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

项目摘要/摘要 创伤后应激障碍(PTSD)是一种令人衰弱的精神障碍，影响着6%的美国成年人，但 70%的受影响个人和高达85%的低收入个人得不到治疗。全国三分之一的人口 低收入个人在联邦合格的健康中心(FQHC)接受治疗，这些中心没有 有能力为所有患者提供一线、循证的创伤后应激障碍治疗 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(初级护理的PE：PE-PC)，有效地治疗低年龄和低收入的创伤后应激障碍 资源设置。然而，一些患者仍然需要高强度的治疗(例如，完全PE) 持续的临床益处。因此，迫切需要开发适应性的、阶梯式护理模式来治疗创伤后应激障碍 在FQHC中，根据对最初的低成本策略的反应，结合有效的治疗。长的- 这项研究的长期目标是通过实施以下措施改善获得有效创伤后应激障碍治疗的机会 低资源家庭环境中基于经验的阶梯式护理行为干预。整体而言 本方案的目标是为创伤后应激障碍制定一种循序渐进的多阶段护理干预方案。 分配，随机试验(SMART)。中心假设是，从低-或中等-开始- 强度创伤后应激障碍干预，然后根据早期反应迹象滴定强度将导致 临床上--通过节约资源显著减少创伤后应激障碍症状。理由是阶梯式护理 创伤后应激障碍的干预是可扩展的，而且比静态治疗成本更低，从而提高了效率。至 为了实现这一目标，该项目将采用一种智能设计，在6个FQHC中使用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创伤后应激障碍教练或PE-PC。四周后，早期响应人员将采取行动 在他们目前的治疗策略中，下降到较低的频率相互作用。反应迟缓的人将被重新- 随机选择要么继续他们目前的治疗策略，要么在八周内增加到完全PE。这个 具体目标是：(1)测试使用PE-PC与PTSD Coach启动治疗的有效性 在3个月(终点)、6个月随访和9个月随访时减少创伤后应激障碍症状，以及(2)测试 第二阶段战术(继续或逐步达到完全PE)对反应迟缓者的有效性。探索性目标 是：(A)确定最佳分步护理治疗顺序；(B)进行成本效益分析；(C) 确定治疗反应的关键调解人/主持人；和(D)通过以下方式为未来的实施做好准备 流程评估。该项目将为以下领域做出贡献：基于经验的阶梯式护理干预 创伤后应激障碍。这一贡献意义重大，因为它将通过建立一个 有效的治疗序列，可以以可扩展、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转变目前创伤后应激障碍治疗的临床范式 从固定的、静态的和难以获得的治疗策略到动态、自适应和可获得的方法。

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.