Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT04821960
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Memory and Fear Study (Fear of Memory Loss Study)
Sponsor:
Organization:
Raw JSON
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Griffith', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data were collected over a 10 week period.', 'eventGroups': [{'id': 'EG000', 'title': 'Conventional Mindfulness Program', 'description': 'Routine mindfulness lessons and activities.\n\nConventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tailored Mindfulness Program for Fear of Memory Loss', 'description': 'Tailored mindfulness lessons and activities for fear of memory loss.\n\nTailored Mindfulness Program for Fear of Memory Loss: The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Mindfulness Program', 'description': 'Routine mindfulness lessons and activities.\n\nConventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities.'}, {'id': 'OG001', 'title': 'Tailored Mindfulness Program for Fear of Memory Loss', 'description': 'Tailored mindfulness lessons and activities for fear of memory loss.\n\nTailored Mindfulness Program for Fear of Memory Loss: The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '60.3', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks Post-Baseline', 'description': 'A 24-item scale to assess fear of memory loss. Scores range from 24-120 points with a higher score indicating a higher fear of memory loss.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up", 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Mindfulness Program', 'description': 'Routine mindfulness lessons and activities.\n\nConventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities.'}, {'id': 'OG001', 'title': 'Tailored Mindfulness Program for Fear of Memory Loss', 'description': 'Tailored mindfulness lessons and activities for fear of memory loss.\n\nTailored Mindfulness Program for Fear of Memory Loss: The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '45.2', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Weeks Post-Baseline', 'description': "A 30-item scale to assess fear of Alzheimer's disease. Minimum score = 0; maximum score = 120. A higher score indicates a greater fear of developing Alzheimer's Disease.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Memory Failure Scale (MFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Mindfulness Program', 'description': 'Routine mindfulness lessons and activities.\n\nConventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities.'}, {'id': 'OG001', 'title': 'Tailored Mindfulness Program for Fear of Memory Loss', 'description': 'Tailored mindfulness lessons and activities for fear of memory loss.\n\nTailored Mindfulness Program for Fear of Memory Loss: The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '32.2', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 Week Post-Baseline', 'description': 'A 12-item scale that measures memory failure that people tend to experience in everyday life. Minimum score=12; maximum score= 60. A higher score indicates a greater likelihood of memory failures.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Mindfulness Program', 'description': 'Routine mindfulness lessons and activities.\n\nConventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities.'}, {'id': 'FG001', 'title': 'Tailored Mindfulness Program for Fear of Memory Loss', 'description': 'Tailored mindfulness lessons and activities for fear of memory loss.\n\nTailored Mindfulness Program for Fear of Memory Loss: The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional Mindfulness Program', 'description': 'Routine mindfulness lessons and activities.\n\nConventional Mindfulness Program: Routine non-tailored mindfulness lessons and activities.'}, {'id': 'BG001', 'title': 'Tailored Mindfulness Program for Fear of Memory Loss', 'description': 'Tailored mindfulness lessons and activities for fear of memory loss.\n\nTailored Mindfulness Program for Fear of Memory Loss: The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.'}, {'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': '20', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.7', 'groupId': 'BG000', 'lowerLimit': '55.5', 'upperLimit': '83.9'}, {'value': '67', 'groupId': 'BG001', 'lowerLimit': '55.1', 'upperLimit': '90.2'}, {'value': '65.4', 'groupId': 'BG002', 'lowerLimit': '55.1', 'upperLimit': '90.2'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '41', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-01', 'size': 319638, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-01T13:43', 'hasProtocol': True}, {'date': '2022-06-22', 'size': 123859, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-22T12:12', 'hasProtocol': False}, {'date': '2021-03-01', 'size': 134420, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-01T13:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2021-03-23', 'resultsFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-06', 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up', 'timeFrame': '10 Weeks Post-Baseline', 'description': 'A 24-item scale to assess fear of memory loss. Scores range from 24-120 points with a higher score indicating a higher fear of memory loss.'