Testing Adaptive Interventions to Improve PTSD Treatment Outcomes in Federally Qualified Health Centers

项目概要/摘要 创伤后应激障碍（PTSD）是一种使人衰弱的精神疾病，影响6%的美国成年人，但 70%的受影响个体和高达85%的低收入个体未得到治疗。全国三分之一的 低收入者在联邦合格的卫生中心（FATHCs）接受治疗，这些中心没有 有能力为所有患者提供一线的、基于证据的创伤后应激障碍治疗，如延长 暴露（PE）。为了解决这个问题，研究小组开发了一种低强度干预（PTSD 教练）和中等强度的干预（PE初级保健：PE-PC），有效地治疗创伤后应激障碍，在低- 资源设置。然而，一些患者仍然需要高强度治疗（例如，全PE）， 持续的临床效益。因此，迫切需要开发适应性的分步护理模式来治疗PTSD 通过结合有效的治疗方法，根据对初始低成本策略的反应，很长的- 这一系列研究的长期目标是通过实施有效的PTSD治疗， 在低资源家庭环境中以医疗为基础的分步护理行为干预。整体 本提案的目的是采用序贯、多重、多阶段的方法， 分配，随机试验（SMART）。核心假设是，从低或中- 强化PTSD干预，然后根据早期反应迹象滴定强度， 临床上显著的PTSD症状减轻与资源的吝啬。其基本原理是， 创伤后应激障碍的干预措施是可扩展的，比静态治疗成本更低，从而提高了效率。到 为了达到这个目标，这个项目将采用SMART设计，在六个社区卫生中心有430名患有创伤后应激障碍的成年人。 参与者最初将被随机分配到PTSD教练或PE-PC。四周后，早期反应人员将 在他们目前的治疗策略中降低频率的相互作用。反应迟钝者将被重新- 随机分配至继续当前治疗策略或逐步升级至完全PE，持续8周。的 具体目标是：（1）测试PE-PC与PTSD教练在以下方面的有效性： 在3个月（终点）、6个月随访和9个月随访时减少PTSD症状，以及（2）测试 第二阶段战术（继续或逐步达到全PE）对反应迟钝者的有效性。探索性目标 是（A）确定最佳的阶梯式护理治疗顺序;（B）进行成本效益分析;（C） 确定治疗反应的关键介质/调节剂;以及（D）通过以下方式为未来实施做好准备： 过程评价该项目将有助于该领域的一个以外科为基础的阶梯式护理干预， 创伤后应激障碍这一贡献是重要的，因为它将通过建立一个 有效的治疗顺序，可以以可扩展的，可持续的方式提供。这项建议是 创新，因为它将使用新的方法来帮助改变目前的PTSD治疗的临床模式 从固定的、静态的和难以获得的治疗策略到动态的、自适应的和可获得的方法。

Project Summary/Abstract Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that affects 6% of U.S. adults, yet is left untreated in 70% of affected individuals and up to 85% of low-income individuals. One third of the nation’s low-income individuals are treated in Federally Qualified Health Centers (FQHCs), which do not have the capacity to provide all their patients with first-line, evidence-based treatments for PTSD such as Prolonged Exposure (PE). To address this problem, the study team has developed a low-intensity intervention (PTSD Coach) and a medium-intensity intervention (PE for Primary Care: PE-PC) that effectively treat PTSD in low- resource settings. However, some patients will still require high-intensity treatments (e.g., Full PE) for sustained clinical benefit. Thus, there is a critical need to develop adaptive, stepped-care models to treat PTSD in FQHCs by combining efficacious treatments, based on response to initial lower-cost strategies. The long- term goal of this line of research is to improve access to efficacious PTSD treatments by implementing empirically-based stepped-care behavioral interventions in low-resource domestic settings. The overall objective in this proposal is to develop a stepped-care intervention for PTSD using a Sequential, Multiple Assignment, Randomized Trial (SMART). The central hypothesis is that beginning with a low- or medium- intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically-significant PTSD symptom reduction with parsimony of resources. The rationale is that stepped-care interventions for PTSD are scalable and less costly than static treatments, thereby improving efficiency. To accomplish the objective, this project will employ a SMART design with 430 adults with PTSD in six FQHCs. Participants will be initially randomized to PTSD Coach or PE-PC. After four weeks, early responders will step down to lower frequency interaction within their current treatment strategy. Slow responders will be re- randomized to either continue their current treatment strategy or step up to Full PE for eight weeks. The specific aims are to: (1) Test the effectiveness of initiating treatment with PE-PC versus PTSD Coach in reducing PTSD symptoms at 3 months (endpoint), 6-month follow-up and 9-month follow-up, and (2) Test the effectiveness of second-stage tactics (continue or step up to Full PE) for slow responders. Exploratory aims are to (A) Identify the optimal stepped-care treatment sequence; (B) Conduct cost-effectiveness analysis; (C) Identify key mediators/moderators of treatment response; and (D) Prepare for future implementation through process evaluation. This project will contribute to the field an empirically-based stepped-care intervention for PTSD. This contribution is significant because it will improve clinical practice for PTSD by establishing an effective treatment sequence that can be delivered in a scalable, sustainable manner. This proposal is innovative because it will use novel methodologies to help shift the current clinical paradigm of PTSD treatment from fixed, static, and hard-to-access treatment strategies to a dynamic, adaptive, and accessible approach.