Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders (CARE)
Psychotic Disorders, Prevention
About this trial
This is an interventional prevention trial for Psychotic Disorders focused on measuring Psychosis-Risk Syndromes, high-risk, Cognitive Disturbances, Artificial Intelligence
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 Exclusion Criteria: manifest psychosis (ICD-10 F2x.x, F3x.3) according to the definition of the Structured Interview for Psychosis-Risk Syndromes . 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 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 for >30 days (cumulative number of days). At or above the minimum dose for a psychotic first episode according to the the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) S3 guidelines an antipsychotic medication in the 3 months prior to baseline. (regardless of the length of time taken) at or above the minimum dose for a psychotic first episode according to the 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
Sites / Locations
- ZfP Reichenau - Akademisches Lehrkrankenhaus Universität KonstanzRecruiting
- Zentralinstitut für Seelische GesundheitRecruiting
- Klinik für Psychiatrie und Psychotherapie Universität TübingenRecruiting
- Klinikum der Ludwig-Maximilians-Universität MünchenRecruiting
- Zentrum für psychische Gesundheit, U11iversitätsklinikum WürzburgRecruiting
- Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Universitätsklinikum Aachen, RWTH Universität AachenRecruiting
- LWL-Universitätsklinikum Bochum der Ruhr--Universität Bochum, Klinik für Psychiatrie, Psychotherapie und PräventivmedizinRecruiting
- KJPP LVR-Klinik Bon'nRecruiting
- Universitätsklinikum Bonn Klinik für Psychiatrie und PsychotherapieRecruiting
- Klinik und Poliklinik für Psychiatrie und Psychotherapie Heinrich-Heine-Universität DüsseldorfRecruiting
- Uniklinik Köln, Klinik und Poliklin-ik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und JugendaltersRecruiting
- Institut für Translationale PsychiatrieRecruiting
- Rheinhessen Fachklinik AlzeyRecruiting
- Otto-von-Guericke- Universität MagdeburgRecruiting
- UKD Dresden, Klinik und Poliklinik für Psychiatrie und Psychotherapie
- Zentrum für Integrative Psychiatrie KielRecruiting
- Zentrum für Integrative Psychiatrie (ZIP) und Fachklinik für Junges Leben (JuLe) Kinder- und JugendpsychiatrieRecruiting
- Vivantes Klinikum Am UrbanRecruiting
- Charité - Universitätsmedizin BerlinRecruiting
- Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf {UKE)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
CARE interventional treatment
Standard of Care Control arm
AI-computerassisted prognosis of high risk psychosis profile and adapted study-specific therapy taking place in early-recognition centers.
Treatment as usual (TAU) patient will receive their usual treatment from their local physicians and therapeutic personnel.