A randomised trial comparing the clinical and cost effectiveness of usual, facility based care compared to an additional collaborative community care package for people and their families living with schizophrenia in India

Not Applicable

Completed

Conditions: Mental health/schizophrenia
Mental and Behavioural Disorders
Schizophrenia

Registration Number: ISRCTN56877013

Lead Sponsor: Kings College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 327

Inclusion Criteria

Since this is an effectiveness trial, we propose to have broad inclusion criteria that can be generalised to routine, real life settings. Therefore, for inclusion in the trial participants must:
1. Be between the ages of 18 - 60 years, either sex
2. Meet International Classification of Disease, 10th revision, Diagnostic Criteria for Research (ICD-10 DCR) criteria for schizophrenia
3. Have been ill for at least 12 months
4. Be currently having at least an moderate overall severity of the illness based on the Clinical Global Impression-Schizophrenia (CGI-S) scale rating

Two pathways for recruitment are anticipated: people from within the existing caseloads at each of the sites who have ongoing positive symptoms or those who present with a relapse of symptoms; and people who have presented for care for the first time and meet all inclusion criteria irrespective of their treatment status.

Exclusion Criteria

1. The presence of a medical illness needing immediate hospitalisation
2. Participant is unlikely to reside in the identified CBI area for the duration of the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in positive psychotic symptoms in people with schizophrenia measured at baseline and at 12 months, as assessed by the Positive and Negative Syndrome Scale (PANSS) that has been used widely in India before.

Secondary Outcome Measures