Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-15 @ 1:15 AM
Study NCT ID:
NCT04357418
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012934', 'term': 'Social Isolation'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-18', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)', 'description': 'The "State Trait Inventory Anxiety" is widely used both in practice and in clinical research. It consists of separate scales for assessing state (STAI form Y-A) and trait (STAI form Y-B). Each of the scales includes 20 items, the E scale to assess how subjects feel at the time, the T scale to capture how subjects feel generally.The STAI is intended for self-administration. It can be completed individually or in a group.'}, {'measure': 'State Anxiety assessed by the State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'Up to one month and a half after the end of the lockdown (from May 11th to June 25th)', 'description': 'The "State Trait Inventory Anxiety" is widely used both in practice and in clinical research. It consists of separate scales for assessing state (STAI form Y-A) and trait (STAI form Y-B). Each of the scales includes 20 items, the E scale to assess how subjects feel at the time, the T scale to capture how subjects feel generally.The STAI is intended for self-administration. It can be completed individually or in a group.'}], 'secondaryOutcomes': [{'measure': 'Visual numeric scales assessing anger and stress the ongoing week.', 'timeFrame': 'Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)', 'description': '1 to 7 Likert scales. Anger scale going from "No anger, at no time" to "strong and sustained anger". Stress scale going from "No stress, at no time" to "strong and sustained stress".'}, {'measure': 'Visual numeric scales assessing anger and stress the ongoing week.', 'timeFrame': 'Up to one month and a half after the end of the lockdown (from May 11th to June 25th)', 'description': '1 to 7 Likert scales. Anger scale going from "No anger, at no time" to "strong and sustained anger". Stress scale going from "No stress, at no time" to "strong and sustained stress".'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'Up to one month and a half after the beginning of the lockdown (From March 17th to May 1st 2020)', 'description': 'The tool provides a quantitative estimate of the intensity of depressive feelings.'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'Up to one month and a half after the end of the lockdown (from May 11th to June 25th)', 'description': 'The tool provides a quantitative estimate of the intensity of depressive feelings.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety', 'depression', 'anger', 'quarantine', 'health care workers'], 'conditions': ['Anxiety State', 'COVID-19', 'Isolation, Social', 'Health Personnel Attitude']}, 'descriptionModule': {'briefSummary': 'The purpose of the investigators is to study the psychological impact of the COVID-19 lockdown on the members of the Ville Evrard Hospital staff and their close relatives, and to identify potential lockdown conditions that could increase anxiety, anger and depressive symptoms in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is about hospital staff and close relatives', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For hospital staff: Adult members of the Ville Evrard Hospital staff (trainees or employees) willing to participate to at least one survey during the COVID lockdown.\n* For close relatives: Adult relatives of the Ville Evrard Hospital staff members, living or not with them.\n\nExclusion Criteria:\n\n* NONE'}, 'identificationModule': {'nctId': 'NCT04357418', 'acronym': 'ICOS', 'briefTitle': 'Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives', 'organization': {'class': 'OTHER', 'fullName': 'Centre hospitalier de Ville-Evrard, France'}, 'officialTitle': 'Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives (ICOS)', 'orgStudyIdInfo': {'id': '10477M-ICOS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hospital staff', 'interventionNames': ['Other: it is a survey']}, {'label': 'close relatives.', 'interventionNames': ['Other: it is a survey']}], 'interventions': [{'name': 'it is a survey', 'type': 'OTHER', 'description': 'this interview can be carried out face to face or remotely.', 'armGroupLabels': ['close relatives.', 'hospital staff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93330', 'city': 'Neuilly-sur-Marne', 'country': 'France', 'facility': 'URC Ville Evrard', 'geoPoint': {'lat': 48.85373, 'lon': 2.54903}}], 'overallOfficials': [{'name': 'Clemence ISAAC, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Ville Evrard'}, {'name': 'Dominique JANUEL, Pr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CH Ville Evrard'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre hospitalier de Ville-Evrard, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Psychologist', 'investigatorFullName': 'Clémence ISAAC', 'investigatorAffiliation': 'Centre hospitalier de Ville-Evrard, France'}}}}