Personalized Metacognitive Training for Psychosis: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metacognitive Training (MCT) for psychosis.
- Who it may be relevant to
- Registry conditions: Schizophrenia Spectrum Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis
Overview
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
- Behavioral Metacognitive Training (MCT) for psychosis
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 participan
Primary outcome measures
- P-MCT benefits on total psychotic symptoms [Time frame: Day 0]
- P-MCT benefits on total psychotic symptoms [Time frame: Day 7]
- P-MCT benefits on total psychotic symptoms [Time frame: Day 14]
- P-MCT benefits on total psychotic symptoms [Time frame: Day 21]
- P-MCT benefits on total psychotic symptoms [Time frame: Day 28]
- P-MCT benefits on total psychotic symptoms [Time frame: Day 35]
- P-MCT benefits on total psychotic symptoms [Time frame: Day 42]
- P-MCT benefits on total psychotic symptoms [Time frame: Day 49]
- P-MCT benefits on total psychotic symptoms [Time frame: Day 56]
- P-MCT benefits on total psychotic symptoms [Time frame: Day 63]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07146802 · 9603