Health Trials

About this trial

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 patients diagnosed with psychosis who had a history of delusions. More precisely, we will compare classic MCT to P-MCT in a randomized clinical trial.We expect personalised MCT treatment will see more improvement than classical MCT in outcome variables measuring treatment efficacy.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Psychological treatment (P-MCT)
  • Psychological treatment (MCT)

Treatment groups

252 Participants
are divided into 2 treatment groups

Locations

6
Chile
Universidad de Valparaíso2340000, ValparaísoValparaiso, Chile
France
University Hospitals of Strasbourg67091, StrasbourgStrasbourg Cedex, France
Germany
University Medical Center Hamburg-Eppendorf20246, HamburgFree and Hanseatic City of Hamburg, Germany
Poland
The Institute of Psychology, The Polish Academy of Sciences00-378, WarsawWarsaw, Poland

Sponsors and collaborators

Polish Academy of Sciences

Lead sponsor

Fundació Sant Joan de Déu

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Collaborator

University Hospitals of Strasbourg

Collaborator

Universitat Politècnica de Catalunya

Collaborator

Universidad de Valparaiso

Collaborator

Source ClinicalTrials.gov