Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-29 @ 5:44 PM
Study NCT ID:
NCT03055520
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2017-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arithmetic Training With the Kumon Method for Cognition 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2017-02-10', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement in attention', 'timeFrame': 'change from baseline to 6 months and to 12 months', 'description': 'neuropsychological battery'}, {'measure': 'improvement in working memory', 'timeFrame': 'change from baseline to 6 months and to 12 months', 'description': 'neuropsychological battery'}, {'measure': 'improvement in executive function', 'timeFrame': 'change from baseline to 6 months and to 12 months', 'description': 'neuropsychological battery'}], 'secondaryOutcomes': [{'measure': 'psychopathology', 'timeFrame': 'change from baseline to 6 months and to 12 months', 'description': 'Evaluation with the Positive and Negative Syndrome Scale (PANSS)'}, {'measure': 'functioning', 'timeFrame': 'change from baseline to 6 months and to 12 months', 'description': 'Evaluation with the Personal and Social Performance (PSP) scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'cognition', 'arithmetic training', 'Kumon method'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'A randomized placebo-controlled trial of arithmetic training (with the Kumon Method) as an errorless learning method for improvement of cognition in schizophrenia. Outpatients were included after signing an informed consent. The trial consisted of 48 sessions of arithmetic training (twice a week, for 6 months) or placebo (nonspecific recreation, 48 sessions). The patients were evaluated with a neuropsychological battery at baseline, after 6 months (end of intervention) and after 12 months after baseline. The Positive and Negative Syndrome Scale (PANSS) and the Personal and Social Performance scale (PSP) were applied at baseline, after 6 months (end of intervention) and 12 months after baseline. Primary outcome was the performance on three cognitive domains (attention, executive functions and working memory).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Literate (≥5 years of formal education).\n* Diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR).\n* Clinically stable, with constant antipsychotic medication regimen for ≥8 weeks before screening\n* No hospitalizations in the last 6 months.\n\nExclusion Criteria:\n\n* Other Axis I psychiatric disorders, substance abuse or dependence.\n* History of head trauma or other neurologic diseases.\n* Severe or uncontrolled medical diseases, history of mental retardation or attendance in special-education classes,\n* Suicide risk\n* Participation in any other kind of psychosocial intervention.'}, 'identificationModule': {'nctId': 'NCT03055520', 'briefTitle': 'Arithmetic Training With the Kumon Method for Cognition in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Arithmetic Calculation Training With the Kumon Errorless Learning Method for Cognitive Rehabilitation of Patients With Schizophrenia: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'cognition schizophrenia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'arithmetic training (Kumon method)', 'interventionNames': ['Other: cognitive training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'nonspecific recreation', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'cognitive training', 'type': 'OTHER', 'description': 'The Kumon method (www.kumon.com) of arithmetic calculation employs the errorless-learning (EL) strategy and consists of a structured, hierarchical series of exercises, beginning with simple ones (e.g. addition and subtraction) and then proceeding to more complex exercises (e.g. advanced algebra, calculus).', 'armGroupLabels': ['arithmetic training (Kumon method)']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'nonspecific recreation including befriending and free simple activities.', 'armGroupLabels': ['nonspecific recreation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mario R. Louza, MD, PhD', 'investigatorAffiliation': 'University of Sao Paulo'}}}}