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. 2018 Jun;12(3):292-306.
doi: 10.1111/eip.12459. Epub 2017 Jul 18.

Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients

Barnaby Nelson  1   2 , G Paul Amminger  1   2 , Hok Pan Yuen  1   2 , Nicky Wallis  1   2 , Melissa J Kerr  1   2 , Lisa Dixon  3 , Cameron Carter  4 , Rachel Loewy  5 , Tara A Niendam  4 , Martha Shumway  5 , Sarah Morris  6 , Julie Blasioli  1   2 , Patrick D McGorry  1   2
Affiliations

Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients

Barnaby Nelson et al. Early Interv Psychiatry. 2018 Jun.

Abstract

Aim: Previous research indicates that preventive intervention is likely to benefit patients "at risk" of psychosis, in terms of functional improvement, symptom reduction and delay or prevention of onset of threshold psychotic disorder. The primary aim of the current study is to test outcomes of ultra high risk (UHR) patients, primarily functional outcome, in response to a sequential intervention strategy consisting of support and problem solving (SPS), cognitive-behavioural case management and antidepressant medication. A secondary aim is to test biological and psychological variables that moderate and mediate response to this sequential treatment strategy.

Methods: This is a sequential multiple assignment randomised trial (SMART) consisting of three steps: Step 1: SPS (1.5 months); Step 2: SPS vs Cognitive Behavioural Case Management (4.5 months); Step 3: Cognitive Behavioural Case Management + Antidepressant Medication vs Cognitive Behavioural Case Management + Placebo (6 months). The intervention is of 12 months duration in total and participants will be followed up at 18 months and 24 months post baseline.

Conclusion: This paper reports on the rationale and protocol of the Staged Treatment in Early Psychosis (STEP) study. With a large sample of 500 UHR participants this study will investigate the most effective type and sequence of treatments for improving functioning and reducing the risk of developing psychotic disorder in this clinical population.

Keywords: antidepressant medication; clinical trial; prodrome; psychosis; ultra high risk.

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Figures

FIGURE 1
FIGURE 1
Staged Treatment in Early Psychosis (STEP) study design
See this image and copyright information in PMC

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