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

南非焦虑症和创伤后应激障碍的简短跨诊断治疗：混合有效性试验

• 批准号: 10491868
• 负责人: Kristina Jo Korte
• 金额: $ 18.4万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10491868
• 关键词: 3-Dimensional; AIDS/HIV problem; Accounting; Address; Anxiety; Anxiety Disorders; Area; Behavior; Clinic; Clinical; Clinical Trials; Collaborations; Complex; Control Groups; Data; Development; Diagnosis; Disease; Dissemination and Implementation; Educational Background; Effectiveness; Evidence based treatment; Goals; Health Services Accessibility; Hybrids; Impairment; Individual; Intervention; Interview; Literature; Malaria; Measures; Medical; Mental Health; Mental disorders; Mentorship; Methods; Minority; Modeling; Nurses; Outcome; Patient Participation; Patients; Perception; Persons; Phase; Population; Post-Traumatic Stress Disorders; Primary Health Care; Primary Nursing Care; Protocols documentation; Provider; Public Health; Publications; Randomized; Research Methodology; Research Personnel; Resources; Safety; Sampling; Schizophrenia; Severities; South Africa; South African; Therapeutic Intervention; Time; Training; Work; acceptability and feasibility; base; career; comorbidity; design; disability; dissemination science; effective therapy; effectiveness evaluation; effectiveness implementation design; effectiveness implementation study; effectiveness implementation trial; effectiveness trial; experience; implementation barriers; implementation evaluation; implementation facilitators; implementation outcomes; implementation science; implementation strategy; implementation trial; improved; low and middle-income countries; meetings; primary outcome; scale up; secondary outcome; skills; standard care; therapy design; training opportunity; treatment of anxiety disorders

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.

背景：创伤后应激障碍（PTSD）和焦虑症非常普遍，是导致 我的长期职业目标是解决低收入和中等收入国家 (LMIC) 的残疾原因。 成为实施和传播这些疾病的主要专家，以减轻这些疾病带来的负担 用于中低收入国家的这些疾病的循证治疗 (EBT) 这一目标是由观察推动的。 尽管 EBT 得到了发展，但绝大多数都是来自文献和我自己的工作。 中低收入国家的需求（即 85%）没有接受治疗，即使接受治疗，也不是基于经验。 中低收入国家显然需要 EBT，但在中低收入国家实施 EBT 存在三个主要障碍 这些障碍包括：(1) EBT 往往是单一疾病，只集中治疗一种疾病。 时间，(2) 持续时间长（例如，治疗一种疾病需要 12-16 次治疗），(3) 它们往往是 鉴于训练有素的提供者的可用性较低，因此需要高水平的管理技能。 中低收入国家采用的方法比典型的 EBT 简单、文化上一致且简单，非常适合 减少这些障碍当前的研究旨在评估简短的跨诊断治疗。 针对焦虑症和 PTSD（虚假安全行为消除治疗；F-SET；Schmidt 等，2012） 在南非初级保健诊所的使用 目标遵循完善的实施和传播。 首先，我们将进行深入的定性研究。 与患者 (n=24) 以及提供者和工作人员 (n=10) 进行访谈，以评估关键障碍和促进因素 F-SET 干预措施在南非初级保健诊所的实施和可持续性（具体目标 1) 其次，F-SET 干预和实施策略将根据调查结果进行调整。 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。 评估改编后的 F-SET 的有效性并探索实施的促进因素和障碍 （具体目标 3）我们将使用混合方法（定性和定量）来评估 F-SET。 初级保健护士实施的干预措施与强化标准护理对照组的比较 我们将评估患有焦虑症和 PTSD 的个体样本（N=60）。 实施的实施情况通过以下指标来衡量：(1) 患者的参与和保留，以及 (2) 提供者的看法 F-SET 的障碍和促进因素将被用作调节因素。 这些数据将用于提交 R01，以进行第 4 年临床随机化的全动力试验。 培训 目标：这个 K01 提案将为我提供实现我的长期职业目标所需的培训 培训内容：(1) 在全球心理健康领域开展基于文化的临床试验，(2) 混合方法 实施试验研究，以及 (3) 实施和传播科学 K01 培训包括。 专家指导、南非丰富的实地经验、哈佛大学的课程作业和出版物。