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Clinical Trials/NCT04867447
NCT04867447
Completed
Not Applicable

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

Parc de Salut Mar1 site in 1 country199 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychotic Disorders
Sponsor
Parc de Salut Mar
Enrollment
199
Locations
1
Primary Endpoint
Childhood Trauma exposure
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
March 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Parc de Salut Mar
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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".

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.

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.

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.

Secondary Outcomes

  • 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 Sites (1)

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