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

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.

This will be a two-arm, pragmatic, cluster randomised controlled trial to test the cost-effectiveness of a community-based psychosocial intervention for elderly depressed individuals delivered mostly by Nurse Assistants (task-shifting) employed by existing primary care service in São Paulo, Brazil. The trial will involve 1,236 participants registered with 20 Family Health Units (clusters). Those in the intervention arm will receive the psychosocial intervention divided into acute (3 months) and maintenance (5 months) phases. The Nurse Assistant will have a major role liaising closely with the community and the primary care team to ensure the best care possible (collaborative care). The acute phase starts with three sessions for all participants including psycho-education and advice on simple things to improve mood. Those not responding will receive additional sessions (stepped-care) with modules based on Problem Solving and Behaviour Activation models. These individuals will also be regularly reviewed during weekly team meetings. During the maintenance phase all participants will receive monthly sessions with general support, reinforcement of skills acquired previously and a relapse prevention component. 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 continuous support. The control group will receive 'enhanced' usual care in so far as improved case identification and a safety net for the most severe cases. The clinical team in both arms will receive updated training in the management of depression at the start of the trial. We will compare recovery rates (PHQ-9 total score <5) across arms at 4 and 9 months after entering the trial using an intention-to-treat analysis. We will also compare functioning and quality of life. Direct and indirect costs in both arms will be measured to undertake a cost-effectiveness analysis.

1) Society: The rapid growth of elderly population around the world is posing a huge challenge for societies in terms of how best to cater for needs of these populations. Among these needs, health problems are a major challenge in terms of magnitude and costs. This project will attempt to tease out some possible cost-effective solutions for managing depression among the elderly more effectively. We expect findings will be applicable to Brazil but also other countries throughout the world.
2) Low-and-middle-income-countries (LMIC): There is little health research in LMIC and no other trial to improve the management of depression for the elderly with a vision of integrating health care services more closely.
3) Brazil: Undoubtedly Brazil is the main beneficiary of this project. It is for this reason that FAPESP is interested in co-funding it. Among the main Brazilian beneficiaries are: the Ministry of Health, Municipalities, and NGOs delivering health services. However it is important to bear in mind that the process of scaling up usually takes some time to come to fruition (see Araya et al, 2012). Brazilian Universities would also benefit with strengthening their research capacity, in particular in areas such as health economics that has been relatively neglected in Brazil. It is worth mentioning that this project might also benefit primary care staff, especially low-cadre health workers, whose skills are often unexploited and receive little training and support. The project will also allow us to explore alternative and more efficient ways of providing supervision to staff members, something that may be of use for other health and social problems. Finally Brazilian elderly people will benefit from improved services dealing with their mental health and aiming to improve their functioning and quality of life.
4) United Kingdom: The findings may be of interest to review how services are delivered in the UK and whether or not there are other more cost-effective ways to explore. Task-shifting is already provided in the UK primary care when it comes to delivering psychological interventions (IAPT). However, this project goes one step beyond through using less qualified health workers to deliver the intervention compared to the UK. There will be also benefits in terms of student exchanges and collaboration across countries and universities, something at which the LSHTM and most of the have experience with.
5) Elderly people: This group has been relatively neglected throughout most of the developing world. However their needs cannot be overlooked any longer. The project is just a starting point in terms of finding ways of meeting the mental health needs of this population.
6) Researchers on mental health: The project is the first large randomized controlled trial from a LMIC to address this problem. Some ideas introduced in our model were taken from programmes designed in the more developed world but are being adapted to the reality of Brazil. This project will be able to test a programme which is 'leaner' than those tried in the more developed world.
7) Researchers on health in particular chronic diseases among the elderly: The problems of the elderly are often multiple. This project aims to begin the process of integrating mental health programmes into other health programmes for the elderly within the public health infrastructure.
8) Researchers on communication technology including private sector (mobile phone, software development, and so on). These projects as well as others we are conducting are pioneer efforts to introduce communication technology into mental health.