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.

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.

Substance use in the correctional settings: A qualitative exploration of individual and contextual characteristics and intervention strategies using the behavior change wheel framework.

BACKGROUND AND OBJECTIVES: Planning and implementing prison-based substance use disorder (SUD) interventions are challenging. We wanted to understand why and how people in correctional settings (CS) use drugs and to explore what policies, environmental, and interpersonal factors influence substance use among incarcerated people. Using the Behavior Change Wheel (BCW) framework, we proposed a thematic map with intervention functions to reduce substance use in CS. METHODS: We used the Framework Method of qualitative analysis. We did snowball sampling for the incarcerated people with drug use (PWD) and convenience sampling for the staff. The in-depth interview sample comprised 17 adult PWD, three prison administrative, and two healthcare staff. We determined the sample size by thematic data saturation. We followed a mixed coding approach for generating categories, i.e., deductive (based on the BCW framework) and inductive. The study constructed the final theoretical framework by determining the properties of the categories and relationships among the categories. RESULTS: We identified eleven categories aligned with the BCW framework. The themes were prison routine, interpersonal dynamics of the incarcerated population, exposure to substance use, attitude of staff towards PWD, experience with prison healthcare, willingness (to reduce drug use) and coping, compassion, drug use harms, conflict between staff and residents, stigma, and family/peer support. The BCW framework aided the identification of potential intervention functions and their interactions with the organizational policies that could influence PWD's capability-opportunity-motivation (COM) and drug use behavior (B). CONCLUSION: There is a need to raise awareness of SUD prevention and intervention among decision-makers and revisit the prison policies.

SMARThealth PRegnancy And Mental Health study: protocol for a situational analysis of perinatal mental health in women living in rural India.

Introduction: The situation for women experiencing mental health problems during pregnancy and postpartum in rural India is critical: a high burden of disease, a high estimated number of women are undiagnosed and untreated with mental health problems, a substantial gap in research on women's perinatal health, and severe stigma and discrimination. The SMARThealth Pregnancy study is a cluster randomised trial using a digital intervention to identify and manage anaemia, hypertension, and diabetes in the first year after birth in rural India. Within this study, the SMARThealth Pregnancy and Mental Health (PRAMH) study is a situational analysis to understand mental health problems during pregnancy and in the first year following birth in this population. Methods/design: This situational analysis aims to analyse and to assess the context of perinatal mental health, health services, barriers, facilitators, and gaps in Siddipet district of Telangana state in India, to develop an implementation framework for a future intervention. A tested, standardised situational analysis tool will be adapted and applied to perinatal mental health in rural India. A desktop and policy review will be conducted to identify and analyse relevant mental health and pregnancy care policies at the national and state levels. We will conduct in-depth interviews with policymakers, planners, mental health professionals and other experts in perinatal mental health (n = 10-15). We will also conduct focus group discussions with key stakeholders, including women with perinatal mental health problems, their families and carers, and community health workers (n = 24-40). A theory of change workshop with key stakeholders will be conducted which will also serve as a priority setting exercise, and will clarify challenges and opportunities, priorities, and objectives for a pilot intervention study. The analysis of qualitive data will be done using thematic analysis. Based on the data analysis and synthesis of the findings, an implementation framework will be developed to guide development, testing and scale up of a contextually relevant intervention for perinatal mental health. Discussion: The situational analysis will help to establish relationships with all relevant stakeholders, clarify the context and hypotheses for the pilot intervention and implementation.

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.

A cross-sectional survey of climate and COVID-19 crises in young people in Indian slums: context, psychological responses, and agency.

