Prevalence of Post-traumatic Stress Disorder and Trauma Symptoms in a General Population Sample

NCT05679245 | Unknown

• 1 other identifier: CS01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder; Psychological Trauma

Keywords

post-traumatic stress disorder; psychological trauma; healthy controls

Outcome Measures

Primary Outcomes (3)

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

  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.

  cross-sectional, baseline

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

  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.

  cross-sectional, baseline

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

  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.

  cross-sectional, baseline

Secondary Outcomes (7)

• 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

• 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

Study Arms (1)

Healthy Controls

Healthy controls without mental disorder in the general population of the Barcelona area of Catalonia, Spain to be assessed for exposure to traumatic life events, post-traumatic stress disorder, trauma symptoms, dissociative symptoms, affective symptoms, and psychosocial functioning.

Diagnostic Test: Assessment for exposure to psychological trauma and related symptoms

Interventions

Assessment for exposure to psychological trauma and related symptoms DIAGNOSTIC_TEST

To be assessed for exposure to traumatic life events, post-traumatic stress disorder, trauma-related symptoms, dissociative symptoms, affective symptoms, and psychosocial functioning.

Healthy Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult controls without mental disorder from the Barcelona region of Catalonia, Spain.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Alicia Valiente

Barcelona, 08019, Spain

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Trauma

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Alicia Valiente-Gómez, PhD

CONTACT

933268500; avaliente@psmar.cat

Bridget Hogg

CONTACT

933268500; bhogg@imim.es

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 10, 2023
• Study Start: March 28, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2022-12

Locations

ES (1)