NCT04331106

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

March 27, 2020

Last Update Submit

January 25, 2021

Conditions

Keywords

AnxietyPandemicCorona-VirusSARS-CoV-2CoronaCovid-19Public HealthMental HealthHealthMental Disorders

Outcome Measures

Primary Outcomes (2)

  • Characteristics of COVID-19-related anxiety

    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

    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 Outcomes (7)

  • Self-efficacy and coping with 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

  • Consequences of COVID-19 in the last three weeks.

    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

    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

    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

    baseline (1 day) + after 3 weeks + after 6 weeks + after 9 weeks + after 6 months + after 7 months + after 9 months + after 12 months

  • +2 more secondary outcomes

Study Arms (1)

Population in Germany

Reasonably large and representative sample of the general population in Germany

Diagnostic Test: Online Questionnaire

Interventions

Online QuestionnaireDIAGNOSTIC_TEST

Online Questionnaire via SoSci Survey

Population in Germany

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General population in Germany

You may qualify if:

  • informed consent was given
  • age ≥ 18
  • able to complete the questionnaire in German
  • country of residence: Germany

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

Berlin, 10117, Germany

RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Anxiety DisordersCOVID-19Psychological Well-BeingMental Disorders

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal SatisfactionBehavior

Study Officials

  • Andreas Ströhle, Prof.Dr.

    Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

    STUDY DIRECTOR
  • Antonia Bendau, M.Sc.Psych.

    Charité-Universitätsmedizin Berlin - Department of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Bendau, M.Sc.Psych.

CONTACT

Andreas Ströhle, Prof.Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2020

First Posted

April 2, 2020

Study Start

March 27, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations