Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04555005
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2020-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mindfulness-based Crisis Intervention for COVID-19 Frontline Healthcare Workers During COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived helpfulness to reduce current stress', 'timeFrame': 'through study completion, up to three days', 'description': 'The outcome was measured by a 10-point visual analogue scale developed for this study, where 0 was "it did not help me at all" and 10 was "it helped me a lot".'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mindfulness', 'COVID-19', 'Healthcare Worker']}, 'referencesModule': {'references': [{'pmid': '33329103', 'type': 'DERIVED', 'citation': 'Rodriguez-Vega B, Palao A, Munoz-Sanjose A, Torrijos M, Aguirre P, Fernandez A, Amador B, Rocamora C, Blanco L, Marti-Esquitino J, Ortiz-Villalobos A, Alonso-Sanudo M, Cebolla S, Curto J, Villanueva R, de-la-Iglesia MJ, Carracedo D, Casado C, Vidal E, Trigo D, Iglesias N, Cabanas D, Mellado L, Garcia D, Fernandez-Encinas C, Navarro R, Mediavilla R, Vidal-Villegas MP, Bravo-Ortiz MF, Bayon C. Implementation of a Mindfulness-Based Crisis Intervention for Frontline Healthcare Workers During the COVID-19 Outbreak in a Public General Hospital in Madrid, Spain. Front Psychiatry. 2020 Oct 30;11:562578. doi: 10.3389/fpsyt.2020.562578. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The COVID-19 outbreak is having an impact on the well-being of healthcare workers. Previous reports on pandemics show that such an impact may last beyond the time of the outbreak. Mindfulness-based interventions help healthcare professionals to reduce stress and may foster resilience and recovery, although they have never been tested in a context such as the current one. This single-arm trial explores the acceptability, safety and usefulness of an on-site, brief Mindfulness-based intervention to reduce stress for front line health workers during a crisis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All frontline healthcare workers present in the ward at the time of intervention\n\nExclusion Criteria:\n\n* Extreme adverse events'}, 'identificationModule': {'nctId': 'NCT04555005', 'briefTitle': 'Mindfulness-based Crisis Intervention for COVID-19 Frontline Healthcare Workers During COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Hospital Universitario La Paz'}, 'officialTitle': 'Implementation of a Mindfulness-based Crisis Intervention for Frontline Healthcare Workers During the COVID-19 Outbreak in a Public General Hospital in Madrid, Spain', 'orgStudyIdInfo': {'id': 'Mind-COVID-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mindfulness based intervention', 'description': 'Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak', 'interventionNames': ['Other: Mindfulness based intervention']}], 'interventions': [{'name': 'Mindfulness based intervention', 'type': 'OTHER', 'description': 'Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak', 'armGroupLabels': ['Mindfulness based intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'La Paz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Hospital Universitario La Paz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}