Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-31 @ 11:28 AM
Study NCT ID:
NCT00587561
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Social Cognition Training in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joanna.fiszdon@va.gov', 'phone': '2039325711', 'title': 'Dr. Joanna Fiszdon', 'phoneExt': '2231', 'organization': 'VA Connecticut Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group: Social Cognition Interaction Training', 'description': 'First period of Intervention Group, social cognition interaction training from 0 -6 months.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Intervention Group: Treatment As Usual', 'description': 'Second period of Intervention Group, treatment as usual after 6 months.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Waitlist Control Group, Treatment As Usual', 'description': 'First period of Waitlist Control Group, treatment as usual from 0 - 6 months.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Waitlist Control Group, Social Cognition Interaction Training', 'description': 'Second period of Waitlist Control Group, social cognition interaction training after 6 months.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'hospitalization', 'notes': 'psychiatric symptom exacerbation and hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'hospitalization for suicidal ideation', 'notes': 'hospitalization for symptom exacerbation with suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Social Cognitive Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Social Cognition Interaction Training', 'description': 'social cognition training'}, {'id': 'OG001', 'title': 'Waitlist Control', 'description': 'wait list control'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '-1.68', 'spread': '2.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months - baseline', 'description': 'change score for Facial Emotion Identification Task (FEIT), FEIT scores range from 0-19 with higher scores indicating better performance, higher change scores indicate greater improvement', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Basic Cognitive Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Social Cognition Interaction Training', 'description': 'social cognition training'}, {'id': 'OG001', 'title': 'Waitlist Control', 'description': 'wait list control'}], 'classes': [{'categories': [{'measurements': [{'value': '1.61', 'spread': '7.42', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '5.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months - baseline', 'description': 'change score on Matrics Consensus Cognitive Battery (MCCB) 6 domain composite average t-score, t-score mean = 50 and SD=10, higher change scores indicate greater improvement; please note outcome is not a t-score itself but a change in t-score', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Social cognition interaction training (0 - 6 months), then crossed-over to treatment as usual.'}, {'id': 'FG001', 'title': 'Waitlist Control', 'description': 'Treatment as usual (0 - 6 months), then crossed-over to social cognition interaction training.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Our initial plan had been to recruit and enroll 48 participants. 67 volunteers were assessed for eligibility. Of those, 9 did not meet inclusion criteria and 7 declined to participate after learning more about the study. Our initial plan had been to randomized 48 volunteers however due to concerns about potential drop-out, we recruited and randomized 51 participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': '20-26 sessions of a manualized group treatment called social cognition interaction training (0 - 6 months), then crossed-over to treatment as usual.'}, {'id': 'BG001', 'title': 'Waitlist Control', 'description': '6 months of treatment as usual followed by Social Cognition Interaction Training'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.56', 'spread': '10.97', 'groupId': 'BG000'}, {'value': '49.96', 'spread': '9.15', 'groupId': 'BG001'}, {'value': '47.80', 'spread': '10.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2007-12-21', 'resultsFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-15', 'studyFirstPostDateStruct': {'date': '2008-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social Cognitive Measures', 'timeFrame': '6 months - baseline', 'description': 'change score for Facial Emotion Identification Task (FEIT), FEIT scores range from 0-19 with higher scores indicating better performance, higher change scores indicate greater improvement'}], 'secondaryOutcomes': [{'measure': 'Basic Cognitive Measures', 'timeFrame': '6 months - baseline', 'description': 'change score on Matrics Consensus Cognitive Battery (MCCB) 6 domain composite average t-score, t-score mean = 50 and SD=10, higher change scores indicate greater improvement; please note outcome is not a t-score itself but a change in t-score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'social cognition', 'cognition', 'treatment', 'outcome'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '37599886', 'type': 'RESULT', 'citation': 'Fiszdon JM, Dixon HD, Davidson CA, Roberts DL, Penn DL, Bell MD. Efficacy of social cognition and interaction training in outpatients with schizophrenia spectrum disorders: randomized controlled trial. Front Psychiatry. 2023 Aug 4;14:1217735. doi: 10.3389/fpsyt.2023.1217735. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The term social cognition refers to how social information is processed. Individuals with schizophrenia and schizoaffective disorder have been shown to have significant deficits in social cognition. Moreover, it has been speculated that these deficits may in turn have a negative impact on their overall functioning. Behavioral interventions targeting social cognition are just beginning to emerge, and there is a need to evaluate their efficacy.\n\nObjectives:\n\nThis is a small trial evaluating the efficacy of social cognition interaction training (SCIT) an experimental behavioral treatment for improving social cognition in schizophrenia.\n\nResearch Design and Methodology:\n\nApproximately 48 participants with schizophrenia-spectrum disorders will be randomized into one of two conditions: 1) a 20 to 24 session manualized social cognition interaction training group (SCIT), or 2) wait-list control. Pre-and post-group therapy assessments of symptoms, social cognition, basic cognition, and community function will be conducted. Data obtained from this study will allow us to determine the efficacy of SCIT training in improving symptom, cognitive, and functional measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of schizophrenia or schizoaffective disorder\n* Age between 18 and 65\n* minimum of 30 days since discharge from last hospitalization\n* minimum of 30 days since last change in psychiatric medications\n* no housing changes in the past 30 days\n\nExclusion Criteria:\n\n* current diagnosis of alcohol or substance abuse/dependence\n* history of brain trauma or neurological disease\n* mental retardation or developmental disability\n* auditory or visual impairment that would interfere with study procedures'}, 'identificationModule': {'nctId': 'NCT00587561', 'briefTitle': 'Efficacy of Social Cognition Training in Schizophrenia', 'organization': {'class': 'FED', 'fullName': 'VA Connecticut Healthcare System'}, 'officialTitle': 'Efficacy of Social Cognition Training in Schizophrenia', 'orgStudyIdInfo': {'id': 'JMF0005'}, 'secondaryIdInfos': [{'id': 'D4628W'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Social Cognition Interaction Training', 'description': 'Will receive 20-26 sessions of a manualized group treatment called Social Cognition Interaction Training', 'interventionNames': ['Behavioral: Social Cognition Interaction Training']}, {'type': 'OTHER', 'label': '2 Wait List Control', 'description': 'Wait list control; 6 months of treatment as usual followed by Social Cognition Interaction Training group', 'interventionNames': ['Behavioral: WLC']}], 'interventions': [{'name': 'Social Cognition Interaction Training', 'type': 'BEHAVIORAL', 'description': 'manualized group therapy', 'armGroupLabels': ['1 Social Cognition Interaction Training']}, {'name': 'WLC', 'type': 'BEHAVIORAL', 'description': 'wait-list control for 6 months, followed by the experimental group therapy', 'armGroupLabels': ['2 Wait List Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Mental Health Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Healthcare System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Joanna Fiszdon, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Connecticut Heathcare System and Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Connecticut Healthcare System', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}