}, {'measure': "Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up", 'timeFrame': '10 Weeks Post-Baseline', 'description': "A 30-item scale to assess fear of Alzheimer's disease. Minimum score = 0; maximum score = 120. A higher score indicates a greater fear of developing Alzheimer's Disease."}], 'secondaryOutcomes': [{'measure': 'Memory Failure Scale (MFS)', 'timeFrame': '10 Week Post-Baseline', 'description': 'A 12-item scale that measures memory failure that people tend to experience in everyday life. Minimum score=12; maximum score= 60. A higher score indicates a greater likelihood of memory failures.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'Fear of memory loss'], 'conditions': ['Anxiety and Fear']}, 'referencesModule': {'references': [{'pmid': '38030988', 'type': 'DERIVED', 'citation': "Farina FR, Regan J, Marquez M, An H, O'Loughlin P, Pavithra P, Taddeo M, Knight RC, Bennett M, Lenaert B, Griffith JW. Reducing fear and avoidance of memory loss improves mood and social engagement in community-based older adults: a randomized trial. BMC Geriatr. 2023 Nov 29;23(1):786. doi: 10.1186/s12877-023-04470-4."}, {'pmid': '34328428', 'type': 'DERIVED', 'citation': "O'Loughlin P, Pavithra P, Regan J, Bennett M, Knight R, Lenaert B, Marquez M, Taddeo M, Griffith J, Shapiro R, Farina F. A Randomized Controlled Trial Investigating the Feasibility of a Low-Intensity Psychological Intervention for Fear of Memory Loss and Quality of Life in Older Adults: Protocol for the Reducing Fear and Avoidance of Memory Loss (REFRAME) Study. JMIR Res Protoc. 2021 Jul 30;10(7):e30514. doi: 10.2196/30514."}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized control study to determine the impact of a tailored, web-based mindfulness program to reduce anxiety and increase the quality of life in older adults experiencing dementia-related fears, relative to a conventional meditation program.', 'detailedDescription': 'The study will test two different types of online mindfulness programs to see if an online self-paced mindfulness program can help reduce anxiety related to memory loss. Participants will be involved in the study for a total of 10 weeks. Participants will log on to an online mindfulness program 4 days per week for about 10-20 minutes each. The total program will last 3 weeks. Participants will also be asked to complete questionnaires before starting the program, during the program, and after they complete the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 55 years of age or older\n* Elevated dementia-related fear\n* Able to read/write in English\n* Willingness to be randomized to intervention group\n* Willingness to complete three weeks of self-guided intervention, questionnaires, and cognitive tests.\n* Access to a reliable internet connection\n\nExclusion Criteria:\n\n* Diagnosis of mild cognitive impairment, Alzheimer's Disease, or dementia by a healthcare provider.\n* Impaired cognitive or neurologic function\n* Unstable medical condition\n* Severe depression\n* Current treatment for anxiety or depression\n* Current participation in another psychotherapy\n* Current use of psychiatric medication\n* Current substance use disorder\n* Inadequate vision or hearing to interact with study materials"}, 'identificationModule': {'nctId': 'NCT04821960', 'briefTitle': 'Memory and Fear Study (Fear of Memory Loss Study)', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Improving Emotional Well-being and Quality of Life in Older Adults Experiencing Dementia-related Fear.', 'orgStudyIdInfo': {'id': 'STU00214078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Mindfulness Program', 'description': 'Routine mindfulness lessons and activities.', 'interventionNames': ['Behavioral: Conventional Mindfulness Program']}, {'type': 'EXPERIMENTAL', 'label': 'Tailored Mindfulness Program for Fear of Memory Loss', 'description': 'Tailored mindfulness lessons and activities for fear of memory loss.', 'interventionNames': ['Behavioral: Tailored Mindfulness Program for Fear of Memory Loss']}], 'interventions': [{'name': 'Tailored Mindfulness Program for Fear of Memory Loss', 'type': 'BEHAVIORAL', 'otherNames': ['Conventional Mindfulness Program'], 'description': 'The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.', 'armGroupLabels': ['Tailored Mindfulness Program for Fear of Memory Loss']}, {'name': 'Conventional Mindfulness Program', 'type': 'BEHAVIORAL', 'description': 'Routine non-tailored mindfulness lessons and activities.', 'armGroupLabels': ['Conventional Mindfulness Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified data may be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}