Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-05 @ 5:59 PM
Study NCT ID:
NCT03024203
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2016-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Cognitive Training Approaches in Psychotic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-12', 'studyFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2017-01-15', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline', 'timeFrame': 'Post-treatment (within 2 weeks following the end of treatment)', 'description': "Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks"}], 'secondaryOutcomes': [{'measure': 'Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline', 'timeFrame': 'Post-treatment (within 2 weeks following the end of treatment)', 'description': 'The MCCB is the gold standard cognitive assessment for schizophrenia research'}, {'measure': 'Change in Neurophysiology - EEG from Baseline', 'timeFrame': 'Post-treatment (within 2 weeks following the end of treatment)', 'description': 'Alpha and Theta band synchronization, p300, mismatch negativity'}, {'measure': 'Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline', 'timeFrame': 'Post-treatment (within 2 weeks following the end of treatment)', 'description': 'Performance based measure of real life functional skills using role-play'}, {'measure': 'Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline', 'timeFrame': 'Follow-Up (3 months after the end of treatment)', 'description': "Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks"}, {'measure': 'Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline', 'timeFrame': 'Follow-Up (3 months after the end of treatment)', 'description': 'The MCCB is the gold standard cognitive assessment for schizophrenia research'}, {'measure': 'Change in Neurophysiology - EEG from Baseline', 'timeFrame': 'Follow-Up (3 months after the end of treatment)', 'description': 'Alpha and Theta band synchronization, p300, mismatch negativity'}, {'measure': 'Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline', 'timeFrame': 'Follow-Up (3 months after the end of treatment)', 'description': 'Performance based measure of real life functional skills using role-play'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psychotic Disorders']}, 'referencesModule': {'references': [{'pmid': '30845819', 'type': 'DERIVED', 'citation': 'Best MW, Milanovic M, Iftene F, Bowie CR. A Randomized Controlled Trial of Executive Functioning Training Compared With Perceptual Training for Schizophrenia Spectrum Disorders: Effects on Neurophysiology, Neurocognition, and Functioning. Am J Psychiatry. 2019 Apr 1;176(4):297-306. doi: 10.1176/appi.ajp.2018.18070849. Epub 2019 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for individuals with psychosis, however, there is no gold standard method of cognitive remediation available. Cognitive training refers to the training component of CR in which people practice computerized exercises that train specific cognitive abilities. There is no agreed upon approach within the field as to the type of training that is most effective with some studies, training higher level cognitive abilities, some training perceptual abilities, and others training general cognitive skills. This study will directly compare two competing methods of cognitive training on measures of neurophysiology, neurocognition, functional competence, and real-world functional performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* psychotic disorder\n* No previous cognitive remediation in past 6 months\n\nExclusion Criteria:\n\n* Brain injury\n* Substance abuse\n* Neurocognitive disorder\n* Developmental Disability'}, 'identificationModule': {'nctId': 'NCT03024203', 'briefTitle': 'A Comparison of Cognitive Training Approaches in Psychotic Disorders', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'A Comparison of Cognitive Training Approaches in Psychotic Disorders', 'orgStudyIdInfo': {'id': 'PSYC-173-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Executive Training', 'description': 'Executive Training (ET) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. ET will be delivered in both individual and group settings.', 'interventionNames': ['Behavioral: Cognitive Remediation - Executive Training']}, {'type': 'EXPERIMENTAL', 'label': 'Perceptual Training', 'description': 'Perceptual Training (PT) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. PT will be delivered in both individual and group settings.', 'interventionNames': ['Behavioral: Cognitive Remediation - Perceptual Training']}], 'interventions': [{'name': 'Cognitive Remediation - Executive Training', 'type': 'BEHAVIORAL', 'description': 'Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as memory, and problem solving ability.', 'armGroupLabels': ['Executive Training']}, {'name': 'Cognitive Remediation - Perceptual Training', 'type': 'BEHAVIORAL', 'description': 'Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as attention, and processing speed.', 'armGroupLabels': ['Perceptual Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 5P6', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Christopher Bowie', 'investigatorAffiliation': "Queen's University"}}}}