Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT06582927
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-28
First Post:
2024-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mindfulness Training for First Responders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in sustained attention', 'timeFrame': 'Baseline to week 11', 'description': 'The Sustained Attention to Response Task (SART) is used to assess attentional performance and mind wandering (i.e., off-task thinking which is typically self-generated and compromises the performance of the task at hand). The task uses a continuous performance paradigm involving button presses to frequently presented nontargets (numbers 0, 1, 2, 4, 5, 6, 7, 8, and 9) but requires the participants to withhold their motor response to the infrequent target (number 3). Withholding responses only to infrequent targets encourages a pre-potent response and mind wandering. Real-time subjective experience of mind wandering during SART is assessed through experience-sampling probes randomly presented throughout the task.'}, {'measure': 'Change in resilience', 'timeFrame': 'Baseline to week 11', 'description': 'Resilience is assessed via the 6-item Brief Resilience Scale (BRS). The scores range from 6 to 30, with a higher score indicating a higher level of resilience.'}], 'secondaryOutcomes': [{'measure': 'Change in decentering', 'timeFrame': 'Baseline to week 11', 'description': 'Decentering is assessed via the 11-item decentering sub-scale of the experience questionnaire (EQ-D). The decentering score ranges from 1 to 55, with a higher score indicating a higher level of decentering.'}, {'measure': 'Change in positive affect', 'timeFrame': 'Baseline to week 11', 'description': 'Positive Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Positive has 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 11', 'description': 'Negative Affect is assessed with the 5-item negative sub-scale from Positive and Negative Affect Schedule (PANAS-10). PANAS Negative has 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 11', 'description': 'Perceived stress is assessed with the 4-item Perceived Stress Scale (PSS-4). PSS-4 has a range of scores from 0 to 16, with a higher score indicating a higher level of perceived stress.'}, {'measure': 'Change in burnout', 'timeFrame': 'Baseline to week 11', 'description': 'Burnout is assessed with the 12-item Burnout Assessment Tool (BAT-12). BAT-12 has a range of score from 1 to 5, with a higher score indicated a higher level of burnout.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burnout']}, 'descriptionModule': {'briefSummary': 'The present study evaluates the efficacy of Mindfulness-Based Attention Training on measures targeting cognitive abilities and emotional well-being in first responders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals who are between 18 and 75 years of age\n2. Individuals who are fluent English speakers\n3. Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection\n4. Individuals who are willing and able to consent to participate in the study\n5. Participants in all phases of the study must be individuals who are affiliated with the Los Angeles County Fire Department peer support group.\n\nExclusion Criteria:\n\n1\\. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month'}, 'identificationModule': {'nctId': 'NCT06582927', 'briefTitle': 'Mindfulness Training for First Responders', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Mindfulness Training for First Responders', 'orgStudyIdInfo': {'id': '20240877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness Training Group A', 'description': 'Participants in this group will receive mindfulness training in up to 8 weeks.', 'interventionNames': ['Behavioral: Mindfulness-Based Attention Training (MBAT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wait-list condition Group B', 'description': 'Participants in this group will be on a waiting list to receive the identical intervention as the experimental group at a later time. Total participation in the mindfulness training will be 8 weeks', 'interventionNames': ['Behavioral: Mindfulness-Based Attention Training (MBAT)']}], 'interventions': [{'name': 'Mindfulness-Based Attention Training (MBAT)', 'type': 'BEHAVIORAL', 'description': 'MBAT is an evidence-based 8-hour mindfulness program that comprises 4 central topics and associated practices. The concentration topic introduces participants to mindfulness "basics," including discussion of focused attention and mind wandering. The body awareness theme involves the cultivation of greater self-awareness, and the development of equanimity. The open monitoring theme emphasizes awareness of and receptivity to changing experiences and moments of uncertainty. The theme of connection addresses leadership and group cohesion, and the cultivation of kindness and connection with others.\n\nThe course content and materials in the present study will entail the foundational MBAT curriculum and other related content delivered virtually over Zoom but will consist of 8, 1-hour sessions delivered across 8 consecutive weeks.', 'armGroupLabels': ['Mindfulness Training Group A', 'Wait-list condition Group B']}]}, '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'}, 'collaborators': [{'name': 'Unlikely Collaborators Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Amishi Jha', 'investigatorAffiliation': 'University of Miami'}}}}