Recruiting

CBT-I for UC

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT07428629

Conditions

Insomnia

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CBT-I UC

Study Details

Brief summary:

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

Insomnia

Ulcerative Colitis

Study ID

NCT07428629

Start date

Apr 17, 2026

Status verified date

Apr, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBT-I UC Treatment

All participants entered into the study will receive telehealth CBT-I for UC.

Interventions

CBT-I UC

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

Primary outcome measure

  • Retention [ Time Frame: Baseline, 8 weeks ]
  • Recruitment rate [ Time Frame: From study initiation until we are no longer actively recruiting (approximately 3 months) ]
  • Acceptability [ Time Frame: 8 weeks ]
  • Treatment acceptability questionnaire score [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Jessica K Salwen-Deremer, PhD

(603) 650-5261jessica.k.salwen-deremer@hitchcock.org

Locations

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Jessica Salwen-Deremer, PhD

603-650-6388jessica.k.salwen-deremer@hitchcock.org

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Aug 28, 2026

Last verified

Apr, 2026

Keywords

  • telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-08-28.