Active not recruitingNAINTERVENTIONAL

Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders

This research trial is investigating whether a computer-assisted tool, called pronia.ai, can help doctors identify young people aged 16-40 who are at a higher risk of developing psychosis. The study aims to detect these risks earlier and provide tailored support. Participants will either receive care guided by the AI tool, which includes extra assessments and specific talking therapy, or they will receive standard care from their local doctors. The main goal is to see if early, targeted support, informed by AI, can reduce the chances of someone actually developing psychosis compared to just receiving standard care.

At a glance

Status

Active not recruiting

Phase

Sponsor

Heinrich-Heine University, Duesseldorf

Enrolment target

260

Start

01 May 2023

Estimated completion

01 Mar 2026

Psychotic Disorders Prevention

What is this study about?

This study is looking into a new way to help young people who might be at a higher risk of developing a serious mental health condition called psychosis. Psychosis can affect how someone thinks, feels, and sees the world. The study uses a special computer programme, or 'AI tool', called pronia.ai. This tool helps doctors understand an individual's specific risk level and customise the care they receive.

The main idea is to see if identifying these risks earlier, and then providing support that is specifically designed for that person's needs, can stop psychosis from fully developing. Some participants will receive this new, AI-guided approach, which includes more detailed checks and a specific type of talking therapy. Others will receive the usual care that would typically be offered by their local healthcare services.

Ultimately, this research aims to improve how we support young people at risk, hopefully preventing them from becoming unwell or helping them to manage their condition better if it does develop. It's about finding out if this smart technology can make a real difference in early mental health support.

Key takeaways

This study aims to discover if early, personalised support can reduce the chances of developing psychosis.
It uses a special computer tool (AI) to help identify and assess individual risk.
Participants will either receive AI-guided care with specific talking therapy or standard care.
The target age group is 16-40 years old who show early signs of psychosis risk.
The study is comparing a new approach against current standard practice for early intervention.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would typically be between 16 and 40 years old. You must also have been identified by doctors as having certain early signs that suggest you might be at a higher risk of developing psychosis. This would be based on specific interviews and assessments.

You would not be able to participate if you have already been diagnosed with full-blown psychosis. Also, if you have certain existing brain conditions, have recently taken specific antipsychotic medications for more than a month, or if doctors feel you are not able to fully understand and agree to take part in the study, you would not be eligible. Severe thoughts of self-harm during the recruitment phase would also prevent participation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I aged between 16 and 40 years old?
Have doctors said I show early signs of being at high risk for psychosis?
Do I currently have full-blown psychosis?
Have I taken certain antipsychotic medicines for more than a month recently?
Do I have any specific brain conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two groups: either the 'AI-guided' group or the 'usual care' group. If you're in the AI-guided group, you'll have extra, in-depth assessments, including tests that look at your thinking abilities. The special computer programme, pronia.ai, will use information from these assessments to give a non-binding risk profile that helps guide your treatment plan. This plan involves between 16 and 24 sessions of specific talking therapy (called Integrated Preventive Psychological Intervention, or IPPI) over six months. If you are in the usual care group, you will be referred back to your local doctors for ongoing treatment, as is standard practice. The total duration of participation in the study is not specified in detail, but the active treatment period is six months.

Potential risks and benefits

Taking part in a study like this might offer the benefit of receiving potentially more tailored and intensive support than usual, which could help reduce your risk of developing psychosis. You would also contribute valuable knowledge that could help others in the future. As with any medical study, there's always a chance that the new approach may not work as expected, or that you might experience some discomfort from the additional assessments. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (21)

ZfP Reichenau - Akademisches Lehrkrankenhaus Universität Konstanz
Verified postcode
Konstanz, Germany
Zentralinstitut für Seelische Gesundheit
Verified postcode
Mannheim, Germany
Klinik für Psychiatrie und Psychotherapie Universität Tübingen
Verified postcode
Tübingen, Germany
Bezirkskrankenhaus Augsburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Universität Augsburg
Verified postcode
Augsburg, Germany
Klinikum der Ludwig-Maximilians-Universität München
Verified postcode
München, Germany
Zentrum für psychische Gesundheit, U11iversitätsklinikum Würzburg
Verified postcode
Würzburg, Germany
Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Universitätsklinikum Aachen, RWTH Universität Aachen
Verified postcode
Aachen, Germany
LWL-Universitätsklinikum Bochum der Ruhr--Universität Bochum, Klinik für Psychiatrie, Psychotherapie und Präventivmedizin
Verified postcode
Bochum, Germany
KJPP LVR-Klinik Bonn
Verified postcode
Bonn, Germany
Universitätsklinikum Bonn Klinik für Psychiatrie und Psychotherapie
Verified postcode
Bonn, Germany
Uniklinik Köln, Klinik und Poliklin-ik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
Verified postcode
Cologne, Germany
Klinik und Poliklinik für Psychiatrie und Psychotherapie Heinrich-Heine-Universität Düsseldorf
Verified postcode
Düsseldorf, Germany

Common questions

What is psychosis?

Psychosis is a mental health condition where someone might have difficulty telling what is real from what isn't. This can include seeing or hearing things others don't, or having strong beliefs that aren't based in reality.

What does 'risk of psychosis' mean?

It means doctors have noticed some early signs or symptoms that suggest someone might be more likely to develop psychosis in the future, but they haven't developed it yet.

What is pronia.ai?

Pronia.ai is a computer tool that uses information about a person to help understand their individual risk of developing psychosis and how they might cope over time. It helps doctors make informed decisions about care.

Will I know if I'm getting the AI-guided treatment or usual care?

Yes, you will be told which group you are in. This study relies on different approaches so it's important for you to know what kind of support you will receive.

What kind of talking therapy is involved?

The therapy used in the AI-guided group is called 'Integrated Preventive Psychological Intervention' (IPPI). It's a type of cognitive behavioral therapy (CBT) designed to help prevent psychosis.