Community-Based Rehabilitation for Persons with Severe Mental Illness in a Rural Community of Karnataka: Methodology of a Randomized Controlled Study.

Abstract

Background:Task shifting has been recommended as a strategy to reach out to persons with mental illness and bridge the treatment gap. There is a need to explore task-shifting using existing health staff like Accredited Social Health Activists (ASHAs).Aim and Context:ASHAs are involved in ongoing community-based rehabilitation (CBR) program run with a public–private partnership over the last 5 years at Jagaluru Taluk (an administrative block) in Davanagere district (Karnataka, India). This article aims to summarize a randomized controlled trial (RCT) to examine whether CBR delivered by ASHAs is more effective than treatment as usual (TAU) control group in reducing disability associated with severe mental illness (SMI).Method:A group of proactive ASHAs is already working with us for a follow-up of persons with SMI. For the study, we would allocate areas that are currently not being covered proactively by ASHAs randomly in a 1:1 ratio via computer-generated randomization list to receive either ASHAs delivered CBR arm or TAU control group. A sample size of about 100 in each arm is enough to identify an effect size of 0.5 in total IDEAS score between the intervention and control arms with a power of 90% and an alpha of 0.05. We use the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement to describe the methods of the trial.Result:The study has been approved by the institute ethics committee and registered with CTRI (CTRI/2019/08/020585 dated 6th August 2019). The recruitment of subjects is ongoing. The patients will be followed up for 1 year and assessed. The trial is funded by the Indian Council of Medical Research, Government of India.Discussion:The results of the study will be helpful from a public health perspective in delivering cost-effective and replicable CBR for persons with SMI through ASHAs. If the model turns successful, this could be expanded throughout the state/country. This would go a long way in bridging the huge treatment gap.