COVID19NCT04359121
COVID-19 and the Developement of Phobic Fears of Disease
An observational study of COVID19, run by Medical University of Graz at 1 site in Austria.
Trial summary
A lot of people suffer from phobias. Phobias concerning certain diseases are not rare. This study will examine whether the COVID-19 (Coronavirus Disease) crisis was able to rise phobias in people and if those with preexisting phobias or fears were more likely to develop a phobia concerning COVID. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID19
- What is being tested?
- Questionnaires for specific phobia
- How many people
- 600 participants
- Where
- 1 siteAustria
- Study dates
- 15 Dec 2020to 15 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: physicians, medical staff, general public, patients with psychiatric disorders
Who may be able to join
- Person gives written consent
- Persons between 18-90 years of age (men and women)
- No positive COVID infection known at time of first examination
Who cannot join
- Dementia, Delirium (not able to give consent)
- Not fulfilling the inclusion criteria
- COVID infection known at first examination point
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, Styria, 8036
Andreas Baranyi, Prof. MD, +4331638586241, an.baranyi@medunigraz.at
About this study
A lot of people suffer from phobias. Phobias concerning certain diseases are not rare. This study will examine whether the COVID-19 (Coronavirus Disease) crisis was able to rise phobias in people and if those with preexisting phobias or fears were more likely to develop a phobia concerning COVID. It will look at different subtypes - physicians, medical staff, general public (not medically affiliated) and patients with psychiatric disorders.
- Conditions
- COVID19
- Being tested
- Questionnaires for specific phobia
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires for specific phobiaOther
Questionnaires will be used.
| Study group | Role | What they receive |
|---|---|---|
| Physicians | Questionnaires Receives: Other: Questionnaires for specific phobia | |
| Medical staff | Questionnaires Receives: Other: Questionnaires for specific phobia | |
| General public | Questionnaires Receives: Other: Questionnaires for specific phobia | |
| Patients with psychiatric disorders | Questionnaires Receives: Other: Questionnaires for specific phobia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of phobias
Specific Phobia Questionnaire (SPQ): The SPQ consists of 43 items, each rated using a 5-point Likert scale on two dimensions: (1) level of fear, with scores ranging from 0 (no fear) to 4 (extreme fear) and (2) extent to which the fear interferes with one's daily life, with scores ranging from 0 (no interference) to 4 (extreme interference). The SPQ is scored by combining fear ratings of each Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) specific phobia type.
Severity Measure for Specific Phobia-Adult: The total score can range from 0 to 40 with higher scores indicating greater severity of specific phobia.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 Dec 2020
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Baranyi, Prof., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359121
- Sponsor's protocol ID
- 32-354 ex 19/20
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2020
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and the Developement of Phobic Fears of Disease
- ClinicalTrials.gov ID
- NCT04359121
- Acronym / sponsor ID
- 32-354 ex 19/20
- Conditions
- COVID19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A lot of people suffer from phobias. Phobias concerning certain diseases are not rare. This study will examine whether the COVID-19 (Coronavirus Disease) crisis was able to rise phobias in people and if those with preexisting phobias or fears were more likely to develop a phobia concerning COVID. It will look at different subtypes - physicians, medical staff, general public (not medically affiliated) and patients with psychiatric disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: Questionnaires for specific phobiaQuestionnaires |
| Medical staff | – | Other: Questionnaires for specific phobiaQuestionnaires |
| General public | – | Other: Questionnaires for specific phobiaQuestionnaires |
| Patients with psychiatric disorders | – | Other: Questionnaires for specific phobiaQuestionnaires |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- physicians, medical staff, general public, patients with psychiatric disorders
Key inclusion criteria (3 listed)
- Person gives written consent
- Persons between 18-90 years of age (men and women)
- No positive COVID infection known at time of first examination
Key exclusion criteria (3 listed)
- Dementia, Delirium (not able to give consent)
- Not fulfilling the inclusion criteria
- COVID infection known at first examination point
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires for specific phobiaQuestionnaires will be used. | Other | General public, Medical staff, Patients with psychiatric disorders, Physicians |
Primary outcome
Development of phobias
Time frame: 2 years
Specific Phobia Questionnaire (SPQ): The SPQ consists of 43 items, each rated using a 5-point Likert scale on two dimensions: (1) level of fear, with scores ranging from 0 (no fear) to 4 (extreme fear) and (2) extent to which the fear interferes with one's daily life, with scores ranging from 0 (no interference) to 4 (extreme interference). The SPQ is scored by combining fear ratings of each Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) specific phobia type. Severity Measure for Specific Phobia-Adult: The total score can range from 0 to 40 with higher scores indicating greater severity of specific phobia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Baranyi, Prof. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Baranyi, Prof. (0043-316-385-86241, an.baranyi@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of phobias (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.