Personalized Metacognitive Training for Psychosis: A Randomized Controlled Trial
Recruiting · NCT07146802 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Strasbourg, France
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study aims to compare the efficacy of classical Metacognitive Training (MCT) and personalized Metacognitive Training (P-MCT) for individuals with psychosis. MCT is a psychoeducational program derived from cognitive-behavioral therapy (CBT) that targets cognitive biases associated with psychotic symptoms. The goal is to assess which intervention is more effective to improve the overall functioning of individuals with psychosis. The study will use machine learning to personalize the treatment approach and evaluate its impact on clinical symptoms, cognitive functions, and quality of life.
Who can take part
Inclusion criteria
- Adults, 18 - 65 years of age.
- Patient affiliated to health insurance
- Inpatients and outpatients with DSM-5 diagnosis of schizophrenia spectrum disorder.
- Presence of positive symptoms at inclusion (PANSS delusions, suspiciousness or grandiosity ≥3).
- Stable condition with no expected changes in medication or symptoms during the last 3 months (information from clinical services, note that stable condition includes lack of suicidality).
- Patient providing informed consent.
Exclusion criteria
- Having received MCT in the previous year.
- Neurological disorder, or severe medical condition other than psychosis
- A score above 5 in the "Hostility" and the "Suspiciousness" items of the PANSS Positive subscale (to preserve group dynamics).
- Patient considered by his psychiatrist to be at serious risk of harm to self or others (e.g. previous aggressive or suicidal behaviors)
- Patient in an exclusion period defined by another research protocol
- Patient involved in another Investigational Medicinal Product trial
- Patient under guardianship (i.e. French "tutelle")
- Patients deprived of freedom because of a judicial measure.
Where it is running
1 location listed.
- Service de psychiatrie - Strasbourg, France