Post-traumatic Stress DisorderNCT05679245
Prevalence of Post-traumatic Stress Disorder and Trauma Symptoms in a General Population Sample
An observational study of Post-traumatic Stress Disorder and Psychological Trauma, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder, Psychological Trauma
- What is being tested?
- Assessment for exposure to psychological trauma and related symptoms
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 28 Mar 2023to Mar 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult controls without mental disorder from the Barcelona region of Catalonia, Spain.
Who may be able to join
- to be an adult (18-65 years inclusive)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Alicia Valiente
Barcelona, 08019
Alicia Valiente, 393268500 ext. 8403, avaliente@psmar.cat
About this study
Official title: 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.
Read the 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.
- Being tested
- Assessment for exposure to psychological trauma and related symptoms
- Keywords
- post-traumatic stress disorder, psychological trauma, healthy controls
- Medical subject headings
- Stress Disorders, Post-Traumatic, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment for exposure to psychological trauma and related symptomsDiagnostic test
To be assessed for exposure to traumatic life events, post-traumatic stress disorder, trauma-related symptoms, dissociative symptoms, affective symptoms, and psychosocial functioning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Assessment for exposure to psychological trauma and related symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: cross-sectional, baseline
Secondary outcomes (7)
Prevalence of depressive symptoms in a sample of healthy controls without mental disorder
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.
Measured: cross-sectional, baseline
Prevalence of psychiatric symptoms in a sample of healthy controls without mental disorder
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.
Measured: cross-sectional, baseline
Prevalence of symptoms of somatoform dissociation in a sample of healthy controls without mental disorder
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.
Measured: cross-sectional, baseline
Prevalence of depersonalisation dissociative symptoms in a sample of healthy controls without mental disorder
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.
Measured: cross-sectional, baseline
Prevalence of difficulties in psychosocial functioning in a sample of healthy controls without mental disorder
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.
Measured: 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
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.
Measured: cross-sectional, baseline
Prevalence of recent stressful life events in a sample of healthy controls without mental disorder
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.
Measured: cross-sectional, baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start28 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679245
- Sponsor's protocol ID
- CS01
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Post-traumatic Stress Disorder and Trauma-related Symptoms in a Sample of Healthy Controls in the Barcelona Region of Catalonia, Spain
- ClinicalTrials.gov ID
- NCT05679245
- Acronym / sponsor ID
- CS01
- Keywords
- post-traumatic stress disorder, psychological trauma, healthy controls
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Diagnostic Test: Assessment for exposure to psychological trauma and related symptomsHealthy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult controls without mental disorder from the Barcelona region of Catalonia, Spain.
Key inclusion criteria (1 listed)
- to be an adult (18-65 years inclusive)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment for exposure to psychological trauma and related symptomsTo be assessed for exposure to traumatic life events, post-traumatic stress disorder, trauma-related symptoms, dissociative symptoms, affective symptoms, and psychosocial functioning. | Diagnostic test | Healthy Controls |
Primary outcome
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.
7 secondary outcomes
Prevalence of depressive symptoms in a sample of healthy controls without mental disorder
Time frame: cross-sectional, baseline
Prevalence of psychiatric symptoms in a sample of healthy controls without mental disorder
Time frame: 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 depersonalisation dissociative symptoms in a sample of healthy controls without mental disorder
Time frame: 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 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 recent stressful life events in a sample of healthy controls without mental disorder
Time frame: cross-sectional, baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-traumatic Stress Disorder 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alicia Valiente-Gómez, PhD (933268500 ext. 8403, avaliente@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of post-traumatic stress disorder in a sample of healthy controls without mental disorder (time frame: cross-sectional, baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.