MRC-FAPESP cluster randomised controlled trial (RCT) for late life depression in socioeconomically deprived areas of São Paulo, Brazil

Abstract

Depression among the elderly is common and is often unrecognized, untreated, or receive sub-optimal treatment. Health care services in Brazil are ill-prepared to serve the health needs of this population. This proposal aims to estimate to what extent adding to usual care a psychosocial, community-based intervention mostly delivered by Community Health Workers (CHWs) and integrated within the existing primary care system improves recovery rates among depressed older adults from poor socioeconomic background in São Paulo, Brazil. The cost-effectiveness of this intervention will also be compared with 'enhanced' usual care. This will be a two-arm cluster randomised controlled trial involving moderately or severely depressed participants aged 60 or older who are registered with the participating Family Health Units (FHU). FHUs are randomized to one of two treatment groups; usual care or usual care plus a collaborative care psychosocial intervention for depression. Potentially eligible participants are identified and invited to participate in the study. The intervention, with strong community-based and task shifting components, consists of 8 to 11 home sessions, depending on severity of depression delivered over 17 weeks. CHWs will be supported with tablet computers to deliver the intervention, and will receive further training and supervision. The control group will receive 'enhanced' usual care alone in so far as cases being identified at the start of the trial. The primary outcome measure is the Patient Health Questionnaire-9 (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, levels of functioning, stressful life events, and others. Direct and indirect costs in both arms will be measured to undertake a cost-effectiveness analysis. We anticipate a total of 1440 participants, registered in 20 FHUs (clusters) yielding a power of 86.5% for 15% difference (25% to 40%) in recovery between the control and intervention groups 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). This project, if it proves cost-effective, has the potential for a noticeable impact and may constitute a timely contribution on treatment options for depressed older adults reducing dependency on specialized mental health resources, a problem seen in Brazil and most LMIC.