Psychiatric DisorderEPICEANCT06065553
Prevalence of Psychiatric and Substance Abuse Disorders Among People in Precarious Situations in Cayenne
An observational study of Psychiatric Disorder and Substance Use Disorders, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial summary
This is an observational, descriptive, cross-sectional, single-center study. The main objective of the study is to estimate the prevalence of the main psychiatric disorders and substance abuse disorders among people living in precarious, excluded and/or wandering on Cayenne and its surroundings Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorder, Substance Use Disorders
- How many people
- 150 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 9 Jun 2023to 30 Sep 2025
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People in precarious situations, extreme exclusion and/or wandering on Cayenne and its surroundings
Who may be able to join
- Adults over 18 years old
- person who uses support services intended for people in situations of precariousness, extreme exclusion and/or wandering on Cayenne and its surroundings - person agreeing to participate in the study.
Who cannot join
- Person refusing to participate in the study
- Person presenting an acute state of decompensation of a psychiatric pathology and/or a state of crisis (agitation crisis, suicidal crisis) and/or confusion or presenting an acute intoxication to a substance preventing him/her from understanding and answering questions.
- Impossibility of having an interpreter for a person with no (or little) French
Trial locations and contacts
1 site in 1 country.
French Guiana1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Cayenne
Cayenne, 97300
Caroline JANVIER, MD, +594 594 30 50 47, caroline.janvier@ch-cayenne.fr
Edith PELLERIN, +594 594 30 50 47, edith.pellerin@ch-cayenne.fr
About this study
Official title: Study on the Prevalence of Psychiatric and Substance Abuse Disorders Among People in Precarious Situations, Extreme Exclusion and/or Wandering on Cayenne and Its Surroundings.
This is an observational, descriptive, cross-sectional, single-center study. The main objective of the study is to estimate the prevalence of the main psychiatric disorders and substance abuse disorders among people living in precarious, excluded and/or wandering on Cayenne and its surroundings
Read the detailed description
In French Guiana, the mental health care and support system (health, medical-social, social, associative and institutional structures) is structurally lagging behind.
The density of specialist professionals is low; the psychiatric private sector is absent.
In order to adapt care provision, it is necessary to gain a better understanding of certain target populations, in particular those with multiple vulnerabilities, who have specific needs and expectations.
As highlighted by the results of a number of studies already carried out in France and elsewhere in the world, psychaitric disorders and substance-related addictive disorders have a greater impact on people living in situations of extreme exclusion, precariousness and homelessness.
In 2017, in French Guiana, one person out of two lives below the poverty line, compared to 14.9% in France.
A recent study estimated the prevalence rate of psychiatric disorders in the general population of the CACL (Communauté d'Agglomération du Centre Littoral) in French Guiana (SMPG - Santé Mentale en Population générale - study in 2021). Nowadays, there is no recent study measuring the prevalence of psychiatric disorders specifically among populations in precarious situations, wandering and/or extreme exclusion on Cayenne Island.
The main hypothesis of the research would therefore be to observe a prevalence of psychiatric disorders and addictive disorders in the precarious population that is at least as high, if not higher, than in the general population of the CACL.
Another hypothesis of the research would be to find that the distribution of the prevalence of each psychiatric disorder is not identical to that found in the general population of the CACL (more addictive disorders and more psychotic disorders in the precarious population, more disorders linked to post-traumatic stress disorder in migrant populations).
Another research hypothesis would be to observe that the use of healthcare and the perception of health are different from those of the general population of the CACL, and that it is therefore necessary to develop appropriate human and structural resources.
However, it seems essential to know this prevalence in order to adjust the offer of care and adapt it as much as possible to the specific needs of this population.
- Conditions
- Psychiatric Disorder, Substance Use Disorders
- Keywords
- Psychiatric disorders, Substance abuse, Precarity, French Guiana
- Medical subject headings
- Mental Disorders, Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of psychiatric disorders and substance abuse disorders
To estimate the prevalence of the main psychiatric disorders, as well as the prevalence of addictive disorders to psychoactive substances among people in a precarious situation, excluded and/or wandering on Cayenne Island and who use primary care services
Measured: Baseline
Secondary outcomes (3)
Description of socio-demographic profiles
Describe the different socio-demographic profiles of people in a precarious situation, excluded and/or wandering on Cayenne Island and who use primary care services.
