Effectiveness of WHO mhGAP-IG in identification and management of depression by primary level non-specialist health workers – protocol of a cluster randomized controlled trial from India

BACKGROUND: Reports suggest that > 90% of the cases go undetected in low- and middle-income countries (LMICs) leading to a huge treatment gap. Evidence shows that task-sharing interventions such as training HWs, screening led to improved detection of depression at the primary level. In this regard, the World Health Organization (WHO) developed the mhGAP-IG to aid non-specialist HWs to detect and manage common mental health disorders such as depression to bridge the gap. The present study aims to design and test the effectiveness of a digital mental health intervention designed by contextualizing e-mhGAP in improving the detection and management of depression at the primary care level. METHODS: Formative phase will involve qualitative interviews, literature review aimed at co-developing a mobile application with the district mental health program. This will be followed by a cRCT. The trial will be conducted in eight PHCs, located in Tumkur district, Karnataka, and Wardha district, Maharashtra. Randomisation will be done at the PHC level. We plan to enrol non-specialist HWs working in these PHCs and a sample of 2400 adults who are availing the PHC services. Intervention PHC will receive training for HWs and a mobile application. Control PHCs will follow usual care. Both the groups will be encouraged to identify, manage, and follow-up people with mild depression. Study tools include PHQ-2, PHQ-9, acceptability of intervention measure, and Eq. 5D5L instrument. Change in the detection rates of depression between intervention and control arms will be the primary outcome. Cost effectiveness analysis will be done. DISCUSSION: This trial advocates for integrating mental health services into primary healthcare, which aligns with the Comprehensive Mental Health action plan that seeks to enhance the capacity of non-specialist HWs in mental healthcare delivery. Co-development with the district mental health program, features of app such as offline functionality, multimedia visuals, and follow-up tracking are some of the strengths. If this intervention is found effective, then it could significantly impact the treatment gap for depression by integrating mental health within the ambit of primary care model across India. TRIAL REGISTRATION: Prospectively registered with the Clinical Trials Registry of India on 23/04/2024 (Reference number- CTRI/2024/04/066142).