Contents lists available at ScienceDirect General Hospital Psychiatry journal homepage: www.elsevier.com/locate/genhospsych 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 Abiodun O. Adewuya a,b,c, ⁎ , Bolanle A. Ola a , Olurotimi Coker a , Olayinka Atilola a , Adedolapo Fasawe c , Tolu Ajomale c a Department of Behavioural Medicine, Lagos State University College of Medicine, Ikeja, Lagos, Nigeria b Centre for Mental Health Research & Initiative (CEMHRI), Lagos, Nigeria c Lagos State Ministry of Health, Lagos, Nigeria ARTICLE INFO Keywords: Depression Primary care Collaborative stepped care Lagos ABSTRACT 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 en- hanced usual care (eUCA) control group. Participants were adults (18–60 years) with clinically significant de- pression 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 anti- depressants. 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. Trial Registration: http://www.isrctn.com/ISRCTN66243738. 1. Introduction Depression is the most prevalent and the leading neuropsychiatric cause of burden of disease both globally and in low- and medium-in- come countries (LMICs) and is projected to be the second leading cause of burden of disease by 2020 [1]. Depression impacts on functioning, is associated with increased mortality, often co-morbid with other chronic diseases, and is responsible for a sizable proportion of disability asso- ciated with these conditions [1]. In Nigeria, about 10–25% of primary health centres (PHCs) attendees have clinically significant depressive symptoms [2,3]. Over 70% of people with depression in Africa do not receive any form of treatment for their condition [4]. This huge treat- ment gap had been reported to be due to factors like non-availability of mental health services at the community level, shortage of mental health work-force, lack of evidence-based depression management practice, high medication cost, poor adherence to prescribed interven- tion and stigma [5,6]. Studies have shown that low intensity psychological interventions like problem solving therapy (PST), are effective in LMICs, even when delivered by lay health workers [7,8]. Also, the stepped care model has been shown to be an ideal delivery model for treating depression in a pragmatic setting with a wide range of illness severity, differentials in patients' preferred treatment choices, and, a short supply of specialist mental health workers [9,10]. The stepped care approach emphasizes that while simple psychological intervention may be provided to all participants by trained non-medical personnel, non-responders or those https://doi.org/10.1016/j.genhosppsych.2019.07.012 Received 17 February 2019; Received in revised form 16 July 2019; Accepted 17 July 2019 ⁎ Corresponding author at: Dept of Behavioural Medicine, Lagos State University College of Medicine, 1-5, Oba Akinjobi Way, Ikeja, Lagos, Nigeria. E-mail address: abiodun.adewuya@lasucom.edu.ng (A.O. Adewuya). General Hospital Psychiatry 60 (2019) 76–82 0163-8343/ © 2019 Elsevier Inc. All rights reserved. T