Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-02-01 @ 4:41 AM
Study NCT ID:
NCT05066750
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2021-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
What Makes People Better at Retrieving Difficult Words?
Sponsor:
Organization:
Raw JSON
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'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mindful Breathing Video', 'description': 'Participants watch a 10 minute mindful breathing video\n\nMindful breathing: Participants watch a 10 minute mindful breathing video'}, {'id': 'BG001', 'title': 'Control Video', 'description': 'Participants watch a 10 minute control video\n\nControl video: Participants watch a 10 minute control video'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2024-02-11', 'size': 77187, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-16T17:33', 'hasProtocol': True}, {'date': '2022-01-03', 'size': 159621, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-07T10:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants in each condition do not know what other participants are doing, nor that there is another condition.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to one of two behavioral intervention conditions before performing a word retrieval task'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2021-09-08', 'resultsFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2021-09-22', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-07', 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Word Retrieval Performance', 'timeFrame': 'During the 1.25 hour experimental session', 'description': 'Percent of trials with correct responses and percent of trials that are word retrieval failures will be measured on a task created for this purpose. Specifically, participants will try to provide words that best fit definitions, indicating when a word gets stuck on the "tip of their tongue."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindful breathing', 'anxiety', 'word retrieval'], 'conditions': ['Healthy Aging']}, 'descriptionModule': {'briefSummary': "This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce words in response to definitions. Participants will watch a video, then see definitions and try to come up with a word that fits each one. Participants will also complete some surveys and other measures. Collected data will give researchers a better understanding of how individuals' personality and cognitive traits and setting in which word retrieval occurs relate to the ability to produce individual words.", 'detailedDescription': "This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce words in response to definitions. Adult participants ages 18-30 and 65-80 will participate in videoconference calls during which a video is shown and definitions are presented. Participants will try to come up with a word that fits each definition, and then complete some surveys, including some about anxiety, mindfulness, attention, vocabulary, and demographics. Participation will take approximately 1.25 hours. Collected data will be de-identified, and the aggregate data will give researchers a better understanding of how individuals' personality and cognitive traits and setting in which word retrieval occurs relate to peoples' ability to produce individual words."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fluent speakers of English ages 18-30 or ages 65-80'}, 'identificationModule': {'nctId': 'NCT05066750', 'briefTitle': 'What Makes People Better at Retrieving Difficult Words?', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Colorado Springs'}, 'officialTitle': 'What Makes People Better at Retrieving Difficult Words?', 'orgStudyIdInfo': {'id': '2020-005'}, 'secondaryIdInfos': [{'id': 'R15AG063111-01', 'link': 'https://reporter.nih.gov/quickSearch/R15AG063111-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindful breathing video', 'description': 'Participants watch a 10 minute mindful breathing video', 'interventionNames': ['Behavioral: Mindful breathing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control video', 'description': 'Participants watch a 10 minute control video', 'interventionNames': ['Behavioral: Control video']}], 'interventions': [{'name': 'Mindful breathing', 'type': 'BEHAVIORAL', 'description': 'Participants watch a 10 minute mindful breathing video', 'armGroupLabels': ['Mindful breathing video']}, {'name': 'Control video', 'type': 'BEHAVIORAL', 'description': 'Participants watch a 10 minute control video', 'armGroupLabels': ['Control video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80918', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'UCCS', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}], 'overallOfficials': [{'name': 'Lori James, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Colorado Springs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified participant data may be posted on a website for open access to other researchers, if the publication outlet requires it, but it is not currently planned.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Colorado Springs', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lori James', 'investigatorAffiliation': 'University of Colorado, Colorado Springs'}}}}