Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT04576832
Status:
TERMINATED
Last Update Posted:
2024-06-28
First Post:
2020-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness Training for Senior Leaders
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': 91}}, 'statusModule': {'whyStopped': 'Due to an enrollment strategy change', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Leadership Questionnaire', 'timeFrame': 'Baseline (T1) to post-4-week training interval (T2).', 'description': 'Leadership Questionnaire consists of a set of questions that gather information about the self-reported leadership skills and attitudes of Senior Army leaders.'}, {'measure': 'Change in Anger score', 'timeFrame': 'Baseline (T1) to post-4-week training interval (T2).', 'description': 'Dimensions of Anger Reactions (DAR-5) is a self-report measure of anger frequency, intensity, duration, aggression, and impact on social functioning over the past 4 weeks. The scale includes 4 items with a score range of 5-25. Higher scores indicate greater anger levels.'}, {'measure': 'Change in Marital Satisfaction', 'timeFrame': 'Baseline (T1) to post-4-week training interval (T2).', 'description': "Marital Satisfaction Questionnaire (MSAT) measures one's satisfaction in their current relationship. The scale includes 4 items with a score range of 3-21. Higher scores indicate greater satisfaction with a current relationship."}, {'measure': 'Applied Mindfulness Practice', 'timeFrame': 'Post-4-week training interval 1 (T2) and post-4-week training interval 2 (T3).', 'description': "The Applied Mindfulness Process Scale (AMPS) measures one's daily enactment of mindfulness in daily life. Total score ranges from 0 to 60: a higher score indicates a greater application of mindfulness in everyday life."}], 'primaryOutcomes': [{'measure': 'Change in Sustained attention to response task (SART) score', 'timeFrame': 'Baseline (T1) to post-4-week training interval (T2).', 'description': 'The SART involves pressing a button to frequently presented non-target trials (numbers 1, 2, 4, 5, 6, 7, 8, and 9) and withholding the button press to the infrequent target trials (number 3). The participants can have a total score between 0 and 100% with a higher score indicating better sustained attention.'}], 'secondaryOutcomes': [{'measure': 'Change in 5FMQ scores', 'timeFrame': 'Baseline (T1) to post-4-week training interval (T2).', 'description': "Five-Facet Mindfulness Questionnaire (5FMQ) is used to assess the five major aspects of mindfulness. The present study will use the 15-item short version. The scores range from 15 to 75, with higher scores indicating greater levels of mindfulness in different aspects of one's life."}, {'measure': 'Change in Decentering score', 'timeFrame': 'Baseline (T1) to post-4-week training interval (T2).', 'description': 'Decentering consists of 11 items measuring various thoughts and experiences, and the tendency to distance from those. The decentering score ranges from 1 to 55, with a higher score indicating a high level of decentering.'}, {'measure': 'Change in PANAS positive affect score', 'timeFrame': 'Baseline (T1) to post-4-week training interval (T2).', 'description': 'Positive and Negative Affect Scale (PANAS) is a widely used self-reported measure of positive and negative affect. The present study will use a short version with a 5-item positive subscale. The score ranges from 5 to 25 with a higher score indicating a higher positive mood.'}, {'measure': 'Change in PANAS negative affect score', 'timeFrame': 'Baseline (T1) to post-4-week training interval (T2).', 'description': 'Positive and Negative Affect Scale (PANAS) is a widely used self-reported measure of positive and negative affect. The present study will use a short version with a 5-item negative subscale. The score ranges from 5 to 25 with a higher score indicating a higher negative mood.'}, {'measure': 'Change in PSS score', 'timeFrame': 'Baseline (T1) to post-4-week training interval (T2).', 'description': "Perceived Stress Scale (PSS) is a questionnaire measuring the degree to which situations in one's life are viewed as stressful within the past month. The present study will use the 4-item short version, with the total score ranging from 0 to 16, with a higher score indicating a higher level of perceived stress."}, {'measure': 'Change in PHQ4 scores', 'timeFrame': 'Baseline (T1) to post-4-week training interval (T2).', 'description': 'Patient Health Questionnaire 4 items (PHQ4) is an ultra-brief 4-item measure of depression and anxiety in the general population with the total score ranging from 0 to 12. Higher score indicates higher level of anxiety and depression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindfulness training', 'psychological health'], 'conditions': ['Cognitive Change']}, 'descriptionModule': {'briefSummary': 'The overarching goal of the project is to investigate if a mindfulness-based attention training (MBAT) program contextualized for Military Senior Leaders (SLs) might benefit SLs in three key domains: (1) cognitive abilities, (2) psychological well-being and self-reported physical health, and (3) strategic leadership skills and ability. The MBAT-SL program will be tested by the training cohorts and compared to the wait-list control cohorts who will receive the training after a no-training interval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals who are between 18 and 65 years of age.\n2. Individuals who are fluent English speakers.\n3. Individuals who are active-duty service members\n4. Individuals who are willing and able to consent to participate in the study.\n5. Individuals who participated in the courses provided by the Army War College (AWC).\n\nExclusion Criteria:\n\n1\\. Individuals who have been hospitalized for psychological/mental health issues within the last month'}, 'identificationModule': {'nctId': 'NCT04576832', 'briefTitle': 'Mindfulness Training for Senior Leaders', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Mindfulness Training for U.S. Army Senior Leaders', 'orgStudyIdInfo': {'id': '20201075'}, 'secondaryIdInfos': [{'id': 'W911QY-17-C-0101', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (MT group)', 'description': 'Participants will receive 4 weeks of mindfulness training during the first training interval between the first (T1) and second (T2) assessment sessions.', 'interventionNames': ['Behavioral: Mindfulness-Based Attention Training (MBAT) web-course']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (Wait-list group)', 'description': 'Participants will not receive 4 weeks of mindfulness training during the first training interval; they will receive 4 weeks of mindfulness training during the second training interval between the second (T2) and third (T3) assessment sessions.', 'interventionNames': ['Behavioral: Mindfulness-Based Attention Training (MBAT) web-course']}], 'interventions': [{'name': 'Mindfulness-Based Attention Training (MBAT) web-course', 'type': 'BEHAVIORAL', 'description': 'Pre-recorded weekly sessions for 4 weeks. Each session will consist of approximately 2 hours of video content per week and weekly mindfulness exercises. This video will include MBAT program lectures, pre-recorded testimony from military leaders, and teaching materials. The course will also include 15-min daily mindfulness practice drills.', 'armGroupLabels': ['Group A (MT group)', 'Group B (Wait-list 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', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Amishi Jha', 'investigatorAffiliation': 'University of Miami'}}}}