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

NCT ID: NCT05813080

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-03-31

Brief Summary

Multicenter randomized controlled trial (RCT) with artificial intelligence (AI)-staged early diagnostics and risk-adapted treatment (RAB) as interventional treatment arm and treatment-as-usual (TAU) as control treatment arm for patients with an increased clinical risk for psychosis.

Detailed Description

The study is a Investigator Initiated Trial (IIT)/Other clinical trial of a class 2a medical device according to article 82 medical devices regulation of the European Union.

The aim of risk-adapted treatment (RAB) arm is to reduce the number of patients with an increased clinical risk for psychosis to actually develop a manifest psychosis.

Patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing.

The AI-supported algorithm "pronia.ai" uses information from both the individual patient data of the specialized routine diagnostics as well as from in-depth clinical diagnostics.

There are two predictions, an individual quantitative assessment of the individual risk of transition to psychosis and the individual prognosis with regard to the level of psychosocial functioning 12 months after inclusion in the study.

The therapists and patients receive a non-binding risk profile from the AI-based recommendation to adjust the treatment intensity from 16 to 24 sessions over a period of six months.

The cognitive behavioral therapy-based manual "Integrated Preventive Psychological Preventive Psychological Intervention (IPPI)" manual is used. In the treatment-as-usual arm (TAU),the patients receive referral back to the previous care system; further treatment (and additional diagnostics, if necessary) is left to the referring primary care providers.

Conditions

Psychotic Disorders; Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CARE interventional treatment

AI-computerassisted prognosis of high risk psychosis profile and adapted study-specific therapy taking place in early-recognition centers.

Group Type: EXPERIMENTAL

"pronia.ai" medical device for high risk psychosis prognosis

Intervention Type: DEVICE

In addition to the computer-assisted prognosis of risk for reaching a psychosis, all patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing. Adapted psychological treatment will be offered consisting of 16 to 24 sessions over a period of six months.

Standard of Care Control arm

Treatment as usual (TAU) patient will receive their usual treatment from their local physicians and therapeutic personnel.

Group Type: ACTIVE_COMPARATOR

Treatment-as-usual (TAU)

Intervention Type: OTHER

Referral back to the previous care system. Further treatment is left to the referring primary care providers.

Interventions

"pronia.ai" medical device for high risk psychosis prognosis

In addition to the computer-assisted prognosis of risk for reaching a psychosis, all patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing. Adapted psychological treatment will be offered consisting of 16 to 24 sessions over a period of six months.

Intervention Type: DEVICE

Treatment-as-usual (TAU)

Referral back to the previous care system. Further treatment is left to the referring primary care providers.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The increased risk of psychosis includes either a symptomatic "ultra high-risk" stage of the Structured Interview for Psychosis-Risk Syndromes or the "Cognitive Disturbances" risk criterion of the Schizophrenia Proneness Instrument - Children and Youth and Adult versions
• ages 16 to 40
• Presence of a written informed consent from the patient and, if applicable, the legal guardian.

Exclusion Criteria

• manifest psychosis according to the definition of the Structured Interview for Psychosis-Risk Syndromes (according to the PRONIA-study) (At least one P-syndrome with a rating of 6 on a daily frequency and for a period of more than one week)
• Lack of capacity to give consent (the patient lacks the capacity to consent if the individual case with regard to the specific treatment measure is excluded. Only when the physician has concrete indications that the patient's capacity to consent may be lacking, he may and must must examine it. Mental disorders (e.g. delirium, dementia, psychosis, mania, depression) or cognitive impairments can have an influence on the capacity to consent. Indications for doubts of a ability to give informed consent exist if the physician has the impression that the patient is not able to understand the provided patient information and is not able to reproduce essential information about the study in his or her own words and is not aware of the possible consequences of the proposed measures
• Severe suicidality during the recruitment phase (CDSS items 8 ≥2)
• A current or past neurological disease of the brain.
• a current or past known somatic disease that potentially affects the structure or function of the brain
• Antipsychotic medication in the indication treatment of psychotic symptoms for >30 days (cumulative number of days) at or above the starting dose for psychosis according to the current German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) S3 guidelines.
• an antipsychotic medication in the indication treatment of psychotic symptoms in the 3 months prior to the initial examination (regardless of the duration of use) at or above the starting dose for psychosis according to the current DGPPN S3 guidelines
• An inadequate level of hearing for neurocognitive testing
• a current or past head trauma with unconsciousness (>5 min).
• a current or past alcohol dependence (ICD-10 F10.x)
• A current polytoxicomania (multiple substance dependence) or polytoxicomania in the past 6 months (ICD-10 F19.x)
• Presence of medical reasons that contraindicate performance of an MRI
• Insufficient language skills to understand the indication and the purpose of the intended examinations and interventions
• stationary accommodation against the patient's will

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Meisenzahl-Lechner, Prof.

Role: PRINCIPAL_INVESTIGATOR

Klinik und Poliklinik für Psychiatrie und Psychotherapie LVR-Klinikum Düsseldorf

Locations

ZfP Reichenau - Akademisches Lehrkrankenhaus Universität Konstanz

Konstanz, Baden-Wurttemberg, Germany

Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, Germany

Klinik für Psychiatrie und Psychotherapie Universität Tübingen

Tübingen, Baden-Wurttemberg, Germany

Bezirkskrankenhaus Augsburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Universität Augsburg

Augsburg, Bavaria, Germany

Klinikum der Ludwig-Maximilians-Universität München

München, Bavaria, Germany

Zentrum für psychische Gesundheit, U11iversitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Universitätsklinikum Aachen, RWTH Universität Aachen

Aachen, North Rhine-Westphalia, Germany

LWL-Universitätsklinikum Bochum der Ruhr--Universität Bochum, Klinik für Psychiatrie, Psychotherapie und Präventivmedizin

Bochum, North Rhine-Westphalia, Germany

KJPP LVR-Klinik Bonn

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum Bonn Klinik für Psychiatrie und Psychotherapie

Bonn, North Rhine-Westphalia, Germany

Uniklinik Köln, Klinik und Poliklin-ik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters

Cologne, North Rhine-Westphalia, Germany

Klinik und Poliklinik für Psychiatrie und Psychotherapie Heinrich-Heine-Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Institut für Translationale Psychiatrie

Münster, North Rhine-Westphalia, Germany

Rheinhessen Fachklinik Alzey

Alzey, Rhineland-Palatinate, Germany

UKD Dresden, Klinik und Poliklinik für Psychiatrie und Psychotherapie

Dresden, Saxony, Germany

Otto-von-Guericke- Universität Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Zentrum für Integrative Psychiatrie Kiel

Kiel, Schleswig-Holstein, Germany

Zentrum für Integrative Psychiatrie (ZIP) und Fachklinik für Junges Leben (JuLe) Kinder- und Jugendpsychiatrie

Lübeck, Schleswig-Holstein, Germany

Vivantes Klinikum Am Urban

Berlin, , Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf {UKE)

Hamburg, , Germany

Countries

Germany

References

Bommhardt T, Peschl J, Schultze-Lutter F, Koutsouleris N, Meisenzahl E, Koberlein-Neu J; CARE Study Group. Enhancing early detection and treatment of psychosis in Germany: a protocol for the health economic evaluation of an artificial intelligence-guided complex intervention. BMJ Open. 2025 Jun 18;15(6):e103151. doi: 10.1136/bmjopen-2025-103151.

Reference Type: DERIVED

PMID: 40533222 (View on PubMed)

Other Identifiers

HeinrichHeine

Identifier Type: -

Identifier Source: org_study_id