- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05679245
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
Recruiting
Intervention / Treatment
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
Observational
Enrollment (Estimated)
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
- Name: Alicia Valiente-Gómez, PhD
- Phone Number: 8403 933268500
- Email: avaliente@psmar.cat
Study Contact Backup
- Name: Bridget Hogg
- Phone Number: 8403 933268500
- Email: bhogg@imim.es
Study Locations
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-
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Barcelona, Spain, 08019
- Recruiting
- Alicia Valiente
-
Contact:
- Alicia Valiente
- Phone Number: 8403 393268500
- Email: avaliente@psmar.cat
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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
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
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
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)
March 28, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
December 21, 2022
First Submitted That Met QC Criteria
January 9, 2023
First Posted (Actual)
January 10, 2023
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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