Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-09 @ 6:12 PM
Study NCT ID:
NCT04244032
Status:
TERMINATED
Last Update Posted:
2024-12-13
First Post:
2020-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Enhancement Through Computerized Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-24', 'releaseDate': '2025-06-09'}], 'estimatedResultsFirstSubmitDate': '2025-06-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'enrollment barriers', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2020-01-22', 'studyFirstSubmitQcDate': '2020-01-24', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Working Memory', 'timeFrame': 'Baseline and up to 3 weeks', 'description': 'Performance on neuropsychological measures indexing working memory capacity. Score range: 0-100 (scores \\<40 are poor \\[0-16th percentile\\]; scores \\>60 are good \\[84th-100th percentile\\]).'}, {'measure': 'Inhibitory Control', 'timeFrame': 'Baseline and up to 3 weeks', 'description': 'Performance on neuropsychological measures indexing inhibitory control capacity. Score range: 0-100 (scores \\<40 are poor \\[0-16th percentile\\]; scores \\>60 are good \\[84th-100th percentile\\]).'}, {'measure': 'General Executive Function', 'timeFrame': 'Baseline and up to 3 weeks', 'description': 'Performance on neuropsychological measures indexing general executive functioning. Score range: 0-100 (scores \\<40 are poor \\[0-16th percentile\\]; scores \\>60 are good \\[84th-100th percentile\\]).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Training', 'Alcohol Use Disorder'], 'conditions': ['Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'Alcohol use disorder is characterized by widespread neurocognitive impairments, however despite substantial advances in the intervention and treatment of alcohol use disorders, exceptionally few studies have been directed to improving these deficits. This project leverages computerized cognitive training, applied as an adjunct to inpatient treatment, to enhance neurocognitive recovery. This project informs public health and future intervention efforts by interrogating factors critical to intervention efficacy and clarifying relationships between neurocognitive recovery and treatment outcomes, including post-discharge alcohol consumption.', 'detailedDescription': 'Programmatic investigation of neurocognitive functioning in alcohol use disorder (AUD) has revealed widespread and sustained impairments. Despite conceptual relevance to treatment efficacy, few AUD interventions have been directed to the remediation of these impairments. This project is responsive to this gap. It will answer critical questions regarding the potential of cognitive training (CT), applied as an adjunct to inpatient treatment, to improve cognitive recovery and post-discharge functional outcomes in AUD.\n\nThe current project will investigate the efficacy of two experimental cognitive training interventions in a sample of inpatients in treatment for AUD. While the effectiveness of CT to enhance function is supported by diverse literatures, it remains largely unexamined in AUD. The current project will interrogate the degree to which cognitive training interventions can "transfer" cognitive gains to untrained tasks/domains, and improve overall executive functioning. It will apply conceptual models from the CT and alcohol literatures to identify factors associated with CT efficacy. The impact of cognitive training on functional outcomes, including post-discharge drinking, will be investigated. Finally, relationships between cognitive recovery during treatment and post-discharge adaptation will be examined. Thus, the current work will be of substantial import to public health, alcohol science, and will inform future intervention efforts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum of 10 years of education\n* Meet DSM-5 criteria for alcohol use disorder\n\nExclusion Criteria:\n\n* Medical histories confounding interpretation regarding change in neuropsychological functioning (e.g., stroke)\n* Meet DSM-5 criteria for current/unremitted psychotic, panic, or bipolar disorders'}, 'identificationModule': {'nctId': 'NCT04244032', 'briefTitle': 'Cognitive Enhancement Through Computerized Training', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Cognitive Enhancement Through Computerized Training', 'orgStudyIdInfo': {'id': 'IRB201901330'}, 'secondaryIdInfos': [{'id': 'K01AA026893', 'link': 'https://reporter.nih.gov/quickSearch/K01AA026893', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Working Memory Training (WM)', 'description': 'Participants complete training in a working memory task designed to utilize individually-adapted difficulty levels.', 'interventionNames': ['Behavioral: Working Memory Training']}, {'type': 'EXPERIMENTAL', 'label': 'Inhibitory Control Training (IC)', 'description': 'Participants complete training in an inhibitory control task designed to utilize individually-adapted difficulty levels.', 'interventionNames': ['Behavioral: Inhibitory Control Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bias Modification Training (BM)', 'description': 'Participants complete training in an active comparator task designed to weaken approach responses to alcohol-associated cues.', 'interventionNames': ['Behavioral: Bias Modification Training']}, {'type': 'NO_INTERVENTION', 'label': 'Non-Trained control (NTC)', 'description': 'No active intervention is delivered beyond typical care.'}], 'interventions': [{'name': 'Working Memory Training', 'type': 'BEHAVIORAL', 'description': 'Participants complete up to 12 sessions of computerized training (30-45 min each) in a working memory task designed to utilize individually-adapted difficulty levels.', 'armGroupLabels': ['Working Memory Training (WM)']}, {'name': 'Inhibitory Control Training', 'type': 'BEHAVIORAL', 'description': 'Participants complete up to 12 sessions of computerized training (30-45 min each) in an inhibitory control task designed to utilize individually-adapted difficulty levels.', 'armGroupLabels': ['Inhibitory Control Training (IC)']}, {'name': 'Bias Modification Training', 'type': 'BEHAVIORAL', 'description': 'Participants complete up to 12 sessions of computerized training (30-45 min each) in a bias modification task designed to utilize individually-adapted difficulty levels.', 'armGroupLabels': ['Bias Modification Training (BM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Ben Lewis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-09', 'type': 'RELEASE'}, {'date': '2025-06-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Florida'}}}}