CompletedNo phase
LiverSleep: A Behavioral Sleep Intervention for Patients With Cirrhosis and Insomnia
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 11 people enrolled
- Started
- 26 Feb 2026
- Ended
- 9 Jul 2026
- Type of study
- Interventional
- Treatments tested
- Adapted Virtual Insomnia Program
- Record updated
- 23 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Severe restless leg syndrome
- Current alcohol misuse
- Diagnosis of obstructive sleep apnea that is untreated or high-risk for obstructive sleep apnea
- Those with night/rotating shift work
Where in United States
- Massachusetts General HospitalBoston, United StatesNo longer taking part
About the trial
What the trial wants to find out
This is a pilot trial to test the feasibility and acceptability of a virtual cognitive behavioral program for insomnia for patients with cirrhosis.
The group in the trial
- Behavioral: Intervention - Adapted Virtual Insomnia ProgramTreatment being tested
4 sessions (approximately 45 min/each, weekly) delivered virtually. Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences of patients with cirrhosis. Interventionists will participate in weekly supervision. Participants will be asked to complete sleep diaries and wear sleep trackers for one-week prior to starting the intervention and one-week after completing the intervention.
Treatment: Adapted Virtual Insomnia Program
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- LiverSleep: An Adapted Telehealth-Delivered Cognitive Behavioral Therapy Intervention for Patients With Cirrhosis and Insomnia
- Record updated
- 23 July 2026