A PILOT EFFECTIVENESS TRIAL OF COGNITIVE PROCESSING THERAPY AUGMENTED WITH SUICIDE RISK MANAGEMENT FOR INDIVIDUALS WITH COMORBID PTSD AND BPD

7.项目总结 该项目是一项旨在评估认知加工疗法的先导性有效性试验 加强自杀风险管理协议(CPT+SRM)，作为一种可行的治疗方法 患有创伤后应激障碍(PTSD)和边缘人格的个体 精神障碍(BPD)。创伤后应激障碍是一个重大的公共卫生问题，与衰弱有关 自杀、就业困难和家庭破裂等后果。这些结果是 当创伤后应激障碍与BPD并存时，情况进一步恶化。创伤后应激障碍与BPD的共病 (PTSD-BPD)高达58%，并与更大的功能损害相关(例如， 自杀风险)，以及随后的医疗保健利用率，而不是仅限于这两种疾病。尽管 与创伤后应激障碍相关的临床和经济负担，对此几乎没有治疗方法 人口和新兴治疗是漫长、密集、资源密集型的，而且很难 在现实世界的社区环境中保持。使用一种实验性的治疗学方法，这 提案评估CPT+SRM是一种针对关键目标的节俭、综合干预 创伤后应激障碍和BPD的共同机制--即情绪反应和认知功能障碍。 斯坦福大学门诊普通成人心理社会治疗诊所将作为 治疗地点和研究治疗师将是社区临床医生，兼职预约在 诊所。这项调查的第一阶段将由最初的病例系列(N=5)组成，在该系列中我们将 开发和迭代手册，开发保真度衡量标准，并简化我们的研究 程序。最终的治疗手册将在第二阶段进行测试，这是一种随机- 对照试验(N=28)比较12个单独疗程/6周CPT+SRM(n=14)与6个疗程 仅SRM治疗周(n=14)。参与者将在治疗前、治疗中/3- 治疗后/6周和治疗后3个月的随访。目标1将评估 CPT+SRM的可行性、可接受性和安全性。目标2将初步评估 CPT+SRM的有效性。目标3将检查我们的变化与 假定的目标机制(使用自我报告、行为和生理测量 指标)和主要临床结果(即创伤后应激障碍和BPD严重程度)。长期的 这项研究的目的是通过一项后续的大规模干预试验 R01机制，并最终加强服务提供和护理的可及性 临床复杂且经济负担沉重的人群。

7. Project Summary This project is a pilot effectiveness trial designed to evaluate Cognitive Processing Therapy augmented with a suicide risk management protocol (CPT+SRM), as a viable treatment for individuals with comorbid posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD). PTSD is a significant public health problem associated with debilitating outcomes such as suicide, employment difficulties, and family disruption. These outcomes are further compounded when PTSD is comorbid with BPD. The comorbidity of PTSD and BPD (PTSD-BPD) is as high as 58% and is associated with even greater functional impairment (e.g., suicide risk) and, subsequently, healthcare utilization than either disorder alone. Despite the clinical and economic burden associated with PTSD-BPD, few treatments exist for this population and emerging treatments are lengthy, intensive, resource-heavy, and difficult to sustain in real-world community settings. Using an experimental therapeutics approach, this proposal evaluates CPT+SRM as a parsimonious, integrative intervention that targets key mechanisms shared across PTSD and BPD- i.e., emotional reactivity and cognitive dysfunction. The Stanford Outpatient General Adult Psychosocial Treatment Clinic will serve as the treatment site and study therapists will be community clinicians with part-time appointments at the clinic. Phase 1 of this investigation will consist of an initial case series (N=5) in which we will develop and iterate the manual, develop fidelity measures, and streamline our research procedures. The finalized treatment manual will then be tested in Phase 2, a randomized- controlled trial (N=28) comparing 12 individual sessions/6 weeks of CPT+SRM (n=14) versus 6 weeks of SRM only (n=14). Participants will be assessed at pre-treatment, mid-treatment/3- weeks, post-treatment/6-weeks, and 3-month post-treatment follow-up. Aim 1 will be to evaluate the feasibility, acceptability, and safety of CPT+SRM. Aim 2 will be to preliminarily evaluate the effectiveness of CPT+SRM. Aim 3 will be to examine the relationship between change in our putative target mechanisms (measured using self-report, behavioral, and physiological indicators), and primary clinical outcomes (i.e., PTSD and BPD severity). The long-term objective of this research is to conduct a subsequent large-scale intervention trial through an R01 mechanism and ultimately enhance service delivery and accessibility of care for this clinically complex and economically burdensome population.