Mental health/schizophrenia Mental and Behavioural Disorders Schizophrenia
Conditions
Interventions
For the trial, we will be recruiting participants from three sites in India:
1. In Tamil Nadu, the study will be conducted in four rural blocks or sub-districts: Kattankolathur, Sriperambudur, Kunnuat
Sponsors
Kings College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Participants: 1. Change in baseline to 12 month follow-up scores on the locally developed Indian Disability Evaluation and Assessment Scale (IDEAS) which has been used previously in India 2. Cost of Illness Schedule (CIS) for the computing the costs related to the illness; this has been developed and used in India in community studies before 3. Participants adherence to recommended treatment recorded using a specially designed tool that measures adherence from individual, family and treating doctor's assessments 4. Discrimination and Stigma Scale (DISC), a standardised assessment of service user experiences of discrimination because of mental illness that has undergone field trials in India 5. Euroqol (EQ-5D) for estimation of QALYs 6. Internalised Stigma of Mental Illness (ISMI), Alienation Subscale (assessment of internalised stigma) 7. Willingness to disclose - patient version item Primary caregivers: 1. Burden Assessment Schedule (BAS) which has been developed and widely used in India 2. Knowledge and attitudes of family members using the Knowledge about Schizophrenia Interview (KASI) which has been used in LAMIC settings earlier 3. Family Interview Schedule, (Stigma Section) for the assessment of family perceptions of stigma and discrimination which has been used in India before 4. Willingness to disclose item - caregiver version item In addition, we will obtain important socio-demographic information about the participant and the primary caregiver at baseline using specially designed forms. All quantitative outcomes using these scales will be assessed at baseline and at 12 months, except for the CIS, adherence scale and the IDEAS which will also be assessed at 6 months - the CIS because recall of service use over a prolonged period may lead to inaccuracies, the adherence scale because of similar problems with recall and the IDEAS as this time period has been found to be feasible in previous studies. To maintain blinding of these assessments, all outcome m | — |
Countries
India
Outcome results
None listed