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

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

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Cirrhosis
• Intervention / Treatment: Behavioral: Adapted Virtual Insomnia Program

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William Munroe; Phone Number: 617-726-0161; Email: Wlmunroe@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Nneka Ufere; Phone Number: 4047885335

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult (≥ 18 years) patients with cirrhosis (either compensated or decompensated) receiving ambulatory care at the MGH Liver Clinic or MGH Liver Transplant Evaluation Clinic
2. Have the ability to communicate in English
3. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Behavioral: Intervention - Adapted 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. 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.

Behavioral: Adapted 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Enrollment rate of those screened and eligible	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.	Baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction	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	Baseline to Week 8 (4 weeks post-intervention)
Change in Insomnia Severity	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.	Baseline up to Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sleep Quality	Change in sleep quality will be assessed using the validated Pittsburgh Sleep Quality Index.	Baseline up to Week 8 (1 month post-intervention)
Change in Pain Severity	Change in pain severity will be assessed using the validated Brief Pain Index	Baseline up to Week 8 (1 month post-intervention)
Change in Symptom Burden	Change in symptom burden will be assessed using the validated Edmonton Symptom Assessment System	Baseline up to Week 8 (1 month post-intervention)
Change in Cognitive Function	Change in cognitive function will be assessed using the validated Simplified Animal Naming Test	Baseline up to Week 8 (1 month post-intervention)
Change in health-related quality of life	Change in health-related quality of life, including fatigue, will be assessed using the validated PROMIS-29+2 scale	Baseline up to Week 8 (1 month post-intervention)
Change in nightly subjective sleep and covariance with objective sleep	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.	Baseline up to Week 8 (1 month post-intervention)
Change in nightly objective sleep and covariance with subjective sleep	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)	Baseline up to Week 8 (1 month post-intervention)
Change in Anxiety and Depression Symptoms	Change in anxiety and depression symptoms will be assessed using the validated Hospital Anxiety and Depression Scale. Score range 0-21 with higher scores indicating higher psychological distress.	Baseline up to Week 8 (1 month post-intervention)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Pathologic Processes; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Fibrosis; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2026P000134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No