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Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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 details
    Insomnia
    Ulcerative Colitis

NCT07428629

Dartmouth-Hitchcock Medical Center

13 May 2026

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