Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-25 @ 2:13 PM
Study NCT ID:
NCT04426266
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2020-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D003863', 'term': 'Depression'}], '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': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-28', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sociodemopraphic factors', 'timeFrame': '5 months', 'description': '6 items - age, sex, city of residence, marital status, level of education, employment status'}, {'measure': 'perceived stress', 'timeFrame': '5 months', 'description': "Perceived Stress Scale (PSS), 10 items about thoughts and feelings that characterize a person's perception of stress"}, {'measure': 'level of anxiety', 'timeFrame': '5 months', 'description': 'The General Anxiety Disorder Assessment GAD-2, 2 items to examine the level of anxiety'}, {'measure': 'self-reported health state', 'timeFrame': '5 months', 'description': 'EQ5D-VAS, 1 item to examine health status'}, {'measure': 'number of complaints', 'timeFrame': '5 months', 'description': 'Self-administered inventory of complaints (Hungarian questionnaire), 20 items to measure number of complaints.'}, {'measure': 'strategies in coping with stressful situations', 'timeFrame': '5 months', 'description': 'Shortened (Hungarian) version of the Ways of Coping Questionnaire (WOC), 22 items to measure cognitive or behavioral strategies in coping with stressful situations'}, {'measure': "psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic", 'timeFrame': '5 months', 'description': "psychological effects of the coronavirus pandemic on the participants' mood and ways of coping with difficulties arising from the pandemic, 2 open-ended questions (not obligatory to answer) in connection with psychological effects of the coronavirus pandemic (its effects on the participants' mood and ways of coping with difficulties arising from the pandemic)."}, {'measure': 'level of depression', 'timeFrame': '5 months', 'description': 'The Patient Health Questionnaire PHQ-2, 2 items to examine the level of depression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Questionnaire Designs', 'COVID-19 Pandemic', 'Psychological Stress', 'Coping Skills', 'Two-Item Generalised Anxiety Disorder Scale', 'Patient Health Questionnaire Anxiety and Depression Scale', 'Health Status Index', 'Subjective Health Complaint', 'Mood']}, 'referencesModule': {'references': [{'pmid': '32093461', 'type': 'BACKGROUND', 'citation': 'Xiao C. A Novel Approach of Consultation on 2019 Novel Coronavirus (COVID-19)-Related Psychological and Mental Problems: Structured Letter Therapy. Psychiatry Investig. 2020 Feb;17(2):175-176. doi: 10.30773/pi.2020.0047. Epub 2020 Feb 25. No abstract available.'}, {'pmid': '32200399', 'type': 'BACKGROUND', 'citation': 'Ho CS, Chee CY, Ho RC. Mental Health Strategies to Combat the Psychological Impact of Coronavirus Disease 2019 (COVID-19) Beyond Paranoia and Panic. Ann Acad Med Singap. 2020 Mar 16;49(3):155-160. No abstract available.'}, {'pmid': '32155789', 'type': 'BACKGROUND', 'citation': 'Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to explore the psychological effects of the COVID-19 pandemic among Hungarian adults with the use of an anonymous online questionnaire that consists of 65 items. With these results it will possible to identify coping strategies that can help Hungarian adults to deal with the difficulties arising from the pandemic.', 'detailedDescription': 'Planned course of the project:\n\n1. We make the questionnaire using Google Forms.\n2. The link of the online questionnaire is sent to three public groups via the social media website Facebook.\n3. By clicking on the sent link, all participants are able to read information about the project and about the consent to participate in it. Then the participant will be able to give consent to participate in the project. After giving consent, the participant will be able to start filling out the questionnaire. If the participant indicates that he/she does not want to give consent to the study, the website will indicate that the participation of him/her has ended in the project.\n4. Anonymous answers will be automatically saved.\n5. The participants will be given code numbers based on the order in which they filled out the questionnaire.\n6. The data will be analysed by the researchers. For a participant, completing the online questionnaire takes approximately 10-15 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult Hungarian', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe participant must have access to the internet and to the social media website Facebook.\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT04426266', 'briefTitle': 'Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population', 'organization': {'class': 'OTHER', 'fullName': 'Szeged University'}, 'officialTitle': 'Psychological Effects of the COVID-19 Pandemic on the Hungarian Adult Population', 'orgStudyIdInfo': {'id': 'PSZ-002'}}, 'contactsLocationsModule': {'locations': [{'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'University of Szeged Department of Dermatology and Allergology', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}], 'overallOfficials': [{'name': 'Lajos Kemény, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Szeged, Department of Dermatology and Allergology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Szeged University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}