Status:
NOT_YET_RECRUITING
Personalized Metacognitive Training for Psychosis: A Randomized Controlled Trial
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Schizophrenia Spectrum Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 der...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT07146802
Start Date
October 1 2025
End Date
April 1 2027
Last Update
September 15 2025
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