Abstract / Summary
Family caregivers play a pivotal role in the recovery of people experiencing first-episode psychosis (FEP). However, they may suffer from high levels of psychological distress and lack access to structured support. Although international recommendations highlight the need for psychoeducational interventions for caregivers, their implementation in France remains limited. This study aims to evaluate the impact of a structured, multicomponent support pathway, coordinated by advanced practice nurses (APNs), for family caregivers of people with FEP. This multicentre, stepped-wedge (cluster with sequential permutation) randomized controlled trial involves six centres specializing in FEP in France. The intervention includes an initial consultation conducted by an APN, a single-family psychoeducational programme (BREF) and a multifamily psychoeducational programme (PEPs Aidant). The primary outcome measure is the change in caregiver burden between 0 and 6 months. Secondary outcome measures include caregiver mood, self-efficacy and quality of life, as well as patient engagement and perception of recovery. A qualitative study will explore the processes and experiences related to the implementation of the intervention. The reporting of the study follows the SPIRIT guidelines. The intervention aims to reduce caregiver burden, improving their coping strategies and self-efficacy and strengthening patient engagement. The results should enable the development of evidence-based guidelines for structured caregiver support in FEP services. This project aims to provide families with support and a structured, coordinated care pathway led by advanced nurse practitioners with rigorous comparative evaluation and potential generalization to other FEP services. The present trial has been registered in the ClinicalTrials.gov database (NCT07041463) since 26 June 2025.