Feasibility and acceptability of a novel community-based mental health intervention delivered by community volunteers in Maharashtra, India: the Atmiyata programme.

BACKGROUND: Many community-based intervention models for mental health and wellbeing have undergone robust experimental evaluation; however, there are limited accounts of the implementation of these evidence-based interventions in practice. Atmiyata piloted the implementation of a community-led intervention to identify and understand the challenges of delivering such an intervention. The goal of the pilot evaluation is to identify factors important for larger-scale implementation across an entire district in India. This paper presents the results of a feasibility and acceptability study of the Atmiyata intervention piloted in Nashik district, Maharashtra, India between 2013 and 2015. METHODS: A mixed methods approach was used to evaluate the Atmiyata intervention. First, a pre-post survey conducted with 215 cases identified with a GHQ cut-off 6 using a 3-month interval. Cases enrolled into the study in one randomly selected month (May-June 2015). Secondly, a quasi-experimental, pre-post design was used to conduct a population-based survey in the intervention and control areas. A randomly selected sample (panel) of 827 women and 843 men age between 18 to 65 years were interviewed to assess the impact of the Atmiyata intervention on common mental disorders. Finally, using qualitative methods, 16 Champions interviewed to understand an implementation processes, barriers and facilitators. RESULTS: Of the 215 participants identified by the Champions as being distressed or having a common mental disorder (CMD), n = 202 (94.4%) had a GHQ score at either sub-threshold level for CMD or above at baseline. Champions accurately identified people with emotional distress and in need of psychological support. After a 6-session counselling provided by the Champions, the percentage of participants with a case-level GHQ score dropped from 63.8 to 36.8%. The second sub-intervention consisted of showing films on Champions' mobile phones to raise community awareness regarding mental health. Films consisted of short scenario-based depictions of problems commonly experienced in villages (alcohol use and domestic violence). Champions facilitated access to social benefits for people with disability. Retention of Atmiyata Champions was high; 90.7% of the initial selected champions continued to work till the end of the project. Champions stated that they enjoyed their work and found it fulfilling to help others. This made them willing to work voluntarily, without pay. The semi-structured interviews with champions indicated that persons in the community experienced reduced symptoms and improved social, occupational and family functioning for problems such as depression, domestic violence, alcohol use, and severe mental illness. CONCLUSIONS: This study shows that community-led interventions using volunteers from rural neighbourhoods can serve as a locally feasible and acceptable approach to facilitating access social welfare benefits, as well as reducing distress and symptoms of depression and anxiety in a low and middle-income country context. The intervention draws upon social capital in a community to engage and empower community members to address mental health problems. A robust evaluation methodology is needed to test the efficacy of such a model when it is implemented at scale.

The Healthy Activity Program lay counsellor delivered treatment for severe depression in India: systematic development and randomised evaluation.

BACKGROUND: Reducing the global treatment gap for mental disorders requires treatments that are economical, effective and culturally appropriate. AIMS: To describe a systematic approach to the development of a brief psychological treatment for patients with severe depression delivered by lay counsellors in primary healthcare. METHOD: The treatment was developed in three stages using a variety of methods: (a) identifying potential strategies; (b) developing a theoretical framework; and (c) evaluating the acceptability, feasibility and effectiveness of the psychological treatment. RESULTS: The Healthy Activity Program (HAP) is delivered over 6-8 sessions and consists of behavioral activation as the core psychological framework with added emphasis on strategies such as problem-solving and activation of social networks. Key elements to improve acceptability and feasibility are also included. In an intention-to-treat analysis of a pilot randomised controlled trial (55 participants), the prevalence of depression (Beck Depression Inventory II ⩾19) after 2 months was lower in the HAP than the control arm (adjusted risk ratio = 0.55, 95% CI 0.32-0.94,P= 0.01). CONCLUSIONS: Our systematic approach to the development of psychological treatments could be extended to other mental disorders. HAP is an acceptable and effective brief psychological treatment for severe depression delivered by lay counsellors in primary care.

Effectiveness of a community-based intervention for people with schizophrenia and their caregivers in India (COPSI): a randomised controlled trial.

