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

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 middleincome countries. We did the COmmunity care for People with Schizophrenia in India (COPSI) trial to compare the eff ectiveness 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 Classifi cation 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 stratifi ed 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 modifi ed 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 diff erence –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 diff erence 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 signifi cant 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 traffi c 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 eff ective 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

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

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

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

The systematic development and pilot randomized evaluation of counselling for alcohol problems, a lay counselor-delivered psychological treatment for harmful drinking in primary care in India: the PREMIUM study.

BACKGROUND: Despite harmful drinking causing a significant burden on global health, there is a large treatment gap, especially in low- and middle-income countries. A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments. This paper describes the systematic process used to develop Counselling for Alcohol Problems (CAP), a brief psychological treatment (PT) for delivery by lay counselors in routine primary care settings to men with harmful drinking in India. METHODS: CAP was developed using a methodology involving 3 sequential steps: (i) identifying potential treatment strategies; (ii) developing a theoretical framework for the treatment; and (iii) evaluating the acceptability and feasibility of the treatment. RESULTS: CAP is a 3-phase treatment delivered over 1 to 4 sessions based on a motivational interviewing (MI) stance and involves the following strategies: assessment and personalized feedback, family engagement, drink refusal skills, skills to address drinking urges, problem-solving skills and handling difficult emotions, and relapse prevention and management. Data from a case series were used to inform several adaptations to enhance the acceptability of CAP to the recipients and feasibility of delivery by lay counselors of the treatment, for example expansion of the target group to include alcohol-dependent patients and the extension of the delivery settings to include home-based delivery. There was preliminary evidence of the effectiveness of CAP. CONCLUSIONS: CAP is an acceptable brief PT for harmful drinking delivered by lay counselors in primary care whose effectiveness is currently being tested in a randomized controlled trial based in primary care in Goa, India

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 explanatory models and coping strategies for alcohol use disorders: an exploratory qualitative study from India.

PURPOSE: The explanatory models (EM) and coping strategies for mental health problems influence treatment seeking and the subsequent patient journey. The goal of this study was to explore the EMs and coping strategies for alcohol use disorders (AUD). METHODS: We conducted semi structured interviews with 29 men with AUD and 10 significant others (SO) in two sites in India. Thematic analysis was used to analyse data. RESULTS: The former were predominantly married, literate and employed; the latter were predominantly wives, literate and employed. Alcohol consumption and AUDs are seen to be mainly associated with psychosocial stress, with other factors being peer influences, availability of disposable income and drinking for pleasure. They are perceived to result in a range of adverse impacts on social life, family life, personal health and family finances. Various coping strategies were deployed by men with AUD and their significant others, for example avoidance, substitution, distraction, religious activities, support from AA/friends/family, restricting means to buy alcohol and anger management. Reduction/cessation in drinking, improved family relationships, improved emotional/physical wellbeing and better occupational functioning were the most desired treatment outcomes. CONCLUSION: There are considerable similarities, as well as some key differences, observed between the EMs for AUD in India and those reported from other cultures which have implications for the global applicability and contextual adaptations of evidence based interventions for AUD