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

July 2, 2023 updated by: Parc de Salut Mar

Prevalence of Traumatic Events and Post-traumatic Stress Disorder in Immigrant and Non-immigrant Patients With Psychotic Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08019
        • Unidad de Investigación del Centro Fórum y Instituto Hospital del Mar de Investigaciones Médicas.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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).
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

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childhood Trauma exposure
Time Frame: From birth to age 18 (216 months)
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)
PTSD prevalence
Time Frame: From birth to study evaluation, assessed up to 250 months.
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.
Global Trauma exposure by Cumulative Trauma Scale
Time Frame: From birth to study evaluation, assessed up to 250 months.
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
Time Frame: 1 year (previous to study evaluation) .
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) .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dissociative symptoms prevalence
Time Frame: 1 week (previous to study evaluation)
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
1 week (previous to study evaluation)
Substance use disorder prevalence.
Time Frame: From birth to study evaluation, assessed up to 250 months.
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.
From birth to study evaluation, assessed up to 250 months.
Positive and Negative Syndrome Scale (PANSS)
Time Frame: 1 week (previous to study evaluation)

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."
1 week (previous to study evaluation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Collaborators

Universitat Autonoma de Barcelona

Investigators

  • Principal Investigator: Amira Trabsa Biskri, MD, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/8398/I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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