Schizophrenia Spectrum DisorderPERMEPSYNCT07146802
Personalized Metacognitive Training for Psychosis: A Randomized Controlled Trial
A study testing Metacognitive Training (MCT) for psychosis in people with Schizophrenia Spectrum Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Spectrum Disorder
- What is being tested?
- Metacognitive Training (MCT) for psychosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de psychiatrie
Strasbourg, 67000
Fabrice BERNA, PUPH, 33 (0)3 88 11 64 62, fabrice.berna@chru-strasbourg.fr
About this study
Official title: Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis
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.
- Conditions
- Schizophrenia Spectrum Disorder
- Being tested
- Metacognitive Training (MCT) for psychosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Training (MCT) for psychosisBehavioural
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 group | Role | What they receive |
|---|---|---|
| Classical MCT (MCT) | Active comparator | 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. Receives: Behavioral: Metacognitive Training (MCT) for psychosis |
| Personalized MCT (P-MCT) | Experimental | 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. Receives: Behavioral: Metacognitive Training (MCT) for psychosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
P-MCT benefits on total psychotic symptoms
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.
Measured: Day 0
P-MCT benefits on total psychotic symptoms
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.
Measured: Day 7
P-MCT benefits on total psychotic symptoms
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.
Measured: Day 14
P-MCT benefits on total psychotic symptoms
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.
Measured: Day 21
P-MCT benefits on total psychotic symptoms
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) -
Measured: Day 28
P-MCT benefits on total psychotic symptoms
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.
Measured: Day 35
P-MCT benefits on total psychotic symptoms
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.
Measured: Day 42
P-MCT benefits on total psychotic symptoms
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.
Measured: Day 49
P-MCT benefits on total psychotic symptoms
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.
Measured: Day 56
P-MCT benefits on total psychotic symptoms
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.
Measured: Day 63
P-MCT benefits on total psychotic symptoms
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.
Measured: Day 70
P-MCT benefits on total psychotic symptoms
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.
Measured: Months 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start3 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146802
- Sponsor's protocol ID
- 9603
- Acronym
- PERMEPSY
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis
- ClinicalTrials.gov ID
- NCT07146802
- Acronym / sponsor ID
- PERMEPSY / 9603
- Conditions
- Schizophrenia Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical MCT (MCT) | Active comparator | Behavioral: Metacognitive Training (MCT) for psychosisIn 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. |
| Personalized MCT (P-MCT) | Experimental | Behavioral: Metacognitive Training (MCT) for psychosisParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive Training (MCT) for psychosisMCT 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. | Behavioural | Classical MCT (MCT), Personalized MCT (P-MCT) |
Primary outcome
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.
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.
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.
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.
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) -
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Training (MCT) for psychosis in people with Schizophrenia Spectrum Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice BERNA, MD (33 (0)3 88 11 64 62, fabrice.berna@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P-MCT benefits on total psychotic symptoms (time frame: Day 0). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.