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

晚年的抑郁症很常见，代价高昂，可能会对患者、他们的亲属和社会造成毁灭性的后果。尽管如此，它通常得不到承认和治疗，尤其是在中低收入国家。巴西人口正在迅速老龄化，60岁或以上的人口已达2000万。巴西卫生保健系统，特别是精神卫生部门，对迎接这一挑战准备不足。迫切需要为生活在低收入和中等收入国家的老年人制定具有成本效益的抑郁症治疗方案。巴西的初级保健制度是引入和评估干预措施的极佳环境，以惠及这一被忽视人口中的很大一部分人。拟议的干预措施(主动)旨在克服治疗患有抑郁症的老年人的障碍，例如患者与社会隔绝，难以获得服务，缺乏熟练和得到支持的工作人员来提供有效的干预，以及照顾老年人的工作人员之间协调不力和问责不力。Proactive将是一项双臂随机对照试验，旨在比较在常规护理基础上增加主要由现有初级保健系统雇用的社区卫生工作者在家中提供的心理社会、社区干预的有效性和成本效益。这项干预将与巴西S圣保罗60岁或以上贫困社会经济背景成年人在减少抑郁疾病和改善功能方面的常规护理进行比较。初级保健家庭保健单位将随机分为这两个治疗组中的一个。单位内的所有或随机抽样的家庭健康队将获邀请参加，视乎单位的规模而定。Proactive包括8到11次家庭会议，根据抑郁症的严重程度，在17周内提供。最初阶段向所有参与者提供，包括心理教育和学习改善情绪的简单应对策略的三个阶段。第二阶段以行为激活和复发预防战略为基础；疗程的数量取决于症状的严重程度。社区卫生工作者将配备平板电脑，以协助实施干预和问责，并接受进一步的培训和监督。那些在特定临床算法方面没有通过干预改善的参与者将在监督和定期团队会议上进行讨论，如果需要，将采取其他临床决定。控制组将接受“强化”常规护理，以改进对按照“高危”方案处理的高危病例的识别和定期评估。Proactive的主要结果衡量标准是9项患者健康问卷(PHQ-9)。我们将使用意向治疗分析，比较进入试验后8个月和12个月各武器部队的病例(PHQ-9和10)的恢复情况。还将衡量一些次要结果，包括生活质量和功能水平。将衡量两个部门的直接和间接费用，以进行成本效益分析。我们预计招募在20个FHU(群)注册的1,440名参与者，产生86.5%的权力，在8个月后恢复15个百分点(25%到40%)。我们已经开发并成功地测试了拟议中的S初级保健干预的可行性和可接受性。该项目有可能对抑郁的老年人的福祉产生及时和重大的影响，进一步减少对巴西和大多数LMIC已经面临压力的专门精神卫生资源的依赖。巴西初级保健模式正在其他几个低收入中等收入国家复制，有助于增加这种干预措施在其他低收入中等收入国家的可移植性，如果其成本效益得到证明的话。

Depression in later life is common, costly, and can have devastating consequences for those affected, their relatives, and society. Notwithstanding this, it usually goes unrecognised and untreated, especially in low-middle income countries. The Brazilian population is ageing rapidly, with already 20 million people aged 60 or more. The Brazilian health care system, especially the mental health sector, is poorly prepared to meet this challenge. There is an urgent need to develop cost-effective depression treatment programmes for older people living in low- and middle-income countries. The Brazilian primary care system is an excellent setting to introduce and evaluate an intervention to reach a large proportion of this neglected part of the population. The intervention proposed (PROACTIVE) aims to overcome barriers for treating old people with depression, such as patients' social isolation and difficulties in accessing services, lack of skilled and supported staff to deliver effective interventions, and poor coordination and accountability among staff caring for elderly people. PROACTIVE will be a two-arm cluster randomised controlled trial aiming to compare the effectiveness and cost-effectiveness of adding to usual care a psychosocial, community-based intervention mostly delivered at home by Community Health Workers employed by the existing primary care system. The intervention will be compared with an 'enhanced' usual care in reducing depressive illness and improving functioning among adults 60 years or older from poor socioeconomic backgrounds in São Paulo, Brazil. Primary Care Family Health Units will be randomised to one of these two treatment groups. All or a random sample of the Family Health Teams within a Unit, depending on size of the Unit, will be invited to participate. PROACTIVE consists of 8 to 11 home sessions, depending on severity of depression, delivered over 17 weeks. The initial phase is given to all participants and comprises three sessions covering psycho-education and learning simple coping strategies to improve mood. The Second Phase is based on behaviour activation and relapse prevention strategies; the number of sessions depends on the severity of symptoms. Community Health Workers will be equipped with tablet computers to assist with the delivery and accountability of the intervention and to receive further training and supervision. Those participants who do not improve with the intervention, in relation to specified clinical algorithms, will be discussed in supervision and regular team meetings and, if needed, other clinical decisions will be adopted. The control group will receive 'enhanced' usual care in so far as improved identification and periodic assessments of high-risk cases treated as per a 'high-risk' protocol. The primary outcome measure of PROACTIVE is the 9-item Patient Health Questionnaire (PHQ-9). We will compare the recovery of cases (PHQ-9<10) across arms at 8 and 12 months after entering the trial, using an intention-to-treat analysis. Several secondary outcomes will be also measured including quality of life and levels of functioning. Direct and indirect costs in both arms will be measured to undertake a cost-effectiveness analysis. We anticipate recruiting a total of 1,440 participants registered in 20 FHUs (clusters), yielding 86.5% power for a 15 percentage point difference (25% to 40%) in recovery at 8 months. We have developed and successfully tested the feasibility and acceptability of the proposed intervention in primary care in São Paulo (RCUK/FAPESP). This project has the potential for a timely and major impact on the wellbeing of depressed older adults, further reducing dependency on specialised mental health resources already under strain in Brazil and most LMIC. The Brazilian primary care model is being replicated in several other LMIC, contributing to increase the portability of this intervention to other LMIC should its cost-effectiveness be demonstrated.