About this trial
The goal of this observational study is to learn about the long-term effects of key factors such as cognitive flexibility, social support, and physiological stress on the occurrence of Post-Traumatic Stress Disorder (PTSD) in adult trauma patients treated in the emergency department. The main question it aims to answer is:
Among emergency department patients who have experienced major trauma, can factors such as early post-trauma cognitive flexibility, level of social support, inflammatory markers, and trauma severity predict the development of PTSD within 6 months? Participants will complete a series of online questionnaires and clinical assessments at baseline, 1 month, 3 months, and 6 months after the traumatic event.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years old (inclusive);
Experienced a life-threatening major traumatic event, clearly diagnosed by a clinician;
The patient is able to communicate normally with medical staff through language;
The subject is fully informed and voluntarily signs the informed consent form.
Disqualifiers
History of psychiatric disorders or current use of psychotropic medications;
Pre-existing cognitive impairment (e.g., dementia, Alzheimer's disease);
Terminal illnesses (such as advanced malignant tumors, end-stage organ failure, advanced neurological diseases, or any other condition judged by the attending physician to have a life expectancy of less than 6 months);
Inability to cooperate with follow-up.
Trial population
This study is a single-center, prospective cohort study that plans to enroll a total of 250 adult trauma patients. The study subjects will be trauma patients seeking treatment at the Emergency Department of Xijing Hospital from January 2026 to December 2026.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
PTSD Incidence as Assessed by the PTSD Checklist for DSM-5 (PCL-5)
Number of participants with a total score ≥33 on the PCL-5 (range 0-80, higher scores indicate more severe PTSD symptoms) at 6 months after the traumatic event, indicating probable post-traumatic stress disorder (PTSD).
Secondary outcomes
Association of Sociodemographic, Trauma-Related, and Psychosocial Factors with PTSD Status
Odds ratios (ORs) and 95% confidence intervals for the association of each candidate factor (e.g., age, sex, injury severity score \[ISS\], social support \[SSRS score\], anxiety/depression \[HADS score\], cognitive flexibility \[CFI score\], inflammatory biomarkers \[IL-6, CRP\]) with probable PTSD status at 6 months, as determined by multivariable logistic regression.
Locations
Sponsors and contacts
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