Exploring the feasibility and public health impact of integrating a community-based recovery-oriented intervention for people living with schizophrenia in partnership with a tertiary care mental hospital in India.

Background: There is a priority need to make community-based care widely available for people living with schizophrenia (PLwS) in low- and middle-income countries. An innovative approach for increasing access could be to integrate clinical services available in tertiary care hospitals with community-based care through a task-sharing approach. We describe such an integrated intervention that was implemented at Tezpur in northeast India in collaboration with the Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH). Method: The objectives of the study were to illustrate the feasibility of integrating and implementing the intervention and to describe its individual, systemic, and public health impacts. Due to the limited resources available, we conducted a pragmatic single-arm longitudinal evaluation of the intervention cohort over 24 months. Results: Of the 239 PLwS enrolled in the intervention, 198 (83%) were followed up for 24 months, with nearly three-quarters reporting a >70% reduction in disabilities, most notably between 6 and 18 months. There was a marked reduction in unmet needs across multiple domains, and at 24 months, 62% of the cohort was engaged in individual jobs or other market-linked livelihood opportunities. There was greater uptake and retention with outpatient contacts at the LGBRIMH, and PLwS experienced a marked (82%) reduction in inpatient admissions rates, as compared to before enrolment. Over a period of 24 months, primary caregivers reported that their families experienced significantly fewer social difficulties such as unemployment, interpersonal conflicts, and social isolation. The intervention had a significant public health impact, with an estimated 51.8% effective treatment coverage rate for the integrated intervention. Conclusion: Our findings provide preliminary evidence of the feasibility of implementing the integrated intervention and its effectiveness. We believe that there is merit in further in-depth refinement and exploration of this implementation-related research and cost analysis while replicating the intervention in other tertiary care institutions.

In low- and middle-income countries such as India, integrating clinical services available at tertiary mental health hospitals with community-based care through a task-sharing approach is an innovative way to make community-based care widely available for people living with schizophrenia (PLwS). The purpose of our study was to investigate the feasibility of implementing such an intervention in a community in Tezpur, northeastern India, in collaboration with a Lokopriya Gopinath Bordoloi Regional Institute of Mental Health (LGBRIMH), and to describe the individual, systemic, and public health effects of the intervention. Our findings suggest that integrating the intervention is feasible, has significant impacts on individuals and public health, and is an effective way to expand access to community-based care for PLwS through partnerships with existing tertiary care institutions.

Updating the WHO Model Lists of Essential Medicines to promote global access to the most cost-effective and safe medicines for mental disorders.

Since 1977, the WHO Model Lists of Essential Medicines (EML) have been a benchmark to guide the procurement of medicines at the national level, especially in low-income and middle-income countries. Aiming to include the most effective, safe, and cost-effective medicines for priority conditions, WHO updates the EML for adults and the EML for children every 2 years. Over the past 45 years, updates to the EML mental health section have been infrequent, in most cases with additions of individual medicines. A comprehensive revision of the entire section has never been attempted. With the aim of increasing the use of the WHO EML to expand the selection of the most effective and safe medicines for mental disorders, a series of evidence-based applications were submitted to the WHO Expert Committee on the Selection and Use of Essential Medicines in 2022, recommending a substantial revision of the entire mental health section. In this Health Policy, we summarise the recommended update and the evidence justifying it. We also discuss challenges in the update process, suggesting possible solutions. The requested comprehensive revision of the WHO EML mental health section aligns the list with the latest evidence. The revision offers an opportunity for countries to promote access to the most effective, safe, and cost-effective medicines for mental disorders, contributing to universal health coverage and global mental health equity.

Lichens as spatially transferable bioindicators for monitoring nitrogen pollution.

