RecruitingNot ApplicableNCT07417163

LiverSleep: A Behavioral Sleep Intervention for Patients With Cirrhosis and Insomnia

LiverSleep: An Adapted Telehealth-Delivered Cognitive Behavioral Therapy Intervention for Patients With Cirrhosis and Insomnia

Sponsor

Massachusetts General Hospital

Enrollment

10 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Insomnia Cirrhosis

Summary

This is a pilot trial to test the feasibility and acceptability of a virtual cognitive behavioral program for insomnia for patients with cirrhosis.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Adult (≥ 18 years) patients with cirrhosis (either compensated or decompensated) receiving ambulatory care at the MGH Liver Clinic or MGH Liver Transplant Evaluation Clinic
Have the ability to communicate in English
Have at least mild insomnia (ISI score ≥8) and report sleep difficulty, defined as ≥ 30 min to fall asleep or spending at least 30 min awake during the night

Exclusion Criteria6

Uncontrolled neuropsychiatric disorders such as severe depression, schizophrenia, or suicidal ideation which prohibits their ability to provide informed consent.
Cognitive impairment, which we will screen for using the simplified Animal Naming Test
Current alcohol misuse
Diagnosis of obstructive sleep apnea that is untreated or high-risk for obstructive sleep apnea
Severe restless leg syndrome
Those with night/rotating shift work

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALAdapted Virtual Insomnia Program

4 sessions (approximately 45 min/each, weekly) plus 3 check-ins (approximately 15 min/each, between-sessions) delivered virtually. Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences of patients with cirrhosis.