BACKGROUND Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. METHODS/DESIGN We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale -up. DISCUSSION The results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information - a critical gap for addressing a leading global cause of disability. TRIAL REGISTRATION ClinicalTrials.gov NCT03466346, registered March 15, 2018.

中文翻译：

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公共部门精神卫生保健扩大实施研究 (SMART-DAPPER)：一项针对重度抑郁症和创伤后应激障碍 (DAPPER) 的非专科心理治疗和/或药物治疗的序贯多重分配随机试验 (SMART)肯尼亚一家县医院的门诊诊所。


背景技术精神障碍是全球残疾的主要原因，主要由抑郁和焦虑驱动。大部分疾病负担发生在低收入和中等收入国家 (LMIC)，其中 75% 的患有精神障碍的成年人无法获得服务。我们的研究团队在肯尼亚西部工作了近十年。肯尼亚初级保健人群重度抑郁症 (MDD) 和创伤后应激障碍 (PTSD) 的患病率很高。为了通过可持续、可扩展的精神卫生保健策略满足这些治疗需求，我们正在与肯尼亚和乌干达的当地和国家精神卫生利益相关者合作，确定 1) 由非机构提供的一线和二线治疗的循证策略。专家与初级保健相结合，2）调查治疗结果的假定调节因素，3）确定患者层面的治疗效果调节因素，以通过成本分析为个性化、资源高效、非专业治疗和排序提供信息。我们的实施方法以探索、准备、实施、维持 (EPIS) 框架为指导。方法/设计 我们将使用序贯、多任务随机试验 (SMART) 将基苏木县医院 (KCH) 门诊部的 2710 名患有 MDD、PTSD 或两者兼而有之的患者随机分组，接受每周 12 次的非专家提供的人际互动治疗。心理治疗 (IPT) 或由护士或临床官员开出 6 个月的氟西汀处方。治疗结束时未缓解的参与者将被重新随机分配接受其他治疗（IPT 接受氟西汀，反之亦然）或联合治疗（IPT 和氟西汀）。 SMART-DAPPER 实施资源团队 (IRT) 将在研究过程中推动 EPIS 模型的应用和调整，以优化数据的相关性，以实现普遍性和规模化。讨论 这项研究的结果将在三个方面具有重要意义：1）他们将确定非专业提供的一线和二线治疗 MDD 和/或 PTSD 的有效性，2）他们将调查每种药物的关键作用机制3) 他们将制定量身定制的适应性治疗策略，这对于在资源匮乏的环境中对 MDD 和/或 PTSD 进行最佳治疗顺序至关重要，并提供相关的成本信息——这是解决全球主要残疾原因的关键差距。试验注册 ClinicalTrials.gov NCT03466346，于 2018 年 3 月 15 日注册。