A Cluster Randomized Controlled Trial of a Stepped-Care Intervention Delivered by Lay Health Workers for Primary Care Patients with Major Depressive Disorder in Nigeria

Abstract

BACKGROUND: Little is currently known about how to scale up care for depression in settings where non-physician lay workers constitute the bulk of frontline providers. METHODS: Cluster randomized trial conducted in thirty-five primary care clinics in Ibadan, Nigeria (18 intervention arm, 17 control arm). Participants were adults, aged 18 or older, not pregnant, and with moderate to severe depression. The intervention arm received 8 sessions of individual problem-solving therapy, with additional sessions if needed (STEP), plus enhanced usual care (EUC). Control arm received EUC alone. Usual care was enhanced by the use of WHO mhGAP intervention guide. Primary outcome, conducted by blinded assessors, was depression remission at 12 months (score =6 on the 9-item Patient Health Questionnaire). Secondary outcomes were depressive symptoms, disability and quality of life at 6 and 12 months. Service utilization and associated costs were measured. Trial registration number is ISRCTN 46754188. FINDINGS: Participants were 1178 (STEP plus EUC: 631; EUC: 547); 82·8% females. Baseline mean PHQ-9 score was 13·7 (±2·6), 87·9% completed 12-month follow-up (STEP plus EUC: 89%; EUC: 86%). At 12-month, remission from depression was 75·6% in the intervention arm and 77·4% in the control arm [adjusted risk difference -1·8% (95% CI: -6·9, 3·4%), adjusted odds ratio 1·0 (95% CI: 0·70, 1·40)]. At 6 months, the STEP plus EUC group had lower mean depression symptoms than EUC group (3·4 vs. 4·3; adjusted difference in means -0·7 (95% CI -1·3 to -0·2)). No differences in other secondary outcomes were evident. INTERPRETATION: Among primary care patients with moderate to severe depression receiving care from non-physician primary health care workers in Nigeria, STEP plus EUC had similar costs and clinical outcomes as EUC alone. Enhancing usual care with mhGAP-IG may provide simple and affordable approach to scaling up depression care in sub-Saharan Africa. Trial Registration Number: ISRCTN 46754188. Funding: Medical Research Council (MRC) Declaration of Interest: The authors declare that they have no competing interests. Ethical Approval: The Study was approved by the UI/UCH Ethics Committee and its conduct monitored by an independent Trial Steering Committee. All participants provided written (or witnessed, if illiterate) informed consent.