Prescient FAQs - participants

Prescient FAQs - participants

UNDERSTANDING MORE ABOUT THE PRESCIENT STUDY

Choosing to participate in a study is an important personal decision. The following frequently asked questions provide detailed information about the PRESCIENT study. It is often helpful to talk to a clinician, family members, or friends when deciding to consent to a study.

WHAT DOES ULTRA HIGH RISK FOR PSYCHOSIS MEAN?

People at Ultra High Risk (UHR) for psychosis have an elevated risk of developing a psychotic disorder compared to the general population because of particular symptoms and/or family history. Symptoms vary for different individuals, but can include feeling low in mood, feeling paranoid, or seeing or hearing things that they know aren’t there. Other people in the UHR group may not experience any of these symptoms, but have a family member with a psychotic disorder and might be having more difficulty than usual coping with work, school or relationships.

WHAT IS THE PRESCIENT STUDY ABOUT?

When young people seek mental health support, we need to be able to predict the outcomes of their symptoms and what kind of treatments will work best. PRESCIENT will examine a range of potential risk factors for young people at Ultra High Risk (UHR) for psychosis, with the aim of creating tools to better predict outcomes and develop more effective treatments.  We will recruit a large number of participants across Australia, Asia and Europe – and collect a broad range of information about their symptoms, family history and biology – to achieve this. Your data will be pooled so that it can be used and re-used to help current and future generations.

WHY IS IT IMPORTANT TO STUDY PEOPLE OVER A LONGER TIMEFRAME? 

This study keeps track of participants over a long period of time (2 years). This gives us a better understanding of different mental health concerns and how they develop and change, which may help us improve early treatments. PRESCIENT will be run under the guidance of a Human Research Ethics Committee operated by Melbourne Health in addition to local ethics and/or governance committees within Australia and internationally. 

WHO WILL TAKE PART IN PRESCIENT? 

PRESCIENT participants will include young people who may be at risk of their symptoms becoming more severe to the point that a psychotic disorder is diagnosed – this group is referred to as the Ultra High Risk (UHR) group. The study will also include young people who have not experienced mental health concerns so that we can compare their mental health over time. Participants will know which group they are allocated to. 

HOW LONG WILL PRESCIENT GO FOR?

Participants will be recruited over a two-year period and follow up will go for two years. In total, we expect PRESCIENT to run for four years. 

The study is expected to go from July 2021 to June 2025. 

WHERE ARE THE PRESCIENT STUDY SITES?

The study is being conducted at the following sites and centres across Australia, Asia and Europe: 

Australia

•   Orygen Specialist Program (Melbourne, Victoria) and Orygen Clinical Trials Unit (OCTU); 

•   headspaces Craigieburn, Glenroy, Melton, Sunshine and Werribee (Melbourne, Victoria); and 

•   headspace and headspace Early Psychosis program in Adelaide (Adelaide, South Australia). 
 

Asia 

•   Department of Psychiatry, University of Hong Kong (Hong Kong);

•   Early Psychosis Intervention Program Clinic (Singapore); and

•   Gwangju Early Treatment & Intervention Clinic (South Korea).

 

Europe 

•   Academic Medical Centre (The Netherlands); 

•   Centre for Psychiatric Neuroscience (CNP), Department of Psychiatry, Lausanne University Hospital (Switzerland); 

•   Copenhagen Research Centre for Mental Health (Denmark); 

•   Forward Thinking Birmingham (United Kingdom); 

•   The University Hospital Jena, Department of Psychiatry (Germany); and

University Hospital of Cologne (UHC), Cologne, Germany

WHAT TYPES OF THINGS WILL BE LOOKED AT OVER THE 24 MONTHS?

•   Clinical interviews: You will be asked about your day-to-day life and activities, behaviour, emotions and moods over the two-year period.

•   Neurocognitive tasks: You will complete tasks that assess attention and memory, and the way you respond to stimuli. 

•   Electrical brain activity recording (EEG): EEGs detect electrical activity in your brain using small metal discs (electrodes) attached to your scalp.

•   Brain imaging scan (MRI): You will complete MRI scans so that brain structure and functioning can be measured. 

•   Blood sample: You will provide blood samples to analyse potential biological markers of psychosis risk.

•   Saliva sample: You will provide saliva samples to monitor levels of the stress hormone cortisol. 

•   Speech sample: You will be asked to have a 20-minute audio-recorded open conversation with a Research Assistant. Speech patterns and their association with thought disorder will be assessed. 

•   Video sample: If you consent, you will be recorded via video so that facial expression characteristics can be analysed.

•   Participants will be invited to record their daily mood and behaviour through a smartphone app (this is optional). 

HOW DO I CONSENT TO PARTICIPATE IN THE PRESCIENT STUDY?

Prospective participants need to be current clients at one of the centres listed above, or live nearby. If a young person appears to be eligible, a Research Assistant will approach them to ask if they would like to take part in the project. A consent discussion will then be arranged. You can also email prescientstudy@orygen.org.au to enquire as to whether you might be eligible.

WHAT AGE DOES SOMEONE HAVE TO BE TO PARTICIPATE IN THE PRESCIENT STUDY?

Young people between 12 and 30 years of age, inclusive, can participate in the study. 

I’LL BE TURNING 31 SOON, CAN I STILL PARTICIPATE IN PRESCIENT?

Yes, if you are enrolled in the study while still aged 30.

IS THERE ANY FINANCIAL EXPENSE FROM TAKING PART IN PRESCIENT? 

There are no costs associated with participating in the research project, and you won’t be paid. You will, however, be reimbursed for your time and expenses associated with completing the research assessments. A breakdown of reimbursements is provided in the consent form. 

WHAT HAPPENS IF I BEGIN PRESCIENT AND THEN DECIDE I DON’T WANT TO CONTINUE?

The study is voluntary, and all participants have the right to withdraw from the study at any point. If a participant would like to withdraw, it is important for them to let the research assistant know to ensure the appropriate care can be provided. 

WHAT HAPPENS IF I NEED TO BE REFERRED TO ANOTHER SERVICE DURING PRESCIENT? 

If you need to be referred to another service during the study period, please notify the Research Assistant.

I AM EXPERIENCING THE SYMPTOMS YOU MENTIONED ABOVE, CAN I TAKE PART IN PRESCIENT IF I AM NOT ATTENDING A STUDY SITE?

Yes. Young people can take part in PRESCIENT even if they are not clients at one of the centres listed above, as long as they are receiving some kind of support including from a GP or an external psychologist or psychiatrist. However, the study team encourages young people seeking support to contact their local centre. 

WHO DO I CONTACT ABOUT PARTICIPATING IN THE PRESCIENT STUDY?

Participants can be referred for study enrolment by their treating clinician at one of the centres listed above. Interested young people and parents can also get in touch with the study team at prescientstudy@orygen.org.au , who will respond and keep a record of the enquirer’s details.

Only young people who consent and meet all of the inclusion and none of the exclusion criteria will be eligible to participate in PRESCIENT. 


INCLUSION CRITERIA 

All participants

Participants will be considered eligible if they:

•   are aged 12–30 years inclusive; 

•   understand and sign informed consent; and

•   meet Ultra High Risk (UHR) or healthy control (HC) criteria.
 

UHR participants

UHR participants must meet one or more UHR for psychosis groups


HC participants

Healthy control participants will be recruited from the community. They must not meet any exclusion criteria or: 

•   meet UHR criteria, have a current or past Cluster A personality disorder, or a current or past psychotic disorder; 

•   be receiving any current treatment with psychotropic medication; or

•   have a family history (in first-degree relatives) of psychotic spectrum disorders. 


Participants will be considered ineligible it they have:

•   Antipsychotic medication exposure equivalent to a total lifetime haloperidol dose of >50 mg, estimated based on available information (e.g., medical file documentation, patient and family report).

•   Documented history of intellectual disability.

•   Past or current clinically significant central nervous system disorder. When necessary, Research Assistants will consult with study team investigators (including medical personnel) to determine if the central nervous system disorder is deemed to be clinically relevant. 

•   Traumatic brain injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument.

•   Current or past treated or untreated psychotic episode.

HREC/68873/MH-2021