Atmiyata, a community led psychosocial intervention, for common mental disorders: A stepped wedge, cluster randomized controlled trial in rural Gujarat, India

Abstract This study evaluates the effectiveness of a volunteer community-led psychosocial intervention on depression and anxiety symptoms among people living in rural Gujarat, India. Stepped-wedge cluster randomized controlled trial design implemented in 645 villages in Mehsana district, Gujarat, India. Primary outcome was improvement in depression and/or anxiety symptoms using GHQ-12 at 3-month follow-up. Data was analyzed using generalized linear mixed effects models.Of the 1191 participants (608- intervention & 583-control) recruited, 1014 (85%) completed 3-month follow-up. After adjusting for baseline covariates, period, and cluster effects, participants in the intervention condition showed significant recovery from symptoms of depression or anxiety (OR 2.2; 95% CI 1.2 to 4.6; p < 0.05) at the end of 3-months, with effects sustained at 8-month follow-up (OR 3.0; 95% CI 1.6 to 5.9). The study findings have implications for the broader implementation and scale-up of community-based mental health delivery models in LMICs.Trial registration detailsThe trial was registered prospectively with the Clinical Trial Registry in India (registry number: CTRI/2017/03/008139).