Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2026-02-21 @ 4:07 PM
Study NCT ID:
NCT02383095
Status:
TERMINATED
Last Update Posted:
2019-10-21
First Post:
2015-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of Art-therapy in Psychotic Disorders
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001155', 'term': 'Art Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Difficulties of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Response times between baseline and after 16 therapy sessions', 'timeFrame': 'Baseline and after 16 therapy sessions (up to 6 months)'}], 'secondaryOutcomes': [{'measure': 'Change in Clinical scales (SAPS and SANS) between baseline and after 16 therapy sessions', 'timeFrame': 'Baseline and after 16 therapy sessions (up to 6 months)'}, {'measure': 'Change in esthetic perception between baseline and after 16 therapy sessions', 'timeFrame': 'Baseline and after 16 therapy sessions (up to 6 months)', 'description': 'Esthetic Perception Test'}, {'measure': 'Change in errors in visual organization tasks between baseline and after 16 therapy sessions', 'timeFrame': 'aseline and after 16 therapy sessions (up to 6 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Art-therapy', 'Visual organization'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The main purpose of the protocol is to test the efficiency of art-therapy versus metacognitive rehabilitation on the visual perception disorders observed in patients with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* schizophrenia according to DSM IV\n\nExclusion Criteria:\n\n* addiction problem\n* invalidating visual sensory problems\n* neurological history'}, 'identificationModule': {'nctId': 'NCT02383095', 'briefTitle': 'Efficiency of Art-therapy in Psychotic Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Efficiency of Art-therapy in Psychotic Disorders', 'orgStudyIdInfo': {'id': '5937'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Art-therapy', 'description': '16 Art-therapy sessions', 'interventionNames': ['Behavioral: Art therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metacognitive therapy', 'description': '16 Metacognitive therapy sessions', 'interventionNames': ['Behavioral: metacognitive therapy']}], 'interventions': [{'name': 'Art therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Art-therapy']}, {'name': 'metacognitive therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Metacognitive therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de psychiatrie, Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Anne GIERSCH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}