Protocol for the MyPREPED trial: hybrid type 2 effectiveness-implementation trial of a peer-delivered digital self-management tool (MyBRANCHES) for young people in Australia transitioning from early intervention in psychosis services.
Аннотация
BACKGROUND
Peer-supported self-management at discharge from early intervention in psychosis services (EIPS) has received limited attention. The MyPREPED (My Personal Recovery Plan for Early Discharge) trial will evaluate a co-designed, digital and paper-based, peer-delivered recovery and self-management focused intervention, tailored for young people exiting EIPS.
AIMS: This protocol describes a hybrid type 2 effectiveness-implementation trial designed to assess MyPREPED's impact, feasibility, real-world implementation and cost-utility.
METHOD: This multi-site, mixed-method, two-arm (1:1), parallel-group, randomised controlled trial (MyPREPED versus treatment as usual) trial will be delivered across eight Australian EIPS that deliver ultra-high risk and/or first-episode psychosis streams, using a hybrid type 2 implementation-effectiveness design. Eligible participants are young people aged 16 years and over within 6 months of planned discharge from EIPS. Peer coaches will deliver up to ten sessions of using a self-management plan (modules: discharge, recovery, well-being, relapse prevention, goal-setting, service navigation). Co-primary outcomes include (a) mental health recovery (Recovery Assessment Scale - Domains and Stages; effectiveness outcome) and (b) feasibility (Feasibility of Implementation Measure; implementation outcome). Secondary outcomes assess broader effectiveness domains (mental health quality of life, clinical and functional outcomes) and other implementation outcomes. A cost-utility analysis will estimate incremental costs and quality-adjusted life-years associated with MyPREPED, alongside a secondary cost-effectiveness analysis. Analyses will follow intention-to-treat principles, using mixed-effects models.
CONCLUSIONS
This study will provide the first rigorous test of a co-designed, peer-delivered recovery and self-management focused intervention specifically targeting EIPS discharge.
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