Escuela de Medicina, Universidad de Talca, Talca, Maule, 3460000, Chile.
Department of Psychiatry and Behavioral Sciences School of Medicine, UC Davis Medical Center, Sacramento, Californa, 95616, USA.
F1000Res. 2024 Oct 11;11:203. doi: 10.12688/f1000research.75764.2. eCollection 2022.
Major depression (MD) is a prevalent and disabling condition in Chile, with most cases being treated at the primary care level. In Chilean primary care, the authors have identified key factors associated with more complex presentations of MD and a poorer prognosis, such as a history of childhood trauma, suicidality, and comorbidities. These findings underscore the need for a multidimensional, trauma-informed, and interprofessional approach to the treatment of depression.
This protocol is a two-arm, single-blinded, cluster RCT to compare the effectiveness of a collaborative multidimensional approach for depression (CMAD) versus usual care to treat MD in primary care clinics in Chile. In total, 394 depressed adults from 18 to 65 years of age in twelve clinics located in Chile's Maule Region will be consented to participate in the study. Patients and care teams from each clinic will be randomized to the intervention or to the control arm.Interprofessional teams in the intervention arm will attend 27 hours of didactic and active learning sessions focused on clinical competences to effectively engage, treat and follow up patients with the factors associated to the complex presentation of MD. Team in the control arm will receive 27 didactic sessions on current clinical guidelines for MD.Patients of both arms will be blindly assessed at baseline, three months, and six months. The primary outcome will be the reduction in depressive symptoms, with secondary outcomes including improvements in anxiety symptoms, interpersonal and social functioning, and treatment adherence.
This protocol proposes the evaluation of an intervention designed to improve depression symptoms by enhancing the clinical competencies of primary care teams. These competencies are structured around collaborative care and trauma-informed practices.
NCT05016388, registered on 16 August 2021 at ClinicalTrials.gov.
重度抑郁症（MD）在智利较为普遍且会导致残疾，多数病例在初级保健层面接受治疗。在智利的初级保健中，作者已确定与 MD 更复杂表现和预后较差相关的关键因素，如儿童期创伤史、自杀意念和合并症。这些发现强调了需要采用多维、以创伤为中心和跨专业的方法来治疗抑郁症。
本方案是一项两臂、单盲、集群 RCT，旨在比较协作多维方法治疗抑郁症（CMAD）与常规护理治疗智利初级保健诊所中 MD 的疗效。总共将有 394 名年龄在 18 至 65 岁之间、来自智利马乌莱地区 12 个诊所的抑郁成年人同意参与该研究。每个诊所的患者和护理团队将被随机分配到干预组或对照组。干预组的跨专业团队将参加 27 小时的理论和主动学习课程，重点是临床能力，以有效地与与 MD 复杂表现相关的因素接触、治疗和跟进患者。对照组的团队将接受 27 个关于 MD 现行临床指南的理论课程。两组患者将在基线、三个月和六个月时进行盲法评估。主要结果将是抑郁症状的减轻，次要结果包括焦虑症状、人际和社会功能以及治疗依从性的改善。
本方案提出了评估一种干预措施的建议，该干预措施旨在通过增强初级保健团队的临床能力来改善抑郁症状。这些能力是围绕协作护理和以创伤为中心的实践构建的。
NCT05016388，于 2021 年 8 月 16 日在 ClinicalTrials.gov 注册。
