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

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.

The proportion of elderly people is growing throughout the world. Depression is common and disabling among elderly people and often goes unrecognised and untreated. This will be a two-arm cluster randomised controlled trial to compare the effectiveness and cost-effectiveness of a psychosocial, community-based intervention delivered by Community Health Workers (CHWs) employed within the existing primary care system with an 'enhanced' usual care to treat depressed old adults from low socioeconomic backgrounds in São Paulo, Brazil. Participants will be recruited among those aged 60 or older who are registered with the participating Family Health Units (clusters). These units will be randomised to one of the two treatment groups. The intervention arm, with strong community-based and task-shifted components, consists of 8 to 11 home sessions, depending on severity of depression. CHWs will be supported with tablet computers to deliver the intervention and to receive supervision and support. Those participants who do not improve with the intervention, as shown by clearly specified algorithms, will be discussed in supervision and regular team meetings and further clinical decisions adopted if needed. 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. Recovery rates (PHQ-9 scores <10) will be compared across arms at 8 and 12 months after entering the trial using an intention-to-treat analysis. Direct and indirect costs in both arms will be measured to undertake a cost-effectiveness analysis. We anticipate a total of 1,440 participants, registered in 20 FHUs (clusters) yielding a power of 86.5% for a 15 percentage point difference (25% to 40%) in recovery rates at 8 months. Our research team has developed and successfully tested the feasibility and acceptability of the proposed intervention in primary care in São Paulo (RCUK/FAPESP).

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 the needs of these populations. Among these needs, health problems are a major challenge because of the magnitude and costs associated. This project will tease out some possible cost-effective solutions for one of the commonest health problems in this population i.e. depression.
2. Low-and-middle-income-countries (LMIC): There is little mental health research focused on the elderly from LMIC and this will be the first trial on how to improve the management of depression within this age group in LMIC. This study will provide unique information on how to make progress in this neglected field. Findings ought to be applicable to other countries with similar health systems and demographic transitions throughout the world.
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, all of which need to find cost-effective solutions to tackle depression in the elderly. Brazilian Universities would also benefit with strengthening their research capacity. It is worth mentioning that this project might also benefit primary care staff, especially low-cadre health workers, whose capabilities are often unexploited and receive little support or recognition for their work. The project will also allow us to explore alternative and more efficient ways of providing training and supervision to staff members, something that may be of use for other health and social problems. Finally, Brazilian elderly people will benefit from improved health 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 there are other more cost-effective ways to consider. Task-shifting is already being used in primary care in the UK, for instance when it comes to delivering psychological interventions (IAPT). This project goes one step beyond through using even less qualified health workers to deliver the intervention compared to the UK. There will also be benefits in terms of student exchanges and research collaboration across countries and universities. The Centre for Global Mental Health at KCL hosts a successful MSc progamme that attracts a large number of bright students with an interest to pursue a career in global mental health. The PI leads a research and training hub that includes six Latin American countries and has a strong capacity building component.
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 and health services: The project is the first large randomised controlled trial from a LMIC to address this problem. Some ideas introduced in our model were taken from programmes designed to deliver mental health care in other LMIC and adapted to the reality of Brazil. South-South knowledge transfer is proving a very efficient and rewarding way of finding successful solutions to major health challenges in LMIC. PROACTIVE will generate a fair amount of good quality scientific data that will be made publicly available. The applicants will be responsible for ensuring that high-quality publications are prepared and submitted.
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.