Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-02 @ 8:38 PM
Study NCT ID:
NCT04122534
Status:
COMPLETED
Last Update Posted:
2020-12-31
First Post:
2019-09-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample
Sponsor:
Organization:
Raw JSON
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Knight', 'organization': 'Montana State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Outcome measures collected during COVID-19 pandemic.'}}, 'adverseEventsModule': {'timeFrame': '15 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group', 'description': 'Treatment groups receives the intervention training.\n\nSomatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Secondary Traumatic Stress Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Treatment groups receives the intervention training.\n\nSomatic Mindfulness Training: Educational and experiential training to reduce occupational-based secondary trauma.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.23', 'spread': '13.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This outcome measure will be assessed at week 15.', 'description': 'Measures occupational-based secondary traumatic stress using a total scale range of 17(min) to 85 (max). 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Scores above 37 indicate moderate or higher secondary traumatic stress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data.'}, {'title': 'Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31.42', 'spread': '15.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measures symptoms of post-traumatic stress disorder using a total scale range of 0 (min) to 80 (max), with a score of 33 or higher indicating that participants maybe suffering from Post Traumatic Stress Disorder.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-08', 'size': 1037031, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-12-07T20:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2019-09-28', 'resultsFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-07', 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Secondary Traumatic Stress Scale', 'timeFrame': 'This outcome measure will be assessed at week 15.', 'description': 'Measures occupational-based secondary traumatic stress using a total scale range of 17(min) to 85 (max). Scores above 37 indicate moderate or higher secondary traumatic stress.'}], 'secondaryOutcomes': [{'measure': 'Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)', 'timeFrame': 'This outcome measure will be assessed at week 15.', 'description': 'Measures symptoms of post-traumatic stress disorder using a total scale range of 0 (min) to 80 (max), with a score of 33 or higher indicating that participants maybe suffering from Post Traumatic Stress Disorder.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Occupational-based Secondary Trauma']}, 'descriptionModule': {'briefSummary': 'This pilot study evaluates a somatic mindfulness training. Reductions in mental and physical health correlates of secondary trauma are assessed using a pretest-posttest design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be either employed or volunteering as a victim service provider, or enrolled at Montana State University as an undergraduate student.\n\nExclusion Criteria:\n\n* Participant is under age 18.'}, 'identificationModule': {'nctId': 'NCT04122534', 'briefTitle': 'Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample', 'organization': {'class': 'OTHER', 'fullName': 'Montana State University'}, 'officialTitle': 'Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample', 'orgStudyIdInfo': {'id': '1111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Treatment groups receives the intervention training.', 'interventionNames': ['Behavioral: Somatic Mindfulness Training']}], 'interventions': [{'name': 'Somatic Mindfulness Training', 'type': 'BEHAVIORAL', 'description': 'Educational and experiential training to reduce occupational-based secondary trauma.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59717', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'Montana State University', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montana State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kelly Knight', 'investigatorAffiliation': 'Montana State University'}}}}