Duke University Medical Center, Durham, NC, USA.
Duke University Medical Center, Durham, NC, USA; Durham VA Healthcare System, Durham, NC, USA.
Contemp Clin Trials. 2021 Mar;102:106269. doi: 10.1016/j.cct.2021.106269. Epub 2021 Jan 8.
Posttraumatic stress disorder (PTSD) has been associated with accelerated progression of coronary heart disease (CHD). However, the underlying pathophysiological pathway has remained elusive and it is unclear whether there is a direct link between PTSD and CHD risk. This paper describes the methods of a randomized controlled trial developed to examine how changes in PTSD symptoms affect CHD disease pathways. One hundred twenty participants with current PTSD and who are free of known CHD will be randomized to receive either an evidence-based treatment for PTSD (Cognitive Processing Therapy; CPT) or a waitlist control (WL). Before and after CPT/WL, participants undergo assessment of CHD risk biomarkers reflecting autonomic nervous system dysregulation, systemic inflammation, and vascular endothelial dysfunction. The primary hypothesis is that individuals who show improvement in PTSD symptoms will show improvement in CHD risk biomarkers, whereas individuals who fail to improve or show worsening PTSD symptoms will have no change or worsening in CHD biomarkers. This study is expected to provide knowledge of the role of both the direct impact of PTSD symptoms on CHD risk pathways and the role of these systems as candidate mechanisms underlying the relationship between PTSD and CHD risk. Further, results will provide guidance on the utility of cognitive therapy as a tool to mitigate the accelerated progression of CHD in PTSD. Clinical Trials Registration: https://clinicaltrials.gov/ct2/show/NCT02736929; Unique identifier: NCT02736929.
创伤后应激障碍（PTSD）与冠心病（CHD）的进展加速有关。然而，其潜在的病理生理途径仍不清楚，PTSD 与 CHD 风险之间是否存在直接联系也尚不清楚。本文介绍了一项随机对照试验的方法，该试验旨在研究 PTSD 症状的变化如何影响 CHD 疾病途径。将 120 名目前患有 PTSD 且无已知 CHD 的参与者随机分为接受基于证据的 PTSD 治疗（认知加工治疗；CPT）或候补名单对照（WL）组。在 CPT/WL 之前和之后，参与者接受反映自主神经功能紊乱、全身炎症和血管内皮功能障碍的 CHD 风险生物标志物的评估。主要假设是，PTSD 症状改善的个体将改善 CHD 风险生物标志物，而未能改善或 PTSD 症状恶化的个体则不会改变或恶化 CHD 生物标志物。这项研究有望提供 PTSD 症状对 CHD 风险途径的直接影响以及这些系统作为 PTSD 和 CHD 风险之间关系的潜在机制的作用的知识。此外，研究结果将为认知疗法作为减轻 PTSD 中 CHD 加速进展的工具的效用提供指导。临床试验注册：https://clinicaltrials.gov/ct2/show/NCT02736929；独特标识符：NCT02736929。
