Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
Study NCT ID:
NCT04331106
Status:
UNKNOWN
Last Update Posted:
2021-01-27
First Post:
2020-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Survey of the Anxiety Associated With the COVID-19 Pandemic
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': 'D000092862', 'term': 'Psychological Well-Being'}, {'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'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2020-03-27', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristics of COVID-19-related anxiety', 'timeFrame': '1 day', 'description': 'To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.'}, {'measure': 'COVID-19-related anxiety symptoms', 'timeFrame': '1 day', 'description': 'Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.'}], 'secondaryOutcomes': [{'measure': 'Self-efficacy and coping with COVID-19', 'timeFrame': 'baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months', 'description': 'Self-efficacy and coping with the COVID-19 pandemic are measured with 13 self created items. Values ranging from 1 to 6; higher scores indicate a better outcome (except inverted items).'}, {'measure': 'Consequences of COVID-19 in the last three weeks.', 'timeFrame': 'baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months', 'description': 'Personal consequences of the COVID-19 pandemic in the last three weeks are collected with five self-created items.'}, {'measure': 'General Illness Attitude', 'timeFrame': 'baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months', 'description': 'General illness attitudes are measured with 3 subscales (Worry about illness; Thanatophobia; Bodily preoccupations) of the German version of the Illness Attitude Scales (IAS) by Hiller \\& Rief (2004). 9 Items; values ranging from 1 to 5, higher scores indicate a worse outcome.'}, {'measure': 'Media reporting', 'timeFrame': 'baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months', 'description': 'Frequency, effects and formats of consumed media related to COVID-19 are measured with 5 self created items.'}, {'measure': 'Ultra-brief screening scale for anxiety and depression', 'timeFrame': 'baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months', 'description': 'To screen for general anxiety and depressive symptoms the German version of the Patient Health Questionnaire-4 (PHQ-4) by Löwe (2015) is used. 4 items; values ranging from 0 to 3, higher scores indicate a worse outcome.'}, {'measure': 'Change in characteristics of COVID-19-related anxiety', 'timeFrame': 'baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months', 'description': 'To investigate specific fears regarding the COVID-19 pandemic 9 self created items are used. Values ranging from 1 to 6, higher scores indicate a worse outcome.'}, {'measure': 'Change in COVID-19-related anxiety symptoms', 'timeFrame': 'baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months', 'description': 'Modified German version of the DSM-5 Severity-Measure-For-Specific-Phobia-Adult-Scale by Beesdo-Baum et al. (2014). 10 items, values ranging from 1 to 5, higher scores indicate a worse outcome. The Scale was adapted to anxiety symptoms related to COVID-19.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Pandemic', 'Corona-Virus', 'SARS-CoV-2', 'Corona', 'Covid-19', 'Public Health', 'Mental Health', 'Health', 'Mental Disorders'], 'conditions': ['Anxiety Related to the COVID-19 Pandemic']}, 'referencesModule': {'references': [{'pmid': '38769221', 'type': 'DERIVED', 'citation': 'Bendau A, Petzold MB, Strohle A, Plag J. Viral Transmission? A Longitudinal Study of Media Use and Its Relation to Mental Strain During the First 2 Years of the COVID-19 Pandemic. Int J Behav Med. 2025 Apr;32(2):214-226. doi: 10.1007/s12529-024-10293-3. Epub 2024 May 20.'}, {'pmid': '37158010', 'type': 'DERIVED', 'citation': 'Bendau A, Petzold MB, Plag J, Asselmann E, Strohle A. Illness anxiety predicts higher mental strain and vaccine willingness-A nine-wave longitudinal study during the first 1.5 years of the COVID-19 pandemic in Germany. Stress Health. 2023 Dec;39(5):1137-1147. doi: 10.1002/smi.3255. Epub 2023 May 9.'}, {'pmid': '32633094', 'type': 'DERIVED', 'citation': 'Olsson A, Olsson M, Fedorowski A, Hagell P, Wictorin K. The Orthostatic Hypotension Questionnaire in Swedish tested in patients with parkinsonism. Brain Behav. 2020 Sep;10(9):e01746. doi: 10.1002/brb3.1746. Epub 2020 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to systematically examine various aspects of the anxiety associated with the COVID-19 pandemic in Germany. The data collection is carried out online with longitudinal repeated measurements.', 'detailedDescription': 'The COVID-19 pandemic is currently one of the greatest challenges for numerous countries - also for Germany. In addition to its somatic and economic consequences, the psychological dimension of the Coronavirus pandemic is discussed increasingly and is visible in public life - e.g. in the "pandemic-caused experience of threat", "loss of control" and "panic" of multiple people. The study examines the phenomenon of this "corona-related anxiety" in terms of epidemiological, clinical and psychosocial characteristics. It is investigated how "corona anxiety" affects people who already have an anxiety disorder or other mental illnesses as well as formerly mentally healthy people. It is also examined how media reporting and personal consequences of COVID-19 are connected with corona-related anxiety and if there is a need for therapeutic support regarding corona-related anxiety.\n\nTo answer these questions a longitudinal online survey targeting the general population in Germany is carried out. The survey takes place all three weeks as long as the pandemic lasts and ends with one follow-up one year later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'General population in Germany', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent was given\n* age ≥ 18\n* able to complete the questionnaire in German\n* country of residence: Germany\n\nExclusion Criteria:\n\n* if at least one of the inclusion criteria is not met'}, 'identificationModule': {'nctId': 'NCT04331106', 'acronym': 'CORA', 'briefTitle': 'Survey of the Anxiety Associated With the COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Online-based Survey of the Anxiety Associated With the COVID-19 Pandemic in the General Population in Germany', 'orgStudyIdInfo': {'id': 'EA1/071/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Population in Germany', 'description': 'Reasonably large and representative sample of the general population in Germany', 'interventionNames': ['Diagnostic Test: Online Questionnaire']}], 'interventions': [{'name': 'Online Questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'Online Questionnaire via SoSci Survey', 'armGroupLabels': ['Population in Germany']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'role': 'CONTACT', 'email': 'corona-angst@charite.de', 'phone': '+49 30 450 517 285'}], 'facility': 'Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Antonia Bendau, M.Sc.Psych.', 'role': 'CONTACT', 'email': 'antonia.bendau@charite.de', 'phone': '+4930450517274'}, {'name': 'Andreas Ströhle, Prof.Dr.', 'role': 'CONTACT', 'email': 'andreas.stroehle@charite.de', 'phone': '+4930450517217'}], 'overallOfficials': [{'name': 'Andreas Ströhle, Prof.Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy'}, {'name': 'Antonia Bendau, M.Sc.Psych.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonia Bendau', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}