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OpenTrials
Completed

NCT Number: NCT04867447

Prevalence of Traumatic Events and PTSD 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Barcelona, 08019, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychological trauma evaluation

Diagnostic Test

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).

Primary outcomes

  1. 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".

  2. 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.

  3. 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.

  4. 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

  1. 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."

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Universitat Autonoma de Barcelona

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2021
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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