The STEP study (Staged Treatment in Early Psychosis), one of Orygen’s largest research projects, commences recruitment this month. The study, funded by the National Institute of Mental Health (NIMH) in Washington DC, will produce an evidence-base to guide a stepwise clinical approach to treatment for young people at ultra high risk (UHR) of psychosis.
The study aims to recruit 500 participants over a two year period. The trial has commenced within the Orygen Youth Health Clinical Program and headspace Glenroy, and our other headspace centres at Sunshine, Werribee and Craigieburn will join the study in the coming weeks.
The stepwise design of the study involves all participants receiving Supportive Problem Solving (SPS) over the initial six weeks of the trail (STEP 1). Participants who benefit from SPS will receive ongoing monthly monitoring and maintenance treatment, while those who do not benefit will be randomised to further or additional treatments (Steps 2 and 3).
Aside from determining which young people benefit from what type or level of intervention, the study will also collect data on key biomarkers and other mechanisms potentially underpinning risk, which may ultimately be used to adapt and personalize treatment.
The study is being led by Pat McGorry, Barnaby Nelson, Paul Amminger and Hok Pan Yuen, along with collaborators from the US. The project manager is Nicky Wallis and large team of clinicians and RAs are working across the 5 recruitment sites.