BACKGROUND: Observational evidence suggests that community-based services for people with schizophrenia can be successfully provided by community health workers, when supervised by specialists, in low-income and middle-income countries. We did the COmmunity care for People with Schizophrenia in India (COPSI) trial to compare the effectiveness of a collaborative community-based care intervention with standard facility-based care. METHODS: We did a multicentre, parallel-group, randomised controlled trial at three sites in India between Jan 1, 2009 and Dec 31, 2010. Patients aged 16-60 years with a primary diagnosis of schizophrenia according to the tenth edition of the International Classification of Diseases, Diagnostic Criteria for Research (ICD-10-DCR) were randomly assigned (2:1), via a computer-generated randomisation list with block sizes of three, six, or nine, to receive either collaborative community-based care plus facility-based care or facility-based care alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. The primary outcome was a change in symptoms and disabilities over 12 months, as measured by the positive and negative syndrome scale (PANSS) and the Indian disability evaluation and assessment scale (IDEAS). Analysis was by modified intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN 56877013. FINDINGS: 187 participants were randomised to the collaborative community-based care plus facility-based care group and 95 were randomised to the facility-based care alone group; 253 (90%) participants completed follow-up to month 12. At 12 months, total PANSS and IDEAS scores were lower in patients in the intervention group than in those in the control group (PANSS adjusted mean difference -3.75, 95% CI -7.92 to 0.42; p=0.08; IDEAS -0.95, -1.68 to -0.23; p=0.01). However, no difference was shown in the proportion of participants who had a reduction of more than 20% in overall symptoms (PANSS 85 [51%] in the intervention group vs 44 [51%] in the control group; p=0.89; IDEAS 75 [48%] vs 28 [35%]). We noted a significant reduction in symptom and disability outcomes at the rural Tamil Nadu site (-9.29, -15.41 to -3.17; p=0.003). Two patients (one in each group) died by suicide during the study, and two patients died because of complications of a road traffic accident and pre-existing cardiac disease. 18 (73%) patients (17 in the intervention group) were admitted to hospital during the course of the trial, of whom seven were admitted because of physical health problems, such as acute gastritis and vomiting, road accident, high fever, or cardiovascular disease. INTERPRETATION: The collaborative community-based care plus facility-based care intervention is modestly more effective than facility-based care, especially for reducing disability and symptoms of psychosis. Our results show that the study intervention is best implemented as an initial service in settings where services are scarce, for example in rural areas. FUNDING: Wellcome Trust.

Customising informed consent procedures for people with schizophrenia in India.

BACKGROUND: There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so. METHODS: Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach. FINDINGS: 434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent. CONCLUSIONS: The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.

The development of a lay health worker delivered collaborative community based intervention for people with schizophrenia in India.

BACKGROUND: Care for schizophrenia in low and middle income countries is predominantly facility based and led by specialists, with limited use of non-pharmacological treatments. Although community based psychosocial interventions are emphasised, there is little evidence about their acceptability and feasibility. Furthermore, the shortage of skilled manpower is a major barrier to improving access to these interventions. Our study aimed to develop a lay health worker delivered community based intervention in three sites in India. This paper describes how the intervention was developed systematically, following the MRC framework for the development of complex interventions. METHODS: We reviewed the lierature on the burden of schizophrenia and the treatment gap in low and middle income countries and the evidence for community based treatments, and identified intervention components. We then evaluated the acceptability and feasibility of this package of care through formative case studies with individuals with schizophrenia and their primary caregivers and piloted its delivery with 30 families. RESULTS: Based on the reviews, our intervention comprised five components (psycho-education; adherence management; rehabilitation; referral to community agencies; and health promotion) to be delivered by trained lay health workers supervised by specialists. The intervention underwent a number of changes as a result of formative and pilot work. While all the components were acceptable and most were feasible, experiences of stigma and discrimination were inadequately addressed; some participants feared that delivery of care at home would lead to illness disclosure; some participants and providers did not understand how the intervention related to usual care; some families were unwilling to participate; and there were delivery problems, for example, in meeting the targeted number of sessions. Participants found delivery by health workers acceptable, and expected them to have knowledge about the subject matter. Some had expectations regarding their demographic and personal characteristics, for example, preferring only females or those who are understanding/friendly. New components to address stigma were then added to the intervention, the collaborative nature of service provision was strengthened, a multi-level supervision system was developed, and delivery of components was made more flexible. Criteria were evolved for the selection and training of the health workers based on participants' expectations. CONCLUSIONS: A multi-component community based intervention, targeting multiple outcomes, and delivered by trained lay health workers, supervised by mental health specialists, is an acceptable and feasible intervention for treating schizophrenia in India.

Hunger, fear, and isolation - A qualitative analysis of media reports of COVID-19-related suicides in India.

BACKGROUND: India's suicide rates are among the highest in the world and may increase further as a consequence of COVID-19. There is a need to examine which pandemic related stressors may be contributing to suicide, in order to inform the deployment of suicide prevention strategies, for the current as well as future pandemics. AIM: To understand pandemic related stressors contributing to suicide in India. METHODS: We identified and conducted a thematic analysis of Internet media reports of COVID-19 related suicides in India between February 1, 2020 (2 days after the first COVID-19 case), and May 31, 2020, (the end of phase four of the nationwide lockdown). RESULTS: Ten pandemic stressors spanning both disease and lockdown-related factors were identified in 291 suicides. Economic hardship was present in a third; other notable stressors were: fear of the virus; isolation; desperation to be connected with loved ones or return home; and craving for alcohol. Men and young people seemed particularly vulnerable to these stressors. CONCLUSIONS: COVID-19 related suicides appear to be precipitated by social and economic adversities, mainly associated with containment strategies. These findings need to be confirmed by national suicide data. Suicide prevention strategies should mitigate the impact of recognized stressors in the long term, target high-risk individuals, and offer mental health care alongside containment strategies.

COVID-19 mental health impact and responses in low-income and middle-income countries: reimagining global mental health.

Most of the global population live in low-income and middle-income countries (LMICs), which have historically received a small fraction of global resources for mental health. The COVID-19 pandemic has spread rapidly in many of these countries. This Review examines the mental health implications of the COVID-19 pandemic in LMICs in four parts. First, we review the emerging literature on the impact of the pandemic on mental health, which shows high rates of psychological distress and early warning signs of an increase in mental health disorders. Second, we assess the responses in different countries, noting the swift and diverse responses to address mental health in some countries, particularly through the development of national COVID-19 response plans for mental health services, implementation of WHO guidance, and deployment of digital platforms, signifying a welcome recognition of the salience of mental health. Third, we consider the opportunity that the pandemic presents to reimagine global mental health, especially through shifting the balance of power from high-income countries to LMICs and from narrow biomedical approaches to community-oriented psychosocial perspectives, in setting priorities for interventions and research. Finally, we present a vision for the concept of building back better the mental health systems in LMICs with a focus on key strategies; notably, fully integrating mental health in plans for universal health coverage, enhancing access to psychosocial interventions through task sharing, leveraging digital technologies for various mental health tasks, eliminating coercion in mental health care, and addressing the needs of neglected populations, such as children and people with substance use disorders. Our recommendations are relevant for the mental health of populations and functioning of health systems in not only LMICs but also high-income countries impacted by the COVID-19 pandemic, with wide disparities in quality of and access to mental health care.

The Young Lives Matter study protocol: A case-control study of the determinants of suicide attempts in young people in India.

Suicide is the second leading cause of death among young people in India. Over 40% of all suicides occur in people between 15 and 29 years of age. Suicide attempts are estimated to be 15 times more common than suicides and substantially increase the risk of subsequent death. However, there has been little systematic study of the determinants for suicide attempts in young people, which makes it difficult to design contextually appropriate and comprehensive suicide prevention strategies for this population. The proposed case-control study seeks to address this knowledge gap by studying a range of risk and protective factors for suicide attempts in young people in India. Field work will be in Yashwantrao Chavan Memorial Hospital (YCMH) hospital, in Pimpri-Chinchwad, Pune, India. Cases will be 15-29-year-old individuals admitted to the hospital with self-inflicted non-lethal injuries and poisoning. They will be matched for age and gender with those presenting at the General Medicine outpatient department with other health complaints. In each group, 150 persons will be recruited from YCMH from October 2019 to September 2022 and will undergo a comprehensive semi-structured interview. The primary exposure variable is negative life events over the past 12 months. Secondary exposure variables considered include: demographic characteristics, psychological factors, addictive behaviours, personal resources, adverse experiences over their lifetime, social support, suicidal behaviours in the family and social environment, and exposure to suicide-related information. Data will be analysed using conditional logistic regression. Following completion of the study, workshops will be held with young people, mental health professionals and policy makers to develop a theory of change that will be used to promote suicide prevention. Results will be disseminated via peer-reviewed publications, reports to young people and mental health organisations, and news articles. The study was approved by the Institutional Review Board at Sangath.

