Adaptation of the World Health Organization Electronic Mental Health Gap Action Programme Intervention Guide App for Mobile Devices in Nepal and Nigeria: Protocol for a Feasibility Cluster Randomized Controlled Trial
Authors: Taylor Salisbury Tatiana , Kohrt Brandon A , Bakolis Ioannis , Jordans Mark JD , Hull Louise , Luitel Nagendra P , McCrone Paul , Sevdalis Nick , Pokhrel Pooja , Carswell Kenneth , Ojagbemi Akin , Green Eric P , Chowdhary Neerja , Kola Lola , Lempp Heidi , Dua Tarun , Milenova Maria , Gureje Oye , Thornicroft Graham 
Published: March 2021

Background
There is a growing global need for scalable approaches to training and supervising primary care workers (PCWs) to deliver mental health services. Over the past decade, the World Health Organization Mental Health Gap Action Programme Intervention Guide (mhGAP-IG) and associated training and implementation guidance have been disseminated to more than 100 countries. On the basis of the opportunities provided by mobile technology, an updated electronic Mental Health Gap Action Programme Intervention Guide (e-mhGAP-IG) is now being developed along with a clinical dashboard and guidance for the use of mobile technology in supervision.

Objective
This study aims to assess the feasibility, acceptability, adoption, and other implementation parameters of the e-mhGAP-IG for diagnosis and management of depression in 2 lower-middle-income countries (Nepal and Nigeria) and to conduct a feasibility cluster randomized controlled trial (cRCT) to evaluate trial procedures for a subsequent fully powered trial comparing the clinical effectiveness and cost-effectiveness of the e-mhGAP-IG and remote supervision with standard mhGAP-IG implementation.

Methods
A feasibility cRCT will be conducted in Nepal and Nigeria to evaluate the feasibility of the e-mhGAP-IG for use in depression diagnosis and treatment. In each country, an estimated 20 primary health clinics (PHCs) in Nepal and 6 PHCs in Nigeria will be randomized to have their staff trained in e-mhGAP-IG or the paper version of mhGAP-IG v2.0. The PHC will be the unit of clustering. All PCWs within a facility will receive the same training (e-mhGAP-IG vs paper mhGAP-IG). Approximately 2-5 PCWs, depending on staffing, will be recruited per clinic (estimated 20 health workers per arm in Nepal and 15 per arm in Nigeria). The primary outcomes of interest will be the feasibility and acceptability of training, supervision, and care delivery using the e-mhGAP-IG. Secondary implementation outcomes include the adoption of the e-mhGAP-IG and feasibility of trial procedures. The secondary intervention outcome—and the primary outcome for a subsequent fully powered trial—will be the accurate identification of depression by PCWs. Detection rates before and after training will be compared in each arm.

Results
To date, qualitative formative work has been conducted at both sites to prepare for the pilot feasibility cRCT, and the e-mhGAP-IG and remote supervision guidelines have been developed.

Conclusions
The incorporation of mobile digital technology has the potential to improve the scalability of mental health services in primary care and enhance the quality and accuracy of care.

Trial Registration
ClinicalTrials.gov NCT04522453; https://clinicaltrials.gov/ct2/show/NCT04522453.

International Registered Report Identifier (IRRID)
PRR1-10.2196/24115