Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
Recruiting now · Not applicable
Conditions studied: Insomnia, Ulcerative Colitis
In brief
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
Key facts
- Study ID
- NCT07428629
- Run by
- Dartmouth-Hitchcock Medical Center
- People needed
- 20
- Starts
- 2026-04-17
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
Full record on ClinicalTrials.gov
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