Brief Transdiagnostic Treatment for Anxiety Disorders and PTSD in South Africa: A Hybrid-Effectiveness Trial

背景：创伤后应激障碍(PTSD)和焦虑症非常普遍，并且是主要的 低收入和中等收入国家的残疾原因。我的长期职业目标是解决 这些障碍造成的负担，成为实施和传播 这些疾病的循证治疗(EBTS)用于LMICs。这一目标是由观察推动的。 从文学作品和我自己的作品中。尽管有EBTS的发展，但绝大多数人在 LMIC中有需要的人(即85%)没有接受治疗，即使他们接受治疗，也不是基于经验。尽管 在LMIC对EBTS的明确需求，在#年实施EBTS有三个主要障碍 这些区域。这些障碍包括：(1)EBTS倾向于单一障碍，一次只能治疗一个障碍 时间，(2)持续时间长(例如，治疗一个障碍需要12-16个疗程)，以及(3)倾向于 管理复杂，需要高水平的管理技能。考虑到受过高度培训的供应商在 与典型的EBTS相比，LMIC使用一种简洁、文化一致且不那么复杂的方法是理想的 减少这些障碍。建议的研究。目前的研究旨在评估一种简单的跨诊断治疗方法 用于焦虑症和创伤后应激障碍(虚假安全行为消除治疗；F-set；Schmidt等人，2012年) 在南非初级保健诊所使用。这些目标遵循了良好的实施和传播 所有研究目标的模型(PRISM；Feldstein&Glasgow，2008)。首先，我们将进行深入的定性 采访患者(n=24)和提供者和工作人员(n=10)，以评估关键障碍和促进者 F-set干预在南非初级保健诊所的实施和可持续性(具体目标 1)。第二，F-set干预和实施战略将根据 定性研究(具体目标2)。第三，我们将进行随机混合有效性-实施试验 评估调整后的F-SET的有效性，并探索实施的促进者和障碍 (具体目标3)。我们将使用混合方法(定性和定量)来评估F集 初级保健护士实施的干预措施与强化标准护理控制组的比较 焦虑症和创伤后应激障碍患者样本(N=60)。我们将评估其可行性和可接受性。 实施情况的衡量标准：(1)患者的参与度和保留率；(2)医疗服务提供者对 F-set的障碍和促进者。提供者的忠诚度和治疗交付的质量将被用作主持人。 这些数据将用于提交R01，用于在第四年进行临床随机化的全功率试验。 目标：这份K01建议书将为我提供所需的培训，通过以下方式实现我的长期职业目标 在以下方面进行培训：(1)进行全球心理健康方面的文化知识临床试验；(2)混合方法 实施试验研究；(3)实施和传播学。K01培训包括 专家指导，在南非的广泛实地经验，哈佛大学的课程工作，以及出版物。

Background: Posttraumatic stress disorder (PTSD) and anxiety disorders are highly prevalent and a leading cause of disability in low and middle-income countries (LMICs). My long-term career goal is to address the burden posed by these disorders by becoming a leading expert in the implementation and dissemination of evidence-based treatments (EBTs) for these disorders for use in LMICs. This goal is motivated by observations from the literature and my own work. Despite the development of EBTs, an overwhelming majority of those in need (i.e., 85%) in LMICs do not receive treatment and, when they do, it is not empirically based. Despite the clear need for EBTs in LMICs, there are three primary barriers associated with the implementation of EBTs in these areas. These barriers include: (1) EBTs tend to be single disorder focused only treating one disorder at a time, (2) they are long in duration (e.g., 12-16 treatment sessions to treat one disorder), and (3) they tend to be complex and require a high level of skill to administer. Given the low availability of highly trained providers in LMICs, using an approach that is brief, culturally congruent, and less complex than typical EBTs is ideal for reducing these barriers. Proposed Study. The current study aims to evaluate a brief transdiagnostic treatment for anxiety disorders and PTSD (False Safety Behavior Elimination Treatment; F-SET; Schmidt et al., 2012) for use in South African primary care clinics. The aims follow a well-established implementation and dissemination model (PRISM; Feldstein & Glasgow, 2008) for all study aims. First, we will conduct in-depth qualitative interviews with patients (n=24) and providers and staff (n=10) to assess key barriers and facilitators to the implementation and sustainability of the F-SET intervention in South African primary care clinics (Specific Aim 1). Second, the F-SET intervention and implementation strategy will be adapted based on the findings from the qualitative study (Specific Aim 2). Third, we will conduct a randomized hybrid effectiveness-implementation trial to assess the effectiveness of the adapted F-SET and explore facilitators and barriers to implementation (Specific Aim 3). We will use a mixed methods approach (qualitative and quantitative) to evaluate the F-SET intervention administered by primary care nurses compared to an enhanced standard care control group in a sample of individuals with anxiety disorders and PTSD (N=60). We will evaluate the feasibility and acceptability of implementation as measured by: (1) patient participation and retention and (2) provider’s perceptions of barriers and facilitators of F-SET. Provider fidelity and quality of treatment delivery will be used as moderators. These data will be used to submit an R01 for a fully powered trial with clinic randomization in Year 4. Training Aims: This K01 proposal is will provide me with training needed to achieve my long-term career goal through training in: (1) the conducting culturally informed clinical trials in global mental health, (2) mixed methods research for implementation trials, and (3) implementation and dissemination science. The K01 training includes expert mentorship, extensive field-based experience in South Africa, coursework at Harvard, and publications.