Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-03-27 @ 6:04 PM
Study NCT ID:
NCT01748032
Status:
TERMINATED
Last Update Posted:
2016-04-07
First Post:
2012-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Cognitive Training in Late-life Depression
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Low Recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-06', 'studyFirstSubmitDate': '2012-12-10', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in cognitive functions including fluid intelligence, executive function, language, memory and motor speed', 'timeFrame': 'Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day', 'description': 'Computerized Executive Tasks:\n\n* Number-Letter Task\n* Letter-Memory Task\n* Stroop Task\n\nNon-Computerized Measures:\n\n* Cattell Culture Fair Intelligence Test\n* Mattis Dementia Rating Scale-2 (DRS-2)'}], 'secondaryOutcomes': [{'measure': 'Changes in mood including depression, anxiety and apathy', 'timeFrame': 'Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day', 'description': '* Montgomery Asberg Depression Rating Scale (MADRS)\n* Apathy Evaluation Scale (AES)\n* Hamilton Anxiety Rating Scale (Ham-A)\n* Beck Depression Inventory (BDI)'}]}, 'conditionsModule': {'keywords': ['depression', 'intervention studies'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of the alternative uses training (AUT) and word association training (WAT) on cognitive functions and mood symptoms in late-life depression (LLD).\n\nThe hypotheses are:\n\n1. post-training cognitive performance will be superior to pre-training cognitive performance\n2. post-training depressive symptomatology will be less severe as compared with pre-training clinical severity and\n3. AUT group will show better post-training cognitive performance and improved mood symptoms when compared with the WAT group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Age \\>=55\n* Proficiency in English\n* Current depressive episode and meet criteria for DSM-IV major depressive disorder\n* Hamilton Depression Rating Scale score \\>=15\n* Able to give informed consent\n* Stable medication dosages during the training period\n\nExclusion Criteria:\n\n* Other DSM-IV Axis I psychiatric disorders, except for anxiety disorders due to high comorbidity with mood disorders\n* Mini-Mental State Examination score of \\<26\n* Diagnosis of dementia\n* Neurological and medical conditions known to affect cognition (e.g., stroke, head injury, previous chemotherapy for cancer)\n* Unstable medical illnesses requiring active treatment\n* Vision or hearing impairment affecting ability to participate in training'}, 'identificationModule': {'nctId': 'NCT01748032', 'briefTitle': 'Short-term Cognitive Training in Late-life Depression', 'organization': {'class': 'OTHER', 'fullName': 'Rotman Research Institute at Baycrest'}, 'officialTitle': 'The Effects of Short-term Cognitive Training on Cognition and Mood Symptoms in Late-life Depression: A Pilot Study', 'orgStudyIdInfo': {'id': '12-28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Alternative Uses Training', 'description': 'In this task, subjects are asked to produce atypical and alternative uses for common daily objects.', 'interventionNames': ['Behavioral: Cognitive training']}, {'type': 'OTHER', 'label': 'Word Association Training', 'description': 'In this task, subjects are asked to generate the first word that comes to their mind, and thus, encourages more general and spontaneous divergent thinking.', 'interventionNames': ['Behavioral: Cognitive training']}], 'interventions': [{'name': 'Cognitive training', 'type': 'BEHAVIORAL', 'otherNames': ['cognitive intervention'], 'description': '20 minutes/day for 5 sequential working days', 'armGroupLabels': ['Alternative Uses Training', 'Word Association Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6A 2E1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Rotman Research Institute at Baycrest', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Linda Mah, MD, M.H.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rotman Research Institute at Baycrest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rotman Research Institute at Baycrest', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baycrest', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinician Scientist', 'investigatorFullName': 'Linda Mah, MD', 'investigatorAffiliation': 'Rotman Research Institute at Baycrest'}}}}