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NCT Number: NCT07530432

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. PTSD Incidence as Assessed by the PTSD Checklist for DSM-5 (PCL-5)

    Time frame: 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

  1. Association of Sociodemographic, Trauma-Related, and Psychosocial Factors with PTSD Status

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

yang li, Master's Student

CONTACT

[email protected]

+86 18089193316

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Air Force Medicial University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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