Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07428629

Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-05-05

20

Participants Needed

1

Research Sites

19 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Active Ulcerative Colitis based on PRUCSI
  • Insomnia Severity Index score greater than 8 and sleep onset latency or wake after sleep onset longer than 30 minutes
  • Stable sleep and Ulcerative Colitis medications for more than 3 months
  • Access to internet or cell phone service sufficient for telehealth visits
Not Eligible

You will not qualify if you...

  • PHQ-9 depression score greater than 15
  • GAD-7 anxiety score greater than 15
  • Unstable major psychiatric condition such as bipolar disorder or 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 telehealth visits cannot be conducted

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

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Research Team

J

Jessica K Salwen-Deremer, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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