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

基本信息

批准号：
10199022
负责人：
JEAN C. BECKHAM
金额：
$ 79.25万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
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/10199022
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 response sleep onset sleep quality traumatic event treatment response urinary

项目摘要

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）是一种致残且代价高昂的精神疾病，估计发生在 20% 的人经历过创伤性事件，其中三分之一的病例是慢性的。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相关。然而，PTSD 与心血管疾病 (CVD) 风险之间的关联机制尚不明确。明白了。尽管不良健康行为，包括吸烟、酗酒和不良药物治疗依从性在 PTSD 中很常见，最近的前瞻性研究表明，它们并没有考虑到 PTSD 的严重程度。 PTSD 患者的 CVD 风险。我们建议通过评估 CBT-I 是否导致 PTSD 患者的 CVD 风险生物标志物得到改善。 CVD 相关的成熟生物标志物将使用发病率和死亡率，包括通过肱动脉测量血管内皮功能的指标动脉血流介导的扩张 (FMD)、使用 24 小时动态血压 (BP) 测量的夜间血压 (BP) 下降血压监测 (ABPM) 和 24 小时测量的交感神经系统 (SNS) 活动尿儿茶酚胺。我们还将评估血脂状况，血脂状况与血压一起是可修改的成分对动脉粥样硬化性心血管疾病（ASCVD）风险评分有显着影响。主要睡眠参数兴趣是客观测量的睡眠效率（通过体动记录仪），尽管自我报告失眠测量和还将测量与睡眠相关的唤醒。拟议研究的基本原理是，一旦建立失眠是一种重要且可改变的症状，会增加该人群的 CVD 风险，开发新的创新方法，将失眠治疗与创伤后应激障碍 (PTSD) 相结合可以制定干预措施。 150 名患有 PTSD 和失眠症共病的男性和女性将接受治疗以 2:1 的比例随机分配接受 8 周认知行为治疗 - 失眠 (CBT-I) 干预或等待期控制条件。睡眠质量参数和 CVD 风险生物标志物将在预评估随机化基线、干预后和 6 个月的随访。该研究旨在评估 PTSD 患者失眠与 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心血管疾病风险生物标志物的改善相关。