Excess nitrogen is a pollutant and global problem that harms ecosystems and can severely affect human health. Pollutant nitrogen is becoming more widespread and intensifying in the tropics. There is thus a requirement to develop nitrogen biomonitoring for spatial mapping and trend analysis of tropical biodiversity and ecosystems. In temperate and boreal zones, multiple bioindicators for nitrogen pollution have been developed, with lichen epiphytes among the most sensitive and widely applied. However, the state of our current knowledge on bioindicators is geographically biased, with extensive research effort focused on bioindicators in the temperate and boreal zones. The development of lichen bioindicators in the tropics is further weakened by incomplete taxonomic and ecological knowledge. In this study we performed a literature review and meta-analysis, attempting to identify characteristics of lichens that offer transferability of bioindication into tropical regions. This transferability must overcome the different species pools between source information - drawing on extensive research effort in the temperate and boreal zone - and tropical ecosystems. Focussing on ammonia concentration as the nitrogen pollutant, we identify a set of morphological traits and taxonomic relationships that cause lichen epiphytes to be more sensitive, or more resistant to this excess nitrogen. We perform an independent test of our bioindicator scheme and offer recommendations for its application and future research in the tropics.

A cross-sectional survey of the prevalence and determinants of comorbid psychological distress in attendees at two general hospitals in Gaza.

BACKGROUND: There is an absence of mental health services within general hospitals in Gaza. As part of the Ministry of Health plan to develop mental health liaison services, a cross-sectional survey of the prevalence of and risk factors for psychological distress in attendees at two general hospitals was undertaken to estimate and highlight the need for establishing such services. METHODS: 20 volunteers aged 24-30 years with a degree in psychological or social science from a university accredited by the Palestinian Ministry of Education and Higher Education, and with experience in field data collection for studies in mental health, were selected and trained in the use of the Arabic version of the 12-item General Health Questionnaire (GHQ-12), an internationally and well validated tool for measuring psychological distress in adults. The volunteers were supervised as they screened adult attendees at emergency rooms, inpatient wards and outpatient departments, and women attending the maternity units at two of the largest general hospitals in Gaza (Nasser and Indonesian) over seven consecutive days (March 18-23, 2018). Attendees at emergency and outpatient departments were included if they were on repeat visits with medically unexplained somatic complaints, if they attended with complaints resulting from any kind of social problem, physical or sexual violence, or had a history of any kind of chronic disease. All patients from the internal medicine and inpatient departments were included. The data from the questionnaires were collated and analysed with descriptive and inferential statistics. FINDINGS: 1789 attendees (791 men and 998 women) were screened using the GHQ-12. Of these attendees, 23·8% (426 of 1789) had a GHQ-12 score of 6 or 7, indicating the presence of significant psychological distress with a high possibility of caseness (ie, meeting the diagnostic threshold for clinical depression). 36·2% (648 of 1789) scored 8 or above, indicating the presence of moderate to severe depression or anxiety disorders that require immediate clinical intervention. For all of the hospital departments surveyed, individuals with scores of 6 or greater made up a large proportion of the attendees (385 of 660 [58·3%] in emergency rooms, 197 of 306 [64·4%] in inpatient wards, 430 of 711 [60·5%] in outpatient departments, and 62 of 112 [55·4%] in maternity units), in both hospitals. In addition, a set of risk factors were found to be significantly associated with GHQ-12 scores of 6 or greater. These were being a woman (p=0·020), living in villages adjoining the most conflict prone areas (p<0·0001), no or low formal education (p<0·0001), being divorced (p<0·001) or widowed (p<0·0001), being unemployed (p<0·0001), and low family income (monthly income of <1000 ILS; p<0·0001). On further stepwise regression analysis, unemployment and low family income were found to be the most important risk factors associated with GHQ-12 scores of 6 or greater. INTERPRETATION: In general hospital attendees there was a very high rate of significant psychological distress. Given the absence of mental health services within general hospitals in Gaza, the findings indicate an urgent need to make mental health interventions routinely available through general hospital liaison units in Gaza. The risk factors that were identified indicate that psychosocial interventions and access to developmental support are key components of such clinical services, and will be required to reduce the very large, and mostly unmet, population burden of mental health problems in Gaza. FUNDING: WHO, occupied Palestinian territory, as part of the EU project "Building Palestinian resilience: improving psychosocial and mental health responses in emergency".

Alkaline air: changing perspectives on nitrogen and air pollution in an ammonia-rich world.

Ammonia and ammonium have received less attention than other forms of air pollution, with limited progress in controlling emissions at UK, European and global scales. By contrast, these compounds have been of significant past interest to science and society, the recollection of which can inform future strategies. Sal ammoniac (nushadir, nao sha) is found to have been extremely valuable in long-distance trade (ca AD 600-1150) from Egypt and China, where 6-8 kg N could purchase a human life, while air pollution associated with nushadir collection was attributed to this nitrogen form. Ammonia was one of the keys to alchemy-seen as an early experimental mesocosm to understand the world-and later became of interest as 'alkaline air' within the eighteenth century development of pneumatic chemistry. The same economic, chemical and environmental properties are found to make ammonia and ammonium of huge relevance today. Successful control of acidifying SO2 and NOx emissions leaves atmospheric NH3 in excess in many areas, contributing to particulate matter (PM2.5) formation, while leading to a new significance of alkaline air, with adverse impacts on natural ecosystems. Investigations of epiphytic lichens and bog ecosystems show how the alkalinity effect of NH3 may explain its having three to five times the adverse effect of ammonium and nitrate, respectively. It is concluded that future air pollution policy should no longer neglect ammonia. Progress is likely to be mobilized by emphasizing the lost economic value of global N emissions ($200 billion yr-1), as part of developing the circular economy for sustainable nitrogen management. This article is part of a discussion meeting issue 'Air quality, past present and future'.

Important Steps to Control COVID-19/SARS-CoV-2 Infection.

Elderly patients are having high mortality rates from COVID-19/SARS-CoV-2 infection compared to younger patients. The SARS-CoV-2 virus uses the ACE2 receptor as the entry point to the host cells. ARBs/ACEIs which are widely used in elderly patients, have been found to be associated with overexpression of ACE2.To decrease the severity of COVID-19 infection, ARB/ACEI should be switched to another class drug not known to cause a rise in ACE2 until the COVID-19 infection subsides. Specific human immunoglobulin can be tried for COVID-19 patients with critical conditions under supervision.

Mapping the evidence on pharmacological interventions for non-affective psychosis in humanitarian non-specialised settings: a UNHCR clinical guidance.

BACKGROUND: Populations exposed to humanitarian emergencies are particularly vulnerable to mental health problems, including new onset, relapse and deterioration of psychotic disorders. Inadequate care for this group may lead to human rights abuses and even premature death. The WHO Mental Health Gap Action Programme Intervention Guide (mhGAP-IG), and its adaptation for humanitarian settings (mhGAP-HIG), provides guidance for management of mental health conditions by non-specialised healthcare professionals. However, the pharmacological treatment of people with non-affective psychosis who do not improve with mhGAP first-line antipsychotic treatments is not addressed. In order to fill this gap, UNHCR has formulated specific guidance on the second-line pharmacological treatment of non-affective psychosis in humanitarian, non-specialised settings. METHODS: Following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology, a group of international experts performed an extensive search and retrieval of evidence on the basis of four scoping questions. Available data were critically appraised and summarised. Clinical guidance was produced by integrating this evidence base with context-related feasibility issues, preferences, values and resource-use considerations. RESULTS: When first-line treatments recommended by mhGAP (namely haloperidol and chlorpromazine) are not effective, no other first-generation antipsychotics are likely to provide clinically meaningful improvements. Risperidone or olanzapine may represent beneficial second-line options. However, if these second-line medications do not produce clinically significant beneficial effects, there are two possibilities. First, to switch to the alternative (olanzapine to risperidone or vice versa) or, second, to consider clozapine, provided that specialist supervision and regular laboratory monitoring are available in the long term. If clinically relevant depressive, cognitive or negative symptoms occur, the use of a selective serotonin reuptake inhibitor may be considered in addition or as an alternative to standard psychological interventions. CONCLUSIONS: Adapting scientific evidence into practical guidance for non-specialised health workers in humanitarian settings was challenging due to the paucity of relevant evidence as well as the imprecision and inconsistency of results between studies. Pragmatic outcome evaluation studies from low-resource contexts are urgently needed. Nonetheless, the UNHCR clinical guidance is based on best available evidence and can help to address the compelling issue of undertreated, non-affective psychosis in humanitarian settings.

