RECRUITING Not applicable ClinicalTrials.gov

Personalized Metacognitive Training for Psychosis: A Randomized Controlled Trial

Sponsor: University Hospital, Strasbourg, France • ClinicalTrials.gov ID: NCT07146802

Registry updated: 2026-08-20

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Metacognitive Training (MCT) for psychosis (Behavioral)
MCT for psychosis is based on the theoretical foundations of the cognitive-behavioral model of schizophrenia, but it employs a somewhat different therapeutic approach. The program is comprised of ten modules targeting common cognitive errors, problem-solving biases as well as emotional problems in schizophrenia. These errors and biases may, on their own or in combination, culminate in the establishment of false beliefs to the point of delusions. The aim of the sessions is to raise the participants' awareness of these distortions and to prompt them to critically reflect on, expand upon, and change their current repertoire of problem solving. In addition to the sessions, the program includes homework tasks to reinforce the skills learned between sessions.

Eligibility criteria

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.

Conditions

Schizophrenia Spectrum Disorder

Locations

Service de psychiatrie — Strasbourg, France

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment