Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 6:14 AM
Study NCT ID:
NCT04344834
Status:
UNKNOWN
Last Update Posted:
2021-03-18
First Post:
2020-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short and Long-term Psychological Impact of Covid-19 on The Egyptians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], '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'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2020-04-11', 'studyFirstSubmitQcDate': '2020-04-13', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': '6 months', 'description': 'Hamilton depression scale:The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe). For the 17-item version, scores can range from 0 to 54.Where total scores between 0 and 7 do not indicate the presence of depression, scores between 8 and 13 indicate mild depression, scores between 14 and 18 indicate moderate depression, scores between 19 and 22 indicate severe depression and 23 score or more indicate very severe depression.'}, {'measure': 'Anxiety', 'timeFrame': '6 months', 'description': 'Hamilton anxiety scale:The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where total score 0 -13=normal, 14-17 = mild anxiety, 18-24 = moderate anxiety, 25-30 = severe anxiety.'}, {'measure': 'Obsessive compulsive disorder', 'timeFrame': '6 months', 'description': 'Yale-Brown Obsessive Compulsive Scale (OCD): Each item is rated from 0 (no symptoms) to 4 (extreme symptoms). A score of 0-7 is considered nonclinical. Scores ranging between 8 and 15 are considered mild. Scores between 16 and 23 are considered moderate and scores between 24-31 and 32-40 are considered severe and extreme, respectively.'}, {'measure': 'Sleep disorder', 'timeFrame': '6 months', 'description': 'Pitsburgh sleep quality index'}, {'measure': 'Psychological problems', 'timeFrame': '6 months', 'description': 'Symptom checklist 90'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'Egyptian', 'Health workers', 'population', 'mental health'], 'conditions': ['Mental Health Issue']}, 'descriptionModule': {'briefSummary': 'The World Health Organization (WHO) has recently declared coronavirus disease 2019 (Covid-19) a public health emergency of international concern. Impact of the pandemic of covid-19 on the mental health of patients, health care workers and general population would be affected.', 'detailedDescription': 'Health care workers and general population will be included in the study. A questionnaire will be used to assess their knowledge and practices regarding covid-19 and its impact on mental health.\n\nPatients Mental health will be assessed regarding anxiety, depression and obsessive compulsive disorder, sleep disorder will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health care workers, patients recovered from COVID-19 and general population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Egyptian population\n\nExclusion Criteria:\n\n* Patients not accepting to participate in the questionnaire'}, 'identificationModule': {'nctId': 'NCT04344834', 'briefTitle': 'Short and Long-term Psychological Impact of Covid-19 on The Egyptians', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Psychological Impact of Covid-19 on The Egyptians', 'orgStudyIdInfo': {'id': 'Covid-19 mental health'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health care workers', 'description': 'Egyptian health care workers', 'interventionNames': ['Diagnostic Test: A questionnaire or scales']}, {'label': 'General population', 'description': 'Any Egyptian personnel', 'interventionNames': ['Diagnostic Test: A questionnaire or scales']}, {'label': 'Recovered fromCOVID-19', 'description': 'Patients recovered from COVID-19', 'interventionNames': ['Diagnostic Test: A questionnaire or scales']}], 'interventions': [{'name': 'A questionnaire or scales', 'type': 'DIAGNOSTIC_TEST', 'description': 'A questionnaire or scale to assess the participants mental health.', 'armGroupLabels': ['General population', 'Health care workers', 'Recovered fromCOVID-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Gellan Ahmed', 'role': 'CONTACT'}], 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Gellan Ahmed, Phd', 'role': 'CONTACT', 'email': 'gillankaram@aun.edu.eg', 'phone': '+201093663928'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only the data described in the results of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Psychiatry', 'investigatorFullName': 'Gellan Karamalllah Ramadan Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}