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CompletedNCT04867447Updated Jul 6, 2023

Prevalence of Traumatic Events and PTSD in Immigrant and Non-immigrant Patients With Psychotic Disorder

An observational study in Psychotic Disorders, Psychological Trauma and Stress, Psychological, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-06.

Sponsored by Parc de Salut Mar · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
199
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Psychotic Disorders
  • Psychological Trauma
  • Stress, Psychological
  • Cross-Cultural Comparison
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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 199 is close to the median of 200 across 480 observational studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
199 participants (actual)
Patient registry
No

Groups and cohorts

  • Case-Immigrants psychotic patients

    Individuals who have presented at least one non-affective psychotic episode with an immigrant status, defined as "a person who migrates to another country, usually for permanent residence"

    Diagnostic Test: Psychological trauma evaluation

  • Control-Non immigrants psychotic patients

    Individuals who have presented at least one non-affective psychotic episode who do not have an immigrant status.

    Diagnostic Test: Psychological trauma evaluation

Interventions

  • Diagnostic testPsychological trauma evaluation

    Psychological trauma exposure is assessed by validated scales: * Childhood Trauma Questionnaire (CTQ) * Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) * Cumulative Trauma Scale. * The Holmes and Rahe Stress Scale. Other clinical scales used: * Positive and Negative Syndrome Scale (PANSS). * Dissociative Experiences Scale (DES) * Mini-Mental State Examination (MMSE).

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What researchers measure

Primary outcomes

  1. Childhood Trauma exposure

    Assessed by Childhood Trauma Questionnaire (CTQ): is a self-administered 28-item scale to measure abuse and neglect suffered in childhood on five subscales: emotional, physical or sexual abuse, and emotional or physical neglect, each subscale scored on a 5-point Likert scale. The score for each subscale classifies the severity of the abuse and neglect as: "none to minimal," "low to moderate," "moderate to severe" and "severe to extreme".

    Time frame: From birth to age 18 (216 months)

  2. Global Trauma exposure by Cumulative Trauma Scale

    Cumulative Trauma Scale (CTS): Assesses exposure and emotional involvement to 33 traumatic events, especially oriented to minority groups such as refugees, prisoners or mental health patients. Each item on a 7-point Likert scale (from "1-extremely positive to 7-extremely negative"). Higher scores show more cumulative lifetime traumatic events exposure.

    Time frame: From birth to study evaluation, assessed up to 250 months.

  3. The Holmes and Rahe Stress Scale

    The Holmes and Rahe Stress Scale (Holmes \& Rahe): is used to determine which common stressful life events a patient has experienced in the last 12 months, with each life event scored according to a standardized measure of their impact and a total score provided by summing all those applicable to the patient. Scores \<150 are correlated with low stress, 150-299 scores are correlated with moderate stress and \>300 scores are correlated with high level of stress.

    Time frame: 1 year (previous to study evaluation) .

  4. PTSD prevalence

    Clinician-Administered PTSD Scale for Diagnostic and statistical manual of mental disorders 5th edition (DSM-V), (CAPS-5): is a 55-item clinician-applied scale to determine PTSD diagnosis, based on the current DSM-V criteria. This scale consists of three sections: events, symptoms and functioning.

    Time frame: From birth to study evaluation, assessed up to 250 months.

Secondary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Psychotic symptoms are measured with the Positive and Negative Syndrome Scale (PANSS) for schizophrenia an 30-item clinician administered scale which measures positive, negative and general psychopathological symptoms on a scale of 1-7, based on the severity of the symptom (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme). The higher scores are correlated with more severe symptomatology. A total score of 58 indicates "moderate severity," while a PANSS score of 75 represents "marked severity." A PANSS total score of 95 corresponds to "severe severity," and a score of 116 signifies "very severe severity."

    Time frame: 1 week (previous to study evaluation)

  2. Dissociative symptoms prevalence

    Dissociative Experiences Scale (DES): is a 28-item self-report scale which measures the frequency with which an individual experiences a range of dissociative experiences, from normal to pathological. An overall mean score ranges from 0 to 100, and there are subscales for amnesia, dissociation and depersonalization. A total score of over 30 indicate high levels of dissociation

    Time frame: 1 week (previous to study evaluation)

  3. Substance use disorder prevalence.

    A diagnosis of substance use disorder (alcohol or other illicit substances) will be made according to Diagnostic and statistical manual of mental disorders 5th edition (DSM-V) criteria.

    Time frame: From birth to study evaluation, assessed up to 250 months.

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Study locations

1 site
  • Unidad de Investigación del Centro Fórum y Instituto Hospital del Mar de Investigaciones Médicas.
    Barcelona, 08019, Spain
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References and documents

Publications

  • 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. PubMed 28585740 ↗
  • 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. PubMed 15625195 ↗
  • 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. PubMed 31903545 ↗
  • 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. Erratum In: BMJ. 2016 May 27;353:i2865. doi: 10.1136/bmj.i2865. PubMed 26979256 ↗
  • 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. PubMed 18587677 ↗
  • 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. PubMed 27632064 ↗
  • 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. PubMed 28170004 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04867447
Lead sponsor
Parc de Salut Mar
Collaborators
Universitat Autonoma de Barcelona
Responsible party
Sponsor
First posted
Apr 30, 2021
Start date
Sep 1, 2019
Primary completion
Mar 1, 2023
Completion
Mar 1, 2023
Last update
Jul 6, 2023

Study contacts

Amira Trabsa Biskri, MD
principal investigator · Institut Hospital del Mar d'Investigacions Mèdiques (IMIM)

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 Apr 2023. You cannot join it, but the record below documents what was studied.

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