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

Barnaby Nelson, G. Paul Amminger, Hok Pan Yuen, Nicky Wallis, Melissa J. Kerr, Lisa Dixon, Cameron S Carter, Rachel Loewy, Tara A Niendam, Martha Shumway, Sarah Morris, Julie Blasioli, Patrick D. Mcgorry

Research output: Contribution to journalArticle

21 Scopus citations

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.

Original languageEnglish (US)
JournalEarly Intervention in Psychiatry
DOIs
StateAccepted/In press - 2017

Keywords

  • Antidepressant medication
  • Clinical trial
  • Prodrome
  • Psychosis
  • Ultra high risk

ASJC Scopus subject areas

  • Phychiatric Mental Health
  • Psychiatry and Mental health
  • Biological Psychiatry

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    Nelson, B., Amminger, G. P., Yuen, H. P., Wallis, N., J. Kerr, M., Dixon, L., Carter, C. S., Loewy, R., Niendam, T. A., Shumway, M., Morris, S., Blasioli, J., & Mcgorry, P. D. (Accepted/In press). Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients. Early Intervention in Psychiatry. https://doi.org/10.1111/eip.12459