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: 10471176
• 负责人: JEAN C. BECKHAM
• 金额: $ 77.83万
• 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/10471176
• 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; base; biological sex; brachial artery; cardiovascular disorder risk; cardiovascular risk factor; cigarette smoking; comorbidity; cost; design; disorder risk; evidence base; follow-up; improved; indexing; innovation; interest; medication compliance; men; middle age; mortality; multimodality; poor sleep; post intervention; post-traumatic symptoms; 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）是一种残疾和昂贵的精神疾病，估计发生在 在暴露于创伤事件的人中，有20％的人在三分之一的情况下慢性病。除了它的 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风险显着增加有关。 但是，PTSD与心血管疾病（CVD）风险之间关联的机制不好 理解。尽管不良健康行为，包括吸烟，酗酒和药物不良 依从性在PTSD中很常见，最近的前瞻性研究表明，它们不考虑 PTSD患者的CVD风险。我们建议通过评估CBT-1是否测试中心假设 在患有PTSD的人群中，CVD风险的生物标志物改善了生物标志物。 CVD相关的良好生物标志物 发病率和死亡率将被使用，包括通过臂臂测量的血管内皮功能的度量 动脉流介导的扩张（FMD），夜间血压（BP）使用24小时卧床测量 血压监测（ABPM）和交感神经系统（SNS）活性由24小时测量 泌尿儿茶酚胺。我们还将评估脂质曲线，与BP一起是一个可修改的组件， 对动脉粥样硬化心血管疾病（ASCVD）风险评分的明显影响。主要睡眠参数 兴趣是客观测量的睡眠效率（通过行为），尽管自我报告失眠和 还将测量与睡眠相关的唤醒。拟议的研究的理由是，一旦建立 失眠是一种重要且可修改的症状，可传达该人群中CVD风险的增加， 开发新的和创新的方法，将失眠治疗与以PTSD为中心相结合 可以开发干预措施。 150名合并症PTSD和失眠症的男性和女性将是 以2：1的比率与8周的认知行为疗法 - Insomnia（CBT-I）干预或A进行随机分配 等待期控制条件。睡眠质量参数和CVD风险生物标志物将在前评估 随机基线，干预后以及6个月的随访。该研究旨在评估 失眠和CVD风险生物标志物之间有PTSD的人的关联，并确定是否是否 失眠症状的改善与CVD风险生物标志物的改善有关。