Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-03-01 @ 6:10 AM
Study NCT ID:
NCT02879604
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2016-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2016-08-22', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost-utility questionnaire', 'timeFrame': '12 months', 'description': 'Cost difference between the 2 group of patients'}], 'secondaryOutcomes': [{'measure': 'Functioning questionnaire', 'timeFrame': '3 months', 'description': 'FROGS, Functional Remission of General Schizophrenia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive remediation, cost-effectiveness analysis'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': "Significant cognitive impairment (executive functions, memory, attention) is common in schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years, alternative non-pharmacological therapeutics have been developed in schizophrenia. These techniques called cognitive remediation specifically target cognitive deficits. The first cognitive remediation available for patients was designed to stimulate new learning, or relearning, of cognitive tasks, and thus to improve certain deficient domains. These procedures were efficient in improving cognition as measured by neurocognitive tests but their impact on functioning and daily life was weak. In a second time, compensatory remediation has been developed. Compensatory approaches seek to make improvements in the patient's functioning by avoiding areas of impairment and recruiting other intact cognitive domains or by creating a supportive external environment. In recent meta-analysis compensatory remediation has larger effect-size than classical cognitive remediation, with an impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of California) developed and tested a group-based, manualized, compensatory cognitive training intervention.\n\nCompensatory cognitive training (CCT) is a low-tech, brief intervention and is easily transposable in community care. Our team translated this method into French. The investigators planned a cost -utility study between CCT and treatment as usual in schizophrenia patients with less than 10 years of evolution.", 'detailedDescription': 'This study will take place over 3 years with a recruitment period of 18 months. After verification of the eligibility criteria and signature of the consent, the patients will be divided into 2 groups by randomization: the intervention group and the control group. The duration of participation of the subjects will be 12 months. Assessments are available in 4 steps (V1 at inclusion, V2 at 3 months, V3 at 6 months and V4 at 12 months). These visits include an assessment of the functioning of patients, symptomatology, quality of life, treatment and care received at all visits, occupational activity and cognitive assessment and social knowledge at V1 and V4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic with schizophrénie\n* Less than 10 years of the evolution of the disease\n\nExclusion Criteria:\n\n* History of severe cranial trauma and / or neurological pathology with cognitive impairment\n* Ongoing participation in another study for treatment of negative or cognitive symptoms\n* Ongoing participation in a study on management in psychotherapy for cognitive disorders and negative symptoms'}, 'identificationModule': {'nctId': 'NCT02879604', 'acronym': 'Grecco', 'briefTitle': 'Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia', 'orgStudyIdInfo': {'id': 'RECHMPL15_0503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Compensatory cognitive training', 'description': 'Compensatory cognitive training', 'interventionNames': ['Other: Compensatory cognitive training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'usual treatment', 'description': 'usual treatment for shizophrenai', 'interventionNames': ['Other: Usual']}], 'interventions': [{'name': 'Compensatory cognitive training', 'type': 'OTHER', 'otherNames': ['CCT'], 'description': 'In addition to the usual care, method of compensatory cognitive remediation', 'armGroupLabels': ['Compensatory cognitive training']}, {'name': 'Usual', 'type': 'OTHER', 'description': 'Usual care', 'armGroupLabels': ['usual treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Charles Perrens Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69678', 'city': 'Bron', 'country': 'France', 'facility': 'Le Vinatier Hospital', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Gabriel-Montpied Univesity Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92701', 'city': 'Colombes', 'country': 'France', 'facility': 'Louis Mourier Hospital', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Chenevier Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'La Conception Hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Montpellier University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '38521', 'city': 'Saint-Égrève', 'country': 'France', 'facility': 'Alpes Isère Hospital', 'geoPoint': {'lat': 45.23313, 'lon': 5.68154}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Strasbourg University Hospital', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Delphine DC CAPDEVIELLE, MD-PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Montpellier University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, {'name': 'Hôpital Louis Mourier', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Charles Perrens, Bordeaux', 'class': 'OTHER_GOV'}, {'name': 'University Hospital, Strasbourg', 'class': 'OTHER'}, {'name': 'Hospital Center Alpes-Isère', 'class': 'OTHER'}, {'name': 'Hôpitaux à Bron', 'class': 'OTHER'}, {'name': 'Fondation FondaMental', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}