Stress, PsychologicalNCT04337047
Distress in Crisis Situations During COVID-19
An observational study of Stress, Psychological, run by Wefight at 1 site in France.
Trial summary
There are many scales for screening or assessing the impact of a disease. These scales are generally used to diagnose or assess the severity of a disease and are carried out at the request of a physician by the patient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- questionnaire assesment
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2020to 3 May 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Vik's users in France
Who may be able to join
- Age > 18 years old
- Collection of the subject's non-opposition
- Patient registration on Vik breast, Vik asthma, Vik migraine, Vik depression
Who cannot join
- Patient unable to formulate non-opposition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distress During the COVID-19 Pandemic in France: a National Assessment of At-risk Populations
There are many scales for screening or assessing the impact of a disease. These scales are generally used to diagnose or assess the severity of a disease and are carried out at the request of a physician by the patient. Conversational agents could make it possible to administer these questionnaires remotely, analyse them and use the results on a large scale, without prior medical intervention.
The main objective of this study is to quantify and qualify the distress of a large population in times of pandemic crisis.
Read the detailed description
The Peritraumatic Distress Inventory is the standard tool designed to assess distress in times of crisis. It consists of 13 questions.
Questions will be submitted to the participants from the Vik chatbot. Responses will be analysed and compared according to the demographics and pathologies encountered.
- Conditions
- Stress, Psychological
- Being tested
- questionnaire assesment
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire assesmentOther
questionnaire assesment
| Study group | Role | What they receive |
|---|---|---|
| Vik sein | Vik sein users Receives: Other: questionnaire assesment | |
| Vik asthme | Vik asthme users Receives: Other: questionnaire assesment | |
| Vik migraine | Vik migraine users Receives: Other: questionnaire assesment | |
| Vik depression | Vik depression users Receives: Other: questionnaire assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantify and qualify distress over a large population in times of pandemic crisis.
Measured: 1 month
Secondary outcomes (1)
qualify demographic data vs distress over a large population in times of pandemic crisis.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start31 Mar 2020
- Primary completion30 Apr 2020
- Study completion3 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wefight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, benjamin CHAIX, Wefight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337047
- Sponsor's protocol ID
- WefightDistress20
- Status last verified
- May 2020
- First submitted
- 3 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chaix B, Delamon G, Guillemasse A, Brouard B, Bibault JE. Psychological distress during the COVID-19 pandemic in France: a national assessment of at-risk populations. Gen Psychiatr. 2020 Nov 26;33(6):e100349. doi: 10.1136/gpsych-2020-100349. eCollection 2020.
PubMed 34192239
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress During the COVID-19 Pandemic in France: a National Assessment of At-risk Populations
- ClinicalTrials.gov ID
- NCT04337047
- Acronym / sponsor ID
- WefightDistress20
- Conditions
- Stress, Psychological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- WefightIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 3 May 2020 (actual)
- First posted
- 7 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.
There are many scales for screening or assessing the impact of a disease. These scales are generally used to diagnose or assess the severity of a disease and are carried out at the request of a physician by the patient. Conversational agents could make it possible to administer these questionnaires remotely, analyse them and use the results on a large scale, without prior medical intervention.
The main objective of this study is to quantify and qualify the distress of a large population in times of pandemic crisis.
Detailed description
The Peritraumatic Distress Inventory is the standard tool designed to assess distress in times of crisis. It consists of 13 questions.
Questions will be submitted to the participants from the Vik chatbot. Responses will be analysed and compared according to the demographics and pathologies encountered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vik sein | – | Other: questionnaire assesmentVik sein users |
| Vik asthme | – | Other: questionnaire assesmentVik asthme users |
| Vik migraine | – | Other: questionnaire assesmentVik migraine users |
| Vik depression | – | Other: questionnaire assesmentVik depression users |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Vik's users in France
Key inclusion criteria (3 listed)
- Age > 18 years old
Key exclusion criteria (1 listed)
- Patient unable to formulate non-opposition
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 |
|---|---|---|
| questionnaire assesmentquestionnaire assesment | Other | Vik asthme, Vik depression, Vik migraine, Vik sein |
Primary outcome
quantify and qualify distress over a large population in times of pandemic crisis.
Time frame: 1 month
1 secondary outcome
qualify demographic data vs distress over a large population in times of pandemic crisis.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Derived from this study: PubMed 34192239Chaix B, Delamon G, Guillemasse A, Brouard B, Bibault JE. Psychological distress during the COVID-19 pandemic in France: a national assessment of at-risk populations. Gen Psychiatr. 2020 Nov 26;33(6):e100349. doi: 10.1136/gpsych-2020-100349. eCollection 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Wefight 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 3 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: finished, as of the sponsor's last update on 5 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantify and qualify distress over a large population in times of pandemic crisis. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04337047, which also lists 1 linked publication.
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 5 May 2020.