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

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          Abstract

          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.

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          Most cited references12

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          The positive and negative syndrome scale (PANSS) for schizophrenia.

          L Opler, Jennifer Kay, Paul Opler … (1986)
          The variable results of positive-negative research with schizophrenics underscore the importance of well-characterized, standardized measurement techniques. We report on the development and initial standardization of the Positive and Negative Syndrome Scale (PANSS) for typological and dimensional assessment. Based on two established psychiatric rating systems, the 30-item PANSS was conceived as an operationalized, drug-sensitive instrument that provides balanced representation of positive and negative symptoms and gauges their relationship to one another and to global psychopathology. It thus constitutes four scales measuring positive and negative syndromes, their differential, and general severity of illness. Study of 101 schizophrenics found the four scales to be normally distributed and supported their reliability and stability. Positive and negative scores were inversely correlated once their common association with general psychopathology was extracted, suggesting that they represent mutually exclusive constructs. Review of five studies involving the PANSS provided evidence of its criterion-related validity with antecedent, genealogical, and concurrent measures, its predictive validity, its drug sensitivity, and its utility for both typological and dimensional assessment.
          Article 0 comments Cited 1800 times – based on 0 reviews     Review now
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            Mental health systems in countries: where are we now?

            K S Jacob, P. Sharan, I. Mirza … (2007)
            More than 85% of the world's population lives in 153 low-income and middle-income countries (LAMICs). Although country-level information on mental health systems has recently become available, it still has substantial gaps and inconsistencies. Most of these countries allocate very scarce financial resources and have grossly inadequate manpower and infrastructure for mental health. Many LAMICs also lack mental health policy and legislation to direct their mental health programmes and services, which is of particular concern in Africa and South East Asia. Different components of mental health systems seem to vary greatly, even in the same-income categories, with some countries having developed their mental health system despite their low-income levels. These examples need careful scrutiny to derive useful lessons. Furthermore, mental health resources in countries seem to be related as much to measures of general health as to economic and developmental indicators, arguing for improved prioritisation for mental health even in low-resource settings. Increased emphasis on mental health, improved resources, and enhanced monitoring of the situation in countries is called for to advance global mental health.
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              Outcomes of people with psychotic disorders in a community-based rehabilitation programme in rural India

              Sudipto Chatterjee, Aravind Pillai, Sumeet Jain … (2009)
              Background There is little evidence of the feasibility, acceptability and impact of services for the care of people with psychotic disorders in low- and middle-income countries. Aims To describe the scaling up and impact of a community-based rehabilitation programme for people with psychotic disorders in a very-low-resource setting. Methods Longitudinal study of people with psychotic disorders who had been ill for an average of 8 years in a rural Indian community. All individuals received a community-based intervention package comprising psychotropic medications, psychoeducation, adherence management, psychosocial rehabilitation and support for livelihoods. The primary outcome was change in disability scores. Results The cohort consisted of 256 people with psychotic disorders (schizophrenia, bipolar affective disorder and other psychosis) of whom 236 people completed the end-point assessments (92%), with a median follow-up of 46 months. There were significant reductions (P<0.05) in the levels of disability for the cohort, the vast majority (83.5%) of whom engaged with the programme. On multivariate analyses, lower baseline disability scores, family engagement with the programme, medication adherence and being a member of a self-help group were independent determinants of good outcomes. Lack of formal education, a diagnosis of schizophrenia and dropping out of the programme were independent determinants of poor outcomes. Conclusions Community-based rehabilitation is a feasible and acceptable intervention with a beneficial impact on disability for the majority of people with psychotic disorders in low-resource settings. The impact on disability is influenced by a combination of clinical, programme and social determinants.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Trials
                Title: Trials
                Publisher: BioMed Central
                ISSN (Electronic): 1745-6215
                Publication date Collection: 2011
                Publication date (Electronic): 13 January 2011
                Volume: 12
                Page: 12
                Affiliations
                [1 ]Sangath, Porvorim, Goa, India
                [2 ]Health Service and Population Research Department, Institute of Psychiatry, King's College London, UK
                [3 ]London School of Hygiene & Tropical Medicine, UK
                [4 ]Schizophrenia Research Foundation, Chennai, India
                [5 ]Parivartan, Satara, India
                [6 ]National Institute of Mental Health and Neurosciences, Bangalore, India
                [7 ]Jawaharlal Nehru Medical College, Karnataka, India
                [8 ]Nirmittee, Satara, India
                Article
                Publisher ID: 1745-6215-12-12
                DOI: 10.1186/1745-6215-12-12
                PMC ID: 3033834
                PubMed ID: 21226970
                SO-VID: af8db95d-e1ee-4e6e-8505-f34132118337
                Copyright © Copyright ©2011 Chatterjee et al; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 7 September 2010
                Date accepted : 13 January 2011
                Categories
                Subject: Study Protocol

                ScienceOpen disciplines: Medicine
                Data availability:
                ScienceOpen disciplines: Medicine

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