Background: COVID-19 and the climate crisis have caused unprecedented disruptions across the world. Climate change has affected the mental health and wellbeing of children and adolescent. Young people with a mental illness and without social support are at an increased risk of climate change induced mental ill-health. COVID-19 resulted in a marked increase of psychological distress. Increase in depression, anxiety and insomnia have increased due to the upheavals that people were experiencing including loss of livelihood and breaking of social bonds. Methods: This exploratory study adopted a cross sectional survey design using quantitative methods to understand the perceptions, thoughts, and feelings of young people on both the climate and COVID-19 crises, their concerns, and desires for the future and to understand their sense of agency to contribute to the changes that they want to see. Findings: The findings show that most of the respondents from the sample studied reported nearly similar interference of climate change and COVID-19 on their mental wellbeing. Their climate concern and COVID-19 concern scores were comparable. Tangible experiences of extreme weather events, that were personally experienced or that impacted their family members had a negative impact on their lives, while action around improving the environment had a positive impact.Loss of income, loss of mobility and loss of social contact due to COVID-19 had negative impacts on the respondents, while indulging in leisure activities and bonding with the family had positive impacts. Although the majority of the participants reported having both climate and COVID agency, it did not translate into action to improve the environment. Interpretation: Young people's activism on climate change and COVID-19 has a positive impact on their mental wellbeing hence more opportunities and platforms must be provided to enable young people to take action on both these crises. Funding: None.

Combining general and central measures of adiposity to identify risk of hypertension: a cross-sectional survey in rural India.

AIM: In three socioeconomically diverse regions of rural India, we determined the optimal cut-offs for definition of overweight, the prevalence of overweight, and the relationships between measures of overweight and risk of hypertension. SUBJECTS AND METHODS: Villages were randomly sampled within rural Trivandrum, West Godavari, and Rishi Valley. Sampling of individuals was stratified by age group and sex. Cut-offs for measures of adiposity were compared using area under the receiver operating characteristic curve. Associations between hypertension and definitions of overweight were assessed by logistic regression. RESULTS: Of 11 657 participants (50 % male; median age 45 years), 29.8 % had hypertension. Large proportions were overweight as defined by body mass index (BMI) ≥ 23 kg/m2 (47.7 %), waist circumference (WC) ≥ 90 cm for men or ≥ 80 cm for women (39.6 %), waist-hip ratio (WHR) ≥ 0.9 for men or ≥ 0.8 for women (65.6 %), waist-height ratio (WHtR) ≥ 0.5 (62.5 %), or by BMI plus either WHR, WC or WHtR (45.0 %). All definitions of overweight were associated with hypertension, with optimal cut-offs being at, or close to, the World Health Organization (WHO) Asia-Pacific standards. Having overweight according to both BMI and a measure of central adiposity was associated with approximately twice the risk of hypertension than overweight defined by only one measure. CONCLUSIONS: Overweight, as assessed by both general and central measures, is prevalent in rural southern India. WHO standard cut-offs are appropriate in this setting for assessing risk of hypertension. However, combining BMI with a measure of central adiposity identifies risk of hypertension better than any single measure. The risk of hypertension is significantly greater in those centrally and generally overweight than those overweight by a single measure.

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.

Incentivizing community health workers for scaling up mental health care in rural communities in India: A critical look at principles that work.

Given the low availability of trained mental health professionals, there is evidence on task sharing where basic mental healthcare can be provided by trained community health workers (CHWs). A potential way to reduce the mental health care gap in rural and urban areas in India is to utilize the services of community health workers known as Accredited Social Health Activists (ASHAs). There is a paucity of literature that have evaluated incentivizing non-physician health workers (NPHWs) vis-à-vis maintaining a competent and motivated health workforce especially in the Asia and Pacific regions. The principles around what works and does not work in terms of a mix of incentive packages for CHWs, while providing for mental healthcare in rural areas have not been adequately evaluated. Moreover, performance-based incentives which are receiving increasing attention from health systems worldwide, though evidence on the effectiveness of these incentives in Pacific and Asian countries is limited. CHW programs that have shown to be effective rely on an interlinked incentive framework at the individual, community, and health system levels. Drawing learnings from the past eight years in implementing the SMART (systematic medical appraisal, referral and treatment) Mental Health Program in rural India, we critically examine some of the emerging principles in incentivizing ASHAs while scaling up mental healthcare in communities using a systems approach.

Morbidity and utilisation of healthcare services among people with cardiometabolic disease in three diverse regions of rural India.

