Operational challenges in the implementation of an anti-stigma campaign in rural Andhra Pradesh, India.

BACKGROUND: Despite of literature available on mental health-related stigma interventions, little is reported about the operational challenges faced during the planning, implementation and evaluation phases. METHODS: The Systematic Medical Appraisal, Referral and Treatment Mental Health Project was implemented in 42 villages of the West Godavari district in India. Andersen's Behavioural Model for Health Services Use was adopted to understand the factors influencing anti-stigma campaign delivery and the strategies identified to overcome these challenges. RESULTS: The challenges faced during the planning and implementation phase included distance and time taken for travel by the field staff, inadequate mental health services and infrastructure within communities, engagement of community with the field staff and community's poor mental health literacy and knowledge. Strategies used to overcome these challenges were regular engagement with community stakeholders, understanding mental health literacy levels and seeking inputs from the community regarding campaign design, organizing live drama shows at community's preferred time and place and screening of recorded drama video clips where lives shows were difficult. The evaluation phase posed challenges such as non-availability of key stakeholders and inadequate time and funding to evaluate the entire study population. CONCLUSION: The reported findings can help in planning and scaling up of the anti-stigma campaign in large trials in similar settings.

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.

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 ).

TRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension (TRIUMPH): Study protocol.

BACKGROUND: Hypertension management strategies have traditionally focused on "tailored therapy" and "stepped-care" approaches. These tend to be costly and time consuming and often fail to achieve adequate blood pressure (BP) control. The TRIUMPH study aims to investigate the effectiveness, cost-effectiveness, and acceptability of early use of a 3-in-1 BP-lowering pill ("Triple Pill") compared with usual care for the management of hypertension. METHODS: The prospective, open, randomized controlled clinical trial (n = 700) will compare Triple Pill-based strategy to usual care among individuals with persistent mild-to-moderate hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg, or systolic BP >130 mm Hg and/or diastolic BP >80 mm Hg in patients with diabetes or chronic kidney disease) on no or minimal drug therapy. The study will be conducted within approximately 20 hospital-based clinics in India. Participants will be randomized to the Triple Pill (initially strength 1-telmisartan 20 mg, amlodipine 2.5 mg, hydrochlorothiazide 6.25 mg, with the option of subsequent titration to strength 2-telmisartan 40 mg, amlodipine 5 mg, hydrochlorothiazide 12.5 mg) or continued usual care. Participants will be followed up for 6 months. The primary outcome is the proportion of participants achieving target BP at the end follow-up. CONCLUSION: This study will determine whether early use of a low-dose triple combination therapy has the potential to address some of the challenges in hypertension control through earlier achievement of BP control, better adherence, and fewer adverse effects, in the context of less intensive clinical follow-up.

Cultural adaptation of INDIGO mental health stigma reduction interventions using an ecological validity model in north India.

Background: The International Study of Discrimination and Stigma Outcomes (INDIGO) Partnership is a multi-country international research program in seven sites across five low- and middle-income countries (LMICs) in Africa and Asia to develop, contextually adapt mental health stigma reduction interventions and pilot these among a variety of target populations. The aim of this paper is to report on the process of culturally adapting these interventions in India using an established framework. Methods: As part of this larger program, we have contextualized and implemented these interventions from March 2022 to August 2023 in a site in north India. The Ecological Validity Model (EVM) was used to guide the adaptation and contextualization process comprising eight dimensions. Findings: Six dimensions of the Ecological Validity Model were adapted, namely language, persons, metaphors, content, methods, and context; and two dimensions, namely concepts and goals, were retained. Conclusion: Stigma reduction strategies with varied target groups, based on culturally appropriate adaptations, are more likely to be acceptable to the stakeholders involved in the intervention, and to be effective in terms of the program impact.

Learnings From Implementation of Technology-Enabled Mental Health Interventions in India: Implementation Report.

BACKGROUND: Recent years have witnessed an increase in the use of technology-enabled interventions for delivering mental health care in different settings. Technological solutions have been advocated to increase access to care, especially in primary health care settings in low- and middle-income countries, to facilitate task-sharing given the lack of trained mental health professionals. OBJECTIVE: This report describes the experiences and challenges faced during the development and implementation of technology-enabled interventions for mental health among adults and adolescents in rural and urban settings of India. METHODS: A detailed overview of the technological frameworks used in various studies, including the Systematic Medical Appraisal and Referral Treatment (SMART) Mental Health pilot study, SMART Mental Health cluster randomized controlled trial, and Adolescents' Resilience and Treatment Needs for Mental Health in Indian Slums (ARTEMIS) study, is provided. This includes the mobile apps that were used to collect data and the use of the database to store the data that were collected. Based on the experiences faced, the technological enhancements and adaptations made at the mobile app and database levels are described in detail. IMPLEMENTATION (RESULTS): Development of descriptive analytics at the database level; enabling offline and online data storage modalities; customizing the Open Medical Record System platform to suit the study requirements; modifying the encryption settings, thereby making the system more secure; and merging different apps for simultaneous data collection were some of the enhancements made across different projects. CONCLUSIONS: Technology-enabled interventions prove to be a useful solution to cater to large populations in low-resource settings. The development of mobile apps is subject to the context and the area where they would be implemented. This paper outlines the need for careful testing using an iterative process that may support future research using similar technology. TRIAL REGISTRATION: SMART Mental Health trial: Clinical Trial Registry India CTRI/2018/08/015355; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MjMyNTQ=&Enc=&userName=CTRI/2018/08/015355. ARTEMIS trial: Clinical Trial Registry India CTRI/2022/02/040307; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NDcxMTE=&Enc=&userName=CTRI/2022/02/040307.

Using formative research to inform a mental health intervention for adolescents living in Indian slums: the ARTEMIS study.

BACKGROUND: Adolescents are vulnerable to stressors because of the rapid physical and mental changes that they go through during this life period. Young people residing in slum communities experience additional stressors due to living conditions, financial stress, and limited access to healthcare and social support services. The Adolescents' Resilience and Treatment nEeds for Mental Health in Indian Slums (ARTEMIS) study, is testing an intervention intended to improve mental health outcomes for adolescents living in urban slums in India combining an anti-stigma campaign with a digital health intervention to identify and manage depression, self-harm/suicide risk or other significant emotional complaints. METHODS: In the formative phase, we developed tools and processes for the ARTEMIS intervention. The two intervention components (anti-stigma and digital health) were implemented in purposively selected slums from the two study sites of New Delhi and Vijayawada. A mixed methods formative evaluation was undertaken to improve the understanding of site-specific context, assess feasibility and acceptability of the two components and identify required improvements to be made in the intervention. In-depth interviews and focus groups with key stakeholders (adolescents, parents, community health workers, doctors, and peer leaders), along with quantitative data from the digital health platform, were analysed. RESULTS: The anti-stigma campaign methods and materials were found to be acceptable and received overall positive feedback from adolescents. A total of 2752 adolescents were screened using the PHQ9 embedded into a digital application, 133 (4.8%) of whom were identified as at high-risk of depression and/or suicide. 57% (n = 75) of those at high risk were diagnosed and treated by primary health care (PHC) doctors, who were guided by an electronic decision support tool based on WHO's mhGAP algorithm, built into the digital health application. CONCLUSION: The formative evaluation of the intervention strategy led to enhanced understanding of the context, acceptability, and feasibility of the intervention. Feedback from stakeholders helped to identify key areas for improvement in the intervention; strategies to improve implementation included engaging with parents, organising health camps in the sites and formation of peer groups. TRIAL REGISTRATION: The trial has been registered in the Clinical Trial Registry India, which is included in the WHO list of Registries, Reference number: CTRI/2022/02/040307. Registered 18 February 2022.

Protocol for process evaluation of ARTEMIS cluster randomised controlled trial: an intervention for management of depression and suicide among adolescents living in slums in India.

INTRODUCTION: There are around 250 million adolescents (10-19 years) in India. The prevalence of mental health-related morbidity among adolescents in India is approximately 7.3%. Vulnerable subpopulations among adolescents such as those living in slum communities are particularly at risk due to poor living conditions, financial difficulty and limited access to support services. Adolescents' Resilience and Treatment nEeds for Mental Health in Indian Slums (ARTEMIS) is a cluster randomised controlled trial of an intervention that intends to improve the mental health of adolescents living in slum communities in India. The aim of this paper is to describe the process evaluation protocol for ARTEMIS trial. The process evaluation will help to explain the intervention outcomes and understand how and why the intervention worked or did not work. It will identify contextual factors, intervention barriers and facilitators and the adaptations required for optimising implementation. METHODS: Case study method will be used and the data will include a mix of quantitative metrics and qualitative data. The UK Medical Research Council's guidance on evaluating complex interventions, the Reach, Efficacy, Adoption, Implementation and Maintenance Framework and the Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Safety/Side Effects and, Equity criteria will be used to develop a conceptual framework and a priori codes for qualitative data analysis. Quantitative data will be analysed using descriptive statistics. Implementation fidelity will also be measured. DISCUSSION: The process evaluation will provide an understanding of outcomes and causal mechanisms that influenced any change in trial outcomes. ETHICS AND DISSEMINATION: Ethics Committee of the George Institute for Global Health India (project number 17/2020) and the Research Governance and Integrity Team, Imperial College, London (ICREC reference number: 22IC7718) have provided ethics approval. The Health Ministry's Screening Committee has approved to the study (ID 2020-9770). TRIAL REGISTRATION NUMBER: CTRI/2022/02/040307.

Mental Health Care Support in Rural India: A Cluster Randomized Clinical Trial.

Importance: More than 150 million people in India need mental health care but few have access to affordable care, especially in rural areas. Objective: To determine whether a multifaceted intervention involving a digital health care model along with a community-based antistigma campaign leads to reduced depression risk and lower mental health-related stigma among adults residing in rural India. Design, Setting, and Participants: This parallel, cluster randomized, usual care-controlled trial was conducted from September 2020 to December 2021 with blinded follow-up assessments at 3, 6, and 12 months at 44 rural primary health centers across 3 districts in Haryana and Andhra Pradesh states in India. Adults aged 18 years and older at high risk of depression or self-harm defined by either a Patient Health Questionnaire-9 item (PHQ-9) score of 10 or greater, a Generalized Anxiety Disorder-7 item (GAD-7) score of 10 or greater, or a score of 2 or greater on the self-harm/suicide risk question on the PHQ-9. A second cohort of adults not at high risk were selected randomly from the remaining screened population. Data were cleaned and analyzed from April 2022 to February 2023. Interventions: The 12-month intervention included a community-based antistigma campaign involving all participants and a digital mental health intervention involving only participants at high risk. Primary health care workers were trained to identify and manage participants at high risk using the Mental Health Gap Action Programme guidelines from the World Health Organization. Main Outcomes and Measures: The 2 coprimary outcomes assessed at 12 months were mean PHQ-9 scores in the high-risk cohort and mean behavior scores in the combined high-risk and non-high-risk cohorts using the Mental Health Knowledge, Attitude, and Behavior scale. Results: Altogether, 9928 participants were recruited (3365 at high risk and 6563 not at high risk; 5638 [57%] female and 4290 [43%] male; mean [SD] age, 43 [16] years) with 9057 (91.2%) followed up at 12 months. Mean PHQ-9 scores at 12 months for the high-risk cohort were lower in the intervention vs control groups (2.77 vs 4.48; mean difference, -1.71; 95% CI, -2.53 to -0.89; P < .001). The remission rate in the high-risk cohort (PHQ-9 and GAD-7 scores <5 and no risk of self-harm) was higher in the intervention vs control group (74.7% vs 50.6%; odds ratio [OR], 2.88; 95% CI, 1.53 to 5.42; P = .001). Across both cohorts, there was no difference in 12-month behavior scores in the intervention vs control group (17.39 vs 17.74; mean difference, -0.35; 95% CI, -1.11 to 0.41; P = .36). Conclusions and Relevance: A multifaceted intervention was effective in reducing depression risk but did not improve intended help-seeking behaviors for mental illness. Trial Registration: Clinical Trial Registry India: CTRI/2018/08/015355.

Mental health related stigma, service provision and utilization in Northern India: situational analysis.

Stigma, discrimination, poor help seeking, dearth of mental health professionals, inadequate services and facilities all adversely impact the mental health treatment gap. Service utilization by the community is influenced by cultural beliefs and literacy levels. We conducted a situational analysis in light of the little information available on mental health related stigma, service provision and utilization in Haryana, a state in Northern India. This involved: (a) qualitative key informant interviews; (b) health facility records review; and (c) policy document review to understand the local context of Faridabad district in Northern India. Ethical approvals for the study were taken before the study commenced. Phone call in-depth interviews were carried out with a purposive sample of 13 participants (Mean = 38.07 years) during the COVID-19 pandemic, which included 4 community health workers, 4 people with mental illness, 5 service providers (primary health care doctors and mental health specialists). Data for health facility review was collected from local primary health and specialist facilities while key policy documents were critically analysed for service provision and stigma alleviation activities. Thematic analysis was used to analyse patterns within the interview data. We found poor awareness and knowledge about mental illnesses, belief in faith and traditional healers, scarcity of resources (medicines, trained professionals and mental health inpatient and outpatient clinics), poor access to appropriate mental health facilities, and high costs for seeking mental health care. There is a critical gap between mental health related provisions in policy documents and its implementation at primary and district level.

Reducing stigma and improving access to care for people with mental health conditions in the community: protocol for a multi-site feasibility intervention study (Indigo-Local).

Background: Stigma and discrimination towards people with mental health conditions by their communities are common worldwide. This can result in a range of negative outcomes for affected persons, including poor access to health care. However, evidence is still patchy from low- and middle-income countries (LMICs) on affordable, community-based interventions to reduce mental health-related stigma and to improve access to mental health care. Methods: This study aims to conduct a feasibility (proof-of-principle) pilot study that involves developing, implementing and evaluating a community-based, multi-component, public awareness-raising intervention (titled Indigo-Local), designed to reduce stigma and discrimination and to increase referrals of people with mental health conditions for assessment and treatment. It is being piloted in five LMICs - China, Ethiopia, India, Nepal and Tunisia - and includes several key components: a stakeholder group workshop; a stepped training programme (using a 'Training of Trainers' approach) of community health workers (or similar cadres of workers) and service users that includes repeated supervision and booster sessions; awareness-raising activities in the community; and a media campaign. Social contact and service user involvement are instrumental to all components. The intervention is being evaluated through a mixed-methods pre-post study design that involves quantitative assessment of stigma outcomes measuring knowledge, attitudes and (discriminatory) behaviour; quantitative evaluation of mental health service utilization rates (where feasible in sites); qualitative exploration of the potential effectiveness and impact of the Indigo-Local intervention; a process evaluation; implementation evaluation; and an evaluation of implementation costs. Discussion: The outcome of this study will be contextually adapted, evidence-based interventions to reduce mental health-related stigma in local communities in five LMICs to achieve improved access to healthcare. We will have replicable models of how to involve people with lived experience as an integral part of the intervention and will produce knowledge of how intervention content and implementation strategies vary across settings. The interventions and their delivery will be refined to be acceptable, feasible and ready for larger-scale implementation and evaluation. This study thereby has the potential to make an important contribution to the evidence base on what works to reduce mental health-related stigma and discrimination and improve access to health care.

