<i>Atmiyata</i>, A Community Led Psychosocial Intervention in Reducing Symptoms Associated with Common Mental Disorders: A Stepped Wedge Cluster Randomized Controlled Trial in Rural Gujarat, India

Abstract

Background: While lay-health worker models for mental health care have shown to be effective in controlled trials, there is limited evidence on the effectiveness of these models implemented at scale in rural communities in LMICs. To narrow this evidence gap, we evaluated the impact of Atmiyata, a community-led intervention involving trained community volunteers delivering 4-6 sessions of psychosocial counselling for treating common mental disorders at scale. Methods: Stepped-wedge cluster randomized controlled trial implemented across 645 villages in Mehsana district, Gujarat, India, from April 2017 to August 2019. The primary outcome was improvement on the GHQ-12 at 3-month follow-up. Secondary outcomes were improvement in (a) depression and anxiety symptoms (Patient Health Questionnaire, (PHQ-9), Generalized Anxiety Disorder (GAD-7) & Self-Reporting Questionnaire-20 (SRQ-20)); b) quality of life (EQ- 5D); c) disability (Disability Assessment Scale (WHO-DAS-12)), and social participation (Social Participation Scale SPS). Intention-to-treat outcomes were analyzed using generalized linear mixed effects models. Findings: A total of 1191 trial participants (608 & 583 in intervention & control arms respectively), 1014 (85%) completed 3-month follow-up. After adjusting for baseline covariates, secular trends and cluster effects, participants in the intervention condition showed significant recovery of symptoms from CMD (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). Intervention participants had improved scores on the PHQ-9 (AMD -2.2; 95%CI -3.2 to -1.2), GAD-7 (AMD -1.4; 95%CI -2.3 to -0.5) and SRQ-20 (AMD -1.5; 95%CI -2.4 to -0.5), EQ- 5D (AMD of 0.05 95%CI: 0.02 to 0.08) at 3 months. At 8 months, intervention participants had significant improvement on all secondary outcomes. Interpretation: Atmiyata had significant effect in recovery from CMD with sustained long-term effects when implemented at scale in routine settings. Trial Registration: The trial was registered prospectively with Clinical Trial Registry, India (No: CTRI/2017/03/008139). Funding Statement: Supported by a Transition-to-Scale grant by Grand Challenges Canada (Grant no- 0792-05) and Mariwala Health Initiative. Declaration of Interests: The authors declare no completing interests. Ethics Approval Statement: Permission was obtained from the Department of Health and Family Welfare, Government of Gujarat for project implementation and data collection. Ethics approval was obtained from ILS Ethics Committee (ILS/14/2017) and additional ethical approval was obtained from the local ethics committee of Hospital for Mental Health, Ahmedabad, India (a Government of Gujarat public mental health institution). Informed consent was obtained from all trial participants.