ESSENCE: An Implementation Research Program to Scale Up Depression Care in Rural Communities.

BACKGROUND: Task sharing may involve training nonspecialist health workers (NSHWs) to deliver brief mental health interventions. This approach is promising for reducing the global mental health treatment gap. However, capacity is limited for training large cadres of frontline workers in low- and middle-income countries, hindering uptake of these interventions at scale. METHODS: The ESSENCE (enabling translation of science to service to enhance depression care) project in Madhya Pradesh, India, aims to address these challenges through two sequential randomized controlled trials. First, a training trial will evaluate the effectiveness and cost-effectiveness of digital training, compared with conventional face-to-face training, in achieving clinical competency of NSHWs in delivering an intervention for depression. This initial trial will be followed by an implementation trial aimed at evaluating the effectiveness of a remote enhanced implementation support, compared with routine implementation support, in addressing barriers to delivery of depression care in primary care facilities. RESULTS: This project involved developing and pilot testing a scalable smartphone-based program for training NSHWs to deliver a brief psychological intervention for depression screening. This initial research guided a randomized trial of a digital training approach with NSHWs to evaluate the effectiveness of this approach. This trial will be followed by a cluster-randomized trial to evaluate the effectiveness of remote implementation support in ensuring efficient delivery of depression care in primary care facilities. NEXT STEPS: Findings from these trials may inform sustainable training and implementation support models to integrate depression care into primary care for scale-up in resource-constrained settings.

Development and implementation of COVID-19 safety protocols for conducting a randomized trial in global mental health: Field report from Central India.

The COVID-19 pandemic impacted ongoing clinical trials globally resulting in the suspension, cancellation or transition to entirely remote implementation of studies. In India, the first countrywide lockdown was imposed in phases starting from March 2020 to June 2020, followed by a continued restriction on in-person activities including study procedures, which halted the ESSENCE (Enabling translation of Science to Service to ENhance Depression CarE) trial activities such as recruitment, consenting, baseline assessment, digital training orientation, face to face training and end-line assessment evaluation. This situation made it imperative to amend procedures in order to mitigate the risk and address safety requirements for participants and the research team. This paper summarizes the need, development and implementation of the protocols focused on risk reduction and safety enhancement with an objective to resume and continue the research activities while ensuring the safety of study participants and research staff. These protocols are comprised of guidelines and recommendations based on existing literature tailored according to different components in each arm of the trial such as guidelines for supervisors, travellers, training/recruitment venue safety procedures, individual safety procedures; and procedures to implement the study activities. These protocols can be adapted by researchers in other settings to conduct research trials during pandemics such as COVID-19.

Digital training for non-specialist health workers to deliver a brief psychological treatment for depression in India: Protocol for a three-arm randomized controlled trial.

BACKGROUND: Training non-specialist health workers (NSHWs) at scale is a major barrier to increasing the coverage of depression care in India. This trial will test the effectiveness of two forms of digital training compared to conventional face-to-face training in changing the competence of NSHWs to deliver a brief evidence-based psychological treatment for depression. METHODS: This protocol is for a three-arm, parallel group randomized controlled trial comparing three ways of training NSHWs to deliver the Healthy Activity Program (HAP), a brief manualized psychotherapy for depression, in primary care. The arms are: digital training (DGT); digital training combined with individualized coaching support (DGT+); and conventional face-to-face training (F2F). The target sample comprises N = 336 government contracted NSHWs in Madhya Pradesh, India. The primary outcome is change of competence to deliver HAP; secondary outcomes include cost-effectiveness of the training programs, change in participants' mental health knowledge, attitudes and behavior, and satisfaction with the training. Assessors blind to participant allocation status will collect outcomes pre- (baseline) and post- (endpoint) training to ascertain differences in outcomes between arms. Training program costs will be collected to calculate incremental costs of achieving one additional unit on the competency measure in the digital compared to face-to-face training programs. Health worker motivation, job satisfaction, and burnout will be collected as exploratory outcome variables. DISCUSSION: This trial will determine whether digital training is an effective, cost-effective, and scalable approach for building workforce capacity to deliver a brief evidence-based psychological treatment for depression in primary care in a low-resource setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04157816.

Digital Training for Non-Specialist Health Workers to Deliver a Brief Psychological Treatment for Depression in Primary Care in India: Findings from a Randomized Pilot Study.