Measured: Baseline
Description of perceived health status
To describe the perceived health status of people in a precarious situation, excluded and/or wandering on Cayenne Island and who use primary care services
Measured: Baseline
Description of use and access to health care
To describe the use of and access to care for people in a precarious situation, excluded and/or wandering on Cayenne Island and who use primary care services
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start9 Jun 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline JANVIER, MD, Principal investigator, Centre Hospitalier de Cayenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065553
- Sponsor's protocol ID
- EPICEA
- Acronym
- EPICEA
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2023
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hossain MM, Sultana A, Tasnim S, Fan Q, Ma P, McKyer ELJ, Purohit N. Prevalence of mental disorders among people who are homeless: An umbrella review. Int J Soc Psychiatry. 2020 Sep;66(6):528-541. doi: 10.1177/0020764020924689. Epub 2020 May 28.
PubMed 32460590Ayano G, Shumet S, Tesfaw G, Tsegay L. A systematic review and meta-analysis of the prevalence of bipolar disorder among homeless people. BMC Public Health. 2020 Jun 9;20(1):731. doi: 10.1186/s12889-020-08819-x.
PubMed 32513264Ayano G, Solomon M, Tsegay L, Yohannes K, Abraha M. A Systematic Review and Meta-Analysis of the Prevalence of Post-Traumatic Stress Disorder among Homeless People. Psychiatr Q. 2020 Dec;91(4):949-963. doi: 10.1007/s11126-020-09746-1.
PubMed 32415465Ayano G, Tesfaw G, Shumet S. The prevalence of schizophrenia and other psychotic disorders among homeless people: a systematic review and meta-analysis. BMC Psychiatry. 2019 Nov 27;19(1):370. doi: 10.1186/s12888-019-2361-7.
PubMed 31775786Fazel S, Geddes JR, Kushel M. The health of homeless people in high-income countries: descriptive epidemiology, health consequences, and clinical and policy recommendations. Lancet. 2014 Oct 25;384(9953):1529-40. doi: 10.1016/S0140-6736(14)61132-6.
PubMed 25390578
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Prevalence of Psychiatric and Substance Abuse Disorders Among People in Precarious Situations, Extreme Exclusion and/or Wandering on Cayenne and Its Surroundings.
- ClinicalTrials.gov ID
- NCT06065553
- Acronym / sponsor ID
- EPICEA / EPICEA
- Conditions
- Psychiatric Disorder, Substance Use Disorders
- Keywords
- Psychiatric disorders, Substance abuse, Precarity, French Guiana
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 4 Oct 2023 (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 is an observational, descriptive, cross-sectional, single-center study. The main objective of the study is to estimate the prevalence of the main psychiatric disorders and substance abuse disorders among people living in precarious, excluded and/or wandering on Cayenne and its surroundings
Detailed description
In French Guiana, the mental health care and support system (health, medical-social, social, associative and institutional structures) is structurally lagging behind.
The density of specialist professionals is low; the psychiatric private sector is absent.
In order to adapt care provision, it is necessary to gain a better understanding of certain target populations, in particular those with multiple vulnerabilities, who have specific needs and expectations.
As highlighted by the results of a number of studies already carried out in France and elsewhere in the world, psychaitric disorders and substance-related addictive disorders have a greater impact on people living in situations of extreme exclusion, precariousness and homelessness.
In 2017, in French Guiana, one person out of two lives below the poverty line, compared to 14.9% in France.
A recent study estimated the prevalence rate of psychiatric disorders in the general population of the CACL (Communauté d'Agglomération du Centre Littoral) in French Guiana (SMPG - Santé Mentale en Population générale - study in 2021). Nowadays, there is no recent study measuring the prevalence of psychiatric disorders specifically among populations in precarious situations, wandering and/or extreme exclusion on Cayenne Island.
The main hypothesis of the research would therefore be to observe a prevalence of psychiatric disorders and addictive disorders in the precarious population that is at least as high, if not higher, than in the general population of the CACL.
