Identify the Psychological Impact of ContainmentIMPANCT04353570
Psychological Impact of Confinement on the Adult
An observational study of Identify the Psychological Impact of Containment, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.
Trial summary
This clinical interview is made to allow a clinical follow-up of the patients followed in psychiatry of the EPS Ville-Evrard establishment in a simple way and in a secure medical framework during the period of the epidemic and the confinement from March 30 to June 30, 2020. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Identify the Psychological Impact of Containment
- What is being tested?
- clinical interview
- How many people
- 2,100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 30 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patient followed in outpatient psychiatry at EPS Ville Evrard
Who may be able to join
- Adult patient followed in outpatient psychiatry at EPS Ville Evrard and agrees to participate -
Who cannot join
- Adult patient followed in outpatient psychiatry at EPS Ville Evrard and does not wish to participate
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité de recherche clinique
Neuilly-sur-Marne, Île-de-France Region, 93330
BENCHERIF, CRA, 0143093232
About this study
Official title: Psychological Impact of Confinement on the Adult Population Followed in Outpatient Psychiatry at EPS Ville Evrard: Three-month Longitudinal Clinical Evaluation
This clinical interview is made to allow a clinical follow-up of the patients followed in psychiatry of the EPS Ville-Evrard establishment in a simple way and in a secure medical framework during the period of the epidemic and the confinement from March 30 to June 30, 2020.
- Being tested
- clinical interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical interviewOther
This interview can be carried out face to face or remotely. In the latter case, it is part of telemedicine, which is recognised by the health authorities in France.
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression MINI DIAG and Anxiety questionnaire and the The Global Performance Rating Scale and CGI-truth
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Apr 2020
- Primary completion18 Jun 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Identify the Psychological Impact of ContainmentStudies 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
- Cross-sectional
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Januel, Centre hospitalier de Ville-Evrard, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353570
- Sponsor's protocol ID
- 10477M-IMPA
- Acronym
- IMPA
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 20 Apr 2020
- 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 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of Confinement on the Adult Population Followed in Outpatient Psychiatry at EPS Ville Evrard: Three-month Longitudinal Clinical Evaluation
- ClinicalTrials.gov ID
- NCT04353570
- Acronym / sponsor ID
- IMPA / 10477M-IMPA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 18 Jun 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 20 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.
This clinical interview is made to allow a clinical follow-up of the patients followed in psychiatry of the EPS Ville-Evrard establishment in a simple way and in a secure medical framework during the period of the epidemic and the confinement from March 30 to June 30, 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patient followed in outpatient psychiatry at EPS Ville Evrard
Key inclusion criteria (1 listed)
- Adult patient followed in outpatient psychiatry at EPS Ville Evrard and agrees to participate -
Key exclusion criteria (2 listed)
- Adult patient followed in outpatient psychiatry at EPS Ville Evrard and does not wish 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical interviewThis interview can be carried out face to face or remotely. In the latter case, it is part of telemedicine, which is recognised by the health authorities in France. | Other | – |
Primary outcome
Depression MINI DIAG and Anxiety questionnaire and the The Global Performance Rating Scale and CGI-truth
Time frame: three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: No
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.
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 Identify the Psychological Impact of Containment, run by Centre hospitalier de Ville-Evrard, France 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 2 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 20 Apr 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 Youcef BENCHERIF (0782723674, youcef.bencherif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression MINI DIAG and Anxiety questionnaire and the The Global Performance Rating Scale and CGI-truth (time frame: three month). 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 20 Apr 2020.