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

• 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
• 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

 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（由申请人提供）：近75%的HF患者（约510万美国人）报告睡眠不佳，这些患者功能差，发病率和死亡率高。多达25-56%的HF患者报告慢性失眠（难以启动或维持睡眠或清晨醒来，持续至少一个月的非恢复性睡眠）。慢性失眠可能导致HF的发展和加重以及意外死亡。它还与常见和致残症状（疲劳、呼吸困难、焦虑、抑郁、白天过度嗜睡和疼痛）以及客观和主观功能表现的下降有关。10然而，失眠在这一人群中诊断不足，治疗不足。拟定RCT的目的是评价CBT-I与HF自我管理教育（注意力控制）相比对稳定慢性HF和慢性失眠并接受循证HF疾病管理的患者在12个月内失眠严重程度、睡眠特征、日间症状和功能表现的持续影响。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对无事件生存率的影响。我们将致力于实现以下具体目标（* 主要结果）：（1）测试持续效果（基线- 2周，6，9，12个月）CBT-I在8周内的4个小组会议中提供，与HF自我管理教育相比，（注意力控制条件），在：（1a）* 失眠严重程度和自我报告及活动记录仪记录的睡眠特征（* 睡眠质量，* 睡眠效率，睡眠潜伏期和持续时间）;（1b）症状（* 疲劳、焦虑、抑郁、疼痛、嗜睡、睡眠相关损害）和精神警觉（PVT）;和（1c）症状群[以特定症状的严重程度为特征的群的成员资格;随时间推移在群之间的转变];（2）测试CBT-I对自我报告和客观功能表现的持续影响;和（3）检查CBT-I的成本效益。探索性目的：我们将探索CBT-I对无事件生存期的影响。共200例患者将被随机分配至CBT-I组的4个双周疗程或由HF自我管理教育组成的注意力控制条件。将在基线和随访时获得睡眠、日记、精神警觉性和6分钟步行测试距离的腕动计测量值，以及失眠、睡眠、症状和功能表现的自我报告测量值。数据分析将包括混合效应模型、潜在转移分析、随机成本 有效性分析和生存分析。