Clinical trial NCT05679245: Prevalence of Post-traumatic Stress Disorder and Trauma Symptoms in a General Population Sample
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-traumatic Stress Disorder
Psychological Trauma
Keywords: post-traumatic stress disorder
psychological trauma
healthy controls
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult controls without mental disorder from the Barcelona region of Catalonia, Spain.

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.

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

Primary outcomes:
measure: Prevalence of post-traumatic stress disorder in a sample of healthy controls without mental disorder
timeFrame: cross-sectional, baseline
measure: Prevalence of trauma symptoms in a sample of healthy controls without mental disorder
timeFrame: cross-sectional, baseline
measure: Prevalence of dissociative symptoms in a sample of healthy controls without mental disorder
timeFrame: cross-sectional, baseline
Secondary outcomes:
measure: Prevalence of depressive symptoms in a sample of healthy controls without mental disorder
timeFrame: cross-sectional, baseline
measure: Prevalence of psychiatric symptoms in a sample of healthy controls without mental disorder
timeFrame: cross-sectional, baseline
measure: Prevalence of symptoms of somatoform dissociation in a sample of healthy controls without mental disorder
timeFrame: cross-sectional, baseline
measure: Prevalence of depersonalisation dissociative symptoms in a sample of healthy controls without mental disorder
timeFrame: cross-sectional, baseline
measure: Prevalence of difficulties in psychosocial functioning in a sample of healthy controls without mental disorder
timeFrame: cross-sectional, baseline
measure: Prevalence of childhood trauma events (physical, sexual, or emotional abuse, and physical or emotional neglect) in a sample of healthy controls without mental disorder
timeFrame: cross-sectional, baseline
measure: Prevalence of recent stressful life events in a sample of healthy controls without mental disorder
timeFrame: cross-sectional, baseline
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Alicia Valiente
Study officials:
References: