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: 10369118
• 负责人: Kristina Jo Korte
• 金额: $ 18.29万
• 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/10369118
• 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; Science; Severities; South Africa; South African; Therapeutic Intervention; Time; Training; Work; acceptability and feasibility; base; career; comorbidity; design; disability; effective therapy; effectiveness evaluation; effectiveness implementation design; effectiveness implementation study; effectiveness implementation trial; effectiveness trial; experience; implementation barriers; implementation outcomes; 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）和焦虑症是高度流行的， 低收入和中等收入国家（LMIC）的残疾原因。我的长期职业目标是解决 通过成为实施和传播这些疾病的主要专家， 这些疾病的循证治疗（EBT）用于LMIC。这一目标的动机是观察 从文学作品和我自己的作品中。尽管EBT的发展，绝大多数人在 需要（即，85%）的中低收入国家没有接受治疗，即使接受治疗，也没有经验基础。尽管 由于中低收入国家显然需要EBT，因此在实施EBT方面存在三个主要障碍， 这些地区这些障碍包括：（1）EBT倾向于单一疾病，仅在治疗一种疾病时专注于治疗一种疾病。 时间，（2）它们持续时间长（例如，12-16治疗疗程治疗一种疾病），和（3）他们往往是 复杂且需要高水平的技能来管理。由于缺乏训练有素的医疗服务提供者， LMIC使用的方法简单，文化一致，并且比典型的EBT更简单，是理想的 减少这些障碍。拟议的研究。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PTSD（错误安全行为消除治疗; F-SET;施密特等人，2012年）， 在南非的初级保健诊所使用。这些目标遵循一个良好的实施和传播 模型（PRISM; Feldstein &格拉斯哥，2008）。首先，我们将深入定性 与患者（n=24）和提供者和工作人员（n=10）进行访谈，以评估 南非初级保健诊所F-SET干预措施的实施和可持续性（具体目标 1）。第二，将根据2010年的调查结果，调整F-SET干预和实施战略。 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 评估经调整的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 在一项研究中，初级护理护士与加强标准护理对照组进行了比较， 焦虑症和PTSD患者样本（N=60）。我们将评估其可行性和可接受性 实施的衡量标准：（1）患者的参与和保留，（2）供应商的看法， F-SET的障碍和促进因素。提供者的忠诚度和治疗质量将被用作调节因素。 这些数据将用于在第4年提交一项具有临床随机化的完全把握度试验的R 01。培训 目标：此K 01提案将为我提供实现长期职业目标所需的培训， 培训内容：（1）在全球精神卫生领域开展文化知情的临床试验，（2）混合方法 为实施试验进行研究;（3）实施和传播科学。K 01培训包括 专家指导、在南非的广泛实地经验、在哈佛的课程和出版物。