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

在联邦合格的健康中心测试适应性干预措施以改善 PTSD 治疗结果

• 批准号: 10483163
• 负责人: Rebecca Kaufman Sripada
• 金额: $ 71.64万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-07 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10483163
• 关键词: Address; Administrator; Adult; Affect; Age; Behavior Therapy; Caring; Child; Clinical; Cognitive Therapy; Cost Effectiveness Analysis; Data; Effectiveness; Evidence based treatment; Experimental Designs; Federally Qualified Health Center; Frequencies; Goals; Health Services Accessibility; Improve Access; Individual; Intervention; Interview; Left; Low income; Mediating; Mediator of activation protein; Mental disorders; Methodology; Mission; Mobile Health Application; Modeling; National Institute of Mental Health; Participant; Patients; Post-Traumatic Stress Disorders; Primary Health Care; Provider; Public Health; Quality-Adjusted Life Years; Randomized; Randomized Controlled Trials; Research; Resource-limited setting; Resources; Self Efficacy; Self Management; Sequential Multiple Assignment Randomized Trial; Severities; Symptoms; Testing; Therapeutic Effect; Training; Trauma; Treatment Step; Treatment outcome; Vulnerable Populations; Work; adaptive intervention; base; burden of illness; clinical practice; clinically significant; community setting; coping mechanism; cost; effective therapy; effectiveness testing; efficacious treatment; follow-up; future implementation; improved; innovation; novel; patient oriented; patient screening; practice setting; process evaluation; reduce symptoms; response; sex; telehealth; treatment response; treatment strategy; trial design

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.

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% 的受影响人群和高达 85% 的低收入人群未得到治疗。 低收入个人在联邦合格健康中心 (FQHC) 接受治疗，这些中心没有 有能力为所有患者提供针对 PTSD 的一线循证治疗，例如长期治疗 为了解决这个问题，研究小组开发了一种低强度干预措施（PTSD）。 教练）和中等强度干预（初级保健 PE：PE-PC）可有效治疗低危人群的 PTSD 然而，一些患者仍需要高强度治疗（例如，全面 PE）。 因此，迫切需要开发适应性、阶梯式护理模式来治疗 PTSD。 基于对初始低成本策略的响应，通过结合有效的治疗方法来改善 FQHC。 这一系列研究的长期目标是通过实施 在资源匮乏的家庭环境中进行基于经验的分级护理行为干预。 该提案的目标是使用序贯、多重方法开发一种针对 PTSD 的阶梯式护理干预措施。 分配、随机试验 (SMART) 的中心假设是从低或中-开始。 强度 PTSD 干预，然后根据早期反应迹象滴定强度将导致 临床上显着的创伤后应激障碍（PTSD）症状减少，且资源节约，其基本原理是分级护理。 创伤后应激障碍 (PTSD) 干预措施具有可扩展性，并且比静态治疗成本更低，从而提高了效率。 为了实现这一目标，该项目将采用 SMART 设计，将 430 名患有 PTSD 的成年人纳入 6 个 FQHC。 参与者最初将被随机分配到 PTSD 教练组或 PE-PC 组。四个星期后，早期响应者将采取行动。 反应慢者将重新降低当前治疗策略中的较低频率互动。 随机选择继续当前的治疗策略或升级至全面体育锻炼八周。 具体目标是： (1) 测试使用 PE-PC 与 PTSD Coach 开始治疗的有效性 在 3 个月（终点）、6 个月随访和 9 个月随访时减少 PTSD 症状，以及 (2) 测试 对于反应缓慢的探索性目标，第二阶段策略（继续或升级到全面 PE）的有效性。 (A) 确定最佳的分级护理治疗顺序； (B) 进行成本效益分析； 确定治疗反应的关键调节因素/调节因素；以及 (D) 通过以下方式为未来的实施做好准备： 该项目将有助于该领域基于经验的分级护理干预。 这一贡献意义重大，因为它将通过建立一个临床实践来改善 PTSD。 该提案是可以以可扩展、可持续的方式提供的有效治疗序列。 创新是因为它将使用新颖的方法来帮助改变当前 PTSD 治疗的临床范式 从固定、静态和难以获得的治疗策略到动态、适应性和可访问的方法。