Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-02-01 @ 2:42 PM
Study NCT ID:
NCT02168166
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2014-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Working Memory and Executive Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-02', 'studyFirstSubmitDate': '2014-06-16', 'studyFirstSubmitQcDate': '2014-06-17', 'lastUpdatePostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline executive functioning composite score at post-treatment assessment', 'timeFrame': 'Pre-training assessment (Week 1) and post-training assessment (Week 4)', 'description': 'Composite score based on four tests of cognition'}], 'secondaryOutcomes': [{'measure': 'Change from baseline EEG theta-gamma frequency modulation at post-treatment assessment', 'timeFrame': 'Pre-training assessment (Week 1) and post-training assessment (Week 4)', 'description': 'Predicted to improve in active CR (cognitive remediation) condition compared to placebo CR'}, {'measure': 'Change from baseline EEG alpha power at post-treatment assessment', 'timeFrame': 'Pre-training assessment (Week 1) and post-training assessment (Week 4)', 'description': 'Predicted to increase in active CR (cognitive remediation) condition compared to placebo CR'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neurological Disorders', 'Neuroscience', 'Neuropsychology', 'EEG', 'Cognitive remediation', 'Cognitive Response'], 'conditions': ['Psychotic Disorders']}, 'descriptionModule': {'briefSummary': 'Cognitive remediation (CR) therapies refer to a number of recent developments to use behavioural strategies to improve neurocognitive abilities and improve everyday functioning in mental disorders such as schizophrenia, bipolar disorder, and depression. In this study, we aim to examine whether we can observe CR effects on measures of neuroplasticity, cognition, and functioning when using a rigorous control comparison group. We hypothesize that the active group will exhibit improvements in executive functioning composite scores, improved EEG theta-gamma frequency modulation, and increased EEG alpha power compared to the placebo group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of a chronic mental disorder (defined herein as bipolar disorder, major depressive disorder, or a schizophrenia-spectrum disorder)\n* between the ages of 18 and 65\n* speak and read fluent English\n* able to use a computer\n\nExclusion Criteria:\n\n* active substance abuse or dependence diagnosis\n* sensory or motor issues that would preclude completion of study procedures\n* enrollment in a cognitive remediation program or use of cognitive training programs (e.g. lumosity.com) within the past 6 months'}, 'identificationModule': {'nctId': 'NCT02168166', 'acronym': 'STExFx', 'briefTitle': 'Short-term Working Memory and Executive Training', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Short-Term Executive Functioning Training', 'orgStudyIdInfo': {'id': 'GPSYC-651-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Executive Function Training', 'description': 'Two weeks of training of cognitive domain of executive functioning\n\nUsing online program (Scientific Brain Training Pro)\n\nFour exercises', 'interventionNames': ['Behavioral: Executive Function Training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Training', 'description': 'Two weeks of training with exercises not affecting working memory, information processing speed, or cognitive load\n\nExercises maintain other traditional progressive aspects to preserve appearance of dynamic titration of difficulty levels\n\nUsing online program (Scientific Brain Training Pro)\n\nFour exercises', 'interventionNames': ['Behavioral: Placebo']}], 'interventions': [{'name': 'Executive Function Training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Executive Function Training']}, {'name': 'Placebo', 'type': 'BEHAVIORAL', 'description': 'Placebo version of executive function training', 'armGroupLabels': ['Placebo Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L3N6', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Christopher Bowie, PhD, CPsych', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dr. Christopher Bowie', 'investigatorAffiliation': "Queen's University"}}}}