Effectiveness of a psychoeducational program for caregivers of persons with acquired brain injury: a randomized controlled trial (EDUCA-V)

Abstract

ABSTRACT Objective To assess the effectiveness of a psychoeducational intervention program (PIP) compared to standard attention in reducing caregiver burden after the intervention (at 4 months) and at follow-up (at 8 months). Methods A multicenter, evaluator-blind, randomized controlled trial. The experimental group received a PIP intervention consisting of 10 weekly group sessions, while the control group received standard attention. The primary outcome was measured as the change scores from baseline on the caregiver’s burden (ZBI). The secondary outcomes evaluated included caregiver mental health (GHQ-28), anxiety (STAI), and depression (CES-D). Trial registration: ISRCTN16513116. Results The sample comprised 76 informal caregivers (41 allocated in the intervention condition and 35 in the control). The caregiver’s burden (ZBI) did not show significant differences between groups at 4 months or 8 months. There were favorable and significant changes in the caregiver’s mental health (GHQ) and depression (CES-D) at 4 months in the PIP group. There were no significant differences between groups in anxiety during the trial. Conclusions The PIP intervention group reported positive effects on general mental health and depression after the intervention but not at follow-up. We need more studies which interventions follow expert recommendations and can sustain positive results over time.