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临床试验/NCT04867447
NCT04867447已完成不适用

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

Parc de Salut Mar1 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
199
试验地点
1
主要终点
Childhood Trauma exposure

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Childhood Trauma exposure

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Sponsor

研究点 (1)

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