An evaluation of insomnia treatment to reduce cardiovascular risk in patients with posttraumatic stress disorder

失眠治疗降低创伤后应激障碍患者心血管风险的评估

• 批准号: 10647818
• 负责人: JEAN C. BECKHAM
• 金额: $ 76.67万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10647818
• 关键词: Address; Adult; Alcohol abuse; Ambulatory Blood Pressure Monitoring; Arousal; Atherosclerosis; Behavioral; Biological Markers; Blood Pressure; Cardiovascular Diseases; Catecholamines; Chronic; Cognitive Therapy; Comorbid Insomnia; Data; Development; Evaluation; Event; Exposure to; Goals; Health behavior; Heterogeneity; Hour; Individual; Intervention; Knowledge; Link; Lipids; Measurement; Measures; Mediating; Medical; Mental Depression; Mental disorders; Minority; Morbidity - disease rate; Outcome; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Phenotype; Population; Post-Traumatic Stress Disorders; Prospective Studies; Psychotherapy; Quality Indicator; Quality of life; Randomized; Research; Risk; Risk Factors; Severities; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Sympathetic Nervous System; Symptoms; Testing; Therapeutic; Time; Trauma; Vascular Endothelium; Woman; Work; actigraphy; arm; associated symptom; atherosclerosis risk; biological sex; brachial artery; cardiovascular disorder risk; cardiovascular risk factor; cigarette smoking; comorbidity; comparison control; cost; design; evidence base; follow-up; improved; improvement on sleep; indexing; innovation; interest; medication compliance; men; middle age; mortality; multimodality; poor sleep; post intervention; psychiatric comorbidity; response; sleep onset; sleep quality; traumatic event; treatment response; urinary

Posttraumatic stress disorder (PTSD) is a disabling and costly psychiatric disorder that is estimated to occur in 20% of individuals who are exposed to a traumatic event and is chronic in one third of cases. In addition to its negative impact on quality of life, there is substantial evidence that PTSD (even after controlling for depression and other risk factors) is associated with a markedly increased risk of cardiovascular morbidity and mortality. However, the mechanisms for the association between PTSD and cardiovascular disease (CVD) risk are not well understood. Although adverse health behaviors, including cigarette smoking, alcohol abuse and poor medication adherence are common in PTSD, recent prospective studies show that they do not account for the magnitude of CVD risk among individuals with PTSD. We propose to test our central hypothesis by evaluating whether CBT-I results in improved biomarkers of CVD risk among those with PTSD. Well established biomarkers of CVD related morbidity and mortality will be used including measures of vascular endothelial function measured by brachial artery flow-mediated dilation (FMD), nighttime blood pressure (BP) dipping measured using 24-hour ambulatory blood pressure monitoring (ABPM), and sympathetic nervous system (SNS) activity as measured by 24-hour urinary catecholamines. We will also assess lipid profile, which along with BP is a modifiable component with marked impact on the atherosclerotic cardiovascular disease (ASCVD) risk score. The primary sleep parameter of interest is objectively-measured sleep efficiency (through actigraphy), although self-report insomnia measures and sleep related arousal will also be measured. The rationale for the proposed research is that once it is established that insomnia is an important and modifiable symptom conveying increased CVD risk in this population, the development of new and innovative approaches to integrating insomnia treatment with PTSD-focused interventions can be developed. 150 men and women with comorbid PTSD and insomnia disorder will be randomly assigned with a 2:1 ratio to 8-week cognitive behavioral therapy-Insomnia (CBT-I) intervention or a waiting period control condition. Sleep quality parameters and CVD risk biomarkers will be assessed at pre- randomization baseline, post-intervention, and at a 6-month follow-up. The study is designed to evaluate the association between insomnia and CVD risk biomarkers among persons with PTSD, and determine whether improvements in insomnia symptoms are associated with improvements in CVD risk biomarkers.

创伤后应激障碍（PTSD）是一种致残和昂贵的精神疾病，估计发生在 20%的人暴露于创伤事件，并且在三分之一的情况下是慢性的。除了其 对生活质量的负面影响，有大量证据表明PTSD（即使在控制抑郁症之后） 和其他危险因素）与心血管发病率和死亡率的显著增加的风险相关。 然而，PTSD与心血管疾病（CVD）风险之间的联系机制尚不清楚 明白虽然不良健康行为，包括吸烟，酗酒和不良药物治疗 坚持是常见的创伤后应激障碍，最近的前瞻性研究表明，他们不占的大小， PTSD患者的CVD风险我们建议通过评估CBT-I是否可以测试我们的中心假设 导致PTSD患者心血管疾病风险的生物标志物改善。明确的CVD相关生物标志物 将使用发病率和死亡率，包括通过肱动脉测量的血管内皮功能指标。 动脉血流介导的扩张（FMD），夜间血压（BP）下降，使用24小时动态血压计测量 血压监测（ABPM）和交感神经系统（SNS）活动，如24小时测量的 尿中的儿茶酚胺我们还将评估血脂，这沿着与血压是一个可修改的组成部分， 对动脉粥样硬化性心血管疾病（ASCVD）风险评分有显著影响。主要睡眠参数 感兴趣是客观测量的睡眠效率（通过活动记录仪），尽管自我报告的失眠测量和 还将测量与睡眠相关的觉醒。拟议研究的基本原理是，一旦建立 失眠是一个重要的和可改变的症状，传达了这一人群心血管疾病风险的增加， 开发新的创新方法，将失眠治疗与以PTSD为重点的 可以制定干预措施。150名患有创伤后应激障碍和失眠症的男性和女性， 以2：1的比例随机分配到8周认知行为治疗-干预（CBT-I）或 等待期控制条件。睡眠质量参数和CVD风险生物标志物将在术前评估。 随机化基线、干预后和6个月随访时。该研究旨在评估 在PTSD患者中，失眠与CVD风险生物标志物之间的关联，并确定是否 失眠症状的改善与CVD风险生物标志物的改善相关。