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

November 15, 2023 updated by: Parc de Salut Mar

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Bridget Hogg
  • Phone Number: 8403 933268500
  • Email: bhogg@imim.es

Study Locations

  • Spain
      • Barcelona, Spain, 08019
        • Recruiting
        • Alicia Valiente
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
To be assessed for exposure to traumatic life events, post-traumatic stress disorder, trauma-related symptoms, dissociative symptoms, affective symptoms, and psychosocial functioning.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
cross-sectional, baseline
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.
cross-sectional, baseline
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.
cross-sectional, baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of depressive symptoms in a sample of healthy controls without mental disorder
Time Frame: cross-sectional, baseline
Prevalence of depressive symptoms according to the Hamilton Depression Rating Scale (HDRS), which can provide a total score between 0 and 63, with higher scores meaning greater depressive symptoms.
cross-sectional, baseline
Prevalence of psychiatric symptoms in a sample of healthy controls without mental disorder
Time Frame: cross-sectional, baseline
Prevalence of psychiatric symptoms according to the Brief Psychiatric Rating Scale (BPRS). The first 18 items on this scale provide a total score from 0 to 146, with higher scores signifying more severe psychiatric symptoms, while item 19 provides an estimate of severity of illness on a Likert scale from 1 to 7.
cross-sectional, baseline
Prevalence of symptoms of somatoform dissociation in a sample of healthy controls without mental disorder
Time Frame: cross-sectional, baseline
Prevalence of symptoms of somatoform dissociation according to the Somatoform Dissociation Questionnaire (SDQ-20). Each item is scored on a Likert scale from 1 to 5, up to a total score of 100. Higher scores denote more somatoform symptoms.
cross-sectional, baseline
Prevalence of depersonalisation dissociative symptoms in a sample of healthy controls without mental disorder
Time Frame: cross-sectional, baseline
Prevalence of depersonalisation dissociative symptoms according to the Cambridge Depersonalisation Scale. Each item is scored for frequency (0 to 4) and duration (1 to 6), and these scores are summed together to create a total score. Higher scores indicate greater levels of dissociative symptoms.
cross-sectional, baseline
Prevalence of difficulties in psychosocial functioning in a sample of healthy controls without mental disorder
Time Frame: cross-sectional, baseline
Prevalence of difficulties in psychosocial functioning according to the Functioning Assessment Short Test (FAST). Each item on this scale is scored on a Likert scale of 0 to 3, providing a total score between 0 and 72. Higher scores indicate a greater degree of difficulty in functioning.
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
Time Frame: cross-sectional, baseline
Prevalence of childhood trauma experiences according to the Childhood Trauma Questionnaire (CTQ). This scale provides a score for each subscale of physical, sexual, or emotional abuse, and physical or emotional neglect, with scores categorised as ranging from none to severe.
cross-sectional, baseline
Prevalence of recent stressful life events in a sample of healthy controls without mental disorder
Time Frame: cross-sectional, baseline
Prevalence of recent stressful life events in the previous year according to the Social Readjustment Rating Scale (Holmes & Rahe). This scale provides the number of stressful events. Each event has a weighted score which is summed to create a total score, with higher scores signifying a greater risk of stress-related illness.
cross-sectional, baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Parc de Salut Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CS01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings