ESSENCE (Enabling translation of Science to Service to ENhance Depression CarE)

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PROJECT ABSTRACT (OVERALL COMPONENT) The overall goal of the ESSENCE (Enabling translation of Science to Service to ENhance Depression CarE) project is to generate knowledge on effective implementation approaches for scaling up of evidence based interventions for depression in primary care settings in rural India. The ESSENCE Implementation Trial represents the second of two major trials in the ESSENCE program, and will yield valuable research findings on the effectiveness and costs of remote strategies that can support the uptake and implementation of a depression care package based on the World Health Organization's mhGAP program in routine primary care settings in Sehore district in Madhya Pradesh, India. The ESSENCE Implementation Trial builds directly on the successful roll out and completion of the ESSENCE Training Trial, which demonstrated the effectiveness of leveraging digital technology for building workforce capacity by training community health workers to deliver an evidence- based brief psychological treatment for depression. The ESSENCE Implementation Trial represents the next critical step in supporting the implementation of depression care, by supporting the primary health care facility teams with the adoption and integration of depression care, and establishing the referral pathways for screening and identifying depression cases in the community and then ensuring access to treatment delivered by the newly trained community health workers. The ESSENCE Implementation Trial consists of a cluster-randomized controlled trial, enrolling 14 primary care facilities in Sehore district, with 7 facilities randomly assigned to receive the Enhanced Implementation Support strategy intervention condition, and the remaining 7 facilities randomly assigned to receive the Routine Implementation Support control condition. Our primary hypothesis is that the Enhanced Implementation Support, involving remotely delivered coaching and emphasis on quality improvement, will be superior to Routine Implementation Support in increasing the proportion of outpatients screened for depression (using the PHQ-9, a common screener for depression). Furthermore, we hypothesize that among outpatients screened positive with depression, those in facilities randomized to the Enhanced Implementation Support will show greater reduction in symptom severity at 3-month follow up compared to outpatients in the Routine Implementation Support control condition. All 14 facilities have been trained in the mhGAP depression care package, and the implementation support strategies have been tested in April and May, 2022. The official launch of patient recruitment for the Implementation Trial will begin on June 1st, 2022. This Administrative Supplement will ensure that the key activities for the ESSENCE Implementation Trial can be completed, and that the data analyses and interpretation of the findings can inform the scale up of depression care towards reducing the treatment gap for depression care in India and globally.