Effects of community-based rehabilitation on caregivers of people with schizophrenia in Ethiopia in the RISE trial.

BACKGROUND: Schizophrenia is a severe mental health condition with high impact on those affected and their families. Community-based rehabilitation (CBR) is a recommended treatment component for schizophrenia in low- and middle-income countries (LMIC), as it seeks to address complex social, health and economic needs. There is little evidence on the effects of CBR on caregivers of people with schizophrenia. RISE, conducted in Ethiopia, was the first randomised controlled trial of CBR for schizophrenia in a low-income country. In this paper, we extend our previous examination of caregiver impact by (1) investigating the impact of CBR on caregiver stigma and burden, (2) assessing effect modification of outcomes, and (3) determining predictors of caregiver outcomes at 12 months. METHODS: Data are from the cluster-randomised controlled RISE trial, which investigated CBR and facility-based care versus facility-based care alone among 166 people with schizophrenia and 166 linked caregivers in 48 sub-districts in Ethiopia. We analyse the effect of CBR on caregiver stigma, unemployment and burden measured with the WHO Family Interview Schedule-Impact at 6 and 12 months; and caregiver depression, reduction in work due to caregiving and caregiver burden measured with the Involvement Evaluation Questionnaire at 6 months. Logistic and linear regression models adjusted for clustering by sub-district and health centre were used for binary and continuous outcomes respectively. Effect modification by caregiver sex, age, baseline of the outcome, and baseline disability were assessed. Baseline factors associated with caregiver outcomes across the whole cohort at 12 months were investigated using hierarchal regression modelling. RESULTS: Data were available for 112 caregivers at 6 months (67%), and 149 caregivers at 12 months (90%). There was evidence that CBR was associated with greater tendency to reduce work due to caregiving at 6 months (OR:2.40, 95%CI:1.06-5.45). No evidence of an intervention effect was found on unemployment, depression, stigma or other aspects of caregiver burden. There was no evidence for effect modification. Higher baseline disability was independently associated with greater caregiving burden at 12 months (β:0.26, 95%CI:0.14-0.37). CONCLUSIONS: There appeared to be no positive intervention effect of CBR on caregiver stigma, unemployment and burden in this analysis. Improving the outcomes of caregivers of people with schizophrenia in LMIC requires interventions and research addressing the needs of caregivers, for instance by integrating social and livelihoods interventions. TRIAL REGISTRATION: Clinical Trials.gov Identifier NCT02160249. Registered on 3 June 2014.