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Psychotic DisordersNCT04867447

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

An observational study of Psychotic Disorders and Psychological Trauma, run by Parc de Salut Mar at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Psychological trauma evaluation
How many people
199 participants
Where
1 siteSpain
Study dates
1 Sep 2019to 1 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

    Barcelona, 08019

Other trials in Spain

About this study

Official title: Prevalence of Traumatic Events and Post-traumatic Stress Disorder 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.

Being tested
Psychological trauma evaluation
Medical subject headings
Psychotic Disorders, Psychological Trauma, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychological trauma evaluationDiagnostic 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).
Study groups in NCT04867447
Study groupRoleWhat they receive
Case-Immigrants psychotic patientsIndividuals 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"
Receives: Diagnostic Test: Psychological trauma evaluation
Control-Non immigrants psychotic patientsIndividuals who have presented at least one non-affective psychotic episode who do not have an immigrant status.
Receives: Diagnostic Test: Psychological trauma evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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".

    Measured: From birth to age 18 (216 months)

  2. 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.

    Measured: From birth to study evaluation, assessed up to 250 months.

  3. 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.

    Measured: 1 year (previous to study evaluation) .

  4. 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.

    Measured: From birth to study evaluation, assessed up to 250 months.

Secondary outcomes (3)

  1. 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."

    Measured: 1 week (previous to study evaluation)

  2. 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

    Measured: 1 week (previous to study evaluation)

  3. 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.

    Measured: From birth to study evaluation, assessed up to 250 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2021
  2. Study start1 Sep 2019
  3. Primary completion1 Mar 2023
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04867447
Sponsor's protocol ID
2019/8398/I
Status last verified
Apr 2023
First submitted
12 Apr 2021
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28585740

  • 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.

    PubMed 15625195

  • 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.

    PubMed 31903545

  • 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.

    PubMed 26979256

  • 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.

    PubMed 18587677

  • 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.

    PubMed 27632064

  • 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.

    PubMed 28170004

  • Trabsa A, Redolar-Ripoll D, Vargas L, Llimona A, Hogg B, Valiente-Gomez A, Perez V, Moreno-Alcazar A, Amann BL. A comparison of PTSD and traumatic event rates in a clinical sample of non-refugee immigrants and native-born individuals with a psychotic disorder: a case-control study. Eur J Psychotraumatol. 2023;14(2):2263151. doi: 10.1080/20008066.2023.2263151. Epub 2023 Oct 17.

    PubMed 37846737

Questions about this trial

What is this clinical trial studying?

An observational study of Psychotic Disorders and Psychological Trauma, run by Parc de Salut Mar at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Childhood Trauma exposure (time frame: From birth to age 18 (216 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04867447, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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