Staged Treatment in Early Psychosis (STEP): A sequential multistage randomized clinical trial (SMART) of interventions for Ultra High Risk (UHR) of psychosis patients.


Dataset description

Dataset originates from a Sequential Multiple Assignment Randomised Trial (SMART) designed to evaluate the efficacy of various interventions for young people at ultra high risk (UHR) of psychosis. The study was conducted across five Melbourne clinics, recruiting 340 participants who met the study criteria. The interventions assessed include Support and Problem Solving, Cognitive Behaviour Case Management, and antidepressant medication. The primary aim is to develop individualized treatment strategies that can effectively reduce the risk of progression to psychosis and improve functional outcomes. The randomisation process was protected to ensure treatment allocation remained concealed until participants progressed to Steps 2 and 3. The randomisation schedule was generated by an independent statistician using computer-generated random numbers. Blinding was implemented to mask participants, clinicians, outcome assessors, and data analysts from treatment allocation to maintain the integrity of the trial.
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FOR: Mental Health |

Source Study




Not Applicable


Government body,National Institute of Mental Health

Scientific enquiries

A/Prof Barnaby Nelson

Brief Summary

Psychotic illnesses usually first emerge in young people and result in widespread suffering, protracted disability, premature death, and a huge economic burden. Early intervention represents a vital strategy to reduce this burden. Psychotic disorders are preceded by a prodromal period of distress, impaired functioning and subthreshold psychosis. Although the evidence from 11 Randomised Controlled Trials indicates that interventions can reduce the risk of transition to psychotic disorders by more ....
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Key Inclusion Criteria

1. Age 12 -25 years (inclusive) at entry 2. Ability to speak adequate English (for assessment purposes) 3. Ability to provide informed consent. Where participants are minors (i.e. have not reached the age of eighteen), consent will also be obtained from one of the participant’s parents or legal guardian. Both the parent/legal guardian and participant will be required to sign a consent form in such a case. It will be the investigator’s responsibility to determine whether a participant who is a ma ....
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Key Exclusion Criteria

1. Past history of a psychotic episode of one week or longer, whether treated with antipsychotic medications or not. 2. Attenuated psychotic symptoms only present during acute intoxication. 3. Organic brain disease known to cause psychotic symptoms, e.g. temporal lobe epilepsy. 4. Any metabolic, endocrine or other physical illness, e.g. thyroid disease, with known neuropsychiatric consequences. 5. Diagnosis of a serious developmental disorder, e.g. Severe Autism Spectrum Disorder. 6. Premorbid I ....
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Can healthy volunteers participate?




Sample Size    342

Min. age    12 Years

Max. age    25 Years

Sex    Both males and females

Condition category    Schizophrenia and other psychotic disorders

Condition code    Mental Health


Intervention code Behaviour , Treatment: Drugs

The study treatment sequence involves three stages, which are referred to as steps. Each step follows on immediately from the previous step, without any break. Step 1- Support and Problem Solving (SPS) All trial participants receive Support and Problem Solving treatment in Step 1. This therapy will be administered by allied health professionals. Support and Problem Solving therapy involves providing participants with emotional support and help with resolving their problems in day-to-day life. Th ....
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Control group Active

Step 1: All participants will receive Support and Problem Solving. Step 2: Support and Problem Solving will be compared with Cognitive Behavioural Case Management. Step 3: Cognitive Behavioural Case Management PLUS Selective Serotonin Reuptake Inhibitor (SSRI) will be compared with Cognitive Behavioural Case Management PLUS placebo (microcellulose tablet) Participants in these steps of the trial will be compared with participants who respond to Steps 1 and 2 and are randomised to Support and Pro ....
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Outcome: To test the effect of a sequential treatment approach consisting of Support and Problem Solving/Support and Problem Solving and Support and Problem Solving/Cognitive Behavioural Case Management on functioning levels of Ultra High Risk patients 6 months from baseline (end of Step 2). Functioning will be measured using the Global Functioning: Social and Role Scales assessment tool.
Timepoint: Six months from baseline visit (end of Step 2).

Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

All of the individual trial-related participant data collected during the trial, after de-identification.

When will data be available?

Data is available Immediately for an indefinite time

Available to whom?

Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data sharing policy.

Available for what types of analyses?

To any type of analyses. Assessed on a case-by-case basis.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see