Lau W, Chisholm K, Gallagher M W, Felmingham K, Murray K, Pearce A, Doyle N, Alexander S, O'Brien H, Putica A, Khatri J, Bockelmann P, Hosseiny F, Librado A, Notarianni M, O'Donnell M L
Phoenix Australia - Centre for Posttraumatic Mental Health, Department of Psychiatry, The University of Melbourne, Victoria, Australia.
Department of Psychology, The University of Houston, TX, USA.
Contemp Clin Trials Commun. 2023 Apr 19;33:101134. doi: 10.1016/j.conctc.2023.101134. eCollection 2023 Jun.
Prolonged Exposure (PE), a trauma-focused therapy, is one of the most efficacious treatments available for PTSD. However, many people with PTSD do not lose their diagnosis following delivery of PE. The Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders is a non-trauma focused treatment that may offer an alternative treatment for PTSD.
This paper describes the study protocol for IMPACT, an assessor-blinded randomized controlled trial that examines the non-inferiority of UP relative to PE for participants who meet DSM-5 criteria for current PTSD. One hundred and twenty adult participants with PTSD will be randomized to receive either 10 × 90-min sessions of UP or PE with a trained provider. The primary outcome is severity of PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at post-treatment.
While evidence-based treatments are available for PTSD, high levels of treatment dropout and non-response require new approaches to be tested. The UP is based on emotion regulation theory and is effective in treating anxiety and depressive disorders, however, there has been limited application to PTSD. This is the first rigorous study comparing UP to PE in a non-inferiority randomized controlled trial and may help improve clinical outcomes for those with PTSD.
This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry, Trial ID (ACTRN12619000543189).
延长暴露疗法（PE）是一种针对创伤的疗法，是目前治疗创伤后应激障碍（PTSD）最有效的方法之一。然而，许多患有创伤后应激障碍的人在接受延长暴露疗法后仍未消除该诊断。情绪障碍跨诊断治疗的统一方案（UP）是一种非创伤性治疗方法，可能为创伤后应激障碍提供另一种治疗选择。
本文描述了IMPACT研究方案，这是一项评估者盲法随机对照试验，旨在检验对于符合《精神疾病诊断与统计手册》第5版（DSM-5）当前创伤后应激障碍标准的参与者，统一方案相对于延长暴露疗法的非劣效性。120名患有创伤后应激障碍的成年参与者将被随机分配，接受由经过培训的提供者进行的10次每次90分钟的统一方案治疗或延长暴露疗法治疗。主要结局是治疗后通过《精神疾病诊断与统计手册》第5版临床医生管理的创伤后应激障碍量表（CAPS-5）评估的创伤后应激障碍症状的严重程度。
虽然创伤后应激障碍有循证治疗方法，但高治疗脱落率和无反应率需要测试新的方法。统一方案基于情绪调节理论，在治疗焦虑和抑郁障碍方面有效，然而，其在创伤后应激障碍中的应用有限。这是第一项在非劣效性随机对照试验中将统一方案与延长暴露疗法进行比较的严谨研究，可能有助于改善创伤后应激障碍患者的临床结局。
该试验已在澳大利亚新西兰临床试验注册中心进行前瞻性注册，试验编号（ACTRN12619000543189）。
