Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-04 @ 4:41 PM
Study NCT ID:
NCT01879956
Status:
UNKNOWN
Last Update Posted:
2013-06-18
First Post:
2013-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090663', 'term': 'Schizophrenia, Treatment-Resistant'}, {'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': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BADS (Behavioral Assessment of Functional Status)', 'timeFrame': 'up to 6 months follow-up.', 'description': 'It is a battery which measures neuropsychological executive functions.'}], 'secondaryOutcomes': [{'measure': 'DAFS-BR ( Direct Assessment of Functional Status), ILSS-BR (Habilities of Daily Living-Brazilian validated version).', 'timeFrame': 'at baseline, after 30 sessions of treatment and follow-up 6 months.', 'description': 'DAFS-BR - Evaluates functional aspects of daily living such as dealing with money, shopping, social comunication ILSS-BR- similar to DAFS.'}, {'measure': 'Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.', 'timeFrame': 'at baseline, after 30 sessions of treatment and 6 months follo-up.', 'description': 'Neuropsychological Battery (Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test,Rey Complex Figure, Fluência Verbal, Tapping Visual and Memória Logica)which measure cognitive functions.'}, {'measure': 'Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.', 'timeFrame': 'at baseline, after 30 sessions of treatment and 6 months follo-up.', 'description': 'Neuropsychological Battery (Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test,Rey Complex Figure, Verbal Fluency, Tapping Visual and Memória Logica)which measure cognitive functions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Executive Functions', 'Schizophrenia', 'Occupational Therapy'], 'conditions': ['Refractory Schizophrenia']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nEfficacy of Occupational Therapy (OT) based Occupational Goal Intervention (OGI) in improving executive functions in patients with refractory schizophrenia as measured by the BADS.\n\nSecondary Objectives: improvement of functional aspects,basic and instrumental activities of daily living,negative symptoms and cognitive functions improvement\n\nHypothesis: OT is more effective than control group to improve executive functions in patients with refractory schizophrenia.', 'detailedDescription': 'A single-center, randomized, single blind, controlled study, lasting one year, including the follow-up.\n\nThe study is conducted in two groups:the experimental group is based on the OGI method (N=30 patients) and the control group receives craft activities (N = 30 patients).\n\nPsychiatric, neuropsychological and functional aspects are assessed at the beginning, after 30 sessions and 6 months after the intervention. The scale PANSS (Positive and Negative Syndrome Scale) is used for monitoring psychopathological symptoms during the study.\n\nScales BADS, DAFS-R, ILSS-BR respectively assess executive functions, functionality and basic and instrumental activities of daily living. The neuropsychological evaluation includes a battery to measure attention, executive functions, memory and estimated intellectual efficiency.\n\nStatistical analysis to be used: ANOVA (Analysis of Variance)for repeated measures; data are also calculated to messure clinical efficacy, effect size and needed number to treat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pacients with diagnosis of schizophrenia for DMS IV-R.\n* Pacients that signed the consent in writing and receive explanations about the nature of the study.\n* Patients who carefully counted another responsible person to provide reliable support to the patient and ensure adherence to the same study treatment.\n* Patients with minimum education: five years (elementary school).\n\n * Patients who present rates below those expected for their age group in at least 3 of the executive functions assessed on neuropsychological tests, and evaluation of executive functions.\n* Patients with stable clozapine and which have not been recently admitted (3 months).\n\nExclusion Criteria:\n\n* Comorbid diagnosis of substance dependence or other psychiatric Axis I;\n* History of head trauma and / or other neurological problems;\n* Medical problems that compromise somehow the central nervous system;\n* History of mental retardation;\n* Patients treated with medication other than clozapine;\n* Patients who are suffering other psychosocial treatments.'}, 'identificationModule': {'nctId': 'NCT01879956', 'acronym': 'OTSchizo', 'briefTitle': 'Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Randomized Controlled Trial for the Evaluation of the Efficacy of Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Refractory Schizophrenia', 'orgStudyIdInfo': {'id': 'OT Schizophrenia_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OGI Method', 'description': '\\- experimental group: use the OGI method to improve the executive functioning of patients with refractory schizophrenia.', 'interventionNames': ['Behavioral: OGI Method']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'craft activities', 'description': '\\- control group: use of craft activities, attend the same-number of sessions, but without the intervention of therapists.', 'interventionNames': ['Other: Craft Activities']}], 'interventions': [{'name': 'Craft Activities', 'type': 'OTHER', 'description': 'There is no intervention method used to perform the task.', 'armGroupLabels': ['craft activities']}, {'name': 'OGI Method', 'type': 'BEHAVIORAL', 'description': 'metacognitive approach to assess executive functions.', 'armGroupLabels': ['OGI Method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Adriana Vizzotto, BSc', 'role': 'CONTACT', 'email': 'adrivizzotto@usp.br', 'phone': '+55 11 26618043'}, {'name': 'Helio Elkis, MD PhD', 'role': 'CONTACT', 'email': 'helkis@usp.br'}, {'name': 'Helio Elkis, PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto de Psiquiatria do HCFMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Helio Elkis, MD PhD', 'role': 'CONTACT', 'email': 'helkis@usp.br', 'phone': '+55 11 26617581'}, {'name': 'Adriana Vizzotto, BSc', 'role': 'CONTACT', 'email': 'adrivizzotto@usp.br', 'phone': '+55 11 26618043'}], 'overallOfficials': [{'name': 'Helio Elkis, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departamento de Psiquiatria da FMUSP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of the Department of Psychiatry', 'investigatorFullName': 'Helio Elkis', 'investigatorAffiliation': 'University of Sao Paulo'}}}}