Status:
NOT_YET_RECRUITING
The Personalized Psychological Treatment for Psychosis
Lead Sponsor:
Polish Academy of Sciences
Collaborating Sponsors:
Fundació Sant Joan de Déu
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Schizophrenia
Psychosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The main aim of the clinical trial is to validate the Machin Learning (ML) predictive model for personalized Metacognitive Training (MCT) by comparing classic MCT to personalized MCT (P-MCT) among pat...
Detailed Description
This prospective study will consist of a pilot, double-blind clinical trial comparing Personalized MCT (P-MCT) to classical MCT. This pilot study will serve as a basis to validate the profiling strate...
Eligibility Criteria
Inclusion
- Inpatients and outpatients with a DSM-IV-R and DSM-5 diagnosis of non-affective psychosis or Clinical High Risk for psychosis.
- Presence of positive symptoms during the last year (PANSS delusions, suspiciousness or grandiosity \>=3).
- Adults, 18 - 65 years of age
- Stable condition with no expected changes in medication (information from clinical services).
- Lack of severe cognitive deficits (global assessment or/and information from clinical services);
Exclusion
- Having received MCT in the previous year.
- Neurological disorder, a history of head trauma or premorbid IQ below 70 (based on medical reports and/or other sources);
- A score above 5 in the "Hostility" and the "Suspiciousness" items of the PANSS Positive subscale (to preserve group dynamics).
- aggressive behavior (reports from clinical services if available)
- High risk of suicide (verified with DIAMOND)
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT06603922
Start Date
October 1 2024
End Date
May 31 2026
Last Update
September 19 2024
Active Locations (6)
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1
Universidad de Valparaíso
Valparaíso, Región de Valparaíso, Chile, 2340000
2
University Hospitals of Strasbourg
Strasbourg, Strasbourg Cedex, France, 67091
3
University Medical Center Hamburg-Eppendorf
Hamburg, Hamburg, Germany, 20246
4
The Institute of Psychology, The Polish Academy of Sciences
Warsaw, Warsaw, Poland, 00-378