VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Department of Psychiatry, University of Michigan, Ann Arbor, USA.
VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, USA.
Trials. 2023 Oct 19;24(1):676. doi: 10.1186/s13063-023-07669-3.
Approximately ten percent of US military veterans suffer from posttraumatic stress disorder (PTSD). Cognitive processing therapy (CPT) is a highly effective, evidence-based, first-line treatment for PTSD that has been widely adopted by the Department of Veterans Affairs (VA). CPT consists of discrete therapeutic components delivered across 12 sessions, but most veterans (up to 70%) never reach completion, and those who discontinue therapy receive only four sessions on average. Unfortunately, veterans who drop out prematurely may never receive the most effective components of CPT. Thus, there is an urgent need to use empirical approaches to identify the most effective components of CPT so CPT can be adapted into a briefer format.
The multiphase optimization strategy (MOST) is an innovative, engineering-inspired framework that uses an optimization trial to assess the performance of individual intervention components within a multicomponent intervention such as CPT. Here we use a fractional factorial optimization trial to identify and retain the most effective intervention components to form a refined, abbreviated CPT intervention package. Specifically, we used a 16-condition fractional factorial experiment with 270 veterans (N = 270) at three VA Medical Centers to test the effectiveness of each of the five CPT components and each two-way interaction between components. This factorial design will identify which CPT components contribute meaningfully to a reduction in PTSD symptoms, as measured by PTSD symptom reduction on the Clinician-Administered PTSD Scale for DSM-5, across 6 months of follow-up. It will also identify mediators and moderators of component effectiveness.
There is an urgent need to adapt CPT into a briefer format using empirical approaches to identify its most effective components. A brief format of CPT may reduce attrition and improve efficiency, enabling providers to treat more patients with PTSD. The refined intervention package will be evaluated in a future large-scale, fully-powered effectiveness trial. Pending demonstration of effectiveness, the refined intervention can be disseminated through the VA CPT training program.
ClinicalTrials.gov NCT05220137. Registration date: January 21, 2022.
大约 10%的美国退伍军人患有创伤后应激障碍（PTSD）。认知加工疗法（CPT）是一种高度有效的、基于证据的 PTSD 一线治疗方法，已被退伍军人事务部（VA）广泛采用。CPT 由 12 个疗程的离散治疗组成，但大多数退伍军人（高达 70%）从未完成治疗，而那些中断治疗的人平均只接受了四个疗程。不幸的是，提前退出治疗的退伍军人可能永远无法接受 CPT 最有效的治疗部分。因此，迫切需要使用实证方法来确定 CPT 最有效的组成部分，以便将 CPT 改编为更简短的格式。
多阶段优化策略（MOST）是一种创新的、受工程启发的框架，它使用优化试验来评估多成分干预（如 CPT）中各个干预成分的性能。在这里，我们使用分数阶因子优化试验来识别和保留最有效的干预成分，以形成精炼的、简化的 CPT 干预包。具体来说，我们使用了一个包含 16 个条件的分数阶因子实验，共有 270 名退伍军人（N=270）在三个退伍军人事务医疗中心参与，以测试 CPT 的五个组成部分和每个组成部分之间的两种相互作用的有效性。这种因子设计将确定 CPT 的哪些组成部分对 PTSD 症状的减轻有意义，这是通过 PTSD 症状在 DSM-5 临床医生管理 PTSD 量表上的降低来衡量的，随访时间为 6 个月。它还将确定组成部分有效性的中介和调节因素。
迫切需要使用实证方法来改编 CPT，以确定其最有效的组成部分，从而将其改编为更简短的格式。CPT 的简短格式可能会减少流失，提高效率，使提供者能够治疗更多患有 PTSD 的患者。精炼的干预包将在未来的大规模、全效试验中进行评估。在证明有效性之前，可以通过 VA CPT 培训计划传播精炼的干预措施。
ClinicalTrials.gov NCT05220137。注册日期：2022 年 1 月 21 日。
