Personalized Metacognitive Training for Psychosis: A Randomized Controlled Trial (PERMEPSY)

University Hospital, Strasbourg, France

Status: Not yet enrolling

Conditions: Schizophrenia Spectrum Disorder

Treatments: Behavioral: Metacognitive Training (MCT) for psychosis

Study type: Interventional

Funder types: Other

Identifiers

NCT07146802

9603 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 51 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

51 participants in 2 patient groups

Classical MCT (MCT)

Active Comparator group

Description:

In this arm, participants will follow the standard Metacognitive Training (MCT) protocol. They will receive 10 one-hour sessions of classical MCT delivered in a group setting, following the current standard program. In addition to the sessions, participants will be given standardized homework tasks to reinforce the skills learned between sessions. This group serves as the active control in the study.

Treatment:

Behavioral: Metacognitive Training (MCT) for psychosis

Personalized MCT (P-MCT)

Experimental group

Description:

Participants in this arm will receive Personalized Metacognitive Training (P-MCT), an experimental intervention that uses a machine learning (ML) predictive platform to personalize the homework assignments. While the core MCT program remains unchanged, P-MCT customizes the homework based on individual patient profiles, specifically targeting areas where the patient is predicted to benefit the least. The goal is to enhance the effects of the standard MCT by providing personalized support through tailored exercises.

Treatment:

Behavioral: Metacognitive Training (MCT) for psychosis