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.
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.
This protocol describes a hybrid type 2 effectiveness-implementation trial designed to assess MyPREPED's impact, feasibility, real-world implementation and cost-utility.
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.
This study will provide the first rigorous test of a co-designed, peer-delivered recovery and self-management focused intervention specifically targeting EIPS discharge.
This protocol describes a hybrid type 2 effectiveness-implementation trial designed to assess MyPREPED's impact, feasibility, real-world implementation and cost-utility.
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.
This study will provide the first rigorous test of a co-designed, peer-delivered recovery and self-management focused intervention specifically targeting EIPS discharge.
Authors
Milton Milton, Brown Brown, Arnautovska Arnautovska, Vaughan Vaughan, Gao Gao, Chatterton Chatterton, Stratton Stratton, Hancock Hancock, Chapman Chapman, Iyer Iyer, Singh Singh, Malhotra Malhotra, Batara Batara, Chakma Chakma, De Cicco De Cicco, Lindsay Lindsay, Harris Harris, Siskind Siskind, Warren Warren, McHugh McHugh, McArdle McArdle, Phung Phung, Cook Cook, Thompson Thompson, Glozier Glozier
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