Piloting an Insomnia Treatment in Patients With Ulcerative Colitis (RISE-UC)

April 29, 2026 updated by: Jessica.K.Salwen-Deremer, Dartmouth-Hitchcock Medical Center

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT-I UC Treatment
All participants entered into the study will receive telehealth CBT-I for UC.
Behavioral: CBT-I UC
This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment acceptability questionnaire score
Time Frame: 1 week
The Treatment Acceptability Questionnaire is a 4-item self-report questionnaire designed to assess the overall acceptability of an intervention. Scores range from 1 to 4 and higher scores are indicative of greater acceptability.
1 week
Recruitment rate
Time Frame: From study initiation until we are no longer actively recruiting (approximately 3 months)
Recruitment rate will be based on the average number of participants who are enrolled into the trial per month.
From study initiation until we are no longer actively recruiting (approximately 3 months)
Acceptability
Time Frame: 8 weeks
Visit completion will be based the number of visits (out of 5) completed by each participant.
8 weeks
Retention
Time Frame: Baseline, 8 weeks
Measured based on the percentage of participants who complete the full study.
Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in insomnia symptoms as measured by the Insomnia Severity Index
Time Frame: Baseline, 8 weeks
The Insomnia Severity Index (ISI) is a self-report questionnaire designed to measure severity of insomnia. The ISI is made up of 7 items on insomnia symptoms and related impairments and total scores range from 0-28. Higher scores are indicative of greater insomnia symptoms.
Baseline, 8 weeks
Change in diary-based sleep onset latency
Time Frame: Baseline, 8 weeks
A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary
Baseline, 8 weeks
Change in diary-based wake after sleep onset
Time Frame: Baseline, 8 weeks
A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary
Baseline, 8 weeks
Change in diary-based sleep efficiency
Time Frame: Baseline, 8 weeks
Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary.
Baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02003289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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