Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-28 @ 2:18 PM
Study NCT ID:
NCT04365361
Status:
UNKNOWN
Last Update Posted:
2021-12-10
First Post:
2020-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Psychological Impact of the COVID-19 on Students.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-27', 'studyFirstSubmitDate': '2020-04-25', 'studyFirstSubmitQcDate': '2020-04-25', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress level', 'timeFrame': 'baseline', 'description': 'measured by Stress Scale'}], 'secondaryOutcomes': [{'measure': 'Anxiety and depressive symptoms', 'timeFrame': 'baseline', 'description': 'measured by a 4-item Patient Health Questionnaire'}, {'measure': 'Insomnia symptoms and the associated daytime impairment', 'timeFrame': 'baseline', 'description': 'measured by 7-item Insomnia Severity Index'}, {'measure': 'Psychological response to trauma', 'timeFrame': 'baseline', 'description': 'measured by a 22-item Impact of Event Scale -Revised'}, {'measure': 'Resilience', 'timeFrame': 'baseline', 'description': 'measured by a 2-item Connor-Davidson Resilience Scale'}, {'measure': 'Attitude and practice students regarding preventive measures', 'timeFrame': 'baseline', 'description': 'measured by outcome-based questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress', 'Depression', 'Higher education students', 'Psychological impact'], 'conditions': ['Mental Health Wellness 1']}, 'referencesModule': {'references': [{'pmid': '32043982', 'type': 'BACKGROUND', 'citation': 'Bao Y, Sun Y, Meng S, Shi J, Lu L. 2019-nCoV epidemic: address mental health care to empower society. Lancet. 2020 Feb 22;395(10224):e37-e38. doi: 10.1016/S0140-6736(20)30309-3. Epub 2020 Feb 7. No abstract available.'}, {'pmid': '16278502', 'type': 'BACKGROUND', 'citation': 'Hysenbegasi A, Hass SL, Rowland CR. The impact of depression on the academic productivity of university students. J Ment Health Policy Econ. 2005 Sep;8(3):145-51.'}, {'pmid': '36232227', 'type': 'DERIVED', 'citation': 'Lai AYK, Cheung GOC, Choi ACM, Wang MP, Chan PSL, Lam AHY, Lo EWS, Lin CC, Lam TH. Mental Health, Support System, and Perceived Usefulness of Support in University Students in Hong Kong Amidst COVID-19 Pandemic: A Mixed-Method Survey. Int J Environ Res Public Health. 2022 Oct 9;19(19):12931. doi: 10.3390/ijerph191912931.'}, {'pmid': '34966299', 'type': 'DERIVED', 'citation': 'Lai AY, Sit SM, Lam SK, Choi AC, Yiu DY, Lai TT, Ip MS, Lam TH. A Phenomenological Study on the Positive and Negative Experiences of Chinese International University Students From Hong Kong Studying in the U.K. and U.S. in the Early Stage of the COVID-19 Pandemic. Front Psychiatry. 2021 Dec 13;12:738474. doi: 10.3389/fpsyt.2021.738474. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The COVID-19 outbreak has been rapidly transmitted in late January 2020 and aroused enormous attention globally. The public at large may also experience boredom, disappointment, and irritability under the isolation measures. Depression and anxiety are common mental health problems experienced by university students. This survey aims to investigate the psychological impact of COVID 19 on students.', 'detailedDescription': "The COVID-19 outbreak has been rapidly transmitted in late January 2020 and aroused enormous attention globally. Infected patients may develop severe and even fatal respiratory diseases (e.g., acute respiratory distress syndrome (ARDS) and acute respiratory failure) ending up in intensive care. Apart from physical suffering, it is not uncommon for confirmed or suspected cases of COVID-19 to suffer from great psychological pressure and other health-related problems. The limited knowledge of the COVID-19 and the overwhelming news may lead to anxiety and fear in the public. The public at large may also experience boredom, disappointment, and irritability under the isolation measures.\n\nDepression and anxiety are common mental health problems experienced by university students. Being in higher education is associated with many stressors and transitional events, and students fall within the age range when common mental health problems are at their developmental peak. Depression and anxiety can impair students' academic performance and social functioning, cause significant burden at university, and potentially affect their future career opportunities. The study includes 2 parts. Part A is an online survey study with non-probabilistic convenience sampling and part B is focus group interviews.\n\nThis study aims to explore the psychological impact of COVID-19 and coping methods in higher education students."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Part A: An online survey study with non-probabilistic convenience sampling n=384\n\nPart B: Focus group interviews n=32', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Higher education students aged 18 years and above\n\nExclusion Criteria:\n\n• Subjects refuse to answer this questionnaire'}, 'identificationModule': {'nctId': 'NCT04365361', 'briefTitle': 'The Psychological Impact of the COVID-19 on Students.', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Exploring the Psychological Impact of the COVID-19 on Higher Education Students', 'orgStudyIdInfo': {'id': 'UW20-298'}}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'LAI Agnes, PhD', 'role': 'CONTACT', 'email': 'agneslai@hku.hk', 'phone': '39173628'}, {'name': 'Kelvin Wang, PhD', 'role': 'CONTACT', 'email': 'mpwang@hku.hk', 'phone': '3917'}], 'facility': 'LAI Agnes', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'LAI YK Agnes, PhD', 'role': 'CONTACT', 'email': 'agneslai@hku.hk', 'phone': '+85239176779238'}, {'name': 'Kelvin MP Wang, PhD', 'role': 'CONTACT', 'email': 'mpwang@hku.hk', 'phone': '+85239176636'}], 'overallOfficials': [{'name': 'Agnes YK Lai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Nursing, The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "It was not included in the participants' consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr. Agnes Yuen-Kwan Lai', 'investigatorAffiliation': 'The University of Hong Kong'}}}}