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Clinical Trials/NCT05679245
NCT05679245
Recruiting
N/A

Prevalence of Post-traumatic Stress Disorder and Trauma-related Symptoms in a Sample of Healthy Controls in the Barcelona Region of Catalonia, Spain

Parc de Salut Mar1 site in 1 country50 target enrollmentMarch 28, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post-traumatic Stress Disorder
Sponsor
Parc de Salut Mar
Enrollment
50
Locations
1
Primary Endpoint
Prevalence of post-traumatic stress disorder in a sample of healthy controls without mental disorder
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this observational study is to learn about how many people have post-traumatic stress disorder and related symptoms in the general population of people without any mental illness in the Barcelona region of Catalonia, Spain. The main questions it aims to answer are:

  • What is the prevalence of post-traumatic stress disorder in a sample of healthy controls without other mental disorders?
  • What is the prevalence of trauma-related symptoms in a sample of healthy controls without mental illness?
  • What is the prevalence of dissociative symptoms (including symptoms of depersonalisation and somatoform dissociation) in a sample of healthy controls without mental illness?
  • What is the prevalence of recent and childhood traumatic life events in a sample of healthy controls without mental illness?
  • What is the prevalence of difficulties in psychosocial functioning in healthy controls without mental illness?
  • What is the prevalence of depressive symptoms in healthy controls without mental illness?
  • What is the prevalence of general psychiatric symptoms in healthy controls without mental illness? Participants will be asked to take part in an online screening programme, and then to come to an interview with a clinician who will apply validated scales to test the above.

Detailed Description

This is a study to provide normative data for the prevalence of traumatic life events, post-traumatic stress disorder and trauma-related symptoms, and their impact on psychosocial functioning, and affective symptoms in healthy controls (i.e. without mental illness) in the Barcelona region of Catalonia, Spain.

Registry
clinicaltrials.gov
Start Date
March 28, 2023
End Date
March 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Parc de Salut Mar
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • to be an adult (18-65 years inclusive)

Exclusion Criteria

  • to have a mental disorder except for post-traumatic stress disorder, determined by application of the Mini International Neuropsychiatric Interview (MINI)
  • active suicidal ideation
  • presence of organic brain disease
  • presence of somatic diseases such as fibromyalgia or chronic fatigue syndrome
  • presence of autoimmune diseases such as HIV or AIDS

Outcomes

Primary Outcomes

Prevalence of post-traumatic stress disorder in a sample of healthy controls without mental disorder

Time Frame: cross-sectional, baseline

Prevalence of post-traumatic stress disorder according to criteria of the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition, as per the Global Evaluation of Post-traumatic Stress Disorder Scale (EGEP-5), which assesses the presence or absence of post-traumatic stress disorder.

Prevalence of trauma symptoms in a sample of healthy controls without mental disorder

Time Frame: cross-sectional, baseline

Prevalence of trauma-related symptoms according to the Impact of Events Scale-Revised (IES-R), which is scored on a Likert scale with a maximum score of 110, with higher scores meaning a greater level of trauma symptoms.

Prevalence of dissociative symptoms in a sample of healthy controls without mental disorder

Time Frame: cross-sectional, baseline

Prevalence of dissociative symptoms according to the Dissociative Experiences Scale (DES). The final score is out of 100, with higher scores meaning a greater number of symptoms.

Secondary Outcomes

  • Prevalence of recent stressful life events in a sample of healthy controls without mental disorder(cross-sectional, baseline)
  • Prevalence of symptoms of somatoform dissociation in a sample of healthy controls without mental disorder(cross-sectional, baseline)
  • Prevalence of depersonalisation dissociative symptoms in a sample of healthy controls without mental disorder(cross-sectional, baseline)
  • Prevalence of difficulties in psychosocial functioning in a sample of healthy controls without mental disorder(cross-sectional, baseline)
  • Prevalence of childhood trauma events (physical, sexual, or emotional abuse, and physical or emotional neglect) in a sample of healthy controls without mental disorder(cross-sectional, baseline)
  • Prevalence of depressive symptoms in a sample of healthy controls without mental disorder(cross-sectional, baseline)
  • Prevalence of psychiatric symptoms in a sample of healthy controls without mental disorder(cross-sectional, baseline)

Study Sites (1)

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