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

• ClinicalTrials.gov Identifier: NCT04867447
• Recruitment Status: Recruiting
• First Posted: April 30, 2021
• Last Update Posted: April 30, 2021
• Sponsor: Parc de Salut Mar
• Collaborator: Universitat Autonoma de Barcelona
• Information provided by (Responsible Party): Parc de Salut Mar

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
Psychotic Disorders; Psychological Trauma; Stress, Psychological; Cross-Cultural Comparison	Diagnostic Test: Psychological trauma evaluation

Study Design

• Study Type: Observational
• Estimated 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: September 1, 2019
• Estimated Primary Completion Date: September 1, 2022
• Estimated Study Completion Date: September 1, 2022

Groups and Cohorts

Group/Cohort	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 [ 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 [ Time Frame: 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 [ Time Frame: 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 [ 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 Outcome Measures :

1. Psychotic Symptom Severity [ 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.
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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients who present, according DSM-V criteria, one or more non-affective psychotic episodes from Acute and Chronic inpatients units at Parc de Salut Mar (Barcelona).

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.

Contacts and Locations

Contacts

Contact: Amira Trabsa Biskri, MD; +34 933 26 85 00; 62248@parcdesalutmar.cat

Contact: Benedikt Amann, PhD; +34 933 26 85 00; benedikt.amann@gmail.com

Locations

Spain

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

Barcelona, Spain, 08019

Contact: Amira Trabsa Biskri, MD 933 26 85 00 62248@parcdesalutmar.cat

Contact: Benedikt Amann, PhD 933 26 85 00 bamann@parcdesalutmar.cat

Principal Investigator: Amira Trabsa, MD

Sub-Investigator: Benedikt Amann, PhD

Sub-Investigator: Ana Moreno, PhD

Sub-Investigator: Víctor Pérez Solà, PhD

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)

More Information

Publications of Results:

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: 10.1002/jts.22186. Epub 2017 Jun 6.

Cantor-Graae E, Selten JP. Schizophrenia and migration: a meta-analysis and review. Am J Psychiatry. 2005 Jan;162(1):12-24. Review.

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.

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: BMJ. 2016 May 27;353:i2865.

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.

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. Review.

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. Review.

• Responsible Party: Parc de Salut Mar
• ClinicalTrials.gov Identifier: NCT04867447
• Other Study ID Numbers: 2019/8398/I
• First Posted: April 30, 2021
• Last Update Posted: April 30, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• 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:

Disease; Mental Disorders; Psychotic Disorders; Stress, Psychological; Psychological Trauma; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders