Operational challenges in the pre-intervention phase of a mental health trial in rural India: reflections from SMART Mental Health.

BACKGROUND: Availability of mental health services in low- and middle-income countries is largely concentrated in tertiary care with limited resources and scarcity of trained professionals at the primary care level. SMART Mental Health is a strategy that combines a community anti-stigma campaign with a primary health care workforce strengthening initiative, using electronic decision support with the goal of better identifying and supporting people with common mental disorders in India. METHODS: We describe the challenges faced and lessons learnt during the pre-intervention phase of SMART Mental Health cluster Randomised Controlled Trial. Pre-intervention phase includes preliminary activities for setting-up the trial and research activities prior to delivery of the intervention. Field notes from project site visit, project team meetings and detailed follow-up discussions with members of the project team were used to document operational challenges and strategies adopted to overcome them. The socio-ecological model was used as the analytical framework to organise the findings. RESULTS: Key challenges included delays in government approvals, addressing community health worker needs, and building trust in the community. These were addressed through continuous communication, leveraging support of relevant stakeholders, and addressing concerns of community health workers and community. Issues related to use of digital platform for data collection were addressed by a dedicated technical support team. The COVID-19 pandemic and political unrest led to significant and unexpected challenges requiring important adaptations to successfully implement the project. CONCLUSION: Setting up of this trial has posed challenges at a combination of community, health system and broader socio-political levels. Successful mitigating strategies to overcome these challenges must be innovative, timely and flexibly delivered according to local context. Systematic ongoing documentation of field-level challenges and subsequent adaptations can help optimise implementation processes and support high quality trials. TRIAL REGISTRATION: The trial is registered with Clinical Trials Registry India (CTRI/2018/08/015355). Registered on 16th August 2018. http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=23254&EncHid=&userName=CTRI/2018/08/015355.

COVID-19, adversities and depression among older adolescents in urban slums of India.

PURPOSE: We report findings from a survey on the mental health impact of COVID-19 factoring environmental adversities among older adolescents (15-19 years) living in urban slums in India. METHODS: We report survey results of 3490 older adolescents. Patient Health Questionnaire-9 was used to assess depression, slum adversity questionnaire for slum conditions, and for COVID-19 infection we recorded self-reported positivity status. Sociodemographic details were also collected. Additional sub-group analyses of sample who had depression and tested positive for COVID-19 infection was conducted. We used univariate and multivariate logistic regression models to identify factors and COVID-19 infection that were associated with depression. RESULTS: Adolescents with adversities were three times more likely to report depression. Adolescents who reported COVID-19 infection were about two times more likely to have depression. Sub-group analyses showed that adolescents having experienced adversities and girls were more likely to report depression following COVID-19 infection. CONCLUSIONS: There is a need for an intersectional research framework that incorporates stress arising out of a pandemic, social disadvantage, and systemic inequities. Such a framework will help to assess mental health issues of developmentally vulnerable groups residing in disadvantageous conditions.

Protocol for process evaluation of SMART Mental Health cluster randomised control trial: an intervention for management of common mental disorders in India.

INTRODUCTION: In India about 95% of individuals who need treatment for common mental disorders like depression, stress and anxiety and substance use are unable to access care. Stigma associated with help seeking and lack of trained mental health professionals are important barriers in accessing mental healthcare. Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health integrates a community-level stigma reduction campaign and task sharing with the help of a mobile-enabled electronic decision support system (EDSS)-to reduce psychiatric morbidity due to stress, depression and self-harm in high-risk individuals. This paper presents and discusses the protocol for process evaluation of SMART Mental Health. METHODS AND ANALYSIS: The process evaluation will use mixed quantitative and qualitative methods to evaluate implementation fidelity and identify facilitators of and barriers to implementation of the intervention. Case studies of six intervention and two control clusters will be used. Quantitative data sources will include usage analytics extracted from the mHealth platform for the trial. Qualitative data sources will include focus group discussions and interviews with recruited participants, primary health centre doctors, community health workers (Accredited Social Health Activits) who participated in the project and local community leaders. The design and analysis will be guided by Medical Research Council framework for process evaluations, the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, and the normalisation process theory. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the George Institute for Global Health, India and the Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi. Findings of the study will be disseminated through peer-reviewed publications, stakeholder meetings, digital and social media platforms. TRIAL REGISTRATION NUMBER: CTRI/2018/08/015355.

An integrated community and primary healthcare worker intervention to reduce stigma and improve management of common mental disorders in rural India: protocol for the SMART Mental Health programme.

BACKGROUND: Around 1 in 7 people in India are impacted by mental illness. The treatment gap for people with mental disorders is as high as 75-95%. Health care systems, especially in rural regions in India, face substantial challenges to address these gaps in care, and innovative strategies are needed. METHODS: We hypothesise that an intervention involving an anti-stigma campaign and a mobile-technology-based electronic decision support system will result in reduced stigma and improved mental health for adults at high risk of common mental disorders. It will be implemented as a parallel-group cluster randomised, controlled trial in 44 primary health centre clusters servicing 133 villages in rural Andhra Pradesh and Haryana. Adults aged ≥ 18 years will be screened for depression, anxiety and suicide based on Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorders (GAD-7) scores. Two evaluation cohorts will be derived-a high-risk cohort with elevated PHQ-9, GAD-7 or suicide risk and a non-high-risk cohort comprising an equal number of people not at elevated risk based on these scores. Outcome analyses will be conducted blinded to intervention allocation. EXPECTED OUTCOMES: The primary study outcome is the difference in mean behaviour scores at 12 months in the combined 'high-risk' and 'non-high-risk' cohort and the mean difference in PHQ-9 scores at 12 months in the 'high-risk' cohort. Secondary outcomes include depression and anxiety remission rates in the high-risk cohort at 6 and 12 months, the proportion of high-risk individuals who have visited a doctor at least once in the previous 12 months, and change from baseline in mean stigma, mental health knowledge and attitude scores in the combined non-high-risk and high-risk cohort. Trial outcomes will be accompanied by detailed economic and process evaluations. SIGNIFICANCE: The findings are likely to inform policy on a low-cost scalable solution to destigmatise common mental disorders and reduce the treatment gap for under-served populations in low-and middle-income country settings. TRIAL REGISTRATION: Clinical Trial Registry India CTRI/2018/08/015355 . Registered on 16 August 2018.

SMART Mental Health Project: process evaluation to understand the barriers and facilitators for implementation of multifaceted intervention in rural India.

BACKGROUND: Globally, mental health problems are a growing public health concern. Resources and services for mental disorders are disproportionately low compared to disease burden. In order to bridge treatment gaps, The Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health Project was implemented across 12 villages in West Godavari district of the southern Indian state of Andhra Pradesh. This paper reports findings from a process evaluation of feasibility and acceptability of the intervention that focused on a mental health services delivery model to screen, diagnose and manage common mental disorders (CMDs). METHODS: A mixed methods evaluation was undertaken using quantitative service usage analytics, and qualitative data from in-depth interviews and focus group discussions were conducted with stakeholders including primary care physicians, community health workers, field staff and community members. Barriers to and facilitators of intervention implementation were identified. Andersen's Behavioral Model for Health Services Use was the conceptual framework used to guide the process evaluation and interpretation of data. RESULTS: In all, 41 Accredited Social Health Activists (ASHAs) and 6 primary health centre (PHC) doctors were trained in mental health symptoms and its management. ASHAs followed up 98.7% of screen positive cases, and 81.2% of these were clinically diagnosed and treated by the PHC doctors. The key facilitators of implementation were adequate training and supervision of field staff, ASHAs and doctors, use of electronic decision support, incorporation of a door-to-door campaign and use of culturally tailored dramas/videos to raise awareness about CMDs, and organising health camps at the village level facilitating delivery of intervention activities. Barriers to implementation included travel distance to receive care, limited knowledge about mental health, high level of stigma related to mental health issues, and poor mobile network signals and connectivity in the villages. Lack of familiarity with and access to mobile phones, especially among women, to accessing health related messages as part of the intervention. CONCLUSIONS: The evaluation not only provides a context to the interventions delivered, but also allowed an understanding of possible factors that need to be addressed to make the programme scalable and of benefit to policy makers.

Mental health conditions after snakebite: a scoping review.

INTRODUCTION: Snakebite is a neglected tropical disease. Snakebite causes at least 120 000 death each year and it is estimated that there are three times as many amputations. Snakebite survivors are known to suffer from long-term physical and psychological sequelae, but not much is known on the mental health manifestations postsnakebite. METHODS: We conducted a scoping review and searched five major electronic databases (Ovid MEDLINE(R), Global Health, APA PsycINFO, EMBASE classic+EMBASE, Cochrane Central Register of Controlled Trials), contacted experts and conducted reference screening to identify primary studies on mental health manifestations after snakebite envenomation. Two reviewers independently conducted titles and abstract screening as well as full-text evaluation for final inclusion decision. Disagreements were resolved by consensus. We extracted data as per a standardised form and conducted narrative synthesis. RESULTS: We retrieved 334 studies and finally included 11 studies that met our eligibility criteria. Of the 11 studies reported, post-traumatic stress disorder (PTSD) was the most commonly studied mental health condition after snakebite, with five studies reporting it. Estimate of the burden of PTSD after snakebite was available from a modelling study. The other mental health conditions reported were focused around depression, psychosocial impairment of survivors after a snakebite envenomation, hysteria, delusional disorders and acute stress disorders. CONCLUSION: There is a need for more research on understanding the neglected aspect of psychological morbidity of snakebite envenomation, particularly in countries with high burden. From the limited evidence available, depression and PTSD are major mental health manifestations in snakebite survivors.

The Systematic Medical Appraisal Referral and Treatment Mental Health Project: Quasi-Experimental Study to Evaluate a Technology-Enabled Mental Health Services Delivery Model Implemented in Rural India.

BACKGROUND: Although around 10% of Indians experience depression, anxiety, or alcohol use disorders, very few receive adequate mental health care, especially in rural communities. Stigma and limited availability of mental health services contribute to this treatment gap. The Systematic Medical Appraisal Referral and Treatment Mental Health project aimed to address this gap. OBJECTIVE: This study aimed to evaluate the effectiveness of an intervention in increasing the use of mental health services and reducing depression and anxiety scores among individuals at high risk of common mental disorders. METHODS: A before-after study was conducted from 2014 to 2019 in 12 villages in Andhra Pradesh, India. The intervention comprised a community antistigma campaign, with the training of lay village health workers and primary care doctors to identify and manage individuals with stress, depression, and suicide risk using an electronic clinical decision support system. RESULTS: In total, 900 of 22,046 (4.08%) adults screened by health workers had increased stress, depression, or suicide risk and were referred to a primary care doctor. At follow-up, 731 out of 900 (81.2%) reported visiting the doctor for their mental health symptoms, compared with 3.3% (30/900) at baseline (odds ratio 133.3, 95% CI 89.0 to 199.7; P<.001). Mean depression and anxiety scores were significantly lower postintervention compared with baseline from 13.4 to 3.1 (P<.001) and from 12.9 to 1.9 (P<.001), respectively. CONCLUSIONS: The intervention was associated with a marked increase in service uptake and clinically important reductions in depression and anxiety symptom scores. This will be further evaluated in a large-scale cluster randomized controlled trial.

Longitudinal assessment of an anti-stigma campaign related to common mental disorders in rural India.

BACKGROUND: Stigma related to mental health and lack of trained mental health professionals is a major cause for an increased treatment gap, particularly in rural India. The Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health project delivered a complex intervention involving task sharing, an anti-stigma campaign and use of technology-based, decision-support tools to empower primary care workers to identify and manage depression, anxiety, stress and suicide risk.AimsThe aim of this article is to report changes in stigma perceptions over three time points in the rural communities where the anti-stigma campaign was conducted. METHOD: A multimedia-based anti-stigma campaign was conducted over a 3-month period in the West Godavari district of Andhra Pradesh, India. Following that, the primary care-based mental health service was delivered for 1 year. The anti-stigma campaign was evaluated in two villages and data were captured at three time points over a 24-month period (N = 1417): before and after delivery of the campaign and after completion of the health services delivery intervention. Standardised tools captured data on knowledge, attitude and behaviour towards mental health as well as perceptions related to help seeking for mental illnesses. RESULTS: Most knowledge, attitude and behaviour scores improved over the three time points. Overall mean scores on stigma perceptions related to help seeking improved by -0.375 (minimum/maximum of -2.7/2.4, s.d. 0.519, P < 0.001) during this time. Loss to follow-up was 10%. CONCLUSIONS: The data highlight the positive effects of an anti-stigma campaign over a 2-year period.Declaration of interestNone.

