Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT00481156
Status:
COMPLETED
Last Update Posted:
2018-05-04
First Post:
2007-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Neuroimaging Effects of Cognitive Remediation Training
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': 'D000072466', 'term': 'Cognitive Remediation'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants were randomized to computer-based cognitive training or active social-skills groups. Healthy controls (n=9) received no treatment.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, placebo-controlled, single-blind. An untreated healthy control group was also included to examine simple retest effects.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2007-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2007-05-30', 'studyFirstSubmitQcDate': '2007-05-30', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Working Memory performance', 'timeFrame': 'Post-test', 'description': 'N-Back Performance'}, {'measure': 'Brain activation', 'timeFrame': 'Post-test', 'description': 'Changes in prefrontal cortical functioning'}]}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '20428109', 'type': 'RESULT', 'citation': 'Haut KM, Lim KO, MacDonald A 3rd. Prefrontal cortical changes following cognitive training in patients with chronic schizophrenia: effects of practice, generalization, and specificity. Neuropsychopharmacology. 2010 Aug;35(9):1850-9. doi: 10.1038/npp.2010.52. Epub 2010 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine behavioral and functional brain changes occuring as a result of cognitive remediation training in patients with schizophrenia. Extension and specificity of related changes will also be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia or schizoaffective disorder\n* Stable outpatient\n\nExclusion Criteria:\n\n* Current drug abuse or dependence\n* History of neurological damage, disorder, or disease'}, 'identificationModule': {'nctId': 'NCT00481156', 'briefTitle': 'Functional Neuroimaging Effects of Cognitive Remediation Training', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Functional Neuroimaging Effects of Cognitive Remediation Training', 'orgStudyIdInfo': {'id': '0404M58647'}, 'secondaryIdInfos': [{'id': 'CogRehab'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients: Cognitive Remediation', 'description': 'Patients in the cognitive REM condition attended up to 25 h of training in small groups over 4-6 weeks based on the approach to cognitive remediation described by Wexler and Bell (2005). Patients performed tasks designed to train attention and memory from the battery available within a computerized software package (CogPack Marker Software). This training protocol has been shown to improve memory and executive functioning in patients with schizophrenia (Sartory et al, 2005) and tasks chosen were designed to produce improved working memory and attention capacity in the treated group. In addition, patients in the REM group trained on the word N-back one to two times a week and on N-back tasks using a variety of other stimuli (such as faces) one to two times a week to support the generalization of working memory improvements.', 'interventionNames': ['Behavioral: Cognitive Remediation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients: Cognitive-Behavioral Social Skills Training', 'description': "Patients in the CBSST group also attended up to 25 h of treatment but followed a manualized group therapy protocol (Granholm et al, 2005) using cognitive and behavioral therapy methods to increase patients' skills in symptom recognition, communication, problem solving, and relapse prevention. In both conditions, the facilitators interacted with the clients throughout small group (B4 patients) sessions: in the REM group, this mostly involved brief one-on-one discussions regarding task performance; in the CBSST condition, this interaction was in the context of the group milieu.", 'interventionNames': ['Behavioral: Cognitive Behavioral Social Skills Training']}, {'type': 'OTHER', 'label': 'Controls: Retest control group', 'description': 'Estimate of normal brain functioning and retest effects', 'interventionNames': ['Other: Retest in Health Controls']}], 'interventions': [{'name': 'Cognitive Remediation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Patients: Cognitive Remediation']}, {'name': 'Cognitive Behavioral Social Skills Training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Patients: Cognitive-Behavioral Social Skills Training']}, {'name': 'Retest in Health Controls', 'type': 'OTHER', 'description': 'Pre/Post test performance and neuroimaging only', 'armGroupLabels': ['Controls: Retest control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Angus W MacDonald, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}, {'name': 'Kelvin O Lim, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Minnesota Medical Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}