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Table 2 Summary of outcomes measures for the Task Sharing for the Care of Severe Mental Disorders in a Low-income Country (TaSCS) trial

From: Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial

  Outcome Measure Timing
Primary outcome
1 SMD symptom severity BPRS-E Baseline, 12* and 18 months
Secondary outcomes
1. Functional impairment± WHODAS 2.0 (12-item) Baseline, 12 and 18 months
Local functioning scale Baseline, 12 and 18 months
2. Relapse of mental disorder LCS Baseline, 12 and 18 months
3. Service use costs CSRI Baseline, 12 and 18 months
4. Satisfaction with mental health care Mental health service satisfaction scale (MHSSS) Baseline, 12 and 18 months
Qualitative in-depth interviews From 6 months post-randomisation
5. Nutritional status Body Mass Index Baseline, 12 and 18 months
6. Service use for physical health conditions CSRI Baseline, 12 and 18 months
7. Medication side effects ASC Baseline, 12 and 18 months
8 Patient engagement and adherence Medication Adherence Measure Clinic attendance Baseline, 12 and 18 months
9. Perceived stigma ISMI Baseline, 12 and 18 months
10. Restraint± Proportion chained, restrained or confined in last month Baseline, 12 and 18 months
11. Quality of care Document review Monthly for 3 months, 6, 12 and 18 months
13. Adverse events (AEs) LCS and project reporting mechanisms for AEs Continuous for serious AEs 6-monthly for other AEs
Mediating variable
1. Therapeutic alliance HAQ Baseline, 12 and 18 months
Caregiver outcomes
1. Perceived stigma FIS Baseline, 12 and 18 months
2. Caregiver burden FIS Baseline, 12 and 18 months
3. Time burden of caring and opportunity costs CSRI Baseline, 12 and 18 months
Potential confounding variables
1. Sociodemographic characteristics Structured self-report of age, sex and marital status Baseline
2. Socio-economic status Structured self-report of educational level, occupational status, food insecurity and family size Baseline
3. Alcohol use disorder FAST Baseline
4. Khat use disorder CIDI substance use module Baseline
5. Medical co-morbidity or physical disability Structured self-report Baseline
  1. * Primary outcome; ± proxy version also administered to caregivers. BPRS-E, Brief Psychiatric Rating Scale, expanded version [6, 60]; WHODAS 2.0, World Health Organisation Disability Assessment Schedule, Version 2.0 [61]; LCS, Life Chart Schedule [62]; CSRI, Client Service Receipt Inventory [63, 64]; ASC, Antipsychotic Side Effect Checklist [65], Medication Adherence Measure [66]; ISMI, Internalised Stigma of Mental Illness [67]; HAQ, Helping Alliance Questionnaire [68]; FIS, Family Interview Schedule [69]; FAST, Fast Alcohol Screening Test [70]; CIDI, Composite International Diagnostic Interview [33]