Atmiyata, a community led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India
Abstract Background While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide evidence-based counselling for persons with common mental disorders (CMD) as part of a package of community-based interventions for mental health. Methods The impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial spans across 10 sub-blocks (645 villages) in Mehsana district with 1.52 million rural adult population. 56 PHCs in Mehsana district are equally divided into four clusters of 14 PHCs each, and the intervention is rolled out in cluster in a staggered manner at an interval of 5 months. The primary outcome is symptomatic improvement measured through the GHQ-12 at 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-reporting questionnaire-20 (SRQ-20), functioning using the WHO Disability Assessment Scale (WHO-DAS-12), depression symptoms (Patient Health Questionnaire, PHQ-9)) and anxiety symptoms (Generalized Anxiety Disorder Questionnaire, GAD-7) and social participation using the Social Participation Scale (SPS). Linear mixed effects models are employed for continuous outcomes and generalized linear mixed effects model for binary outcomes. Discussion Stepped wedge designs are progressively being used to evaluate real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a LMIC evaluating the impact of the implementation of a mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in LMICs.