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

Massachusetts General Hospital11 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cirrhosis Insomnia

Interventions

Adapted Virtual Insomnia ProgramBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Week 4

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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