Clinical Trials in France / NCT07146802
Recruiting
Not applicable
Personalized Metacognitive Training for Psychosis: A Randomized Controlled Trial
NCT07146802 · tracked via the Priya Life Science France tracker
Condition(s) studied
Schizophrenia Spectrum Disorder
Investigational drug(s) / intervention(s)
Metacognitive Training (MCT) for psychosis
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 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.
Study 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 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.
Eligibility
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.
Primary outcome measure(s)
- P-MCT benefits on total psychotic symptoms — Day 0
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms. - P-MCT benefits on total psychotic symptoms — Day 7
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms. - P-MCT benefits on total psychotic symptoms — Day 14
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms. - P-MCT benefits on total psychotic symptoms — Day 21
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms. - P-MCT benefits on total psychotic symptoms — Day 28
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms. symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) - - P-MCT benefits on total psychotic symptoms — Day 35
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms. - P-MCT benefits on total psychotic symptoms — Day 42
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms. - P-MCT benefits on total psychotic symptoms — Day 49
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms. - P-MCT benefits on total psychotic symptoms — Day 56
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms. - P-MCT benefits on total psychotic symptoms — Day 63
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms. - P-MCT benefits on total psychotic symptoms — Day 70
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms. - P-MCT benefits on total psychotic symptoms — Months 6
To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -To compare the benefits of P-MCT with classical MCT, we will compare total positive symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -). The subscale includes 7 items, each rated from 1 to 7, for a total score ranging from 7 to 49. Higher scores indicate more severe positive symptoms.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Service de psychiatrie | Strasbourg | France | Recruiting |
More University Hospital, Strasbourg, France trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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