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NCT Number: NCT07146802

Personalized Metacognitive Training for Psychosis: A Randomized Controlled Trial

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.

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Key information

Conditions

Schizophrenia Spectrum Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. P-MCT benefits on total psychotic symptoms

    Time frame: 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.

  2. P-MCT benefits on total psychotic symptoms

    Time frame: 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.

  3. P-MCT benefits on total psychotic symptoms

    Time frame: 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.

  4. P-MCT benefits on total psychotic symptoms

    Time frame: 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.

  5. P-MCT benefits on total psychotic symptoms

    Time frame: 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) -

  6. P-MCT benefits on total psychotic symptoms

    Time frame: 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.

  7. P-MCT benefits on total psychotic symptoms

    Time frame: 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.

  8. P-MCT benefits on total psychotic symptoms

    Time frame: 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.

  9. P-MCT benefits on total psychotic symptoms

    Time frame: 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.

  10. P-MCT benefits on total psychotic symptoms

    Time frame: 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.

  11. P-MCT benefits on total psychotic symptoms

    Time frame: 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.

  12. P-MCT benefits on total psychotic symptoms

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabrice BERNA, MD

CONTACT

[email protected]

33 (0)3 88 11 64 62

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis

Acronym: PERMEPSY

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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