An interventional study of CBT-I UC in Insomnia and Ulcerative Colitis, sponsored by Dartmouth-Hitchcock Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Treatment
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:
Participants will:
Exclusion Criteria:
All participants entered into the study will receive telehealth CBT-I for UC.
Behavioral: CBT-I UC
This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.
Retention
Measured based on the percentage of participants who complete the full study.
Time frame: Baseline, 8 weeks
Recruitment rate
Recruitment rate will be based on the average number of participants who are enrolled into the trial per month.
Time frame: From study initiation until we are no longer actively recruiting (approximately 3 months)
Acceptability
Visit completion will be based the number of visits (out of 5) completed by each participant.
Time frame: 8 weeks
Treatment acceptability questionnaire score
The Treatment Acceptability Questionnaire is a 4-item self-report questionnaire designed to assess the overall acceptability of an intervention. Scores range from 1 to 4 and higher scores are indicative of greater acceptability.
Time frame: 1 week
Change in insomnia symptoms as measured by the Insomnia Severity Index
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.
Time frame: Baseline, 8 weeks
Change in diary-based sleep onset latency
A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary
Time frame: Baseline, 8 weeks
Change in diary-based wake after sleep onset
A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary
Time frame: Baseline, 8 weeks
Change in diary-based sleep efficiency
Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary.
Time frame: Baseline, 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders→
Dartmouth-Hitchcock Medical Center