Cognitive Behavioral Therapy for Insomnia: A Self-Management Strategy for Chronic Illness in Stable Heart Failure

失眠认知行为疗法：稳定型心力衰竭慢性疾病的自我管理策略

基本信息

批准号：
9151633
负责人：
Nancy S Redeker
金额：
$ 70.99万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-28 至 2020-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9151633
关键词：
Address Adverse event Aftercare American Anxiety Attention Behavior Behavior Therapy Behavioral Characteristics Chronic Chronic Disease Chronic Insomnia Clinical Cognition Cognitive Therapy Control Groups Cost Effectiveness Analysis Data Analyses Development Diagnosis Disease Management Disease remission Disease-Free Survival Dyspnea Education Excessive Daytime Sleepiness Fatigue Health Health Care Costs Health Professional Heart failure Hospitalization Intervention Lead Measures Mental Depression Modeling Morbidity - disease rate Outcome Pain Patient Self-Report Patients Performance Population Psychomotor Impairments Quality of life Randomized Randomized Controlled Trials Reporting Resources Self Management Severities Sleep Sleeplessness Survival Analysis Symptoms Testing Time Translations Vulnerable Populations Walking Work Wrist common symptom cost cost effective cost effectiveness diaries disabling symptom evidence base falls follow-up health care service utilization hypnotic improved mortality primary outcome psychologic reduce symptoms survival outcome symptom cluster symptomatic improvement treatment effect trend vigilance

项目摘要

DESCRIPTION (provided by applicant): Almost 75% of HF patients, a group of about 5.1 million Americans who have poor function and high levels of morbidity and mortality, report poor sleep. As many as 25-56% of HF patients report chronic insomnia (difficulty initiating or maintaining sleep or waking early in the morning, with non-restorative sleep that persists for at least a month). Chronic insomnia may contribute to the development and exacerbation of HF and incident mortality. It is also associated with common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance.10 However, insomnia is under-diagnosed and under-treated in this population. The purposes of the proposed RCT are to evaluate the sustained effects of CBT-I, compared with HF self-management education (attention control), on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia and receive evidence-based HF disease management. We will also evaluate the cost-effectiveness of CBT-I compared with the attention- control condition and explore the effects of CBT-I on event-free survival. We will address the following specific aims (*primary outcomes): (1) Test the sustained effects (baseline - 2 weeks, 6, 9, 12 months) of CBT-I provided in 4 group sessions over 8 weeks, compared with HF self-management education (attention control condition), on: (1a) *insomnia severity and self-reported and actigraph-recorded sleep characteristics (*sleep quality, *sleep efficiency, sleep latency, and duration); (1b) symptoms (*fatigue, anxiety, depression, pain, sleepiness, sleep-related impairment), and psychomotor vigilance (PVT); and (1c) symptom clusters [membership in clusters characterized by severity of specific symptoms; transition between clusters over time]; (2) Test the sustained effects of CBT-I on self-reported and objective functional performance; and (3) Examine the cost-effectiveness of CBT-I. Exploratory aim: We will explore the effects of CBT-I on event-free survival. A total of 200 patients will be randomized to 4 bi-weekly sessions of group CBT-I or an attention control condition consisting of HF self-management education. Wrist actigraph measures of sleep, diaries, psychomotor vigilance and 6 minute walk test distance, and self-report measures of insomnia, sleep, symptoms, and functional performance will be obtained at baseline and follow-up. Data analysis will consist of mixed effects models, latent transition analysis, stochastic cost effectiveness analysis, and survival analysis.

描述（由适用提供）：近75％的HF患者，大约510万美国人的功能较差，发病率和死亡率高的美国人报告睡眠不佳。多达25-56％的HF患者报告了慢性失眠（难以在清晨开始或保持睡眠或醒来，而不可感染的睡眠持续至少一个月）。慢性失眠可能导致HF和事件死亡率的发展和加剧。它还与常见和残疾症状（疲劳，呼吸困难，抑郁，白天嗜睡过度和疼痛）以及客观和主观功能性能的减少有关。10但是，失眠不足以诊断并在该人群中治疗不足。与HF自我管理教育（注意力控制）相比，该提议的RCT的目的是评估CBT-I的持续作用，对患有稳定的慢性HF和慢性失眠症的患者的失眠严重程度，睡眠特征，白天症状和功能性能，并在十二个月内进行功能性能。我们还将评估CBT-I与注意力控制条件相比的成本效益，并探讨CBT-I对无事件生存的影响。我们将解决以下具体目标（ *主要结果）：（1）测试与HF自我管理教育（注意控制条件）相比，在4个小组中提供的CBT-I的持续效应（基线-2周，6、9、12个月）在：（1A） * *A *A）的严重程度和自我竞争和自我反应和行动式睡眠状态和睡眠状态（ *）睡眠状态（ *）（1b）符号（*疲劳，焦虑，抑郁，疼痛，嗜睡，与睡眠有关的障碍）和精神病警惕（PVT）；（1C）症状簇[以特定症状的严重性为特征的集群中的成员；随着时间的流逝，簇之间的过渡]；（2）测试CBT-I对自我报告和客观功能性能的持续影响；（3）检查CBT-I的成本效益。探索目的：我们将探索CBT-I对无事件生存的影响。共有200名患者将被随机分为CBT-I组的4个每两周一次，或者由HF自我管理教育组成的注意力控制条件。腕部表演量度的测量，日记，精神运动警惕和步行6分钟的测试距离以及自我报告的失眠，睡眠，症状和功能性能的措施将在基线和随访时获得。数据分析将包括混合效应模型，潜在过渡分析，随机成本有效分析和生存分析。