Cognitive Behavioral Therapy for Insomnia in Stable Heart Failure

描述（由申请人提供）：失眠在慢性心力衰竭（HF）的成年人中很常见，这是一种与功能表现缺陷、症状负担、高发病率和死亡率相关的疾病。迄今为止，关于改善这一庞大人群睡眠的策略的研究还很少。失眠认知行为疗法（CBT-I）是一种有效的治疗失眠合并症的几种医学和精神疾病，但尚未在心衰中进行试验。本探索性发展研究的目的是检验CBT-I对稳定型心衰患者睡眠失眠症状主客观特征及功能表现影响的可行性、可接受性和大小。40例稳定型心衰患者将被随机分为7周的CBT-I或7周的心衰自我管理教育（包括睡眠卫生（注意控制））。主观（日记、问卷）和客观（腕动仪）睡眠特征；在干预前和干预后测量患者的症状和自我报告的功能表现。我们还将获得尿中游离皮质醇、游离肾上腺素/去甲肾上腺素和硫酸褪黑素的昼夜测量。我们将：1)完善CBT-I干预的方案、程序、患者资料和培训手册，并开设群体HF自我管理课程（注意控制）；2)评估CBT-I干预和注意控制条件的可行性和可接受性；3)与注意控制相比，评价CBT-I组对客观（活动记录仪）和主观（问卷和睡眠日记）睡眠特征、失眠症状自述、睡眠信念和态度的影响程度；4)与注意控制相比，评估CBT-I对日间症状（疲劳、抑郁、焦虑、日间过度嗜睡）和功能表现的影响程度。主要结果将是自我报告的睡眠连续性（睡眠效率）。我们还将探讨睡眠特征和失眠症状的变化对症状和日间功能的影响；与注意控制相比，CBT-I对夜间症状的影响，以及与注意控制相比，CBT-I对夜间和白天hpa轴（尿游离皮质醇）、交感神经系统（尿肾上腺素/去甲肾上腺素）和松果体（尿褪黑激素）功能的生物指标的影响。该结果将用于支持未来更大规模疗效研究的设计决策，并可能最终导致cbt - 1转化为心衰患者的治疗。公共卫生相关性：心力衰竭影响超过500万美国人，并与功能不良、阴性症状和生活质量差有关。失眠是一种开始和维持睡眠的障碍，在这些患者中很常见，并有助于白天的症状和功能。我们计划测试认知行为疗法对中老年心力衰竭患者的睡眠、日间症状和功能的影响。

DESCRIPTION (provided by applicant): Insomnia is common in adults with chronic heart failure (HF), a condition associated with functional performance deficits, symptom burden, and high levels of morbidity and mortality. To date there has been little study of strategies to improve sleep in this large population. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia comorbid with several medical and psychiatric disorders, but has not been tested in HF. The purpose of this exploratory developmental research is to test the feasibility, acceptability, and size of the effects of CBT-I on subjective and objective characteristics of sleep and insomnia symptoms and functional performance in patients with stable HF. Forty patients with stable HF will be randomized to 7 weeks of CBT-I or 7-weeks of HF self-management education with sleep hygiene (attention control). Subjective (diaries, questionnaires) and objective (wrist actigraphy) characteristics of sleep; symptoms, and self-reported functional performance will be measured pre- and post-intervention. We will also obtain day and night measures of urinary free cortisol, free epinephrine/norepinephrine, and melatonin sulfate. We will: 1) refine the protocol, procedures, patient materials, and training manual for the CBT-I intervention and a group HF self-management class (attention-control); 2) evaluate the feasibility and acceptability of the CBT-I intervention and the attention-control conditions; 3) evaluate the size of the effects of group CBT-I, compared with attention-control, on objective (actigraph) and subjective (questionnaire and sleep diary) sleep characteristics, self-report of insomnia symptoms, and beliefs and attitudes about sleep; and 4) evaluate the size of the effects of CBT-I, compared with attention-control, on daytime symptoms (fatigue, depression, anxiety, excessive daytime sleepiness) and functional performance. The primary outcome will be self-reported sleep continuity (sleep efficiency). We will also explore the effects of changes in characteristics of sleep and insomnia symptoms on symptoms and daytime function; the effects of CBT-I, compared with attention control, on nocturnal symptoms, and the effects of CBT-I, compared with attention control, on biological indicators of nocturnal and daytime HPA-axis (urinary free cortisol), sympathetic nervous system (urinary epinephrine/norepinephrine, and pineal (urinary melatonin) function. The results will be used to support design decisions for a future larger scale efficacy study and may ultimately lead to translation of CBT-I into the care of patients with HF. PUBLIC HEALTH RELEVANCE: Heart Failure affects over 5 million Americans and is associated with poor functioning, negative symptoms, and poor quality of life. Insomnia, a disorder of initiating and maintaining sleep, is common in these patients and contributes to daytime symptoms and functioning. We plan to test the effects of cognitive behavioral therapy, on sleep, daytime symptoms, and function middle-aged and older adults who have heart failure.