OBJECTIVES: To assess the prevalence and determinants of cardiometabolic disease (CMD), and the factors associated with healthcare utilisation, among people with CMD. METHODS: Using a cross-sectional design, 11,657 participants were recruited from randomly selected villages in 3 regions located in Kerala and Andhra Pradesh from 2014 to 2016. Multivariable logistic regression was used to identify factors independently associated with CMD and healthcare utilisation (public or private). RESULTS: Thirty-four per cent (n = 3629) of participants reported having ≥1 CMD, including hypertension (21.6%), diabetes (11.6%), heart disease (5.0%) or chronic kidney disease (CKD) (1.6%). The prevalence of CMD was progressively greater in regions of greater socio-economic position (SEP), ranging from 19.1% to 40.9%. Among those with CMD 41% had sought any medical advice in the last month, with only 19% utilising public health facilities. Among people with CMD, those with health insurance utilised more healthcare (age-gender adjusted odds ratio (AOR) (95% confidence interval (CI)): 1.31 (1.13, 1.51)) as did those who reported accessing private rather than public health services (1.43 (1.23, 1.66)). DISCUSSION: The prevalence of CMD is high in these regions of rural India and is positively associated with indices of SEP. The utilisation of outpatient health services, particularly public services, among those with CMD is low.

Toward a multi-level strategy to reduce stigma in global mental health: overview protocol of the Indigo Partnership to develop and test interventions in low- and middle-income countries.

There is increasing attention to the impacts of stigma and discrimination related to mental health on quality of life and access to and quality of healthcare. Effective strategies for stigma reduction exist, but most evidence comes from high-income settings. Recent reviews of stigma research have identified gaps in the field, including limited cultural and contextual adaptation of interventions, a lack of contextual psychometric information on evaluation tools, and, most notably, a lack of multi-level strategies for stigma reduction. The Indigo Partnership research programme will address these knowledge gaps through a multi-country, multi-site collaboration for anti-stigma interventions in low- and middle-income countries (LMICs) (China, Ethiopia, India, Nepal, and Tunisia). The Indigo Partnership aims to: (1) carry out research to strengthen the understanding of mechanisms of stigma processes and reduce stigma and discrimination against people with mental health conditions in LMICs; and (2) establish a strong collaborative research consortium through the conduct of this programme. Specifically, the Indigo Partnership involves developing and pilot testing anti-stigma interventions at the community, primary care, and mental health specialist care levels, with a systematic approach to cultural and contextual adaptation across the sites. This work also involves transcultural translation and adaptation of stigma and discrimination measurement tools. The Indigo Partnership operates with the key principle of partnering with people with lived experience of mental health conditions for the development and implementation of the pilot interventions, as well as capacity building and cross-site learning to actively develop a more globally representative and equitable mental health research community. This work is envisioned to have a long-lasting impact, both in terms of the capacity building provided to participating institutions and researchers, and the foundation it provides for future research to extend the evidence base of what works to reduce and ultimately end stigma and discrimination in mental health.

Reduced efficacy of blood pressure lowering drugs in the presence of diabetes mellitus-results from the TRIUMPH randomised controlled trial.

We investigated whether diabetes mellitus (DM) affects the efficacy of a low-dose triple combination pill and usual care among people with mild-moderate hypertension. TRIUMPH (TRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension) was a randomised controlled open-label trial of patients requiring initiation or escalation of antihypertensive therapy. Patients were randomised to a once-daily low-dose triple combination polypill (telmisartan-20mg/amlodipine-2.5 mg/chlorthalidone-12.5 mg) or usual care. This analysis compared BP reduction in people with and without DM, both in the intervention and control groups over 24-week follow-up. Predicted efficacy of prescribed therapy was calculated (estimation methods of Law et al.). The trial randomised 700 patients (56 ± 11 yrs, 31% DM). There was no difference in the number of drugs prescribed or predicted efficacy of therapy between people with DM and without DM. However, the observed BP reduction from baseline to week 24 was lower in those with DM compared to non-diabetics in both the triple pill (25/11 vs 31/15 mmHg, p ≤ 0.01) and usual care (17/7 vs 22/11 mmHg, p ≤ 0.01) groups, and these differences remained after multivariable adjustment. DM was a negative predictor of change in BP (ß-coefficient -0.08, p = 0.02). In conclusion, patients with DM experienced reduced efficacy of BP lowering therapies as compared to patients without DM, irrespective of the type of BP lowering therapy received.

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.

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.

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.

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.