A randomized trial to assess the efficacy of a psychoeducational intervention on caregiver burden in schizophrenia

Background: Patient's relatives usually care for patients with schizophrenia, and as informal caregivers they experience negative consequences. The aim of the EDUCA-III trial is to test the efficacy of a psychoeducational intervention program (PIP) versus standard care to reduce the caregiver burden at post-intervention (4 months), and at follow-up (8 months). Method: A two-arm, evaluator blind, multicentre, randomized controlled trial. The PIP group had 12 weekly group sessions. The control intervention group had the usual support and standard care. Primary outcomes were change scores since baseline on the Zarit Burden Interview (ZBI) and the Involvement Evaluation Questionnaire (IEQ). Results: One hundred and nine caregivers were randomized to PIP and 114 to control condition from 23 research sites. The decrease of ZBI scores was significantly higher on the PIP arm at 4 months (mean difference [MD] = -4.33; 95% CI -7.96, -0.71), and at 8 months (MD = -4.46; 95% CI -7.79, -1.13). There were no significant decreases in the IEQ scores (MD at 4 months = -2.80; 95% CI -6.27, 0.67; MD at 8 months = -2.85; 95% CI -6.51, 0.81). Conclusions: The PIP condition seems to reduce caregiver burden. Trial registration: ISRCTN32545295.