Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813080
Status:
RECRUITING
Last Update Posted:
2023-08-03
First Post:
2023-03-14
Brief Title:
Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE
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 IITOther 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 ICD-10 schizophrenic disorders F2xx affective disorders F3x3 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 proniaai 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 TAUthe patients receive referral back to the previous care system further treatment and additional diagnostics if necessary is left to the referring primary care providers
The aim of risk-adapted treatment RAB arm is to reduce the number of patients with an increased clinical risk for psychosis ICD-10 schizophrenic disorders F2xx affective disorders F3x3 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 proniaai 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 TAUthe patients receive referral back to the previous care system further treatment and additional diagnostics if necessary is left to the referring primary care providers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None