Cluster randomised controlled trial (RCT) for late life depression in socioeconomically deprived areas of São Paulo, Brazil (PROACTIVE)
This will be a two-arm cluster randomised controlled trial aiming to compare the cost-effectiveness of adding to usual care a psychosocial, community-based intervention (PROACTIVE) delivered at home by Community Health Workers employed by the existing primary care system, with an 'enhanced' usual care in reducing depressive illness among adults 60 years or older from poor backgrounds in São Paulo, Brazil.
PROACTIVE consists of 8 to 11 home sessions delivered in a stepped-care fashion and delivered by Community Health Workers equipped with tablet computers to assist with the delivery. We anticipate recruiting 1,440 participants from 20 clinics. We will compare recovery across arms at 8 and 12 months after entering the trial. Several secondary outcomes will be also measured including quality of life and levels of functioning. Direct and indirect costs will be measured to undertake a cost-effectiveness analysis.