Experiences of stigma and discrimination faced by family caregivers of people with schizophrenia in India.

Stigma associated with schizophrenia significantly affects family caregivers, yet few studies have examined the nature and determinants of family stigma and its relationship to their knowledge about the condition. This paper describes the experiences and determinants of stigma reported by the primary caregivers of people living with schizophrenia (PLS) in India. The study used mixed methods and was nested in a randomised controlled trial of community care for people with schizophrenia. Between November 2009 and October 2010, data on caregiver stigma and functional outcomes were collected from a sample of 282 PLS-caregiver dyads. In addition, 36 in-depth-interviews were conducted with caregivers. Quantitative findings indicate that 'high caregiver stigma' was reported by a significant minority of caregivers (21%) and that many felt uncomfortable to disclose their family member's condition (45%). Caregiver stigma was independently associated with higher levels of positive symptoms of schizophrenia, higher levels of disability, younger PLS age, household education at secondary school level and research site. Knowledge about schizophrenia was not associated with caregiver stigma. Qualitative data illustrate the various ways in which stigma affected the lives of family caregivers and reveal relevant links between caregiver-stigma related themes ('others finding out', 'negative reactions' and 'negative feelings and views about the self') and other themes in the data. Findings highlight the need for interventions that address both the needs of PLS and their family caregivers. Qualitative data also illustrate the complexities surrounding the relationship between knowledge and stigma and suggest that providing 'knowledge about schizophrenia' may influence the process of stigmatisation in both positive and negative ways. We posit that educational interventions need to consider context-specific factors when choosing anti-stigma-messages to be conveyed. Our findings suggest that messages such as 'recovery is possible' and 'no-one is to blame' may be more helpful than focusing on bio-medical knowledge alone.

Using consumer perspectives to inform the cultural adaptation of psychological treatments for depression: a mixed methods study from South Asia.

BACKGROUND: Integrating consumer perspectives in developing and adapting psychological treatments (PTs) can enhance their acceptability in diverse cultural contexts. OBJECTIVE: To describe the explanatory models (EMs) of depression in South Asia with the goal of informing the content of culturally appropriate PTs for this region. METHODS: Two methods were used: a systematic review of published literature on the EMs of depression in South Asia; and in-depth interviews with persons with depression and family caregivers in two sites in India. Findings from both were analysed independently and then triangulated. RESULTS: There were 19 studies meeting our inclusion criteria. Interviews were conducted with 27 patients and 10 caregivers. Findings were grouped under four broad categories: illness descriptions, perceived impact, causal beliefs and self-help forms of coping. Depression was characterised predominantly by somatic complaints, stress, low mood, and negative and ruminative thoughts. Patients experienced disturbances in interpersonal relationships occupational functioning, and stigma. Negative life events, particularly relationship difficulties, were perceived as the main cause. Patients mostly engaged in distracting activities, religious practices, and received support from family and friends to cope with the illness. LIMITATIONS: The primary data are entirely from India but the studies from the literature review covering South Asia are consistent with these findings. This study also does not include literature in local languages or explore how consumer perspectives change over time. CONCLUSIONS: EMs can inform cultural adaptations to PTs for depression in South Asia by defining target outcomes, content for psycho-education, and culturally appropriate treatment strategies.

Experiences of stigma and discrimination of people with schizophrenia in India.

