Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT07146802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Metacognitive Training for Psychosis: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Day 0', 'description': '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.\n\nHigher scores indicate more severe positive symptoms.'}, {'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Day 7', 'description': '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.\n\nHigher scores indicate more severe positive symptoms.'}, {'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Day 14', 'description': '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.\n\nHigher scores indicate more severe positive symptoms.'}, {'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Day 21', 'description': '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.\n\nHigher scores indicate more severe positive symptoms.'}, {'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Day 28', 'description': '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.\n\nHigher scores indicate more severe positive symptoms. symptoms subscale score of the Positive and Negative Syndromes Scale (PANSS; Kay et al., 1987) -'}, {'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Day 35', 'description': '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.\n\nHigher scores indicate more severe positive symptoms.'}, {'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Day 42', 'description': '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.\n\nHigher scores indicate more severe positive symptoms.'}, {'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Day 49', 'description': '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.\n\nHigher scores indicate more severe positive symptoms.'}, {'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Day 56', 'description': '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.\n\nHigher scores indicate more severe positive symptoms.'}, {'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Day 63', 'description': '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.\n\nHigher scores indicate more severe positive symptoms.'}, {'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Day 70', 'description': '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.\n\nHigher scores indicate more severe positive symptoms.'}, {'measure': 'P-MCT benefits on total psychotic symptoms', 'timeFrame': 'Months 6', 'description': '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.\n\nHigher scores indicate more severe positive symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia Spectrum Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, 18 - 65 years of age.\n* Patient affiliated to health insurance\n* Inpatients and outpatients with DSM-5 diagnosis of schizophrenia spectrum disorder.\n* Presence of positive symptoms at inclusion (PANSS delusions, suspiciousness or grandiosity ≥3).\n* 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).\n* Patient providing informed consent.\n\nExclusion Criteria:\n\n* Having received MCT in the previous year.\n* Neurological disorder, or severe medical condition other than psychosis\n* A score above 5 in the "Hostility" and the "Suspiciousness" items of the PANSS Positive subscale (to preserve group dynamics).\n* Patient considered by his psychiatrist to be at serious risk of harm to self or others (e.g. previous aggressive or suicidal behaviors)\n* Patient in an exclusion period defined by another research protocol\n* Patient involved in another Investigational Medicinal Product trial\n* Patient under guardianship (i.e. French "tutelle")\n* Patients deprived of freedom because of a judicial measure.'}, 'identificationModule': {'nctId': 'NCT07146802', 'acronym': 'PERMEPSY', 'briefTitle': 'Personalized Metacognitive Training for Psychosis: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis', 'orgStudyIdInfo': {'id': '9603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Classical MCT (MCT)', '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.', 'interventionNames': ['Behavioral: Metacognitive Training (MCT) for psychosis']}, {'type': 'EXPERIMENTAL', 'label': 'Personalized MCT (P-MCT)', '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.', 'interventionNames': ['Behavioral: Metacognitive Training (MCT) for psychosis']}], 'interventions': [{'name': 'Metacognitive Training (MCT) for psychosis', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Classical MCT (MCT)', 'Personalized MCT (P-MCT)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fabrice BERNA, MD', 'role': 'CONTACT', 'email': 'fabrice.berna@chru-strasbourg.fr', 'phone': '33 (0)3 88 11 64 62'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}