Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-04-16 @ 4:58 PM
Study NCT ID:
NCT02170051
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2014-06-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Negative Symptoms of Psychosis In Real-world Environments
Sponsor:
Organization:
Raw JSON
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Scores range from 0-25; higher values indicate greater severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBSST-CCT', 'description': 'Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training\n\nCBSST-CCT'}, {'id': 'FG001', 'title': 'Goal-focused Supportive Contact', 'description': 'Goal-focused supportive contact\n\nGoal focused supportive contact'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Tested at Mid-point', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Tested at Post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'comment': 'Tested at 6-month follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '2 participants received the wrong diagnosis, and were withdrawn from the study; 7 participants had a CAINS score of ≤19, and were excluded from the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CBSST-CCT', 'description': 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[{'measurements': [{'value': '47.7', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '53.2', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '50.6', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-19', 'size': 260074, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-24T18:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2014-06-18', 'resultsFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-24', 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Assessment Interview for Negative Symptoms (CAINS)', 'timeFrame': 'baseline, 12.5 weeks', 'description': 'Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity.'}], 'secondaryOutcomes': [{'measure': 'MATRICS Consensus Cognitive Battery (MCCB)', 'timeFrame': 'baseline, 12.5 weeks', 'description': 'Change in cognitive performance in several domains at 12.5 weeks. Scores range from 0-80; higher scores indicate better performance.'}, {'measure': 'UCSD Performance-based Skills Assessment-Brief (UPSA-B)', 'timeFrame': 'baseline, 12.5 weeks', 'description': 'Change in communication and financial functioning at 12.5 weeks. Scores range from 0-100; higher scores indicate better performance.'}, {'measure': 'Social Skills Performance Assessment (SSPA)', 'timeFrame': 'baseline, 12.5 weeks', 'description': 'Change in social skills performance at 12.5 weeks. Scores range from 2-10; higher scores indicate better social skills.'}, {'measure': 'Specific Levels of Functioning Scale (SLOF)', 'timeFrame': 'baseline, 12.5 weeks', 'description': 'Change in self-reported functioning at 12.5 weeks. Scores range from 30-150. Higher score indicates better functioning.'}, {'measure': 'Independent Living Skills Survey (ILSS)', 'timeFrame': 'baseline, 12.5 weeks', 'description': 'Change in self-reported functioning at 12.5 weeks. Scores range from 0-1; higher score indicates better skills.'}, {'measure': 'Defeatist Performance Attitudes Scale (DPAS)', 'timeFrame': 'baseline, 12.5 weeks', 'description': 'Change in defeatist attitudes at 12.5 weeks. Likert Scale 1-7; scores range from 15-105; higher scores indicate a more severe defeatist performance attitude.'}, {'measure': 'Scale for the Assessment of Negative Symptoms (SANS)', 'timeFrame': 'baseline, 12.5 weeks', 'description': 'Change in negative symptom severity at 12.5 weeks. Scores range from 0-25; higher values indicate greater severity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['negative symptoms', 'cognition', 'functioning', 'defeatist attitudes', 'psychosocial treatment'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '34665853', 'type': 'DERIVED', 'citation': 'Granholm E, Twamley EW, Mahmood Z, Keller AV, Lykins HC, Parrish EM, Thomas ML, Perivoliotis D, Holden JL. Integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training for Negative Symptoms of Psychosis: Effects in a Pilot Randomized Controlled Trial. Schizophr Bull. 2022 Mar 1;48(2):359-370. doi: 10.1093/schbul/sbab126.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention better improves symptoms and functioning in people with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMUST BE A RESIDENT OF BROADWAY HOME, SAN DIEGO, OR A SERVICE USER OF THE MEETING PLACE, ARETA CROWELL, OR PROJECT ENABLE.\n\n1. Voluntary informed consent to participate\n2. Age 18 to 65\n3. DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on MINI/SCID\n4. Moderate-to-severe negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS total score \\>19)\n5. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual)\n6. Stable on medications; no changes within 3 months prior to enrollment\n\nExclusion Criteria:\n\n1. Prior CBT, SST, or CCT in the past 5 years\n2. Severe positive symptoms on the Positive and Negative Syndrome Scale (PANSS Delusions, Disorganization, Hallucinations, or Suspiciousness \\>5)\n3. Severe depression on the Calgary Depression Scale for Schizophrenia (CDSS \\>8)\n4. Ocular damage/disease/surgery/medications that affect pupil dilation\n5. DSM-IV alcohol or substance dependence diagnosis in past 6 months based on the MINI or SCID\n6. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness) .'}, 'identificationModule': {'nctId': 'NCT02170051', 'acronym': 'INSPIRE', 'briefTitle': 'Improving Negative Symptoms of Psychosis In Real-world Environments', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Improving Negative Symptoms of Psychosis In Real-world Environments', 'orgStudyIdInfo': {'id': '130424'}, 'secondaryIdInfos': [{'id': '1R34MH101250', 'link': 'https://reporter.nih.gov/quickSearch/1R34MH101250', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBSST-CCT', 'description': 'Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training', 'interventionNames': ['Behavioral: CBSST-CCT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Goal-focused supportive contact', 'description': 'Goal-focused supportive contact', 'interventionNames': ['Behavioral: Goal focused supportive contact']}], 'interventions': [{'name': 'CBSST-CCT', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training'], 'armGroupLabels': ['CBSST-CCT']}, {'name': 'Goal focused supportive contact', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Goal-focused supportive contact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Elizabeth Twamley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}, {'name': 'Eric Granholm, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Elizabeth Twamley', 'investigatorAffiliation': 'University of California, San Diego'}}}}