Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-29 @ 6:28 AM
Study NCT ID:
NCT03407950
Status:
WITHDRAWN
Last Update Posted:
2021-05-24
First Post:
2017-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study stopped due to major feasibility issues and the notices was expired.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-19', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2018-01-16', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social autonomy', 'timeFrame': '6 months', 'description': "Evaluated by Social autonomy Scale (EAS). It's a scale composing by 17 highly-rated items from 0 to 6 (total score varying 0 in 102, a low score indicating a better social autonomy)."}], 'secondaryOutcomes': [{'measure': 'Clinical symptomatology', 'timeFrame': '6 and 12 months', 'description': "Evaluated by the Assessment of Negative Symptoms (SANS). It's a scale composing by 25 items, highly-rated from 0 to 5."}, {'measure': 'Clinical symptomatology', 'timeFrame': '6 and 12 months', 'description': 'Evaluated by the Lille Apathy Rating Scale (LARS). It\'s a scale composing by 33 questions distributed in 9 columns. A global score is calculated varying of "36-22" (No apathetic person), "21-17" (trend to the apathy), "-16 in -10" (Moderate apathy) and of "-9 has + 36" (Severe apathy).'}, {'measure': 'Clinical symptomatology', 'timeFrame': '6 and 12 months', 'description': 'Evaluated by the Social Anhedonia Scale (SAS). It\'s a scale composing by 40 items quoted by the subject in "truth" or "false".'}, {'measure': 'Clinical cognition', 'timeFrame': '6 and 12 months', 'description': 'Evaluated by scale D2 test'}, {'measure': 'Clinical cognition', 'timeFrame': '6 and 12 months', 'description': 'Evaluated by scale Trail Making Test (TMT)'}, {'measure': 'Clinical cognition', 'timeFrame': '6 and 12 months', 'description': 'Evaluated by scale California Verbal Learning Test (CVLT)'}, {'measure': 'Clinical cognition', 'timeFrame': '6 and 12 months', 'description': 'Evaluated by scale WAIS III. The total score varies between 0 and 21'}, {'measure': 'Clinical cognition', 'timeFrame': '6 and 12 months', 'description': "Evaluated by scale ER-40. It's an computer-based testing translates into French and which lasts 6 minutes. It consists with 40 photos of faces expressing 4 basic feelings (enjoyment, sadness, anger and fear) or neutrals. In every thrown image, 5 choices of feelings are possible."}, {'measure': 'Clinical cognition', 'timeFrame': '6 and 12 months', 'description': 'Evaluated by Social cognition. A score of global social support will be estimated, between 0 (no knowledge, no possibility of emotional or financial support by other people) and 5 (patient having the possibility of living or living at a close person, anybody () gets fresh ideas worrying about the patient and about his coverage(care) and suggesting accompanying him(it) in the diverse administrative procedures or with care, very supported and varied emotional circle of acquaintances, possible financial support by the close friends(relations) and the guarantor(respondent) entirely for the necessities of the patient).'}, {'measure': 'Clinical cognition', 'timeFrame': '6 and 12 months', 'description': 'Evaluated by scale to assess Unawareness of Mental Disorder (SUMD). The answers are quoted(esteemed) from 1 to 5. The highest scores indicate the highest levels of non-consciousness of the disorder.'}, {'measure': 'Clinical functioning', 'timeFrame': '6 and 12 months', 'description': 'Evaluated by scales Quality of life (S-QoL-18)'}, {'measure': 'Clinical functioning', 'timeFrame': '6 and 12 months', 'description': 'Evaluated by scale Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Items are quoted of 1 (never) in 5 (all the time) giving a total score between 14 and 70.'}, {'measure': 'Clinical functioning', 'timeFrame': '6 and 12 months', 'description': 'Evaluated by scale Emotional Reactivity Scale (ERS). The 13 items are quoted of 0 (never) in 4 (always).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deficit Schizophrenia', 'long stay inpatients', 'cognitive remediation', 'negative symptoms'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': "Schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in daily life. Negative symptoms as blunted affect, avolition, social deficit and anhedonia and cognition were prognosis and functioning key's factors. Psychotropic medications have shown only poor effect to improve negative symptoms and cognition as attention, memory and cognitive flexibility. So, cognitive remediation programs were developped to focus cognitive disorders. The IPT (Integrated Psychological Treatment) is one of the most complete program with modules on cognitive and social abilities. The aim of this study is to evaluate the efficacy of IPT+ program to improve autonomy capacities of long stay inpatients suffering from schizophrenia 6 at the end of the program With IPT+ this study will improve autonomy capacities for patients suffering from deficit schizophrenia and allowed patients to go out hospital earlier than before.", 'detailedDescription': "Schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in daily life. Negative symptoms as blunted affect, avolition, social deficit and anhedonia and cognition were prognosis and functioning key's factors. Psychotropic medications have shown only poor effect to improve negative symptoms and cognition as attention, memory and cognitive flexibility. So, cognitive remediation programs were developped to focus cognitive disorders. The IPT (Integrated Psychological Treatment) is one of the most complete program with modules on cognitive and social abilities. The aim of this study is to evaluate the efficacy of IPT+ program to improve autonomy capacities of long stay inpatients suffering from schizophrenia 6 at the end of the program The secondary objectives are to evaluate autonomy 6 months after the program, to evaluate the efficacy of the program on negative symptoms, quality of life, cognitive functions, social cognition and duration of hospitalisation.\n\nThis study propose a randomised controlled study with 2 arms, with blind evaluation to compare the IPT+ versus treatment as usual (TAU). The follow up will be 6 month for the With IPT+ this study will improve autonomy capacities for patients suffering from deficit schizophrenia and allowed patients to go out hospital earlier than before."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* age \\> 18 and \\< 60\n* Diagnosis of schizophrenia on DSM 5\n* criteria of deficit schizophrenia with the schedule for deficit syndrome\n* inpatient at inclusion with at least 6 month of hospitalisation during the last 2 years\n* clinically stable\n* able to understand, talk and read french\n* signing consent form\n\nExclusion criteria:\n\n* change in psychotropic treatment during the last month\n* psychotherapy in the last 8 months or planned during the study\n* CDSS score \\> 9\n* drug dependency during the last year\n* unstable somatic disease\n* somatic disease with impact on cognition'}, 'identificationModule': {'nctId': 'NCT03407950', 'acronym': 'IPT+', 'briefTitle': 'Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia : Impact on the Capacities of Autonomy', 'orgStudyIdInfo': {'id': '9529'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group IPT+', 'description': '2 sessions of IPT+ by week during 6 months', 'interventionNames': ['Behavioral: IPT+']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'group without specific therapy (Treatment as usual) but same number and duration of each sessions than IPT+', 'interventionNames': ['Behavioral: Treatment as usual']}], 'interventions': [{'name': 'IPT+', 'type': 'BEHAVIORAL', 'description': 'Integrated Psychological Treatment and cognitive remediation and relaxation and Mindfulness : IPT+. A blind evaluation will be realized thanks to questionnaires of the current practice to compare the IPT+ versus treatment as usual (TAU).', 'armGroupLabels': ['Group IPT+']}, {'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'description': 'no specific therapy but same number and duration of each sessions than IPT+. A blind evaluation will be realized thanks to questionnaires of the current practice to compare the IPT+ versus treatment as usual (TAU).', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Delphine CAPDEVIELLE', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Delphine CAPDEVIELLE, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}