RecruitingNANCT07428629

Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

Sponsor: Dartmouth-Hitchcock Medical Center

Trial Details

ConditionInsomnia, Ulcerative Colitis
InterventionCBT-I UC
PhaseNA
StatusRecruiting
Participants20
Est. Completion1 July 2026
Last Updated5 May 2026

Primary Outcome

Retention; Recruitment rate; Acceptability; Treatment acceptability questionnaire score

Eligibility Criteria

Inclusion Criteria

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

Trial Sites

Countries

United States
View Registry Entry

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