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

针对患有共病 PTSD 和 BPD 的个体进行认知处理疗法与自杀风险管理相结合的试点有效性试验

• 批准号: 10356409
• 负责人: Janice Rose Kuo
• 金额: $ 18.45万
• 依托单位: PALO ALTO UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-01 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10356409
• 关键词: Adopted; Adult; Aftercare; Appointment; Behavior; Behavioral; Borderline Personality Disorder; Case Series; Client; Clinic; Clinical; Cognitive; Communities; Complex; Coupled; Diagnosis; Disease; Dropout; Economic Burden; Emotional; Emotional disorder; Employment; Family; Frequencies; Gold; Healthcare; Hospitalization; Impaired cognition; Individual; Integrative Therapy; Intervention; Intervention Trial; Interview; Investigation; Investigational Therapies; Knowledge; Manuals; Measures; Mental Health; Modeling; Monitor; Morbidity - disease rate; Outcome; Outpatients; Overutilization of Health Services; Participant; Patient Self-Report; Performance; Phase; Physiological; Population; Post-Traumatic Stress Disorders; Procedures; Protocols documentation; Public Health; Randomized Controlled Trials; Research; Research Project Grants; Resources; Risk; Risk Management; Safety; Severities; Suicide; Suicide attempt; Testing; Therapeutic; Time; affective neuroscience; alternative treatment; base; brief intervention; clinical care; community setting; comorbidity; cost; effectiveness evaluation; effectiveness trial; emotion dysregulation; follow-up; functional disability; health care service utilization; implementation efforts; implementation facilitation; improved; innovation; neuroimaging; non-suicidal self injury; primary outcome; psychosocial; satisfaction; secondary outcome; service delivery; standard care; suicidal behavior; suicidal risk; treatment site; trial design

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.

7.项目摘要 这个项目是一个试验性的有效性试验，旨在评估认知加工疗法 加强自杀风险管理方案（CPT+SRM），作为一种可行的治疗方法， 患有创伤后应激障碍（PTSD）和边缘型人格的患者 疾病（BPD）。创伤后应激障碍是一个重要的公共卫生问题， 自杀、就业困难和家庭破裂等后果。这些结果是 当PTSD与BPD共病时会进一步加重。PTSD与BPD的共病关系 （PTSD-BPD）高达58%，并与更大的功能障碍（例如， 自杀风险）和随后的医疗保健利用率高于单独的任何一种疾病。尽管 与PTSD-BPD相关的临床和经济负担，很少有治疗方法存在 人口和新兴的治疗是漫长的，密集的，资源沉重，难以 在现实世界的社区环境中维持。使用实验治疗方法，这 一项提案将CPT+SRM评估为一种节俭的综合干预措施， PTSD和BPD共有的机制-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 治疗中心和研究治疗师将是社区临床医生，兼职预约在 诊所本研究的第1阶段将包括初始病例系列（N=5），我们将 制定和修订手册，制定保真度措施，并简化我们的研究 程序.最终的治疗手册将在第2阶段进行测试，这是一项随机- 对照试验（N=28），比较了12次单独治疗/6周CPT+SRM（n=14）与6次单独治疗/6周CPT+SRM（n=14） 仅SRM周（n=14）。将在治疗前、治疗中/3- 周、治疗后/6周和治疗后3个月随访。目标1是评估 CPT+SRM的可行性、可接受性和安全性。目标2是初步评估 CPT+SRM的有效性。目标3将是检查我们的变化之间的关系 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，PTSD和BPD严重程度）。长期 本研究的目的是通过一项 R 01机制，并最终加强服务的提供和护理的可及性， 临床复杂且经济负担沉重的人群。