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NCT Number: NCT07428629

Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

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

Recruiting

Interested in participating?

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Key information

Conditions

Insomnia Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Dyssomnias Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location status: Recruiting

Location contact

Jessica Salwen-Deremer, PhD

CONTACT

[email protected]

603-650-6388

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-I UC

Behavioral

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

Primary outcomes

  1. Retention

    Time frame: Baseline, 8 weeks

    Measured based on the percentage of participants who complete the full study.

  2. 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.

  3. Acceptability

    Time frame: 8 weeks

    Visit completion will be based the number of visits (out of 5) completed by each participant.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica K Salwen-Deremer, PhD

CONTACT

[email protected]

(603) 650-5261

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Acronym: RISE-UC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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