RecruitingNot ApplicableNCT07428629

Piloting an Insomnia Treatment in Patients With Ulcerative Colitis


Sponsor

Dartmouth-Hitchcock Medical Center

Enrollment

20 participants

Start Date

Apr 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria13

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALCBT-I UC

This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.


Locations(1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07428629


Related Trials