Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-10 @ 9:39 AM
Study NCT ID:
NCT01546467
Status:
UNKNOWN
Last Update Posted:
2012-03-07
First Post:
2012-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Remediation in Early Phase Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072466', 'term': 'Cognitive Remediation'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'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': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-01', 'studyFirstSubmitDate': '2012-01-12', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MATRICS Consensus Cognitive Battery (MCCB)', 'timeFrame': 'Change in MCCB performance from baseline to 4 months and 9 months', 'description': 'Included in the MCCB are measures of the following cognitive domains: Speed of Processing, Attention, Working memory, Verbal learning, Visual Learning, Reasoning and problem solving and Social Cognition. In addition the following tests are included: HVLT-R and BVMT-R delayed recall to measure memory, TMTB (Halstead Reitan) and Color Word Inteference Test (D-KEFS) to measure executive functioning), Digit span (WAIS-III)to measure working memory, Grooved Pegboard (Halstead Reitan) to measure motor function.'}, {'measure': 'UCSD Performance Based Skilled Assessment Brief Version (UPSA-B)', 'timeFrame': 'Change in UPSA-B performance from baseline to 4 months and 9 months'}, {'measure': 'Cognitive Assessment Interview (CAI)', 'timeFrame': 'Change in CAI scores from baseline to 4 months and 9 months'}, {'measure': 'Social Functioning Scale (SFS)', 'timeFrame': 'Change in SFS scores from baseline to 4 months and 9 months'}], 'secondaryOutcomes': [{'measure': 'Calgary Depression Scale', 'timeFrame': 'Change in CDS scores from baseline to 4 months and 9 months'}, {'measure': 'Global Assessment of Function (GAF)- split version', 'timeFrame': 'Change in GAF scores from baseline to 4 months and 9 months'}, {'measure': 'event related fMRI', 'timeFrame': 'Change in BOLD fMRI signal from baseline to 4 months', 'description': "Event-related fMRI will be performed to measure neuronal activity during a spatial working memory tasks and an executive planning task. All fMRI data will be collected on Ullevål's 3 T General Electric Sigma HDx scanner."}, {'measure': 'Rosenberg Self-Esteem Scale (RSES)', 'timeFrame': 'Change in RSES scores from baseline to 4 months and 9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Schizoaffective disorder', 'Psychosis', 'Early phase', 'Cognitive remediation', 'Functional outcome'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Psychosis NOS']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the effect of a 30 hour cognitive remediation program for young patients with early phase schizophrenia spectrum disorders on cognitive, clinical and functional outcome measures. The remediation program is integrated with whatever active rehabilitation the participant is currently attending (school, work, day program etc).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Early phase schizophrenia, schizoaffective disorder, psychosis NOS\n* Less than 5 years since start of adequate treatment for psychotic disorder\n* Age between 18-40\n* Norwegian speaking (sufficiently to understand and complete assessments)\n\nExclusion Criteria:\n\n* Traumatic brain injury\n* Neurological disorder as determined by medical history\n* IQ below 70'}, 'identificationModule': {'nctId': 'NCT01546467', 'briefTitle': 'Cognitive Remediation in Early Phase Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Cognitive Remediation in Early Phase Psychosis', 'orgStudyIdInfo': {'id': '2010/1788 (REK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive remediation', 'description': '30 hour computer based cognitive remediation integrated in participants current rehabilitation program (school, work, day program)', 'interventionNames': ['Behavioral: Cognitive remediation']}, {'type': 'NO_INTERVENTION', 'label': 'Wait list control group', 'description': 'Participant continues in treatment/rehabilitation program as usual until 9 month assessment when participant receives the same cognitive remediation program as the experimental group.'}], 'interventions': [{'name': 'Cognitive remediation', 'type': 'BEHAVIORAL', 'description': 'Cognitive remediation including feedback from neurocognitive assessment, psychoeducation about cognitive deficits, 30 hours of computer based drill and practise and strategy coaching based cognitive remediation, 1-3 collaborative meetings with cognitive specialist, participant, therapist and teacher, occupational therapist or other therapist (depending on participants rehabilitation situation) to enhance transfer of skills to daily functioning', 'armGroupLabels': ['Cognitive remediation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Torill Ueland, PhD', 'role': 'CONTACT', 'email': 'torill.ueland@medisin.uio.no', 'phone': '+47 22118370'}], 'facility': 'Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital.', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Torill Ueland, PhD', 'role': 'CONTACT', 'email': 'torill.ueland@medisin.uio.no', 'phone': '+47 22118370'}, {'name': 'Ingrid Melle, PhD', 'role': 'CONTACT', 'email': 'ingrid.melle@medisin.uio.no', 'phone': '+47 22118469'}], 'overallOfficials': [{'name': 'Torill Ueland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stiftelsen Helse og Rehabilitering', 'class': 'OTHER'}, {'name': 'South-Eastern Norway Regional Health Authority', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}