Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-03-25 @ 7:08 AM
Study NCT ID:
NCT04589195
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2020-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Mindfulness Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-12', 'studyFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2020-10-09', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Psychological Health', 'timeFrame': 'Baseline to Week 5', 'description': 'Patient Health Questionnaire (PHQ4) will be used to assess depression and anxiety. PHQ has a range of scores from 0 to 12, with a higher score indicating higher level of depression and anxiety.'}, {'measure': 'Change in Mindfulness', 'timeFrame': 'Baseline to Week 5', 'description': 'Mindfulness will be measured with the short 15-item version of the Five-Facet Mindfulness Questionnaire (FFMQ-15). FFMQ-15 has a range of scores from 15 to 75, with a higher score indicating a greater level of mindfulness.'}, {'measure': 'Change in Decentering', 'timeFrame': 'Baseline to Week 5', 'description': 'Decentering will be measured with the decentering scale from the Experience Questionnaire (EQ-D). EQ-D has a range of scores from 11 to 55, with a higher score indicating a greater level of decentering.'}], 'primaryOutcomes': [{'measure': 'Change in Positive Affect', 'timeFrame': 'Baseline to Week 5', 'description': 'Positive affect will be measured with the 10-item version of the Positive and Negative Affect Schedule (PANAS-10). The PANAS positive sub-scale has 5 items and a range of scores from 5 to 25, with a higher score indicating a higher positive mood.'}, {'measure': 'Change in Negative Affect', 'timeFrame': 'Baseline to Week 5', 'description': 'Negative affect will be measured with the 10-item version of the Positive and Negative Affect Schedule (PANAS-10). The PANAS negative sub-scale has 5 items and a range of scores from 5 to 25, with a higher score indicating a higher negative mood.'}, {'measure': 'Change in Perceived Stress', 'timeFrame': 'Baseline to Week 5', 'description': 'Perceived Stress will be measured with the Perceived Stress Scale (PSS). PSS has a range of scores from 0 to 40, with a higher score indicates a higher level of perceived stress.'}], 'secondaryOutcomes': [{'measure': 'Change in Sustained Attention Response Task (SART) scores', 'timeFrame': 'Baseline to Week 5', 'description': 'The SART involves pressing a button to frequently presented non-target trials and withholding the button press to the infrequent target trials. The participants can have a total score between 0 and 100%, with a higher score indicating butter sustained attention.'}, {'measure': 'Change in Cognitive Failures', 'timeFrame': 'Baseline to Week 5', 'description': 'Cognitive Failures will be measured with the Cognitive Failures Questionnaire (CFQ). CFQ has a range of scores from 0 to 100, with a higher score indicating more cognitive failures.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness Training', 'Cognitive Training', 'Psychological Health'], 'conditions': ['Cognitive Change']}, 'descriptionModule': {'briefSummary': 'The purpose of the research study is to learn more about how ROTC cadets may engage with mindfulness training program content that is delivered through a smartphone or website application. Mindfulness training program content includes mindfulness practices that foster attention and awareness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals who are between 18 and 64 years of age.\n2. Individuals who are fluent English speakers.\n3. Individuals who have access to either an Apple or Android smart phone and a desktop or laptop computer, are able to adequately and independently use both devices, and have Internet connection.\n4. Individuals who are willing and able to consent to participate in the study.\n5. Individuals who are in the South Florida ROTC program.\n\nExclusion Criteria:\n\n1.Individuals with an active and untreated mental condition (e.g., Bipolar disorder, Major Depression) and/or hospitalization for psychological/mental health issues within the last month.'}, 'identificationModule': {'nctId': 'NCT04589195', 'briefTitle': 'Measuring Mindfulness Application', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Measurement of an Application - Based Delivery of Mindfulness Training Program Content', 'orgStudyIdInfo': {'id': '20201140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness Training (MT) Group', 'description': 'Participants will receive four weeks of MT.', 'interventionNames': ['Behavioral: Mindfulness Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wait List MT Group', 'description': 'Participants will receive four weeks of MT training after a five week washout period.', 'interventionNames': ['Behavioral: Mindfulness Training']}], 'interventions': [{'name': 'Mindfulness Training', 'type': 'BEHAVIORAL', 'description': 'The intervention includes four weeks of MT application use, accessed via phone or computer, consisting of 15-minute daily mindfulness practices 5 days a week.', 'armGroupLabels': ['Mindfulness Training (MT) Group', 'Wait List MT Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}], 'overallOfficials': [{'name': 'Amishi Jha, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Amishi Jha', 'investigatorAffiliation': 'University of Miami'}}}}