LiverSleep virtual behavioral sleep program for people with cirrhosis and insomnia
LiverSleep: An Adapted Telehealth-Delivered Cognitive Behavioral Therapy Intervention for Patients With Cirrhosis and Insomnia
This pilot tests whether a virtual cognitive behavioral sleep program can help adults with cirrhosis who have insomnia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07417163 on ClinicalTrials.gov |
What this trial studies
This pilot tests the feasibility and acceptability of an adapted virtual cognitive behavioral therapy for insomnia (CBT-I) program delivered to adults with cirrhosis followed at the MGH Liver Clinic. Eligible ambulatory English-speaking patients must report at least mild insomnia (ISI ≥8) and meet sleep difficulty criteria, and will be screened to exclude significant cognitive impairment, active alcohol misuse, untreated obstructive sleep apnea, severe restless leg syndrome, or night/rotating shift work. The intervention is delivered remotely and tailored to the cirrhosis population, and outcomes will focus on feasibility, acceptability, and changes in insomnia symptoms rather than definitive efficacy. This is a single-center pilot at Massachusetts General Hospital intended to inform larger trials and implementation.
Who should consider this trial
Good fit: Adult (≥18) ambulatory patients with compensated or decompensated cirrhosis who receive care at the MGH Liver Clinic or Liver Transplant Evaluation Clinic, speak English, and have at least mild insomnia (ISI ≥8) with documented sleep difficulty are ideal candidates.
Not a fit: Patients with uncontrolled neuropsychiatric disorders, cognitive impairment, current alcohol misuse, untreated or high-risk obstructive sleep apnea, severe restless leg syndrome, or night/rotating shift work are excluded and may not benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could reduce insomnia symptoms and improve sleep quality and daytime functioning for people with cirrhosis using a remotely delivered, liver-tailored approach.
How similar studies have performed: Cognitive behavioral therapy for insomnia (CBT-I) is an established effective treatment in general populations and virtual/adapted CBT-I programs have shown success elsewhere, but evidence specifically in people with cirrhosis is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: William Munroe
- Email: Wlmunroe@mgh.harvard.edu
- Phone: 617-726-0161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.