Analysis of Influencing Factors for the Development of PTSD in Emergency Department Trauma Patients

NCT07530432 — Not yet recruiting, 250 participants, The First Affiliated Hospital of Air Force Medicial University
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RegistryNCT07530432
StatusNot yet recruiting
Study typeObservational
Enrollment250 (Estimated)
SponsorThe First Affiliated Hospital of Air Force Medicial University (Other)
ConditionsTrauma Patients, PTSD
Datesstart 2026-03-20 (estimated), primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-04-15, last updated 2026-04-15

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-Summary

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.

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+Outcome measures

Primary outcomes

  • PTSD Incidence as Assessed by the PTSD Checklist for DSM-5 (PCL-5) [6 months post-trauma]: 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 [Baselin and 6 months post-trauma]: 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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Study documents