Clinical trial NCT05813080: Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders
Official title: Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Prevention
Keywords: Psychosis-Risk Syndromes
high-risk
Cognitive Disturbances
Artificial Intelligence
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 260
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Structured Interview for Psychosis-Risk Syndromes (SIPS)
timeFrame: 12-month after inclusion
Secondary outcomes:
measure: Internalized Stigma of Mental Illness Scale (ISMI)
timeFrame: 12-month after inclusion
measure: Stigma-Stress-Scale
timeFrame: 12-month after inclusion
measure: Self-Identification of Mental Illness Scale (SELF-I)
timeFrame: 12-month after inclusion
measure: Coming-Out with Mental Illness Scale (COMIS)
timeFrame: 12-month after inclusion
measure: Secrecy and disclosure-related distress - scale
timeFrame: 12-month after inclusion
measure: Psychosis own health-concern single score
timeFrame: 12-month after inclusion
measure: Numeracy Scale
timeFrame: 12-month after inclusion
measure: Coping (Ten-Flex)
timeFrame: 12-month after inclusion
measure: Risk Perception Scale
timeFrame: 12-month after inclusion
measure: Risk Recall Scale
timeFrame: 12-month after inclusion
measure: Health-related quality of life (EQ-5D)
timeFrame: 12-month after inclusion
measure: Brief Multidimensional Life Satisfaction Scale (BMLSS)
timeFrame: 12-month after inclusion
measure: Client Sociodemographic and Service Receipt Inventory (CSSRI-EU)
timeFrame: 12-month after inclusion
measure: Patient Satisfaction Questionnaire (ZUF-8)
timeFrame: 12-month after inclusion
measure: Social and occupational assessment scale SOFAS
timeFrame: 12-month after inclusion
measure: Global Functioning Social Scale (GF:S)
timeFrame: 12-month after inclusion
measure: Global Functioning Role Scale (GF:R)
timeFrame: 12-month after inclusion
measure: Secrecy-Symptoms Scale
timeFrame: 12-month after inclusion
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: ZfP Reichenau - Akademisches Lehrkrankenhaus Universität Konstanz
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Zentralinstitut für Seelische Gesundheit
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie Universität Tübingen
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Bezirkskrankenhaus Augsburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Universität Augsburg
state: Bavaria
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universität München
state: Bayern
city: Würzburg
country: Germany
facility: Zentrum für psychische Gesundheit, U11iversitätsklinikum Würzburg
state: Bayern
city: Aachen
country: Germany
facility: Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Universitätsklinikum Aachen, RWTH Universität Aachen
state: NRW
city: Bochum
country: Germany
facility: LWL-Universitätsklinikum Bochum der Ruhr--Universität Bochum, Klinik für Psychiatrie, Psychotherapie und Präventivmedizin
state: NRW
city: Bonn
country: Germany
facility: KJPP LVR-Klinik Bonn
state: NRW
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn Klinik für Psychiatrie und Psychotherapie
state: NRW
city: Düsseldorf
country: Germany
facility: Klinik und Poliklinik für Psychiatrie und Psychotherapie Heinrich-Heine-Universität Düsseldorf
state: NRW
city: Köln
country: Germany
facility: Uniklinik Köln, Klinik und Poliklin-ik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
state: NRW
city: Münster
country: Germany
facility: Institut für Translationale Psychiatrie
state: NRW
city: Alzey
country: Germany
facility: Rheinhessen Fachklinik Alzey
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: Otto-von-Guericke- Universität Magdeburg
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: UKD Dresden, Klinik und Poliklinik für Psychiatrie und Psychotherapie
state: Sachsen
city: Kiel
country: Germany
facility: Zentrum für Integrative Psychiatrie Kiel
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Zentrum für Integrative Psychiatrie (ZIP) und Fachklinik für Junges Leben (JuLe) Kinder- und Jugendpsychiatrie
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Hamburg
country: Germany
facility: Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf {UKE)
Study officials:
affiliation: Klinik und Poliklinik für Psychiatrie und Psychotherapie LVR-Klinikum Düsseldorf
name: Eva Meisenzahl-Lechner, Prof.
role: PRINCIPAL_INVESTIGATOR
References: