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

NCT07417163 | Completed

• 1 other identifier: 2026P000134
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cirrhosis; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline to Week 8 (4 weeks post-intervention)

Other Outcomes (3)

• Change in Insomnia Severity

  Baseline up to Week 8

• Change in nightly subjective sleep and covariance with objective sleep

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

• Change in nightly objective sleep and covariance with subjective sleep

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

Study Arms (1)

Behavioral: Intervention - Adapted Virtual Insomnia Program

EXPERIMENTAL

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.

Behavioral: Adapted Virtual Insomnia Program

Interventions

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.

Behavioral: Intervention - Adapted Virtual Insomnia Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Fibrosis; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: February 26, 2026
• Primary Completion: June 20, 2026
• Study Completion: July 9, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

US (1)