Stress, PsychologicalCOVISTRESSNCT04308187
Influence of the COvid-19 Epidemic on STRESS
An observational study of Stress, Psychological, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The Coronavirus has a major influence on stress for the general population. However, data are currently non-existent concerning the perception and knowledge of the epidemic, the feeling of information from companies / establishments / governments, the means of protection used, the feelings of fear generated and their… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- How many people
- 50,000 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2020to Mar 2022
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: General population
Who may be able to join
- Anyone volunteer to participate
Who cannot join
- Anyone non-voluntary to participate
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital, Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, 0473754963
Frederic DUTHEIL
About this study
Official title: The COVISTRESS Study: Influence of the COvid-19 Epidemic on STRESS
The Coronavirus has a major influence on stress for the general population. However, data are currently non-existent concerning the perception and knowledge of the epidemic, the feeling of information from companies / establishments / governments, the means of protection used, the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.
Read the detailed description
This is an observational study using a REDCap® questionnaire via an internet link, which will be distributed by any means (Facebook, Twitter, institution mailing lists via a referent, flash codes distributed to patients and the public, etc.).
The self-questionnaire will assess stress, perception and knowledge of the epidemic, the feeling of information on the part of businesses / establishments / governments, the means of protection used the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.
- Conditions
- Stress, Psychological
- Keywords
- Stress, Psychological, Coronavirus, Epidemics
- Medical subject headings
- Stress, Psychological, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Stress level will be assessed by questionnaire
Measured: Day 1
Secondary outcomes (5)
Perception and knowledge of the epidemic
Perception and knowledge of the epidemic will be assessed by questionnaire
Measured: Day 1
Feeling of information on the part of companies / establishments / governments
The feeling of information will be assessed by questionnaire
Measured: Day 1
Means of protection
the means of protection used will be assessed by questionnaire
Measured: Day 1
Feelings of fear generated and its impact on feelings of stigmatization towards ethnic groups or categories of patients
The feeling of fear and the impact on stigmatization will be assessed by questionnaire
Measured: Day 1
Sociodemographic factors and lifestyle habits
Sociodemographic factors and lifestyle habits will be assessed by questionnaire
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start11 Mar 2020 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Cross-sectional
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France, Wittyfit, Paris, France
- Responsible party
- Sponsor
- Investigators
- Fréderic DUTHEIL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308187
- Sponsor's protocol ID
- 2020 COVISTRESS
- Acronym
- COVISTRESS
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COVISTRESS Study: Influence of the COvid-19 Epidemic on STRESS
- ClinicalTrials.gov ID
- NCT04308187
- Acronym / sponsor ID
- COVISTRESS / 2020 COVISTRESS
- Conditions
- Stress, Psychological
- Keywords
- Stress, Psychological, Coronavirus, Epidemics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France, Wittyfit, Paris, France
- Study start
- 11 Mar 2020 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 13 Mar 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.
The Coronavirus has a major influence on stress for the general population. However, data are currently non-existent concerning the perception and knowledge of the epidemic, the feeling of information from companies / establishments / governments, the means of protection used, the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.
Detailed description
This is an observational study using a REDCap® questionnaire via an internet link, which will be distributed by any means (Facebook, Twitter, institution mailing lists via a referent, flash codes distributed to patients and the public, etc.).
The self-questionnaire will assess stress, perception and knowledge of the epidemic, the feeling of information on the part of businesses / establishments / governments, the means of protection used the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General population
Key inclusion criteria (1 listed)
- Anyone volunteer to participate
Key exclusion criteria (1 listed)
- Anyone non-voluntary to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stress
Time frame: Day 1
Stress level will be assessed by questionnaire
5 secondary outcomes
Perception and knowledge of the epidemic
Time frame: Day 1
Feeling of information on the part of companies / establishments / governments
Time frame: Day 1
Means of protection
Time frame: Day 1
Feelings of fear generated and its impact on feelings of stigmatization towards ethnic groups or categories of patients
Time frame: Day 1
Sociodemographic factors and lifestyle habits
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
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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.
Fréderic DUTHEIL principal investigator
University Hospital, Clermont-Ferrand
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 Stress, Psychological, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 1 inclusion and 1 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 13 Mar 2020. 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 France. 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 Lise Laclautre (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: Day 1). 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 13 Mar 2020.