Data management and analysis
schizophrenia
REGRESSION
Data collection and management will follow Good Clinical Practice (GCP) guidelines and Standard Operating Procedure. Each participant will be assigned a unique ID so that their reported data could be identified. Data cleaning will follow standard procedure, and all the changes will be documented. Findings of this trial will be reported according to the revised CONSORT guidelines [All statistical analyses were performed using STATA version 16.0 for Mac (Stata Corp, College Station, TX, USA). Descriptive statistics will be applied to summarize the socio-demographic and clinical characteristics, as well as the outcome measures for all trial participants at baseline, intermediate and endline. Participants who are loss-to-follow-up will be compared using chi-square tests and t tests to assess the potential bias. The primary outcome analysis will be masked until the analyses is finalized and approved by all researchers. Adequate intervention will be defined as having received a minimum of 12 group sessions. We will not define adequate FBC for the control arm a priori. CBR worker’s characteristics such as educational background, post-training competency and relative working experience will also be described.Data analysis will be conducted under intention-to-treat assumption. The primary outcome----12-month PANSS total score, adjusted for PANSS scores at baseline and site, and including clustering effects of CBR workers, will be used for examining the comparative effects of intervention and control arm. Personal and social function (PSP score), antipsychotic adherence (MARS score), knowledge of schizophrenia (KAST score) and hospital readmission will be similarly analyzed. A longitudinal analysis including both 6- and 12-month outcomes will also be performed using a GEE or random effects model including an interaction term of time and treatment allowing for modelling changes over time. Long-term outcomes (ADL & IADL, PSSS, EQ-5D, SQLS and BAS score) at 12 months will be analyzed in a similar way to the primary outcome. We will also perform residual analysis to check the data distribution and to detect outliers. Multiple imputation methods will be employed for participants with missing outcome variables.Several sensitivity analyses are planned to be carried out. First, a complete case analysis and a complier average causal effect will be conducted. Second, a dose-response relationship between adherence to CBR intervention (number of group sessions attended) and the intermediate and long-term outcomes will be examined. Third, we will also conduct data analyses that including received quantity of different CBR modules to identify the active components. Furthermore, regression models will also be re-estimated to include possible confounders such as characteristics of CBR workers and participant characteristics that differ at baseline.Exploratory subgroup analyses by gender, urban-rural residence, baseline symptom severity and antipsychotic adherence will be completed, although the power for these analyses has not been specifically allowed for.