Home-based depression care for older people delivered by lay providers in Nigeria: protocol for a proof-of-concept cluster randomised controlled trial using an age adapted electronic mental health gap action programme intervention guide app for mobile devices

Background We conducted iterative adaptation of the generic e-version (2.0) of the WHO Mental Health Gap Action Programme Intervention Guide (emhGAP-IG) to overcome the challenges in detection and home-based management of depression in older people by frontline non-specialist Primary Health Care (PHC) workers. Objectives In this study, we will assess early implementation outcomes (feasibility, appropriateness, and acceptability) and evaluate parameters and procedures to inform a larger trial of the age adapted emhGAP-IG (emhGAP-Age) for home-based management of depression in older people. Methods A cluster Randomised Controlled Trial (cRCT) will be conducted in Ibadan, Nigeria. A minimum of 10 PHC clinics will be randomized to have their staff trained in emhGAP-Age (k=5 PHC clinics) or the emhGAP-IG (k=5 PHC clinics). PHC clinics will be the unit of clustering. Two PHC workers will be recruited per clinic (n=10 PHC workers per arm). They will receive training on a version of intervention relevant to their clinic. PHC workers in the intervention cluster will home-deliver emhGAP-Age to 55 depressed persons who are 60 years or older. 55 depressed older participants in the control clusters will receive clinic-based treatment using the emhGAP-IG (Usual care within PHC clinics in Nigeria). The primary outcome will be postintervention difference in Patient Health Questionnaire (PHQ-9) total scores at 6 months follow-up. Conclusions Home delivery of an age adapted emhGAP-IG has the potential to bridge existing gaps in continuity of care between PHC services and community-based care for depression and other priority mental health conditions in older people. Registration ClinicalTrials.gov (NCT06125899; 08/11/2023).