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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Nneka Ufere
4047885335

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

William Munroe
617-726-0161
Wlmunroe@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.