Clinical trial NCT04867447: Prevalence of Traumatic Events and PTSD in Immigrant and Non-immigrant Patients With Psychotic Disorder
Official title: Prevalence of Traumatic Events and Post-traumatic Stress Disorder in Immigrant and Non-immigrant Patients With Psychotic Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychotic Disorders
Psychological Trauma
Stress, Psychological
Cross-Cultural Comparison
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Universitat Autonoma de Barcelona
First posted: 2021-04-30
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present, according DSM-V criteria, one or more non-affective psychotic episodes from Acute and Chronic inpatients units at Parc de Salut Mar (Barcelona).

Brief summary: Higher rates of psychosis are described in migrant population. Likewise, this populations could suffer several adversities during migration process that could lead to higher exposure to traumatic events and higher rates of posttraumatic stress disorder (PTSD). There is a growing evidence that trauma is associated with psychosis onset.

The aim of this research is to study the association between psychosis and traumatic events exposure/PTSD in immigrant population. Our hypothesis is that the higher incidence of psychosis described in immigrant population is associated to higher trauma exposure.

A case-control observational study is performed. Patients who presented at least one psychotic episode are recruited from acute and chronic units at "Parc Salut Mar" (Barcelona). Estimated total sample is 196 individuals. Trauma exposure is assessed by validated trauma scales. Known factors associated with psychosis are controled during the statistic analysis.


Eligibility criteria: Inclusion Criteria:

* To present history of one or more psychotic episodes defined according to DSM-5 criteria, including patients with diagnoses of Schizophrenia, Schizoaffective Disorder and non-specific psychotic disorders.
* Patients of non-local origins who have undergone a migration process along the life line (as case individuals) and autochthonous patients (as control individuals).
* Age between 18 and 65 years.

Exclusion Criteria:

* Patients who have not clinical stability.
* Important cognitive limitations to understand informed consent nor applied questionnaires.
* Language barrier that limits understanding informed consent nor applied questionnaires.

Primary outcomes:
measure: Childhood Trauma exposure
timeFrame: From birth to age 18 (216 months)
measure: Global Trauma exposure by Cumulative Trauma Scale
timeFrame: From birth to study evaluation, assessed up to 250 months.
measure: The Holmes and Rahe Stress Scale
timeFrame: 1 year (previous to study evaluation) .
measure: PTSD prevalence
timeFrame: From birth to study evaluation, assessed up to 250 months.
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 1 week (previous to study evaluation)
measure: Dissociative symptoms prevalence
timeFrame: 1 week (previous to study evaluation)
measure: Substance use disorder prevalence.
timeFrame: From birth to study evaluation, assessed up to 250 months.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Unidad de Investigación del Centro Fórum y Instituto Hospital del Mar de Investigaciones Médicas.
Study officials:
affiliation: Institut Hospital del Mar d'Investigacions Mèdiques (IMIM)
name: Amira Trabsa Biskri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Betancourt TS, Newnham EA, Birman D, Lee R, Ellis BH, Layne CM. Comparing Trauma Exposure, Mental Health Needs, and Service Utilization Across Clinical Samples of Refugee, Immigrant, and U.S.-Origin Children. J Trauma Stress. 2017 Jun;30(3):209-218. doi: 10.1002/jts.22186. Epub 2017 Jun 6.
citation: Cantor-Graae E, Selten JP. Schizophrenia and migration: a meta-analysis and review. Am J Psychiatry. 2005 Jan;162(1):12-24. doi: 10.1176/appi.ajp.162.1.12.
citation: Anderson KK, Edwards J. Age at migration and the risk of psychotic disorders: a systematic review and meta-analysis. Acta Psychiatr Scand. 2020 May;141(5):410-420. doi: 10.1111/acps.13147. Epub 2020 Jan 20.
citation: Hollander AC, Dal H, Lewis G, Magnusson C, Kirkbride JB, Dalman C. Refugee migration and risk of schizophrenia and other non-affective psychoses: cohort study of 1.3 million people in Sweden. BMJ. 2016 Mar 15;352:i1030. doi: 10.1136/bmj.i1030.
citation: Selten JP, Hoek HW. Does misdiagnosis explain the schizophrenia epidemic among immigrants from developing countries to Western Europe? Soc Psychiatry Psychiatr Epidemiol. 2008 Dec;43(12):937-9. doi: 10.1007/s00127-008-0390-5. No abstract available.
citation: Gibson LE, Alloy LB, Ellman LM. Trauma and the psychosis spectrum: A review of symptom specificity and explanatory mechanisms. Clin Psychol Rev. 2016 Nov;49:92-105. doi: 10.1016/j.cpr.2016.08.003. Epub 2016 Aug 31.
citation: Howes OD, McCutcheon R. Inflammation and the neural diathesis-stress hypothesis of schizophrenia: a reconceptualization. Transl Psychiatry. 2017 Feb 7;7(2):e1024. doi: 10.1038/tp.2016.278.