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.

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.

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 intervention to reduce stigma and improve management of depression, risk of suicide/self-harm and other significant emotional or medically unexplained complaints among adolescents living in urban slums: protocol for the ARTEMIS project.

BACKGROUND: There are around 250 million adolescents in India. Adolescents are vulnerable to common mental disorders with depression and self-harm accounting for a major share of the burden of death and disability in this age group. Around 20% of children and adolescents are diagnosed with/ or live with a disabling mental illness. A national survey has found that suicide is the third leading cause of death among adolescents in India. The authors hypothesise that an intervention involving an anti-stigma campaign co-created by adolescents themselves, and a mobile technology-based electronic decision support system will help reduce stigma, depression, and suicide risk and improve mental health for high-risk adolescents living in urban slums in India. METHODS: The intervention will be implemented as a cluster randomised control trial in 30 slum clusters in each of the cities of Vijayawada and New Delhi in India. Adolescents aged 10 to 19 years will be screened for depression and suicide ideation using the Patient Health Questionnaire (PHQ-9). Two evaluation cohorts will be derived-a high-risk cohort with an elevated PHQ-9 score ≥ 10 and/or a positive response (score ≥ 2) to the suicide risk question on the PHQ-9, and a non-high-risk cohort comprising an equal number of adolescents not at elevated risk based on these scores. DISCUSSION: The key elements that ARTEMIS will focus on are increasing awareness among adolescents and the slum community on these mental health conditions as well as strengthening the skills of existing primary healthcare workers and promoting task sharing. The findings from this study will provide evidence to governments about strategies with potential for addressing the gaps in providing care for adolescents living in urban slums and experiencing depression, other significant emotional or medically unexplained complaints or increased suicide risk/self-harm and should have relevance not only for India but also for other low- and middle-income countries. TRIAL STATUS: Protocol version - V7, 20 Dec 2021 Recruitment start date: tentatively after 15th July 2022 Recruitment end date: tentatively 14th July 2023 (1 year after the trial start date) TRIAL REGISTRATION: The trial has been registered in the Clinical Trial Registry India, which is included in the WHO list of Registries ( https://www.who.int/clinical-trials-registry-platform/network/primary-registries ) Reference No. CTRI/2022/02/040307 . Registered on 18 February 2022. The tentative start date of participant recruitment for the trial will begin after 15th July 2022.

Training for mental health professionals in responding to experienced and anticipated mental health-related discrimination (READ-MH): protocol for an international multisite feasibility study.

BACKGROUND: Mental health and other health professionals working in mental health care may contribute to the experiences of stigma and discrimination among mental health service users but can also help reduce the impact of stigma on service users. However, few studies of interventions to equip such professionals to be anti-stigma agents took place in high-income countries. This study assesses the feasibility, potential effectiveness and costs of Responding to Experienced and Anticipated Discrimination training for health professionals working in mental health care (READ-MH) across low- and middle-income countries (LMICs). METHODS: This is an uncontrolled pre-post mixed methods feasibility study of READ-MH training at seven sites across five LMICs (China, Ethiopia, India, Nepal and Tunisia). OUTCOME MEASURES: knowledge based on course content, attitudes to working to address the impact of stigma on service users and skills in responding constructively to service users' reports of discrimination. The training draws upon the evidence bases for stigma reduction, health advocacy and medical education and is tailored to sites through situational analyses. Its content, delivery methods and intensity were agreed upon through a consensus exercise with site research teams. READ-MH will be delivered to health professionals working in mental health care immediately after baseline data collection; outcome measures will be collected post-training and 3 months post-baseline, followed by qualitative data collection analysed using a combined deductive and inductive approach. Fidelity will be rated during the delivery of READ-MH, and data on training costs will be collected. Quantitative data will be assessed using generalised linear mixed models. Qualitative data will be evaluated by thematic analysis to identify feedback about the training methods and content, including the implementability of the knowledge and skills learned. Pooled and site-specific training costs per trainee and per session will be reported. CONCLUSIONS: The training development used a participatory and contextualised approach. Evaluation design strengths include the diversity of settings, the use of mixed methods, the use of a skills-based measure and the knowledge and attitude measures aligned to the target population and training. Limitations are the uncertain generalisability of skills performance to routine care and the impact of COVID-19 restrictions at several sites limiting qualitative data collection for situational analyses.

Training for mental health professionals in responding to experienced and anticipated mental health related discrimination (READ-MH): protocol for an international multisite feasibility study.

Background: Mental health and other health professionals working in mental health care may contribute to the experiences of stigma and discrimination among mental health service users, but can also help reduce the impact of stigma on service users. However the few studies of interventions to equip such professionals to be anti-stigma agents those took place in High-Income Countries. This study assesses the feasibility, potential effectiveness and costs of Responding to Experienced and Anticipated Discrimination training for health professionals working in mental health care (READ-MH) across Low- and Middle-Income Countries (LMICs). Methods: This is an uncontrolled pre-post mixed methods feasibility study of READ-MH training at seven sites across five LMICs (China, Ethiopia, India, Nepal, and Tunisia). Outcome measures: knowledge based on course content; attitudes to working to address the impact of stigma on service users; and skills in responding constructively to service users' reports of discrimination. The training draws upon the evidence bases for stigma reduction, health advocacy and medical education and is tailored to sites through situational analyses. Its content, delivery methods and intensity were agreed through a consensus exercise with site research teams. READ-MH will be delivered to health professionals working in mental health care immediately after baseline data collection; outcome measures will be collected post-training and three months post-baseline, followed by qualitative data collection. Fidelity will be rated during delivery of READ-MH, and data on training costs will be collected. Quantitative data will be assessed using generalised linear mixed models. Qualitative data will be evaluated by thematic analysis to identify feedback about the training methods and content, including the implementability of the knowledge and skills learned. Pooled and site-specific training costs per trainee and per session will be reported. Conclusions: The training development used a participatory and contextualized approach. Evaluation design strengths include the diversity of settings; the use of mixed methods; the use of a skills-based measure; and knowledge and attitude measures aligned to the target population and training. Limitations are the uncertain generalisability of skills performance to routine care, and the impact of COVID-19 restrictions at several sites limiting qualitative data collection for situational analyses.

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.

Systematic review of interventions to reduce mental health stigma in India.

BACKGROUND: Stigma is a barrier for help-seeking, mental health service access, and contributes to the mental health treatment gap. Because the mental health treatment gap is greatest in low- and middle-income countries, it is vital to identify effective strategies to reduce stigma in these settings. To date, there has been a lack of synthesis of findings from interventions to reduce stigma related to mental disorders within India. METHOD: A systematic review was conducted to provide an overview of the characteristics and effectiveness of stigma reduction interventions studies in India. PubMed, Embase and PsycINFO databases were searched for literature published up to 30th June 2020. RESULTS: From a total of 1,984 articles identified, only 9 were eligible for final inclusion, published between 1990-2020. No study was found from North, North-East, Central or East India. Most stigma-reduction interventions were multi-level, that is, using a combination of intra-personal, inter-personal and community level strategies to target changes in outcomes of individuals, environments and community groups. Three studies focused on health and stigma-related changes at the organisational/institutional level. No interventions focused on the governmental/structural level. There were only two randomised controlled trials, and two studies focused on all three stigma components of knowledge, attitudes and behaviour. Most interventions were delivered to community members. None focused on mental health professionals as intervention delivery target. CONCLUSION: There is a need for the development of comprehensive, culturally acceptable evidence-based interventions that act at multiple levels, and involve a mixture of various stigma reducing strategies with multiple target groups.