DepressionPsyConfPopNCT04374643
Descriptive Study of the PSYchological Impact of CONFinement Measures in the General Population
An observational study of Depression and COVID 19, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Quarantine is an unpleasant experience : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. It may lead to negative mental health consequences and thus the emergence of anxiety and depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, COVID 19
- What is being tested?
- Slef questionnaires fulfilment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 30 Dec 2021
- 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: Adults who agree to participate by answering the questionnaires
Who may be able to join
- age> 18
Who cannot join
- protective measure (curatorship, guardianship)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital
Montpellier, 34295
Catherine Genty, MD, +33 4 67 99 61 45 75, c-genty@chu-montpellier.fr
About this study
Official title: Descriptive Study of the PSYchological Impact of CONFinement Measures in the General Population : PsyConfPop
Quarantine is an unpleasant experience : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. It may lead to negative mental health consequences and thus the emergence of anxiety and depressive symptoms.
From March 17th, 2020 to May 11th 2002, the French government has implemented national containment measures due to the Covid-19 epidemic.
Although there are data on the psychological impact and experience of quarantine measures in people who have been infected or suspected of being carriers of certain pathogens (e.g. Ebola), there are no data on such impact in the French population and quarantines lasting longer than 21 days. Investigators therefore propose to conduct a human and social sciences study in order to better understand the current situation
Read the detailed description
The main objective is to describe the psychological state during confinement (and the impact of the confinement) in a sample of the French general population.
Secondary objectives :
- to assess the evolution of psychological health between the period of confinement and post-confinement.
- to identify clinical factors modulating psychological state during confinement
It is expected to highlight :
- a link between the intensity of anxiety symptoms and the number/quality of social contacts
- a reduction of anxiety and depression symptoms in the post-confinement period.
- higher consumption of drugs during the confinement period
Self-questionnaires (Google form format) are sent by mailing lists or social networks to participants in order to complete the assessment of psychological state. A unique identifier is sent in a separate email. These assessments are performed at least once during the confinement period. It is planned to repeat them when the confinement is lifted: 15 days, 3 and 6 months after the lifting of the confinement because of the risk of developing anxiodepressive symptoms, in particular post-traumatic stressors.
- Conditions
- Depression, COVID 19
- Being tested
- Slef questionnaires fulfilment
- Keywords
- Confinement, Depression, Post traumatic stress, Adults
- Medical subject headings
- Depression, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slef questionnaires fulfilmentOther
Questionnaires to assess the psychological impact of confinement and its evolution over 6 months
| Study group | Role | What they receive |
|---|---|---|
| Confined patients | General population Receives: Other: Slef questionnaires fulfilment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptomatology
depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)
Measured: during confinement
Secondary outcomes (1)
Depressive Symptomatology
depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)
Measured: post-confinement : 15 days, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Apr 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Olie, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374643
- Sponsor's protocol ID
- RECHMPL20_0197
- Acronym
- PsyConfPop
- Status last verified
- Dec 2020
- First submitted
- 30 Apr 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of the PSYchological Impact of CONFinement Measures in the General Population : PsyConfPop
- ClinicalTrials.gov ID
- NCT04374643
- Acronym / sponsor ID
- PsyConfPop / RECHMPL20_0197
- Conditions
- Depression, COVID 19
- Keywords
- Confinement, Depression, Post traumatic stress, Adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 5 May 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.
Quarantine is an unpleasant experience : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. It may lead to negative mental health consequences and thus the emergence of anxiety and depressive symptoms.
From March 17th, 2020 to May 11th 2002, the French government has implemented national containment measures due to the Covid-19 epidemic.
Although there are data on the psychological impact and experience of quarantine measures in people who have been infected or suspected of being carriers of certain pathogens (e.g. Ebola), there are no data on such impact in the French population and quarantines lasting longer than 21 days. Investigators therefore propose to conduct a human and social sciences study in order to better understand the current situation
Detailed description
The main objective is to describe the psychological state during confinement (and the impact of the confinement) in a sample of the French general population.
Secondary objectives :
- to assess the evolution of psychological health between the period of confinement and post-confinement.
- to identify clinical factors modulating psychological state during confinement
It is expected to highlight :
- a link between the intensity of anxiety symptoms and the number/quality of social contacts
- a reduction of anxiety and depression symptoms in the post-confinement period.
- higher consumption of drugs during the confinement period
Self-questionnaires (Google form format) are sent by mailing lists or social networks to participants in order to complete the assessment of psychological state. A unique identifier is sent in a separate email. These assessments are performed at least once during the confinement period. It is planned to repeat them when the confinement is lifted: 15 days, 3 and 6 months after the lifting of the confinement because of the risk of developing anxiodepressive symptoms, in particular post-traumatic stressors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confined patients | – | Other: Slef questionnaires fulfilmentGeneral population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who agree to participate by answering the questionnaires
Key inclusion criteria (1 listed)
- age> 18
Key exclusion criteria (1 listed)
- protective measure (curatorship, guardianship)
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 |
|---|---|---|
| Slef questionnaires fulfilmentQuestionnaires to assess the psychological impact of confinement and its evolution over 6 months | Other | Confined patients |
Primary outcome
Depressive Symptomatology
Time frame: during confinement
depressive symptomatology with Patient Health Questionnaire : PHQ-9 scale (PHQ 9 higher score, more depressive -> min : 0 max : 27)
1 secondary outcome
Depressive Symptomatology
Time frame: post-confinement : 15 days, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Emilie Olie, MD PhD principal investigator
University Hospital, Montpellier
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 Depression and COVID 19, run by University Hospital, Montpellier 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 29 Dec 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 Emilie Olie, MD PhD (+33 4 67 33 85 81, e-olie@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptomatology (time frame: during confinement). 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 29 Dec 2020.