Stigma contributes greatly to the burden of schizophrenia and is a major obstacle to recovery, yet, little is known about the subjective experiences of those directly affected in low and middle income countries. This paper aims to describe the experiences of stigma and discrimination of people living with schizophrenia (PLS) in three sites in India and to identify factors influencing negative discrimination. The study used mixed methods and was nested in a randomised controlled trial of community care for schizophrenia. Between November 2009 and October 2010, data on four aspects of stigma experienced by PLS and several clinical variables were collected from 282 PLS and 282 caregivers and analysed using multivariate regression. In addition, in-depth-interviews with PLS and caregivers (36 each) were carried out and analysed using thematic analysis. Quantitative findings indicate that experiences of negative discrimination were reported less commonly (42%) than more internalised forms of stigma experience such as a sense of alienation (79%) and significantly less often than in studies carried out elsewhere. Experiences of negative discrimination were independently predicted by higher levels of positive symptoms of schizophrenia, lower levels of negative symptoms of schizophrenia, higher caregiver knowledge about symptomatology, lower PLS age and not having a source of drinking water in the home. Qualitative findings illustrate the major impact of stigma on 'what matters most' in the lives of PLS and highlight three key domains influencing the themes of 'negative reactions' and 'negative views and feelings about the self', i.e., 'others finding out', 'behaviours and manifestations of the illness' and 'reduced ability to meet role expectations'. Findings have implications for conceptualising and measuring stigma and add to the rationale for enhancing psycho-social interventions to support those facing discrimination. Findings also highlight the importance of addressing public stigma and achieving higher level social and political structural change.

Outcomes that matter: a qualitative study with persons with schizophrenia and their primary caregivers in India.

BACKGROUND: Involving persons with schizophrenia and their families in designing, implementing and evaluating mental health services is increasingly emphasised. However, there is little information on desired outcomes from the perspectives of these stakeholders from low and middle income countries (LMIC). AIMS: To explore and define outcomes desired by persons with schizophrenia and their primary caregivers from their perspectives. METHOD: In-depth interviews were held with 32 persons with schizophrenia and 38 primary caregivers presenting for care at one rural and one semi-urban site in India. Participants were asked what changes they desired in the lives of persons affected by the illness and benefits they expected from treatment. Data was analysed using thematic and content analysis. RESULTS: Eleven outcomes were desired by both groups: symptom control; employment/education; social functioning; activity; fulfilment of duties and responsibilities; independent functioning; cognitive ability; management without medication; reduced side-effects; self-care; and self-determination. Social functioning, employment/education and activity were the most important outcomes for both groups; symptom control and cognitive ability were more important to persons with schizophrenia while independent functioning and fulfilment of duties were more important to caregivers. CONCLUSIONS: Interventions for schizophrenia in India should target both clinical and functional outcomes, addressing the priorities of both affected persons and their caregivers. Their effectiveness needs to be evaluated independently from both perspectives.

The acceptability, feasibility, and effectiveness of a population-based intervention to promote youth health: an exploratory study in Goa, India.

PURPOSE: To evaluate the acceptability, feasibility, and effectiveness of a population-based intervention to promote health of youth (age: 16-24 years) in Goa. METHODS: Two pairs of urban and rural communities were selected; one of each was randomly assigned to receive a multi-component intervention and the other wait-listed. The intervention comprised educational institution-based peer education and teacher training (in the urban community), community peer education, and health information materials. Effectiveness was assessed through before-after population surveys at baseline and at 18 months. Outcomes were measured using a structured interview schedule with all eligible youth. Logistic regression compared each pair, adjusted for baseline differences, on prevalence of outcomes in the domains of reproductive and sexual health (RSH), violence, mental health, substance use, and help seeking for health concerns. RESULTS: In both intervention communities, prevalence of violence perpetrated and probable depression was significantly lower and knowledge and attitudes about RSH significantly higher (p < .05). The rural sample also reported fewer menstrual complaints and higher levels of help-seeking for RSH complaints by women, and knowledge and attitudes about emotional health and substance use; and, the urban sample reported significantly lower levels of substance use, suicidal behavior, sexual abuse, and RSH complaints. Although information materials were acceptable and feasible in both communities, community peer education was feasible only in the rural community. The institution-based interventions were generally acceptable and feasible. CONCLUSIONS: Multicomponent interventions comprising information materials, educational-institution interventions and, in rural contexts, community peer interventions are acceptable and feasible and likely to be effective for youth health promotion.

Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial.

BACKGROUND: There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR), involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC) intervention, combined with usual Facility Based Care (FBC), is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India. METHODS/DESIGN: This trial is a multi-site, parallel group randomised controlled trial design in India.The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs) working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. DISCUSSION: If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries. TRIAL REGISTRATION: The trial is registered with the International Society for the Registration of Clinical Trials and the allocated unique ID number is ISRCTN 56877013.