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: 10559584
• 负责人: Janice Rose Kuo
• 金额: $ 27.94万
• 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/10559584
• 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; 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; care burden; 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 该项目是一项旨在评估认知处理疗法的试验有效性试验 增强自杀风险管理方案（CPT+SRM），作为可行的治疗方法 病后应激障碍（PTSD）和边缘性格的个人 障碍（BPD）。 PTSD是与使人衰弱有关的重大公共卫生问题 自杀，就业困难和家庭中断等结果。这些结果是 当PTSD与BPD合并时，进一步更加复杂。 PTSD和BPD的合并症 （PTSD-BPD）高达58％，与更大的功能障碍有关（例如， 自杀风险），随后是医疗保健利用，而不是仅任何一种疾病。尽管有 与PTSD-BPD相关的临床和经济负担，对此几乎没有治疗 人口和新兴治疗是冗长，密集，资源繁重且难以 在现实世界社区环境中维持。使用实验治疗方法，这是 提案评估CPT+SRM作为一种针对关键的简约，综合干预措施 在PTSD和BPD-即情绪反应性和认知功能障碍之间共享的机制。 斯坦福大学门诊普通成人社会心理治疗诊所将作为 治疗现场和研究治疗师将是社区临床医生，并在 诊所。本研究的第1阶段将包括初始病例系列（n = 5），我们将 制定并迭代手册，制定忠诚度措施并简化我们的研究 程序。然后，最终确定的治疗手册将在第2阶段进行测试，一个随机 - 对照试验（n = 28）比较12个单独的会话/6周CPT+SRM（n = 14）与6 仅SRM周（n = 14）。参与者将在治疗，中期/3-中进行评估 几周，治疗后/6周和治疗后的3个月。目标1将是评估 CPT+SRM的可行性，可接受性和安全性。目标2将是初步评估 CPT+SRM的有效性。目标3将是检查我们的变化之间的关系 推定的目标机制（使用自我报告，行为和生理学测量 指标）和主要的临床结果（即PTSD和BPD严重程度）。长期 这项研究的目的是通过 R01机制，最终增强服务的服务和护理的可及性 临床上复杂且经济繁重的人口。