Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CBT-I UC
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov