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

Abstract

This proposal aims to estimate to what extent adding to usual care a psychosocial, community-based intervention managed mostly delivered by nurse assistants (NA) and integrated within the existing primary care system improves depression recovery rates and functioning among depressed older adults from poor socioeconomic background in São Paulo, Brazil. This will be a two-arm cluster randomised controlled trial involving 1,280 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 NA based in primary care. The intervention will be mostly delivered at home and will last 8 months. NAs will be supported with tablet computers to deliver the intervention, and to receive further training, supervision and ongoing support. NA acting as case managers will liaise closely with the primary care team to ensure the best care is received by those suffering from depression (collaborative care). Those participants who do not improve with the intervention will be discussed in regular team meetings and further clinical decisions decided, if needed. The control group will receive 'enhanced' usual care alone in so far as cases being identified and the team will receive 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 9 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. (AU)