Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-22 @ 2:17 PM
Study NCT ID:
NCT03278756
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2017-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Cognitive Control Training for Remitted Depressed Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Between subjects-design with two training conditions. The training condition is the only difference between the two groups during the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-08', 'studyFirstSubmitDate': '2017-08-18', 'studyFirstSubmitQcDate': '2017-09-08', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'User engagement', 'timeFrame': 'Assessed at post-training assessment (within 1 week of completing the training) and at 3 months follow-up', 'description': 'Measured by the User Engagement Scale (UES)'}, {'measure': 'Threatening experiences', 'timeFrame': 'Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up', 'description': 'Measured by the List of Threatening Experiences (LTE)'}, {'measure': 'Effortful control', 'timeFrame': 'Assessed at pre-training assessment and at 6 months follow-up', 'description': 'Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ)'}, {'measure': 'Credibility and Expectancy', 'timeFrame': 'Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up', 'description': 'Measured by the Credibility/Expectancy Questionnaire'}, {'measure': 'Behavioral measure for cognitive control', 'timeFrame': 'Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up', 'description': 'Measured by the non-adaptive Paced Auditory Serial Addition Task (PASAT)'}], 'primaryOutcomes': [{'measure': 'Change in depressive symptomatology', 'timeFrame': 'Assessed at pre-training assessment and at 6 months follow-up', 'description': 'Measured by the Beck Depression Inventory - II (BDI-II)'}, {'measure': 'Change in depressive symptomatology', 'timeFrame': 'Assessed at pre-training assessment, at post-training assessment (within 1 week of completing the training), at 3 months follow-up and at 6 months follow-up', 'description': 'Measured by the Depression Anxiety Stress Scales (DASS)'}, {'measure': 'Change in depressive rumination (brooding)', 'timeFrame': 'Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up', 'description': 'Measured by the Ruminative Response Scale (RRS), especially the brooding subscale'}], 'secondaryOutcomes': [{'measure': 'Change in cognitive emotion regulation strategies', 'timeFrame': 'Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up', 'description': 'Measured by the Cognitive Emotion Regulation Questionnaire (CERQ)'}, {'measure': 'Change in quality of life', 'timeFrame': 'Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up', 'description': 'Measured by the Quality of Life in Depression Scale (QLDS)'}, {'measure': 'Remission from depression', 'timeFrame': 'Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up', 'description': 'Measured by the Remission of Depression Questionnaire (RDQ)'}, {'measure': 'Resilience', 'timeFrame': 'Assessed at pre- and post-training assessment (within 1 week of completing the training) and at 3 and 6 months follow-up', 'description': 'Measured by the Connor-Davidson Resilience Scale (CD-RISC)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Remission', 'Relapse prevention', 'Cognitive control training', 'Internet intervention'], 'conditions': ['Major Depression in Remission']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients. Half of the participants will receive a cognitive control training, while the other half will receive a low cognitive load training that acts as an active control condition.', 'detailedDescription': 'Prospective studies have linked impaired cognitive control to increased cognitive vulnerability for future depression. Importantly, experimental studies indicate that cognitive control training can be used to reduce rumination and depressive symptomatology in MDD (major depressive disorder) and RMD (remitted depressed) samples. Provided that remitted depressed patients form a high-risk group for developing future depressive episodes, the current study will explore whether an internet-delivered cognitive control training can be used to reduce vulnerability for future depression in remitted depressed patients.\n\nA computer training, consisting of 10 sessions of 15 minutes each, will be administered to participants, which are remitted depressed patients. This training can either be a cognitive control training, using an adaptive paced auditory serial addition task, or an active control training, with a low cognitive load task.\n\nDependent variables will be assessed pre- and post-training, as well as 3 and 6 months after the training, and consist of depressive symptomatology, related variables and cognitive control measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of ≥ 1 depressive episodes (major or bipolar)\n* Currently in stable full or partial remission (≥ 3 months)\n\nExclusion Criteria:\n\n* Major depressive disorder (current or less than 3 months in remission)\n* Bipolar disorder (current or less than 3 months in remission)\n* Psychotic disorder (current and/or previous)\n* Neurological impairments (current and/or previous)\n* Excessive substance abuse (current and/or previous)\n* No ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency of less than once every three weeks)\n* Use of antidepressant medication is allowed if kept at a constant level'}, 'identificationModule': {'nctId': 'NCT03278756', 'briefTitle': 'Online Cognitive Control Training for Remitted Depressed Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Online Cognitive Control Training for Remitted Depressed Patients', 'orgStudyIdInfo': {'id': 'B/14730/RMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Control Training', 'description': 'A cognitive control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive paced auditory serial addition task, where participants need to click on the sum of the last two heard digits.', 'interventionNames': ['Behavioral: Cognitive control training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control Training', 'description': 'An active control training, consisting of 10 sessions of 15 minutes each, will be administered. The task in this training is an adaptive low load cognitive task, where participants need to click on the last heard digit.', 'interventionNames': ['Behavioral: Active control training']}], 'interventions': [{'name': 'Cognitive control training', 'type': 'BEHAVIORAL', 'description': '10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.', 'armGroupLabels': ['Cognitive Control Training']}, {'name': 'Active control training', 'type': 'BEHAVIORAL', 'description': '10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.', 'armGroupLabels': ['Active Control Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Ernst HW Koster, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}