Mental Health of Migrant PopulationNCT04329936
Epidemiological Study on Mental Health of Migrant Population in the Retention Center of Geispolsheim.
An observational study of Mental Health of Migrant Population, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
In 2019, the lack of studies about mental health of the detained population at retention centers in France is pointed out by the report of Controller-General for Places of Deprivation of Liberty. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Mental Health of Migrant Population
- What is being tested?
- Retention center Geispolsheim population
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2020to May 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The migrant population in the retention center of Geispolsheim is male migrants residing in France without authorization. Their retention is decided by the prefecture of Bas-Rhin and Haut-Rhin. The retention happens after custody or at the end of a term of imprisonment.
Who may be able to join
- Any male person in the first week of detention at CRA Geispolsheim who gave their non-opposition to participation in the study.
- Information and consent protocol signed
Who cannot join
- Refuse to participate to the study
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Djamel RADJI, +33 3 88 11 65 42, djamel.radji@chru-strasbourg.fr
RADJI Djamel
About this study
Official title: Epidemiological Study on Mental Health of Migrant Population in the Retention Center of Geispolsheim
In 2019, the lack of studies about mental health of the detained population at retention centers in France is pointed out by the report of Controller-General for Places of Deprivation of Liberty. The aim of this study is to contribute to this relatively untouched field by describing which psychiatric pathologies are encountered in this population who went through migration and retention. Having a clearer picture of the situation can help to provide a more adapted psychiatric care in retention centers.
The results are expected to show a higher rate of psychiatric disease than in the general population including addiction to substance, anxiety disorder and post-traumatic stress disorder (PTSD).
- Conditions
- Mental Health of Migrant Population
- Being tested
- Retention center Geispolsheim population
- Keywords
- Mental health, Psychiatric diseases, Migration, Retention center
- Medical subject headings
- Psychological Well-Being, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retention center Geispolsheim populationBehavioural
All recently held individuals in the retention center can be included in the study after signing the information and consent protocol.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini International Neuropsychiatric Interview validated and translated in the language used by the interviewed person.
The interview is led by the investigator in the presence of a translator if necessary.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study startMay 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health of Migrant PopulationStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329936
- Sponsor's protocol ID
- 7657
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on Mental Health of Migrant Population in the Retention Center of Geispolsheim
- ClinicalTrials.gov ID
- NCT04329936
- Acronym / sponsor ID
- 7657
- Conditions
- Mental Health of Migrant Population
- Keywords
- Mental health, Psychiatric diseases, Migration, Retention center
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 1 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.
In 2019, the lack of studies about mental health of the detained population at retention centers in France is pointed out by the report of Controller-General for Places of Deprivation of Liberty. The aim of this study is to contribute to this relatively untouched field by describing which psychiatric pathologies are encountered in this population who went through migration and retention. Having a clearer picture of the situation can help to provide a more adapted psychiatric care in retention centers.
The results are expected to show a higher rate of psychiatric disease than in the general population including addiction to substance, anxiety disorder and post-traumatic stress disorder (PTSD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The migrant population in the retention center of Geispolsheim is male migrants residing in France without authorization. Their retention is decided by the prefecture of Bas-Rhin and Haut-Rhin. The retention happens after custody or at the end of a term of imprisonment.
Key inclusion criteria (2 listed)
- Any male person in the first week of detention at CRA Geispolsheim who gave their non-opposition to participation in the study.
- Information and consent protocol signed
Key exclusion criteria (1 listed)
- Refuse to participate to the study
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 |
|---|---|---|
| Retention center Geispolsheim populationAll recently held individuals in the retention center can be included in the study after signing the information and consent protocol. | Behavioural | – |
Primary outcome
Mini International Neuropsychiatric Interview validated and translated in the language used by the interviewed person.
Time frame: 1 hour
The interview is led by the investigator in the presence of a translator if necessary.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Mental Health of Migrant Population, run by University Hospital, Strasbourg, 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 2 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 1 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 RADJI Djamel (+33 3 88 11 65 42, djamel.radji@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini International Neuropsychiatric Interview validated and translated in the language used by the interviewed person. (time frame: 1 hour). 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 1 Apr 2020.