Introduction: Task sharing holds promise for scaling up depression care in countries such as India, yet requires training large numbers of non-specialist health workers. This pilot trial evaluated the feasibility and acceptability of a digital program for training non-specialist health workers to deliver a brief psychological treatment for depression. Methods: Participants were non-specialist health workers recruited from primary care facilities in Sehore, a rural district in Madhya Pradesh, India. A three-arm randomized controlled trial design was used, comparing digital training alone (DGT) to digital training with remote support (DGT+), and conventional face-to-face training. The primary outcome was the feasibility and acceptability of digital training programs. Preliminary effectiveness was explored as changes in competency outcomes, assessed using a self-reported measure covering the specific knowledge and skills required to deliver the brief psychological treatment for depression. Outcomes were collected at pre-training and post-training. Results: Of 42 non-specialist health workers randomized to the training programs, 36 including 10 (72%) in face-to-face, 12 (86%) in DGT, and 14 (100%) in DGT+ arms started the training. Among these participants, 27 (64%) completed the training, with 8 (57%) in face-to-face, 8 (57%) in DGT, and 11 (79%) in DGT+. The addition of remote telephone support appeared to improve completion rates for DGT+ participants. The competency outcome improved across all groups, with no significant between-group differences. However, face-to-face and DGT+ participants showed greater improvement compared to DGT alone. There were numerous technical challenges with the digital training program such as poor connectivity, smartphone app not loading, and difficulty navigating the course content-issues that were further emphasized in follow-up focus group discussions with participants. Feedback and recommendations collected from participants informed further modifications and refinements to the training programs in preparation for a forthcoming large-scale effectiveness trial. Conclusions: This study adds to mounting efforts aimed at leveraging digital technology to increase the availability of evidence-based mental health services in primary care settings in low-resource settings.

Acceptability and feasibility of digital technology for training community health workers to deliver brief psychological treatment for depression in rural India.

INTRODUCTION: Digital technology offers opportunities to train community health workers to deliver psychological treatments towards closing the gap in existing mental health services in low-resource settings. This study explored the acceptability and feasibility of using digital technology for training community health workers to deliver evidence-based brief psychological treatment for depression in rural India. METHODS: This study consisted of two sequential evaluations of digital training prototypes using focus group discussions to explore community health worker perspectives about the digital training platform and the program content. Through an iterative design process, feedback was collected about the first prototype to inform modifications to the second prototype. Qualitative data was analyzed using a framework analysis approach. RESULTS: Thirty-two community health workers participated in three separate focus group discussions. Five overarching themes related to acceptability and feasibility of digital training revealed that training on detection and treatment of depression was considered important by study participants for addressing 'stress' and 'tension' within their communities, while the digital platform was viewed as useful and convenient despite limited familiarity with using digital technology. Moreover, participants suggested simple language for the program and use of interactive content and images to increase interest and improve engagement. DISCUSSION: Digital technology appears acceptable and feasible for supporting training of community health workers to deliver evidence-based depression care in rural India. These findings can inform use of technology as a tool for developing the clinical skills of community health workers for treating depression in low-resource settings.

Scaling up integrated primary mental health in six low- and middle-income countries: obstacles, synergies and implications for systems reform.

BACKGROUND: There is a global drive to improve access to mental healthcare by scaling up integrated mental health into primary healthcare (PHC) systems in low- and middle-income countries (LMICs). AIMS: To investigate systems-level implications of efforts to scale-up integrated mental healthcare into PHC in districts in six LMICs. METHOD: Semi-structured interviews were conducted with 121 managers and service providers. Transcribed interviews were analysed using framework analysis guided by the Consolidated Framework for Implementation Research and World Health Organization basic building blocks. RESULTS: Ensuring that interventions are synergistic with existing health system features and strengthening of the healthcare system building blocks to support integrated chronic care and task-sharing were identified as aiding integration efforts. The latter includes (a) strengthening governance to include technical support for integration efforts as well as multisectoral collaborations; (b) ring-fencing mental health budgets at district level; (c) a critical mass of mental health specialists to support task-sharing; (d) including key mental health indicators in the health information system; (e) psychotropic medication included on free essential drug lists and (f) enabling collaborative and community- oriented PHC-service delivery platforms and continuous quality improvement to aid service delivery challenges in implementation. CONCLUSIONS: Scaling up integrated mental healthcare in PHC in LMICs is more complex than training general healthcare providers. Leveraging existing health system processes that are synergistic with chronic care services and strengthening healthcare system building blocks to provide a more enabling context for integration are important. DECLARATION OF INTEREST: None.

Mental health financing challenges, opportunities and strategies in low- and middle-income countries: findings from the Emerald project.

BACKGROUND: Current coverage of mental healthcare in low- and middle-income countries is very limited, not only in terms of access to services but also in terms of financial protection of individuals in need of care and treatment. AIMS: To identify the challenges, opportunities and strategies for more equitable and sustainable mental health financing in six sub-Saharan African and South Asian countries, namely Ethiopia, India, Nepal, Nigeria, South Africa and Uganda. METHOD: In the context of a mental health systems research project (Emerald), a multi-methods approach was implemented consisting of three steps: a quantitative and narrative assessment of each country's disease burden profile, health system and macro-fiscal situation; in-depth interviews with expert stakeholders; and a policy analysis of sustainable financing options. RESULTS: Key challenges identified for sustainable mental health financing include the low level of funding accorded to mental health services, widespread inequalities in access and poverty, although opportunities exist in the form of new political interest in mental health and ongoing reforms to national insurance schemes. Inclusion of mental health within planned or nascent national health insurance schemes was identified as a key strategy for moving towards more equitable and sustainable mental health financing in all six countries. CONCLUSIONS: Including mental health in ongoing national health insurance reforms represent the most important strategic opportunity in the six participating countries to secure enhanced service provision and financial protection for individuals and households affected by mental disorders and psychosocial disabilities. DECLARATION OF INTEREST: D.C. is a staff member of the World Health Organization.

Delivering a complex mental health intervention in low-resource settings: lessons from the implementation of the PRIME mental healthcare plan in primary care in Sehore district, Madhya Pradesh, India.

BACKGROUND: The PRogramme for Improving Mental health care (PRIME) designed, implemented and evaluated a comprehensive mental healthcare plan (MHCP) for Sehore district, Madhya Pradesh, India.AimsTo provide quantitative measures of outputs related to implementation processes, describe the role of contextual factors that facilitated and impeded implementation processes, and discuss what has been learned from the MHCP implementation. METHOD: A convergent parallel mixed-methods design was used. The quantitative strand consisted of process data on mental health indicators whereas the qualitative strand consisted of in-depth interviews and focus group discussions with key stakeholders involved in PRIME implementation. RESULTS: The implementation of the MHCP in Sehore district in Madhya Pradesh, India, demonstrated that it is feasible to establish structures (for example Mann-Kaksha) and operationalise processes to integrate mental health services in a 'real-world' low-resource primary care setting. The key lessons can be summarised as: (a) clear 'process maps' of clinical interventions and implementation steps are helpful in monitoring/tracking the progress; (b) implementation support from an external team, in addition to training of service providers, is essential to provide clinical supervision and address the implementation barriers; (c) the enabling packages of the MHCP play a crucial role in strengthening the health system and improving the context/settings for implementation; and (d) engagement with key community stakeholders and incentives for community health workers are necessary to deliver services at the community-platform level. CONCLUSIONS: The PRIME implementation model could be used to scale-up mental health services across India and similar low-resource settings.Declaration of interestNone.

Community, facility and individual level impact of integrating mental health screening and treatment into the primary healthcare system in Sehore district, Madhya Pradesh, India.

INTRODUCTION: Programme for Improving Mental Health Care (PRIME) designed a comprehensive mental healthcare plan (MHCP) for Sehore district, Madhya Pradesh, India. The objective of this paper is to describe the findings of the district-level impact evaluation of the MHCP. METHODS: Repeat community-based CS were conducted to measure change in population-level contact coverage for depression and alcohol use disorders (AUD), repeat FDS were conducted to assess change in detection and initiation of treatment for depression and AUD, and the effect of treatment on patient outcomes was assessed using disorder-specific prospective cohort studies. RESULTS: PRIME MHCP did not have any impact on contact coverage/treatment seeking for depression (14.8% at the baseline and 10.5% at the follow-up) and AUD (7.7% at the baseline and 7.3% at the follow-up) and had a small impact on detection and initiation of treatment for depression and AUD (9.7% for depression and 17.8% for AUD compared with 0% for both at the baseline) in the health facilities. Patients with depression who received care as part of the MHCP had higher rates of response (52.2% in the treatment group vs 26.9% in the comparison/usual care group), early remission (70.2% in the treatment group vs 44.8% in the comparison/usual care group) and recovery (56.1% in the treatment group vs 28.5% in the comparison/usual care group), but there was no impact of treatment on their functioning. CONCLUSIONS: While dedicated human resources (eg, Case Managers) and dedicated space for mental health clinics (eg, Mann-Kaksha) strengthen the 'formal' healthcare platform, without substantial additional investments in staff, such as Community Health Workers/Accredited Social Health Activists to improve community level processes and provision of community-based continuing care to patients, we are unlikely to see major changes in coverage or clinical outcomes.