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Piloting CBT-I for Insomnia in Ulcerative Colitis

This study is testing a treatment called CBT-I UC (Cognitive Behavioral Therapy for Insomnia adapted for Ulcerative Colitis) to see if it can help adults with both insomnia and active ulcerative colitis (UC). The treatment involves making changes to thoughts and behaviors that contribute to sleep problems, and it's delivered through telehealth (online or phone). Researchers want to find out if this treatment is practical and well-received by participants, and if it improves insomnia and sleep quality. You would participate in online questionnaires, daily sleep diaries, and 5 telehealth treatment visits over 7-8 weeks, with short phone calls in between. The study aims to enroll 20 participants.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
What's involved
You would complete online questionnaires, an online daily sleep diary, participate in 5 telehealth treatment visits over 7-8 weeks, and have 5-10-minute phone calls between visits.
Compensation
Not stated in the trial record.
Follow-up
Acceptability is measured at 8 weeks, and retention is measured at 8 weeks.

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NCT07428629

Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

Recruiting
NAAges 18+InterventionalTreatment
Dartmouth-Hitchcock Medical Center
~20 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:CBT-I UC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Retention
Measured over Baseline, 8 weeks
+3 more outcomes measured

Conditions

Insomnia
Ulcerative Colitis

Explore related trials

InsomniaUlcerative Colitis

Where it's being run

1 sites across 1 states
New Hampshire1

Who to contact

Jessica K Salwen-Deremer, PhD
[email protected]
(603) 650-5261
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • RetentionBaseline, 8 weeks

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

  • Recruitment rateFrom 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.

  • Acceptability8 weeks

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

  • Treatment acceptability questionnaire score1 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.