Cirrhosis, Insomnia
Conditions
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.
Interventions
BEHAVIORALAdapted Virtual Insomnia Program
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Enrollment rate of those screened and eligible | Baseline to Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction | Baseline to Week 8 (4 weeks post-intervention) | 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 |
Countries
United States
Outcome results
None listed