| Study characteristics |
| Methods |
Allocation: stratified randomised (parallel‐group); randomly assigned in a 2:1 ratio
Design: RCT, multicentre ‐ 3 sites in India: 4 sub‐districts of Kancheepuram district, Tamil Nadu, Goa and Satara district in Maharashtra
Duration: 12‐month follow‐up
Date of study: May 2008 to December 2012
Country: India
Setting: intervention delivered within community
Recruitment method: recruited through collaborating psychiatrists
Masking: Outcome assessors were masked to allocation. Incidences of unmasking were recorded by researchers. If unmasking happened at the 6‐month assessment, a different researcher undertook the 12‐month assessment. |
| Participants |
Inclusion criteria: aged 16 to 60; primary diagnosis of schizophrenia as per ICD‐10 criteria; have had illness duration of at least 12 months and a moderate severity rating as rated on the Clinical Global Impression‐Schizophrenia (CGI‐SCH) scale; be residing within the study catchment area for the next 12 months
Exclusion criteria: none described
Number randomised to intervention and control: 282 (187 intervention, 95 control)
Number completed study: 167 intervention (10 refused, 8 were not found or moved, 2 died), 86 control (6 refused, 1 not found, 2 died)
Age: 16 to 60; intervention mean 36.2 (SD 10.2), control mean 35.6 (10.4)
Sex: intervention 86 (46%) female, control 47 (49%) female
Diagnosis: schizophrenia (ICD‐10‐DCR criteria)
Ethnicity: reported as castes due to location
Intervention: schedule caste 46 (25%), schedule tribe 4 (2%), other backward caste 45 (24%), unknown 18 (10%), none of the above 74 (40%)
Control: schedule caste 20 (21%), schedule tribe 2 (2%), other backward caste 28 (29%), unknown 15 (16%), none of the above 30 (32%)
Any significant differences between intervention and control groups? Not reported by authors, but demographics appear to be well‐balanced in most cases. |
| Interventions |
Type of collaborative care: B
Description of intervention:
Intervention name: community‐based collaborative care + usual facility‐based care
Contains 3 of 4 elements of collaborative care:
A multi‐professional approach to patient care: no, no primary care involvement A structured management plan: yes, an individual treatment plan formulated in collaboration with the patient and family during the first 3 months Scheduled patient follow‐ups: yes; 6 to 8 patient visits at home in first 3 months (intensive engagement phase), 6 to 8 fortnightly sessions in the months 4 to 7 (stabilisation phase) and 6 visits between months 8 and 12 (maintenance phase) Enhanced interprofessional communication: yes, community healthcare workers (CHWs) delivered intervention supervised by psychiatric social workers working as designated intervention co‐ordinators. Psychiatrists provide clinical leadership for the community care teams, and ongoing supervision. Joint on‐site visits, weekly group meetings and scheduled meetings with the psychiatrist.
Other intervention components:
Structured clinical reviews by treatment team and supervision for community health workers Psychoeducational information for participants and caregivers Adherence management strategies Health promotion strategies to address physical health needs Individualised rehabilitation strategies to improve personal, social and work functioning of participants Specific efforts with participants and caregivers to deal with experiences of stigma and discrimination Linkage to self‐help groups and other methods of user‐led support Networks with community agencies to address social issues, to help with social inclusion, access to legal benefits, and employment opportunities.
The intervention is primarily delivered by the CHW. CHW have a minimum of 10 years of schooling and are trained in the intervention over a 6‐week period and assessed for competence. The CHWs are co‐ordinated and supervised by psychiatric social workers trained in supervision and monitoring skills. Treating psychiatrists also supervised through quarterly team reviews and regular supervision.
Maximum caseload of CHW is expected to be 25. Each participant is expected to receive 22 contacts with the CHW across 12 months.
Description of control:
Facility‐based care (usual care provided by mental health providers). Varies between sites due to lack of consistency in healthcare provision in India. |
| Outcomes |
Measures taken at: baseline, 6 and 12 months
Primary outcomes: change in symptoms, change in disabilities
Able to use:
Change in symptoms (Positive and Negative Symptom Scale ‐ PANSS) (baseline and 12 months) Change in disabilities (Indian Disability Evaluation and Assessment ‐ IDEAS) (baseline, 6 and 12 months) Psychiatric admissions Other hospital admissions (any reason) Social functioning (WHO Disability Assessment Scale) Cost‐effectiveness and cost utility (total costs in dollars) (12 months) Deaths from suicide
Unable to use:
Experiences of stigma and discrimination (Discrimination and Stigma Scale ‐ DISC) (baseline and 12 months) – not of interest Knowledge and attitudes about schizophrenia (Knowledge about Schizophrenia Interview ‐ KASI) (baseline and 12 months) – not of interest Burden of caring (Burden Assessment Schedule – BAS) (baseline and 12 months) – not of interest Carer experiences of stigma and discrimination (section extracted from the Family Interview Schedule – FIS) (baseline and 12 months) – not of interest Willingness to disclose mental illness (scale not reported) (baseline and 12 months) – not of interest The caregiver summary assessment of participant adherence (same scale as participants) (baseline and 12 months) Adherence with antipsychotic medication using a 5‐point ordinal scale, a specially designed tool developed for the study (not validated) (baseline, 6 and 12 months, if receiving medication) – not of interest Quality life years (quality of life ‐ EuroQOL EQ‐5D) used but not reported Willingness to disclose mental illness (scale not reported) ‐ not of interest Experience of internalised stigma (Alienation subscale of the Internalized Stigma of Mental Illness Scale – ISMI) ‐ not of interest
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| Notes |
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