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)是一种致残性和代价高昂的精神障碍，估计发生在 20%的人暴露在创伤性事件中，三分之一的人患有慢性疾病。除了它的 对生活质量的负面影响，有大量证据表明，创伤后应激障碍(即使在控制了抑郁症之后 和其他危险因素)与心血管疾病发病率和死亡率的显著增加有关。 然而，创伤后应激障碍与心血管疾病(CVD)风险之间的联系机制还不是很好 明白了。尽管有害的健康行为，包括吸烟、酗酒和不良药物治疗 坚持在创伤后应激障碍中很常见，最近的前瞻性研究表明，它们不能解释创伤后应激障碍的程度 创伤后应激障碍患者的心血管疾病风险。我们建议通过评估CBT-I是否符合我们的中心假设 结果改善了创伤后应激障碍患者心血管疾病风险的生物标志物。心血管疾病相关生物标志物的研究进展 将使用发病率和死亡率，包括由臂部测量的血管内皮功能的测量 24小时动态测量动脉血流介导性扩张(FMD)、夜间血压(BP)下降 24小时血压监测(ABPM)和交感神经系统(SNS)活动 尿儿茶酚胺。我们还将评估血脂概况，它与BP一起是一个可修改的成分，具有 显著影响动脉粥样硬化性心血管疾病(ASCVD)风险评分。的主要睡眠参数 兴趣是客观地测量睡眠效率(通过活动记录仪)，尽管自我报告失眠测量和 与睡眠相关的唤醒也将被测量。提出这项研究的理由是，一旦它被确立 失眠是一种重要的可改变的症状，在这一人群中传递着增加的心血管疾病风险， 开发新的创新方法，将失眠治疗与关注创伤后应激障碍结合起来 干预措施是可以开发的。150名患有创伤后应激障碍和失眠障碍的男性和女性将被 随机分配2：1比例的认知行为疗法-失眠(CBT-I)干预或 等待期控制条件。睡眠质量参数和心血管疾病风险生物标记物将在 随机化基线、干预后和6个月的随访。这项研究旨在评估 创伤后应激障碍患者中失眠与心血管疾病风险生物标记物之间的关系，并确定 失眠症状的改善与心血管疾病风险生物标志物的改善有关。