RecruitingRecruiting
Piloting an Insomnia Treatment in Patients With Ulcerative Colitis
NCT07428629 · Dartmouth-Hitchcock Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-17
Estimated completion: 2026-09-01
Last updated: 2026-05-05
Interventions
Behavioral: CBT-I UC
Primary outcomes
- • Retention (Baseline, 8 weeks)
- • Recruitment rate (From study initiation until we are no longer actively recruiting (approximately 3 months))
- • Acceptability (8 weeks)
Sponsor
Dartmouth-Hitchcock Medical Center · other
Contacts & investigators
ContactJessica K Salwen-Deremer, PhD · contact · jessica.k.salwen-deremer@hitchcock.org · (603) 650-5261
All locations (1)
Dartmouth-Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States