**1. Introduction**

According to the global burden of disease study, nearly 200 million people were living with mental disorders in India by 2017, which represents 14.3% of the total population of the country [1]. This includes over 45 million people living with depressive disorder, the leading mental health contributor to the global disease burden, comprising approximately 3.3% of the total population of the country [1]. The National Mental Health Survey of India 2015–16 found that the prevalence of depression was about 2.7% and the lifetime prevalence was 5.3% in the study population [2]. Several studies have reported a significant gap between those living with depression and those who have access to adequate care [3,4]. The National Mental Health Survey estimated that the care gap for current depression was 79.1% [2], while in some regions of the country this gap exceeds 90% [5].

The World Health Organization's (WHO) Mental Health Gap Action Programme (mhGAP) recommends brief psychological interventions as first-line treatments for depression [6]. However, access to brief psychological treatments remains a significant challenge, particularly in lower-income countries like India. This is partly due to the limited number of available specialist providers to deliver these treatments or supervise care, as well as to train other therapists [7,8]. Task sharing involves building the capacity of non-specialist health workers, which include a broad range of frontline health workers who do not have specialized training in mental health care, to deliver brief evidence-based psychological treatments for common mental disorders [9]. This approach appears to be a key strategy to address the care gap for depression, as reflected by mounting evidence that non-specialist health workers can effectively deliver brief psychological treatments for depression across a range of lower resource settings [10–12].

In India, the formation of the National Mental Health Policy of India in 2014 [13] and enforcement of the Mental Health Care Act 2017 [14], as well as revised guidelines of the National Mental Health Program (NMHP) [15], are major drivers at the policy and health system level for expanding and integrating mental health services in primary health care [16]. These recent legislative developments have highlighted the importance of task sharing as being critical to achieving universal coverage of basic mental health services. A major barrier to the successful implementation and scale up of task sharing is the need to adequately train sufficient non-specialist health workers to deliver brief psychological treatments and to ensure that this workforce achieves the necessary clinical competencies to sustain delivery of high-quality care [17–19].

In India, conventional face-to-face residential training requiring extended stays at government training facilities is the typical approach for training non-specialist health workers, such as ASHAs (Accredited Social Health Activists) through the National Health Mission [20–23]. However, there are financial and logistical challenges, such as the need for expert trainers to lead the training, as well as the requirement of significant travel across long distances for participants to attend the training [7,24]. Therefore, this method of training health workers is limited by poor scalability. The increasing availability and use of digital technologies, such as smartphones, among non-specialist health workers offer new opportunities to support training and skill-building without requiring in-person instruction [25,26]. For instance, mobile internet penetration continues to increase rapidly in many low-resource countries, with close to 450 million people in 2020 in India having internet access from their phones [27]. While many frontline health workers do not have access to or own smartphones, this is changing in several parts of India as government health systems are now providing smartphones to health workers to support them in their work [28,29].

To date, there have been promising initial efforts demonstrating the feasibility of using digital technology as a tool for enhancing in-person training programs for non-specialist health workers in a low-resource setting in rural Pakistan [30]. Additionally, prior studies have demonstrated promising findings using digital technology to support task-sharing mental health services in low-resource settings through the use of digital tools for diagnosis, guiding clinical decision making, and facilitating supervision [25]. Specifically in India, recent studies have reported on a successful digital decision-support platform for supporting community health workers and primary care providers in the screening, diagnosis, and management of common mental disorders [31]; the use of an Android app with tailored video content for training community volunteers about mental health, connecting individuals with available services, and raising awareness [32]; and the initial feasibility and acceptability of a digital game accessible from a smartphone app involving a problem-solving intervention for adolescent mental health [33]. These studies highlight the viability and promise of digital interventions for mental health in low-resource settings such as India; however, there remains an immediate need to generate evidence on the feasibility, acceptability, and potential effectiveness of using a fully remote digital training program delivered on a smartphone application to non-specialist health workers in a rural area of a low-resource setting.

In earlier formative research, we demonstrated the interest in using digital technology for accessing a training program to deliver a brief psychological treatment for depression among non-specialist health workers in Madhya Pradesh, India [34]. We found that a digital platform was feasible for use among non-specialist health workers, and through a series of focus group discussions, we gained valuable stakeholder insights about what features could make a digital training program interesting and appealing for this target group. Specifically, participants provided suggestions for simplifying the language in the program contents and materials, and using familiar terms tailored to the local context; they also recommended adding more images or graphics and interactive features to create a more engaging training program [34]. Drawing from these findings, our team developed a digital program for training non-specialist health workers to deliver the Healthy Activity Program (HAP), a brief evidence-based psychological treatment for depression in primary care [35].

Our next step, and primary objective of this pilot study, was to determine the feasibility and acceptability of this digital training program compared to conventional face-to-face training. In this pilot study, our goal was to collect data on the use of the digital training, such as navigating the smartphone app and accessing the training content, as well as participant feedback to inform refinements to the digital training as well as our study procedures in preparation for a larger fully powered effectiveness trial. Specifically, we conducted this three-arm randomized pilot trial to explore the acceptability and feasibility of two digital training programs (digital training alone and digital training with remote support), and to explore changes in competency outcomes compared to conventional face-to-face training for non-specialist health workers, to deliver the evidence-based HAP treatment for depression in Sehore, a rural district in Madhya Pradesh, India.

We included a third arm in this pilot study to test the use of remote support for enhancing engagement and completion of the digital training program. Our rationale for using remote support stems from the existing online education literature highlighting that additional support can promote participant engagement and completion in online learning programs [36,37]. While this study was primarily focused on determining the feasibility and acceptability of the digital training program, we also collected a measure of competency to assess preliminary effectiveness, which was defined by the acquisition of the knowledge and skills required to deliver HAP.

#### **2. Material and Methods**

This exploratory three-arm randomized pilot study followed the extension of CONSORT guidelines to pilot studies [38]. In this study, non-specialist health workers were recruited from three community health centers (i.e., Doraha, Bilkishganj, and Shyampur) in the Sehore district of Madhya Pradesh, India. This study site was selected because Sangath, the research organization leading this project, has a close partnership and an established Memorandum of Understanding with the state government. Additionally, the goal was to create a model of depression care that could be successfully delivered by non-specialist health workers in Sehore district and then scaled up to other districts in the state, and also to other regions of India. Madhya Pradesh is a large, centrally located state with over 72 million people,

of which nearly 73% reside in rural areas [39]. Relative to many other Indian states, Madhya Pradesh ranks lower with respect to human development and availability of resources [40,41]. According to the 2016 National Mental Health Survey of India, the care gap for mental disorders in Madhya Pradesh exceeds 90% [5]. Ethics review boards at Sangath, India (VP\_2017\_028), and Harvard Medical School, USA (IRB17-0092), approved all study procedures.
