Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT04368312
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2020-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychological Impairment Due to Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2020-04-09', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCL5 Questionnaire', 'timeFrame': '14 days', 'description': 'Validated 20-items questionnaire for PTSD'}, {'measure': 'BSI - Brief symptom inventory', 'timeFrame': '14 days', 'description': 'The Brief Symptom Inventory (BSI) is a 53-item screener for mental health problems with 9 subscales.'}, {'measure': 'PHQD', 'timeFrame': '14 days', 'description': 'Instrument for psychological diagnostics, able to test the severity of mental disorders and the success of their treatment'}, {'measure': 'WHO - QoL BREF', 'timeFrame': '14 days', 'description': "Qol Questionnaire, assessed QoL with respect to the individual's perceptions in the context of culture and value systems."}, {'measure': 'STAXI', 'timeFrame': '14 days', 'description': 'The State-Trait Anger Expression Inventory is used to measure the expressions \\& control of anger'}, {'measure': 'AUDIT questionnaire', 'timeFrame': '14 days', 'description': 'The AUDIT questionnaire is designed to help in the self assessment of alcohol consumption'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quality of life', 'psychological distress'], 'conditions': ['Psychological Distress', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '33937603', 'type': 'DERIVED', 'citation': 'Wesemann U, Hadjamu N, Wakili R, Willmund G, Vogel J, Rassaf T, Siebermair J. Gender Differences in Anger Among Hospital Medical Staff Exposed to Patients with COVID-19. Health Equity. 2021 Apr 19;5(1):181-184. doi: 10.1089/heq.2020.0119. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Hospital staff and emergency personnel are expected to suffer impaired psychological outcomes during a pandemic in terms of Quality of Life, anxiety, depression or other outcomes. The Covid-19 pandemic is a threat for both somatic and psychological health, therefore the impact of the impairment of this event on psychological parameters has to be assessed.', 'detailedDescription': 'Hospital staff and emergency personell are confronted with severe and life-threatening situations, therefore this group is considered to be at risk for impaired psychological health. A pandemic such as the Covid-19 endemic is suggested to severely impair the psychological state of this profession, amongst others Quality of life, anxiety, depression and other parameters. Therefore, it is crucial to assess the impact of impairment due to this global threat on the psychological health of health care providers. We therefore designed this study to evaluate baseline psychological characteristics and to re-assess those values in an interval of 60 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion of all persons which can be attributed to hospital stuff, those include doctors and nurses (male/female)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHospital staff (doctors and nurses)\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT04368312', 'briefTitle': 'Psychological Impairment Due to Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'officialTitle': 'Psychological Impairment Due to Covid-19 in Hospital Staff', 'orgStudyIdInfo': {'id': 'TEMP553914-BO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health care providers/hospital staff', 'description': 'The targeted group are doctors and nurses (hospital stuff) of a large university hospital directly confronted with patients with Cov-19', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention, just of questionnaire including validated tests', 'armGroupLabels': ['Health care providers/hospital staff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}