated 2026-11-12
This pilot will test whether telehealth cognitive behavioral therapy for insomnia, adapted for adults with ulcerative colitis, can improve sleep and is acceptable to patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Status | Recruiting |
| Started | April 17, 2026 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT07428629 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with active ulcerative colitis, an Insomnia Severity Index score >8 with sleep onset latency or wake after sleep onset over 30 minutes, stable UC and sleep medications for at least 3 months, and access to reliable internet or cell service.
✕Probably not a fit
Patients with severe depression or anxiety, unstable psychiatric or substance use conditions, diagnosed sleep disorders like sleep apnea or restless legs, current opioid or systemic steroid use, pregnancy/nursing, ileostomy/colostomy, shift work, or who cannot receive telehealth in their state are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot enrolls adults with active ulcerative colitis and clinically significant insomnia to receive a UC-adapted cognitive behavioral therapy for insomnia delivered by telehealth over five sessions across 7–8 weeks. Participants complete online questionnaires before and after treatment and keep daily online sleep diaries before, during, and after the intervention, with brief phone check-ins between visits. Primary aims are to test feasibility and acceptability of the telehealth format and to measure changes in insomnia severity and sleep continuity (sleep onset latency and wake after sleep onset). Individuals with unstable psychiatric conditions, certain sleep disorders, current opioid or systemic steroid use, or who live in states where the site cannot provide telehealth are excluded.
Why it matters
Potential benefit: If successful, the approach could offer a scalable, non-drug way to reduce insomnia symptoms and improve sleep continuity for people with ulcerative colitis.
How similar studies have gone: CBT-I and telehealth-delivered CBT-I have strong evidence for treating insomnia broadly and in some chronic disease groups, while specific UC-adapted CBT-I is relatively new and less tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States Recruiting
Study contacts
- Study coordinator: Jessica K Salwen-Deremer, PhD
- Email: jessica.k.salwen-deremer@hitchcock.org
- Phone: (603) 650-5261
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.