Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT04407195
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2020-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 and Mental Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D001523', 'term': 'Mental Disorders'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emotional Impact', 'timeFrame': '7 days', 'description': 'The Impact of Event Scale - Revised (IES-R). IES-R is a 22-item scale with possible scores ranging from 0 - 88. Scores higher than 24 are of concern indicating possible health and well-being consequences.'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': '2 weeks', 'description': 'Patient Health Questionaire (PHQ-9). The PHQ-9 has a range from 0 - 27. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.'}, {'measure': 'Anxiety', 'timeFrame': '2 weeks', 'description': 'Generalized Anxiety Disorder 7-item (GAD-7). Scores range from 0 - 21. When screening for anxiety disorders, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder.'}, {'measure': 'Insomnia', 'timeFrame': '1 week', 'description': 'The ISI7 is a 7-item instrument designed to assess the nature, severity, and impact of insomnia in adults. Scores range from 0 - 28. Higher scores indicate increased likelihood of sleep disturbances.'}, {'measure': 'Resilience', 'timeFrame': '2 Weeks', 'description': 'Brief Resilience Scale (BRS) is a 6-item scale with scores ranging from 6-30 with higher scores indicating greater resilience.'}, {'measure': 'Crisis Support Scale', 'timeFrame': '2 weeks', 'description': 'The Crisis Support Scale (CSS) is a 7-item instrument developed to measure received social support. Scores range from 7 - 98, with higher scores correlating with increased social support.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Mental Health Disorder']}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to assess the enormity of mental health outcomes among healthcare providers (nurses and physicians) exposed to COVID-19 during the time of the pandemic in the United States, specifically targeting those areas most effected.', 'detailedDescription': 'Healthcare providers (nurses and physicians) on the frontlines of the COVID-19 response are facing a critical situation and are subject to increased psychological distress. Those directly involved in the diagnosis, treatment and care of patients with COVID-19 are at significant risk of developing physical, psychological, and psychosocial distress.\n\nThe data examined in this study will further clarify the mental distress experienced by healthcare workers and lead to the development of peer-support and educational initiatives to improve these findings. The central hypothesis of this research is that high levels of mental distress will be associated with caring for patients with COVID-19.\n\nThis study will use an observational, cross-sectional on-line survey design. Participants will complete a 15 minute self-administered questionnaire. All data will be de-identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include physicians and nurse who interact with patients with known or suspected COVID-19.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthcare providers (physicians and nurse) working in institutions with known or suspected COVID-19.\n\nExclusion Criteria:\n\n* Nurses and physicians who are retired, or not currently employed or not working in an environment with known or suspected COVID-19.'}, 'identificationModule': {'nctId': 'NCT04407195', 'briefTitle': 'COVID-19 and Mental Health', 'organization': {'class': 'OTHER', 'fullName': 'Northeastern University'}, 'officialTitle': 'Mental Health Outcomes Among US Healthcare Workers Exposed to COVID-19', 'orgStudyIdInfo': {'id': '20-05-22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthcare Providers', 'description': 'Healthcare workers (physicians and nurses) who have interacted with patients with known or suspected COVID-19.', 'interventionNames': ['Other: Exposure to the SARS-CoV-2']}], 'interventions': [{'name': 'Exposure to the SARS-CoV-2', 'type': 'OTHER', 'description': 'This is an observational design. Participants are exposed to the Covid-19 pandemic.', 'armGroupLabels': ['Healthcare Providers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Northeastern University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northeastern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kara Pavone', 'investigatorAffiliation': 'Northeastern University'}}}}