LiverSleep: An Adapted Telehealth-Delivered Cognitive Behavioral Therapy Intervention for Patients With Cirrhosis and Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Feasibility: Enrollment rate of those screened and eligible
研究概览
简要总结
This is a pilot trial to test the feasibility and acceptability of a virtual cognitive behavioral program for insomnia for patients with cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Behavioral: Intervention - Adapted 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. 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.
干预措施: Adapted Virtual Insomnia Program (Behavioral)
结局指标
主要结局
Feasibility: Enrollment rate of those screened and eligible
时间窗: 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.
次要结局
- Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction(Baseline to Week 8 (4 weeks post-intervention))
- Change in Insomnia Severity(Baseline up to Week 8)
研究者
Nneka nnaoke Ufere
Assistant Professor of Medicine
Massachusetts General Hospital