A stepped care intervention for non-specialist health workers' management of depression in the Mental Health in Primary Care (MeHPriC) project, Lagos, Nigeria: A cluster randomised controlled trial

Background: The study aimed to evaluate the clinical effectiveness of a developed stepped care intervention for management of depression in primary care. Methods: A cluster randomised controlled trial with primary care centres (PHCs) as unit of randomization. Five PHCs were randomised to stepped care intervention (SCI) group and another 5 PHCs were randomised to enhanced usual care (eUCA) control group. Participants were adults (18-60 years) with clinically significant depression symptoms. The primary outcome was clinical recovery at 12th months follow up. The outcome assessors were blinded to the cluster allocation. Results: There were 456 participants in SCI group and 451 in eUCA group. At 12 months, clinical recovery was significantly higher in the SCI group compared with the eUCA group (60.3% vs 18.2%, ARR 3.10, 95% CI 2.15-3.87). The SCI group also had significantly better quality of life and lesser rates of disability, death or deliberate self-harm compared to the eUCA group. Subgroup analysis within the SCI group showed no difference in clinical outcomes between participants receiving problem solving therapy (PST) and those receiving antidepressants. Conclusions: Our study showed that stepped care intervention significantly improved clinical outcomes at 12 months. This lends support to growing evidence of clinically effective intervention for depression at primary care level in less resourced countries.