- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04331106
Survey of the Anxiety Associated With the COVID-19 Pandemic (CORA)
Online-based Survey of the Anxiety Associated With the COVID-19 Pandemic in the General Population in Germany
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
To 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Antonia Bendau, M.Sc.Psych.
- Phone Number: +4930450517274
- Email: antonia.bendau@charite.de
Study Contact Backup
- Name: Andreas Ströhle, Prof.Dr.
- Phone Number: +4930450517217
- Email: andreas.stroehle@charite.de
Study Locations
-
-
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Berlin, Germany, 10117
- Recruiting
- Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
-
Contact:
- Phone Number: +49 30 450 517 285
- Email: corona-angst@charite.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- informed consent was given
- age ≥ 18
- able to complete the questionnaire in German
- country of residence: Germany
Exclusion Criteria:
- if at least one of the inclusion criteria is not met
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Population in Germany
Reasonably large and representative sample of the general population in Germany
|
Online Questionnaire via SoSci Survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characteristics of COVID-19-related anxiety
Time Frame: 1 day
|
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.
|
1 day
|
COVID-19-related anxiety symptoms
Time Frame: 1 day
|
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.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy and coping with COVID-19
Time Frame: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
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).
|
baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
Consequences of COVID-19 in the last three weeks.
Time Frame: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
Personal consequences of the COVID-19 pandemic in the last three weeks are collected with five self-created items.
|
baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
General Illness Attitude
Time Frame: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
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.
|
baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
Media reporting
Time Frame: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
Frequency, effects and formats of consumed media related to COVID-19 are measured with 5 self created items.
|
baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
Ultra-brief screening scale for anxiety and depression
Time Frame: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
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.
|
baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
Change in characteristics of COVID-19-related anxiety
Time Frame: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
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.
|
baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
Change in COVID-19-related anxiety symptoms
Time Frame: baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
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.
|
baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months
|
Collaborators and Investigators
Investigators
- Study Director: Andreas Ströhle, Prof.Dr., Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
- Principal Investigator: Antonia Bendau, M.Sc.Psych., Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA1/071/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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