Effectiveness of the Japanese standard family psychoeducation on the mental health of caregivers of young adults with schizophrenia: a randomised controlled trial.

Background: This study examined the effects of the standard model of family psychoeducation (SM-FPE) in Japan on the mental health of relatives who care for young patients with a psychotic disorder.
Methods: Stratified by recent-onset/chronic psychosis, 74 caregivers of outpatients aged 30.1 years (mean) were randomly assigned to receive TAU (treatment as usual) alone or TAU plus SM-FPE. All outcomes were measured at baseline, at the end of the intervention (10 weeks), and 1 month post-intervention (14 weeks). The primary outcome was the trait anxiety of caregivers at 14 weeks. Secondary outcomes included caregivers' state anxiety, psychological distress, care burden, and expressed emotion. Integrating these secondary outcomes, a conceptual framework of caregivers' health state was assessed via structural equation modelling.
Results: Compared with TAU alone, SM-FPE plus TAU did not significantly improve all caregivers' individual outcomes. Direct effects of the intervention were observed in the caregivers of chronic patients as significant improvements of their overall mental health state at 10 weeks, which indirectly continued until 14 weeks. However, such intervention effects were not observed in the caregivers of recent-onset patients.
Conclusions: The lack of effectiveness in the recent-onset stage suggests that the usefulness of the SM-FPE needs to be corroborated by further research.
Trial Registration: The study protocol was retrospectively registered at ClinicalTrials.gov (registration number: NCT01731977; date of registration: 22 November 2012).