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CompletedNCT05423782PREMENTADAUpdated Jun 21, 2022

Prevalence of Mental Disorder and Somatic Co-morbidities Among Asylum Seekers in Marseille

An observational study in Global Health of Asylum Seekers in France, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by Assistance Publique Hopitaux De Marseille · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
419
Ages
18 Years and older
Sex
All
01

Study summary

Introduction : World Health Organization (WHO) considers that the heterogeneity of concepts and definitions of migrants is an obstacle to obtaining evidence to inform public health policies. Thus, it recommends distinguishing refugees from asylum seekers. Asylum seekers are migrants who recently arrived in their host country and whose administrative situation is being examined. They do not have the same access to health care or the same rights as refugees.

In France in 2021, 78,372 major people filled a first asylum application, a 26.4% increase compared to 2020 Regarding the mental health of exiles, a literature review informs us that 31.5% of them suffer from post-traumatic stress disorder (PTSD), 31.5% from depression and 11.1% from anxiety disorders. However, these data are taken from studies that do not make a distinction between refugees and asylum seekers These missing data are a hindrance to the development of efficient strategies for the management of these populations within the health systems of Western countries.

The primary objective of this study was to describe the health status of asylum seekers who have recently arrived in their Western host country. The secondary objective was to investigate potential explanatory factors for the health status of asylum seekers.

Method: Single-center, cross-sectional, observational epidemiological study. The Refugee health screener (RHS15) questionnaire and the Cumulative Illness Rating Scale (CIRS) will be administered by a trained interviewer to each patient included on the day of their inclusion, in the asylum seekers reception platform (PADA).Potential use of tobacco, existence of an adapted treatment in case of a detected pathology and certain socio-demographic data will also be collected.

A telephone interpreting service will be used in the case of an allophone patient whose spoken language is not spoken by the interviewer. Each patient included will have an appointment to perform a standardised blood and urine sample.

Benefits : PREMENTADA study will provide a better understanding of the health status of the population of asylum seekers in France. As the existence of data is a prerequisite for evidence-based medicine, we notice the lack of previous studies specifically addressing this population in France.

Read the detailed description

Introduction : World Health Organization (WHO) considers that the heterogeneity of concepts and definitions of migrants is an obstacle to obtaining evidence to inform public health policies. Thus, it recommends distinguishing refugees from asylum seekers. Asylum seekers are migrants who recently arrived in their host country and whose administrative situation is being examined. They do not have the same access to health care or the same rights as refugees.

In France in 2021, 78,372 major people filled a first asylum application, a 26.4% increase compared to 2020 Regarding the mental health of exiles, a literature review informs us that 31.5% of them suffer from post-traumatic stress disorder (PTSD), 31.5% from depression and 11.1% from anxiety disorders. However, these data are taken from studies that do not make a distinction between refugees and asylum seekers These missing data are a hindrance to the development of efficient strategies for the management of these populations within the health systems of Western countries.

The primary objective of this study was to describe the health status of asylum seekers who have recently arrived in their Western host country. The secondary objective was to investigate potential explanatory factors for the health status of asylum seekers.

Method: Single-center, cross-sectional, observational epidemiological study. The Refugee health screener (RHS15) questionnaire and the Cumulative Illness Rating Scale (CIRS) will be administered by a trained interviewer to each patient included on the day of their inclusion, in the asylum seekers reception platform (PADA).Potential use of tobacco, existence of an adapted treatment in case of a detected pathology and certain socio-demographic data will also be collected.

A telephone interpreting service will be used in the case of an allophone patient whose spoken language is not spoken by the interviewer. Each patient included will have an appointment to perform a standardised blood and urine sample.

Benefits : PREMENTADA study will provide a better understanding of the health status of the population of asylum seekers in France. As the existence of data is a prerequisite for evidence-based medicine, we notice the lack of previous studies specifically addressing this population in France.

02

Conditions studied

  • Global Health of Asylum Seekers in France
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 419 is above the median of 200 across 480 observational studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

asylum Seekers in France

Inclusion criteria

  • Age > 18 years
  • Coming to asylum seekers reception platform in Marseille
  • Have the cognitive capacity to consent to participation in the study
  • Holders of a first asylum application receipt (not older than 21 days )

Exclusion criteria

Exclusion Criteria:

  • Existence of cognitive disorders (dementia, mental retardation) or language difficulties (dysphasia, aphasia) limiting understanding and expression.
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
419 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Refugee Health Screener (RHS-15)

    The RHS-15 is a valid 15-item instrument screening to detect on asylum seekers and refugees Post traumatic stress disorder (PTSD), anxiety or depression symptoms. 14 items are rated on a 5-point Likert scale (0 = not at all to 4 = extremely). The last item is assessing the general ability to handle stress on a 5-point Likert scale and a distress thermometer (DT) ranging from 0 to 10. A screening result is positive if the sum of the first 14 items ≥ 12 or if the DT is ≥ 5

    Time frame: 30 minutes

Secondary outcomes

  1. Cumulative Illness Rating Scale (CIRS)

    The CIRS is a comprehensive measure of multimorbidity previously validated on homeless people. Each item is assigned a severity score by means of an assessment of the impact on the patient: 1 (no problem), 2 (current mild problem or past significant problem), 3 (moderate disability or morbidity), 4 (severe problem), 5 (extremely severe or life-threatening problem). The CIRS classifies all items into 14 body systems (including one on mental disorder) to obtain a final cumulative score.

    Time frame: 20 minutes

07

Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13005, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05423782
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jun 21, 2022
Start date
Feb 11, 2021
Primary completion
Aug 30, 2021
Completion
Aug 30, 2021
Last update
Jun 21, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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