Another hypothesis of the research would be to find that the distribution of the prevalence of each psychiatric disorder is not identical to that found in the general population of the CACL (more addictive disorders and more psychotic disorders in the precarious population, more disorders linked to post-traumatic stress disorder in migrant populations).
Another research hypothesis would be to observe that the use of healthcare and the perception of health are different from those of the general population of the CACL, and that it is therefore necessary to develop appropriate human and structural resources.
However, it seems essential to know this prevalence in order to adjust the offer of care and adapt it as much as possible to the specific needs of this population.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People in precarious situations, extreme exclusion and/or wandering on Cayenne and its surroundings
Key inclusion criteria (2 listed)
- Adults over 18 years old
- person who uses support services intended for people in situations of precariousness, extreme exclusion and/or wandering on Cayenne and its surroundings - person agreeing to participate in the study.
Key exclusion criteria (3 listed)
- Person refusing to participate in the study
- Person presenting an acute state of decompensation of a psychiatric pathology and/or a state of crisis (agitation crisis, suicidal crisis) and/or confusion or presenting an acute intoxication to a substance preventing him/her from understanding and answering questions.
- Impossibility of having an interpreter for a person with no (or little) French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of psychiatric disorders and substance abuse disorders
Time frame: Baseline
To estimate the prevalence of the main psychiatric disorders, as well as the prevalence of addictive disorders to psychoactive substances among people in a precarious situation, excluded and/or wandering on Cayenne Island and who use primary care services
3 secondary outcomes
Description of socio-demographic profiles
Time frame: Baseline
Description of perceived health status
Time frame: Baseline
Description of use and access to health care
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 32460590Hossain MM, Sultana A, Tasnim S, Fan Q, Ma P, McKyer ELJ, Purohit N. Prevalence of mental disorders among people who are homeless: An umbrella review. Int J Soc Psychiatry. 2020 Sep;66(6):528-541. doi: 10.1177/0020764020924689. Epub 2020 May 28.
- Background: PubMed 32513264Ayano G, Shumet S, Tesfaw G, Tsegay L. A systematic review and meta-analysis of the prevalence of bipolar disorder among homeless people. BMC Public Health. 2020 Jun 9;20(1):731. doi: 10.1186/s12889-020-08819-x.
- Background: PubMed 32415465Ayano G, Solomon M, Tsegay L, Yohannes K, Abraha M. A Systematic Review and Meta-Analysis of the Prevalence of Post-Traumatic Stress Disorder among Homeless People. Psychiatr Q. 2020 Dec;91(4):949-963. doi: 10.1007/s11126-020-09746-1.
- Background: PubMed 31775786Ayano G, Tesfaw G, Shumet S. The prevalence of schizophrenia and other psychotic disorders among homeless people: a systematic review and meta-analysis. BMC Psychiatry. 2019 Nov 27;19(1):370. doi: 10.1186/s12888-019-2361-7.
- Background: PubMed 25390578Fazel S, Geddes JR, Kushel M. The health of homeless people in high-income countries: descriptive epidemiology, health consequences, and clinical and policy recommendations. Lancet. 2014 Oct 25;384(9953):1529-40. doi: 10.1016/S0140-6736(14)61132-6.
- Mental health status of homeless people in Paris, 1997Link provided by the sponsor.
- Mental health status and abuse disorders of homeless people in Paris region, 2010Link provided by the sponsor.
- When homelessness puts at risk children mental healthLink provided by the sponsor.
- Public Health Aspects of Mental Health Among Migrants and Refugees: A Review of the Evidence on Mental Health Care for Refugees, Asylum Seekers and Irregular Migrants in the WHO European RegionLink provided by the sponsor.
- Health survey in French Overseas departmentLink provided by the sponsor.
- PTSD screen for DSM-5Link provided by the sponsor.
- 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.
Caroline JANVIER, MD principal investigator
Centre Hospitalier de Cayenne
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 Psychiatric Disorder and Substance Use Disorders, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
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 3 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 26 Jul 2024. 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 French Guiana. 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 Caroline JANVIER, MD (+594 594 39 50 47, caroline.janvier@ch-cayenne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of psychiatric disorders and substance abuse disorders (time frame: Baseline). 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 NCT06065553, which also lists 5 linked publications.
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 26 Jul 2024.