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.

Efficacy, Tolerability, and Biomarker Analyses of Once-Every-2-Weeks Cetuximab Plus First-Line FOLFOX or FOLFIRI in Patients With KRAS or All RAS Wild-Type Metastatic Colorectal Cancer: The Phase 2 APEC Study.

BACKGROUND: In patients with KRAS wild-type (wt) metastatic colorectal cancer (mCRC), outcomes with first-line chemotherapies are improved by adding weekly cetuximab. The APEC study investigated first-line once-every-2-weeks cetuximab plus chemotherapy for patients with KRAS wt mCRC; additional biomarker subgroups were also analyzed. PATIENTS AND METHODS: APEC was a nonrandomized phase 2 trial conducted in the Asia-Pacific region. Patients (n = 289) received once-every-2-weeks cetuximab with investigator's choice of chemotherapy (FOLFOX or FOLFIRI). The primary end point was best confirmed overall response rate (BORR); progression-free survival (PFS) and overall survival (OS) were secondary end points. Early tumor shrinkage (ETS) and depth of response (DpR) were also evaluated. RESULTS: In the KRAS wt population, BORR was 58.8%, median PFS 11.1 months, and median OS 26.8 months. Expanded RAS mutational analysis revealed that patients with RAS wt mCRC had better outcomes (BORR = 64.7%; median PFS = 13.0 months; median OS = 28.4 months). The data suggest that ETS and DpR may be associated with survival outcomes in the RAS wt population. Although this study was not designed to formally assess differences in outcome between treatment subgroups, efficacy results appeared similar for patients treated with FOLFOX and FOLFIRI. There were no new safety findings; in particular, grade 3/4 skin reactions were within clinical expectations. CONCLUSION: The observed activity and safety profile is similar to that reported in prior first-line pivotal studies involving weekly cetuximab, suggesting once-every-2-weeks cetuximab is effective and tolerable as first-line therapy and may represent an alternative to weekly administration.

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.

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.

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.

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.

Psychiatric advance directives: potential challenges in India.

The advance directive is a statement of an individual's preference for future treatment. The concept initially evolved in the context of end-of-life treatment decision making. Subsequently, in some countries, advance directives have been promoted in the care and treatment of people with serious mental disorders. They have recently been endorsed by the United Nations Convention for the Rights of Persons with Disability. In India, the legal framework related to the care of persons with mental illness is currently being reappraised, and significant changes are being contemplated. Thus, this is an appropriate time to review the existing evidence on psychiatric advance directives and examine the potential challenges involved in making them legally binding. A wide spectrum of mental health 'advance statements' have been developed and implemented in some high-resource countries. Of special interest to mental health contexts is the complex Ulysses contract to accommodate situations where the advance directive can be overridden during phases of acute illness or relapse. There have been mixed experiences with advance directives in the last couple of decades and there is scant evidence to suggest that they are effective in improving actual care. There has been almost no discourse in India on the issue of mental health advance directives. Yet this feature is being considered for implementation in the revised legal framework for the care of persons with mental illness. There are significant barriers to the feasibility and acceptability of legally mandated advance directives. There are logistical barriers to operationalising them in a manner that guarantees quality assurance of the process, and minimises the possibility of misuse. Thus, while the advance directive is a highly desirable clinical tool for collaborative decision making between the person with mental illness and the treatment provider, at this time, more needs to be done before legal enforcement is considered in India.

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.