Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-27 @ 2:21 AM
Study NCT ID:
NCT02667834
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2016-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of the French Translation Social Cognition and Interactive Training (SCIT)Program
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-29', 'studyFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Scale of Assessment of Negative Symptoms', 'timeFrame': '40 weeks', 'description': 'Improvement of negative symptoms of schizophrenia in patients who received Social Cognition and Interaction Training (SCIT) program compared to patients receiving a Therapeutic Education Program (ETP), equivalent in number, duration and rhythm of sessions'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in positive and negative symptoms scale (PANSS)', 'timeFrame': '40 weeks', 'description': 'Scales for clinical and psychosocial functioning measurement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['social cognition', 'cognitive remediation'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of Social cognition and interaction training (SCIT) versus treatment as usual (ETP) in helping people with schizophrenia improve their social cognition and social functioning so specially on negative symptoms. Many studies show a connection between negative symptom and social cognition in schizophrenia.', 'detailedDescription': 'This is a multicenter (6 centers in France), randomized, controlled trial compared people aged 18 to 50 years with a diagnostic of schizophrenia according to the Diagnostic and Statistical manual of Mental disorders, 4th edition (DSM-IV-TR), the Social Cognition and Interaction Training (SCIT) program will be compared to an already validated neurocognitive remediation program : therapeutic education program (ETP) Social Cognition and Interaction Training (SCIT) is composed of three phases: emotion training, figuring out situations, and integration. Social Cognition and Interaction Training (SCIT) will be delivered by therapists in 20 weekly sessions over 5 months.\n\n160 patients will be randomized as follows: - Arm1, experimental: Social Cognition and Interaction Training (SCIT): 30h with therapist, videos and photos exercises - Arm 2, control: therapeutic education program (ETP): 30h with therapist, only discussion between patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 to 50 years old\n* Diagnosis of schizophrenia according to the DSM-IV-TR\n* French speaker\n* Unchanged psychotropic treatment during month preceding the inclusion\n* Patients having given their consent lit to participate in the study\n* Patients not having been part of therapeutic education program during six months preceding the inclusion\n* Affiliated to the French social security\n\nExclusion Criteria:\n\n* Alcohol or drug dependence(according to the DSM-IV-TR),except Tobacco\n* History of neurobiological illness or trauma\n* Taking of medicine with somatic aim having a cerebral or psychic impact (ex: corticosteroids)\n* Simultaneous participation on another program of cognitive remediation\n* The ineffectiveness of neuroleptic treatment'}, 'identificationModule': {'nctId': 'NCT02667834', 'acronym': 'SCIT-VF', 'briefTitle': 'Efficiency of the French Translation Social Cognition and Interactive Training (SCIT)Program', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital le Vinatier'}, 'officialTitle': 'Efficiency of the French Translation Program:Social Cognition and Interactive Training (SCIT) of Negative Symptoms in Schizophrenia', 'orgStudyIdInfo': {'id': '2014-A00072-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Social Cognition and Interaction Training (SCIT)', 'description': 'SCIT Social cognition and interaction training program.', 'interventionNames': ['Behavioral: Social Cognition and Interaction Training (SCIT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Therapeutic education program (ETP)', 'description': 'Therapeutic education program', 'interventionNames': ['Behavioral: therapeutic education program (ETP)']}], 'interventions': [{'name': 'Social Cognition and Interaction Training (SCIT)', 'type': 'BEHAVIORAL', 'description': 'A randomized, controled trial of social cognition and interaction training ( SCIT) for patients with schizophrenia Spectrum disorders', 'armGroupLabels': ['Social Cognition and Interaction Training (SCIT)']}, {'name': 'therapeutic education program (ETP)', 'type': 'BEHAVIORAL', 'description': 'usual treatment ,30 hours with therapist, only discussion between patients', 'armGroupLabels': ['Therapeutic education program (ETP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60607', 'city': 'Clermont', 'state': 'OISE', 'country': 'France', 'facility': "Centre Hospitalier de Clermont de l'Oise", 'geoPoint': {'lat': 49.37897, 'lon': 2.41258}}], 'overallOfficials': [{'name': 'FRANCK NICOLAS, PUPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH LE VINATIER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital le Vinatier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}