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Completed

NCT Number: NCT07417163

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

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

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Key information

Conditions

Cirrhosis Dyssomnias Fibrosis Insomnia Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Adapted Virtual Insomnia Program

Behavioral

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.

Primary outcomes

  1. Feasibility: Enrollment rate of those screened and eligible

    Time frame: Baseline to Week 4

    Percent of those screened and eligible who enroll (i.e., sign consent and complete baseline). Reasons for ineligibility, refusal, or drop out, will also be measured along with session attendance.

Secondary outcomes

  1. Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction

    Time frame: Baseline to Week 8 (4 weeks post-intervention)

    Participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the program in exit interviews, which will use open-ended questions and response probes to explicate each rating

Other outcomes

  1. Change in Insomnia Severity

    Time frame: Baseline up to Week 8

    Change in insomnia severity will be assessed using the validated Insomnia Severity Index (ISI). Scores of 8 or higher on the ISI indicate clinically significant insomnia.

  2. Change in nightly subjective sleep and covariance with objective sleep

    Time frame: Baseline up to Week 8 (1 month post-intervention)

    Subjective Sleep: Measured via sleep diary. Total sleep time, sleep latency, sleep efficiency, and wake after sleep onset will be assessed using a sleep diary (i.e., timings of sleep/wake, timings of being in bed) for 1-2 weeks to achieve 7 consecutive days of sleep reporting at each timepoint.

  3. Change in nightly objective sleep and covariance with subjective sleep

    Time frame: Baseline up to Week 8 (1 month post-intervention)

    Objective Sleep: Measured via actigraphy data collection. During the same time period as participants complete the sleep diary, objective sleep will be assessed using actigraphy devices to calculate: total sleep time, sleep latency, sleep efficiency, wake after sleep onset, and a Mean Activity Score (actigraph counts/min)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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