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Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

Study acronym: RISE-UC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 1, 2026 → Dec 1, 2026
See other at-risk trials from Dartmouth-Hitchcock Medical Center

Record History

  1. Primary completion pushed from Jul 1, 2026 to Dec 1, 2026
    • Study completion pushed from Sep 1, 2026 to Dec 1, 2026
    v4
  2. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 15, 2026 to Apr 17, 2026
    v3
  3. Secondary endpoints: details revised at 1 of 4 entriesv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07428629
Lead Sponsor Dartmouth-Hitchcock Medical Center
Conditions
(from sponsor)		 Insomnia, Ulcerative Colitis
Related terms Colitis, Ulcerative, Sleep Initiation and Maintenance Disorders
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov