Testing a Remote Sleep Therapy for Insomnia in Ulcerative Colitis
Tests an online sleep therapy adapted for adults with ulcerative colitis and insomnia.
Key facts
- Who runs it
- Dartmouth-Hitchcock Medical Center
- Where
- Lebanon, United StatesSee the site
- Trial code
- Registry title
- Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 17 Apr 2026
- Expected to end
- 1 Dec 2026
- Type of study
- Interventional
- Treatments tested
- CBT-I UC
- Record updated
- 28 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active ulcerative colitis and insomnia. It tests a video-visit sleep therapy (CBT-I) adapted for ulcerative colitis.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Active ulcerative colitis (based on PRUCSI), and insomnia: Insomnia Severity Index score above 8, and either time to fall asleep or time awake in the night above 30 minutes
- Earlier treatment
- Sleep medicines and ulcerative colitis medicines must have been stable for more than 3 months
Main reasons for not taking part
- Severe depression (PHQ-9 above 15) or severe anxiety (GAD-7 above 15), or an unstable major psychiatric condition
- Current alcohol or substance abuse, opioid use for pain, or systemic corticosteroid use
- Current pregnancy or nursing
- Ileostomy or colostomy, seizure disorder, sleep apnea, or restless leg syndrome
- Night shift or rotating shift work, or frequent travel outside the time zone
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Current systemic corticosteroid use
- 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
- 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
Where in United States
- Dartmouth Hitchcock Medical CenterLebanon, United StatesContact: Jessica Salwen-Deremer, PhDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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
The group in the trial
- CBT-I UC TreatmentTreatment being tested
All participants entered into the study will receive telehealth CBT-I for UC.
Treatment: CBT-I UC
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
- Plain-language title
- Testing a Remote Sleep Therapy for Insomnia in Ulcerative ColitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 28 August 2026