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

Sponsor
Parc de Salut Mar (Other)
Overall Status
Recruiting
CT.gov ID
NCT04867447
Collaborator
Universitat Autonoma de Barcelona (Other)
196
1
36
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Psychological trauma evaluation

Study Design

Study Type:
Observational
Anticipated Enrollment :
196 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Prevalence of Traumatic Events and Post-traumatic Stress Disorder in Immigrant and Non-immigrant Patients With Psychotic Disorder
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. Childhood Trauma exposure [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".

  2. Global Trauma exposure [From birth to study evaluation, assessed up to 250 months.]

    Cumulative Trauma Scale: Assesses exposure and emotional involvement to 33 traumatic events, especially oriented to minority groups such as refugees, prisoners or mental health patients.

  3. Stress exposure [1 year (previous to study evaluation) .]

    The Holmes and Rahe Stress Scale: 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.

  4. PTSD prevalence [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.

Secondary Outcome Measures

  1. Psychotic Symptom Severity [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.

  2. Dissociative symptoms prevalence [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

  3. Substance use disorder prevalence. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unidad de Investigación del Centro Fórum y Instituto Hospital del Mar de Investigaciones Médicas. Barcelona Spain 08019

Sponsors and Collaborators

  • Parc de Salut Mar
  • Universitat Autonoma de Barcelona

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT04867447
Other Study ID Numbers:
  • 2019/8398/I
First Posted:
Apr 30, 2021
Last Update Posted:
Apr 30, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 30, 2021