Common mental disorders and risk factors in rural India: baseline data from the SMART mental health project.

BACKGROUND: About 10% Indians suffer from stress, depression or substance use disorders. Few receive care for these problems, especially in rural areas. AIMS: As part of a broader initiative to deliver technology-enabled mental health services for rural communities (adults ≥18 years), information was collected about the prevalence of depression, anxiety and suicide risk. METHOD: The study was conducted in 12 villages in the West Godavari district of Andhra Pradesh. Depression and anxiety were assessed using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7, respectively. Additionally, data were collected about sociodemographic factors and stressful events, among others. RESULTS: Anxiety, depression and suicidal ideation affected 10.8, 14.4 and 3.5% of participants, respectively (N = 22 377). These were more common among women, and among those who were aged 30-59 years, uneducated, or divorced/ separated/ widowed. Stress due to financial loss was significant. CONCLUSIONS: The study identified a significant number of people at risk of depression, anxiety and suicide, and needing care. DECLARATION OF INTEREST: None.

Operational challenges in conducting a community-based technology-enabled mental health services delivery model for rural India: Experiences from the SMART Mental Health Project.

Background: There are large gaps in the delivery of mental health care in low- and middle-income countries such as India, and the problems are even more acute in rural settings due to lack of resources, remoteness, and lack of infrastructure, amongst other factors. The Systematic Medical Appraisal Referral and Treatment (SMART) Mental Health Project was conceived as a mental health services delivery model using technology-based solutions for rural India. This paper reports on the operational strategies used to facilitate the implementation of the intervention. Method: Key components of the SMART Mental Health Project included delivering an anti-stigma campaign, training of primary health workers in screening, diagnosing and managing stress, depression and increased suicide risk and task sharing of responsibilities in delivering care; and using mobile technology based electronic decision support systems to support delivery of algorithm based care for such disorders. The intervention was conducted in 42 villages across two sites in the state of Andhra Pradesh in south India. A pre-post mixed methods evaluation was done, and in this paper operational challenges are reported. Results: Both quantitative and qualitative results from the evaluation from one site covering about 5000 adults showed that the intervention was feasible and acceptable, and initial results indicated that it was beneficial in increasing access to mental health care and reducing depression and anxiety symptoms. A number of strategies were initiated in response to operational challenges to ensure smoother conduct of the project and facilitated the project to be delivered as envisaged. Conclusions: The operational strategies initiated for this project were successful in ensuring the delivery of the intervention. Those, coupled with other more systematic processes have informed the researchers to understand key processes that need to be in place to develop a more robust study, that could eventually be scaled up.

Process evaluation of the systematic medical appraisal, referral and treatment (SMART) mental health project in rural India.

BACKGROUND: Availability of basic mental health services is limited in rural areas of India. Health system and individual level factors such as lack of mental health professionals and infrastructure, poor awareness about mental health, stigma related to help seeking, are responsible for poor awareness and use of mental health services. We implemented a mental health services delivery model that leveraged technology and task sharing to facilitate identification and treatment of common mental disorders (CMDs) such as stress, depression, anxiety and suicide risk in rural areas of the state of Andhra Pradesh, India. The intervention was delivered by lay village health workers (Accredited Social Health Activists - ASHAs) and primary care doctors. An anti-stigma campaign was implemented prior to this activity. This paper reports the process evaluation of the intervention using mixed methods. METHODS: A mixed methods pre-post evaluation assessed the intervention using quantitative service usage analytics from the server, and qualitative interviews with different stakeholders. Barriers and facilitators in implementing the intervention were identified. RESULTS: Health service use increased significantly at post-intervention, ASHAs could followup 78.6% of those who had screened positive, and 78.6% of the 1243 Interactive Voice Response System calls made, were successful. Most respondents were aware of the intervention. They indicated that knowledge received through the intervention empowered them to approach ASHAs and share their mental health symptoms. ASHAs and doctors opined that EDSS was useful and easy to use. Medical camps organized in villages to increase access to the doctor were received positively by all. However, some aspects or facilitators of the intervention need to be improved, including network connectivity, booster training, anti-stigma campaigns, quality of mental health services provided by doctors, provision of psychotropic medications at primary health centers and frequency of health camps. CONCLUSION: The respondents' views helped to understand the barriers and facilitators for improving the likely effectiveness of the intervention using Andersen's Modified Behavioral Model of Health Services Use, and identify the mechanisms by which those factors affected mental health services uptake in the community. TRIAL REGISTRATION: The study is registered with Clinical Trials Registry India (Applied - 16/07/14-Ref2014/07/007256; registration received - 04/10/17-CTRI/2017/10/009992 ).

