title: Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The trial is registered with the International Society for the Registration of Clinical Trials and the allocated unique ID number is ISRCTN 56877013.
authors.affiliation: Sangath, Porvorim, Goa, India. sudipto_dr@yahoo.com.au
authors.forename: Sudipto
authors.initials: S
authors.lastname: Chatterjee
authors.forename: Morven
authors.initials: M
authors.lastname: Leese
authors.forename: Mirja
authors.initials: M
authors.lastname: Koschorke
authors.forename: Paul
authors.initials: P
authors.lastname: McCrone
authors.forename: Smita
authors.initials: S
authors.lastname: Naik
authors.forename: Sujit
authors.initials: S
authors.lastname: John
authors.forename: Hamid
authors.initials: H
authors.lastname: Dabholkar
authors.forename: Kimberley
authors.initials: K
authors.lastname: Goldsmith
authors.forename: Madhumitha
authors.initials: M
authors.lastname: Balaji
authors.forename: Mathew
authors.initials: M
authors.lastname: Varghese
authors.forename: Rangaswamy
authors.initials: R
authors.lastname: Thara
authors.forename: Vikram
authors.initials: V
authors.lastname: Patel
authors.forename: Graham
authors.initials: G
authors.lastname: Thornicroft
mesh_terms: D017028:Caregivers / Q000523:psychology*; D003156:Community Mental Health Services / Q000191:economics; D003299:Cooperative Behavior; D003362:Cost-Benefit Analysis; D003906:Developing Countries; D004185:Disability Evaluation; D005195:Family Relations; D017048:Health Care Costs; D006801:Humans; D007194:India; D010348:Patient Care Team / Q000191:economics; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D012559:Schizophrenia / Q000175:diagnosis / Q000191:economics / Q000628:therapy*; D012565:Schizophrenic Psychology; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome