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

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867447
• Other study ID #: 2019/8398/I
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2023
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cross-Cultural Comparison
• Mental Disorders
• Psychological Trauma
• Psychotic Disorders
• Stress, Psychological

Intervention

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).

Locations

Country	Name	City	State
Spain	Unidad de Investigación del Centro Fórum y Instituto Hospital del Mar de Investigaciones Médicas.	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Universitat Autonoma de Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Anderson KK, Edwards J. Age at migration and the risk of psychotic disorders: a systematic review and meta-analysis. Acta Psychiatr Scand. 2020 May;141(5):410-420. doi: 10.1111/acps.13147. Epub 2020 Jan 20. — View Citation

Betancourt TS, Newnham EA, Birman D, Lee R, Ellis BH, Layne CM. Comparing Trauma Exposure, Mental Health Needs, and Service Utilization Across Clinical Samples of Refugee, Immigrant, and U.S.-Origin Children. J Trauma Stress. 2017 Jun;30(3):209-218. doi: — View Citation

Cantor-Graae E, Selten JP. Schizophrenia and migration: a meta-analysis and review. Am J Psychiatry. 2005 Jan;162(1):12-24. doi: 10.1176/appi.ajp.162.1.12. — View Citation

Gibson LE, Alloy LB, Ellman LM. Trauma and the psychosis spectrum: A review of symptom specificity and explanatory mechanisms. Clin Psychol Rev. 2016 Nov;49:92-105. doi: 10.1016/j.cpr.2016.08.003. Epub 2016 Aug 31. — View Citation

Hollander AC, Dal H, Lewis G, Magnusson C, Kirkbride JB, Dalman C. Refugee migration and risk of schizophrenia and other non-affective psychoses: cohort study of 1.3 million people in Sweden. BMJ. 2016 Mar 15;352:i1030. doi: 10.1136/bmj.i1030. Erratum In: — View Citation

Howes OD, McCutcheon R. Inflammation and the neural diathesis-stress hypothesis of schizophrenia: a reconceptualization. Transl Psychiatry. 2017 Feb 7;7(2):e1024. doi: 10.1038/tp.2016.278. — View Citation

Selten JP, Hoek HW. Does misdiagnosis explain the schizophrenia epidemic among immigrants from developing countries to Western Europe? Soc Psychiatry Psychiatr Epidemiol. 2008 Dec;43(12):937-9. doi: 10.1007/s00127-008-0390-5. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Childhood Trauma exposure	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)
Primary	Global Trauma exposure by Cumulative Trauma Scale	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.
Primary	The Holmes and Rahe Stress Scale	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) .
Primary	PTSD prevalence	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.
Secondary	Positive and Negative Syndrome Scale (PANSS)	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)
Secondary	Dissociative symptoms prevalence	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)
Secondary	Substance use disorder prevalence.	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.