Increasing use of mental health services in remote areas using mobile technology: a pre-post evaluation of the SMART Mental Health project in rural India.

BACKGROUND: About 25% of the Indian population experience common mental disorders (CMD) but only 15-25% of them receive any mental health care. Stigma, lack of adequate mental health professionals and mental health services account for this treatment gap, which is worse in rural areas. Our project evaluated task shifting and mobile-technology based electronic decision support systems to enhance the ability of primary care health workers to provide evidence-based mental health care for stress, depression, and suicidal risk in 30 remote villages in the state of Andhra Pradesh, India. METHODS: The Systematic Medical Appraisal Referral and Treatment (SMART) Mental Health project between May 2014 and April 2016 trained lay village health workers (Accredited Social Health Activists - ASHAs) and primary care doctors to screen, diagnose and manage individuals with common mental disorders using an electronic decision support system. An anti-stigma campaign using multi-media approaches was conducted across the villages at the outset of the project. A pre-post evaluation using mixed methods assessed the change in mental health service utilization by screen positive individuals. This paper reports on the quantitative aspects of that evaluation. RESULTS: Training was imparted to 21 ASHAs and 2 primary care doctors. 5007 of 5167 eligible individuals were screened, and 238 were identified as being positive for common mental disorders and referred to the primary care doctors for further management. Out of them, 2 (0.8%) had previously utilized mental health services. During the intervention period, 30 (12.6%) visited the primary care doctor for further diagnosis and treatment, as advised. There was a significant reduction in the depression and anxiety scores between start and end of the intervention among those who had screened positive at the beginning. Stigma and mental health awareness in the broader community improved during the project. CONCLUSIONS: The intervention led to individuals being screened for common mental disorders by village health workers and increase in mental health service use by those referred to the primary care doctor. The model was deemed feasible and acceptable. The effectiveness of the intervention needs to be demonstrated using more robust randomized controlled trials, while addressing the issues identified that will facilitate scale up.

The Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health Project: Development and Testing of Electronic Decision Support System and Formative Research to Understand Perceptions about Mental Health in Rural India.

INTRODUCTION: Common mental disorders (CMD) such as depression, suicidal risk and emotional/medically unexplained complaints affect a large number of people in India, but few receive appropriate care. Key reasons for this include few trained mental health professionals and stigma associated with mental health. A potential approach to address poor access to care is by training village healthcare workers in providing basic mental health care, and harnessing India's vast mobile network to support such workers using mobile-based applications. We propose an intervention to implement such an approach that incorporates the use of mobile-based electronic decision support systems (EDSS) to provide mental health services for CMD, combined with a community-based anti-stigma campaign. This will be implemented and evaluated across 42 villages in Andhra Pradesh, a south Indian state. This paper discusses the development and testing of the EDSS, and the formative research that informed the anti-stigma campaign. MATERIALS AND METHODS: The development of the EDSS used an iterative process that was validated against clinical diagnosis. A mixed methods approach tested the user acceptability of the EDSS. Focus group discussions and in-depth interviews provided community-level perceptions about mental health. This study involved 3 villages and one primary health centre. RESULTS: The EDSS application was found to be acceptable, but some modifications were needed. The community lacked adequate knowledge about CMD and its treatment and there was stigma associated with mental illness. Faith and traditional healers were considered to be important mental health service providers. DISCUSSION: A number of barriers and facilitators were identified in implementing the intervention analysed in a framework using Andersen's behavioural model of health services use. CONCLUSION: The findings assisted with refining the intervention prior to large-scale implementation and evaluation.