Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 6:01 AM
Study NCT ID:
NCT05364060
Status:
UNKNOWN
Last Update Posted:
2022-11-10
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 and Mental Health in Eure
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 585}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-06-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of prevalence of severe depression in patients followed in psychiatry in the department of Eure', 'timeFrame': 'Baseline', 'description': 'The scale used is BDI-FS-Fr (Beck Depression Inventory-Fast Screen-French) scale, composed of seven self-assessment items taken from the 21 items of the BDI-II. The BDI-FS-Fr has been validated in France.'}], 'secondaryOutcomes': [{'measure': 'Describe population characteristics', 'timeFrame': 'Baseline', 'description': 'Typical demographic information such as age, gender, education level, current living situation, etc, and characteristics related to COVID-19'}, {'measure': 'Evaluation of sleep disorder', 'timeFrame': 'Baseline', 'description': 'It will be effectuated via the Insomnia Severity Index (ISI) that is a self-reported measure assessing the subjective symptoms and consequences of insomnia, as well as the degree of worry or distress caused by sleep difficulties. The French version of the ISI has also been validated.'}, {'measure': 'Evaluation of post-traumatic stress disorder', 'timeFrame': 'Baseline', 'description': 'The evaluation of post-traumatic stress disorder is performed via the SPAN (Startle, Physiological arousal, Anger, and Numbness) scale. The SPAN is a four-item scale for post-traumatic stress disorder that was empirically derived from the DTS (Davidson Trauma Scale).\n\nThe minimum value for this scale is 0, the maximum, 16. Higher scores mean a worse outcome.'}, {'measure': 'Evaluation of positive and negative thoughts', 'timeFrame': 'Baseline', 'description': 'Both positive and negative thoughts will be assessed using two positive and negative thought screening thermometers. Scoring is calculated from 0 to 10 for each scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19', 'psychiatry'], 'conditions': ['COVID-19 Pandemic', 'Psychiatric Disorder']}, 'descriptionModule': {'briefSummary': 'Research Hypothesis: Living conditions during COVID-19, and lockdowns and curfews impact the psychological state of patients (assessed by the degree of depression, positive and negative thoughts, insomnia, state of post-traumatic stress).', 'detailedDescription': 'From the early stages of the COVID-19 pandemic, concerns were raised about its effect on mental health and on patients with mental illness. Several surveys and cross-sectional assessments, in Italy, England, Ecuador and China in 2020, have suggested that patients with COVID-19 have symptoms of anxiety (including stress disorder traumatic, depression and insomnia.\n\nIn France, a survey by "Santé Publique France" on the impact of COVID-19 on mental health carried out in November 2020, revealed a 20% rate of depressive symptoms in the general population.\n\nThe objective of this study is to assess the level of psychological distress and the prevalence of psychiatric disorders related to COVID-19 as part of the follow-up of psychiatric patients in the department of Eure since March 2020, which has coincided with the onset of the health crisis, including consecutive lockdowns and curfews.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients coming for a psychiatric consultation or hospitalization at the New Hospital of Navarre or in the extra-hospital centers of the department of Eure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old\n* Coming for a psychiatric consultation or hospitalization at the New Hospital of Navarre or in the extra-hospital centers of the department of Eure\n* Patient who has received the information note and who does not refuse to participate in the study\n\nExclusion Criteria:\n\n* Patient not understanding French\n* Patient followed in psychiatry for a major cognitive disorder\n* Patient under legal protection measure (guardianship, curatorship, safeguard of justice, future protection mandate or family authorization)'}, 'identificationModule': {'nctId': 'NCT05364060', 'acronym': 'COVID-SME', 'briefTitle': 'COVID-19 and Mental Health in Eure', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Eure-Seine'}, 'officialTitle': 'Assessment of Severe Depression Related to Psychotrauma in the COVID-19 Context in Patients Followed in Psychiatry in the Department of Eure', 'orgStudyIdInfo': {'id': '2021-A01280-41'}, 'secondaryIdInfos': [{'id': 'CHES N°21/02', 'type': 'OTHER', 'domain': 'CH Eure-Seine'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients followed in psychiatry', 'description': 'Quantitative questionnaires', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Different questionnaires detailed in the objectives part', 'armGroupLabels': ['patients followed in psychiatry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27015', 'city': 'Évreux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sorina Mihailescu, MD', 'role': 'CONTACT', 'email': 'sorina-dana.mihailescu@ch-eureseine.fr', 'phone': '+33232338833'}, {'name': 'Tarik Mazouzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Eure-Seine', 'geoPoint': {'lat': 49.02414, 'lon': 1.15082}}], 'centralContacts': [{'name': 'Sorina Mihailescu, MD', 'role': 'CONTACT', 'email': 'sorina-dana.mihailescu@ch-eureseine.fr', 'phone': '+33232338833'}], 'overallOfficials': [{'name': 'Tarik Mazouzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Hospital of Navarre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Eure-Seine', 'class': 'OTHER'}, 'collaborators': [{'name': 'New Hospital of Navarre', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}