NCT04867447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

July 6, 2023

Status Verified

April 1, 2023

Enrollment Period

3.5 years

First QC Date

April 12, 2021

Last Update Submit

July 2, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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".

    From birth to age 18 (216 months)

  • 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.

    From birth to study evaluation, assessed up to 250 months.

  • 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.

    1 year (previous to study evaluation) .

  • 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.

    From birth to study evaluation, assessed up to 250 months.

Secondary Outcomes (3)

  • Positive and Negative Syndrome Scale (PANSS)

    1 week (previous to study evaluation)

  • Dissociative symptoms prevalence

    1 week (previous to study evaluation)

  • Substance use disorder prevalence.

    From birth to study evaluation, assessed up to 250 months.

Study Arms (2)

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

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).

Case-Immigrants psychotic patientsControl-Non immigrants psychotic patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad de Investigación del Centro Fórum y Instituto Hospital del Mar de Investigaciones Médicas.

Barcelona, 08019, Spain

Location

Related Publications (8)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Trabsa A, Redolar-Ripoll D, Vargas L, Llimona A, Hogg B, Valiente-Gomez A, Perez V, Moreno-Alcazar A, Amann BL. A comparison of PTSD and traumatic event rates in a clinical sample of non-refugee immigrants and native-born individuals with a psychotic disorder: a case-control study. Eur J Psychotraumatol. 2023;14(2):2263151. doi: 10.1080/20008066.2023.2263151. Epub 2023 Oct 17.

MeSH Terms

Conditions

Psychotic DisordersPsychological TraumaStress, Psychological

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersBehavioral SymptomsBehavior

Study Officials

  • Amira Trabsa Biskri, MD

    Institut Hospital del Mar d'Investigacions Mèdiques (IMIM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 30, 2021

Study Start

September 1, 2019

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

July 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations