Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
Recruiting · NCT07428629 · Interventional (participants receive a specific treatment) · Lead sponsor: Dartmouth-Hitchcock Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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 is running
1 location listed across 1 US state.
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States