Cluster randomised controlled trial for late life depression in socioeconomically deprived areas of São Paulo, Brazil

晚年抑郁症很常见，代价高昂，并可能对老年人、其近亲和社会的生活产生毁灭性的后果。尽管如此，它往往得不到承认和治疗。巴西人口正在迅速老龄化，60岁或60岁以上的人已经有2 000万。巴西的保健系统，特别是精神保健系统，对迎接这一挑战准备不足。根据世卫组织的建议，迫切需要在初级保健中为生活在低收入和中等收入国家的老年抑郁症患者开发可行和具有成本效益的抑郁症治疗方法。家庭保健战略是巴西新的初级保健模式，它提供了一个很好的网络，以测试对这一被忽视的人口亚群体的协作、分级保健和以社区为基础的心理社会干预。我们建议推行一项计划，重点是更有效地运用家庭健康小组现有的人力资源，改善“日常护理”，以及在基层护理人员的日常工作中加入简单的创新措施，例如改善个案搜寻、积极外展、在小组会议上有系统地检讨个案，以及让非专科专业人员在适当的训练和支援下担任个案经理。该方案旨在克服在初级保健中治疗老年抑郁症患者的主要障碍，如患者的社会孤立和难以获得服务，工作人员缺乏提供有效心理健康干预措施的技能和支持，以及护理老年人的工作人员之间协调不良。该提案旨在比较主要由现有初级保健系统雇用的护士助理管理的基于社区的心理社会干预措施与“增强型”常规护理在巴西圣保罗60岁或60岁以上贫困社会经济背景的成年人中减少抑郁症和改善功能方面的有效性和成本效益。这将是一项双组随机对照试验，涉及在20个家庭健康单位（集群）注册的1，236名参与者。那些在干预臂将接受心理社会干预和改善病例管理的护士助理领导的基础上，在初级保健，但与社区联络的主要作用。干预将主要在家中进行，并将持续8个月。护士助理将得到平板电脑的支持，以提供干预，保存医疗记录，与包括主管在内的其他人沟通，并接受进一步的培训和持续的支持。护士助理作为个案经理将与初级保健团队的其他成员密切联系，以确保提供最好的护理（合作护理）。那些没有改善的参与者将在定期的团队会议上进行讨论，并在需要时采取进一步的临床决策。对照组将单独接受“强化”常规护理，以便定期识别和评估病例，临床团队在试验开始时接受抑郁症管理的最新培训。我们将使用意向治疗分析比较进入试验后4个月和10个月时各组病例（PHQ-9总分<5）的恢复情况。我们还将评估功能和生活质量。将衡量两个武器的直接和间接费用，以进行成本效益分析。调查结果的传播将包括科学报告、讲习班、媒体宣传和与决策者举行会议。巴西新的初级保健模式吸引了许多其他低收入国家的兴趣，这种干预措施具有很大的潜力，可以移植到其他低收入国家。

Depression in late-life is common, costly, and can have devastating consequences on the life of older people, their close relatives and society. Notwithstanding this, it goes frequently unrecognised and untreated. The Brazilian population is ageing rapidly, with already 20 million people aged 60 or more. The Brazilian health care system, especially mental health care, is poorly prepared to meet this challenge. In keeping with WHO recommendations, there is an urgent need to develop feasible and cost-effective depression treatments in primary care for old people with depression living in low- and middle-income countries. The Family Health Strategy, the new Brazilian primary care model, provides an excellent network to test a collaborative, stepped-care, community-based psychosocial intervention for this neglected sub-group of the population. We are proposing a programme that puts emphasis on using more efficiently existing human resources within Family Health Teams, improving 'usual care', and adding simple innovations to the routine work of the primary care staff, such as improved case finding, active outreach, systematic review of cases at team meetings, and empowering non-specialist professionals to act as case managers with due training and support. This programme aims to overcome the main barriers for treating old people with depression in primary care, such as patients' social isolation and difficulties to access services, lack of skills and support of staff to deliver effective mental health interventions, and poor coordination among members of staff in the care of elderly people. This proposal aims to compare the effectiveness and cost-effectiveness of a psychosocial, community-based intervention managed mainly by nurse assistants employed by the existing primary care system against 'enhanced' usual care in reducing depressive illness and improving functioning among adults 60 years or older from poor socioeconomic backgrounds in São Paulo, Brazil. This will be a two-arm cluster randomised controlled trial involving 1,236 participants registered with 20 Family Health Units (clusters). Those in the intervention arm will receive a psychosocial intervention and improved case management led by a nurse assistant based in primary care but with a major role liaising with the community. The intervention will be mostly delivered at home and will last 8 months. Nurse assistants will be supported with tablet computers to deliver the intervention, keep medical notes, communicate with others including supervisors, and to receive further training and ongoing support. Nurse assistants acting as case managers will liaise closely with other members of the primary care team to ensure the best care possible is offered (collaborative care). Those participants who do not improve with the intervention will be discussed in regular team meetings and further clinical decisions adopted, if needed. The control group will receive 'enhanced' usual care alone in so far as cases being identified and assessed periodically and the clinical team receiving an updated training in the management of depression at the start of the trial. We will compare the recovery of cases (PHQ-9 total scores <5) across arms at 4 and 10 months after entering the trial using an intention-to-treat analysis. We will also assess functioning and quality of life. Direct and indirect costs in both arms will be measured to undertake a cost-effectiveness analysis. Dissemination of findings will include scientific reports, workshops, media awareness, and meetings with policy makers. The new Brazilian primary care model has attracted interest from many other LMIC and an intervention such as this has great potential for portability to other LMIC.