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Not yet recruitingNCT07530432Updated Apr 15, 2026

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

An observational study in Trauma Patients and PTSD, sponsored by The First Affiliated Hospital of Air Force Medicial University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by The First Affiliated Hospital of Air Force Medicial University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years to 65 Years
Sex
All
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Study 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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Conditions studied

  • Trauma Patients
  • PTSD
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In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's planned enrollment of 250 is above the median of 136 across 295 observational studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

The First Affiliated Hospital of Air Force Medicial University is the lead sponsor of 7 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 months post-trauma

Secondary outcomes

  1. 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.

    Time frame: Baselin and 6 months post-trauma

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

  • Study protocol · Dec 25, 2025
  • Informed consent form · Dec 25, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07530432
Lead sponsor
The First Affiliated Hospital of Air Force Medicial University
Responsible party
wei zhao (Associate Professor, The First Affiliated Hospital of Air Force Medicial University) — Principal investigator
First posted
Apr 15, 2026
Start date
Mar 20, 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 15, 2026

Study contacts

yang li, Master's Student
Contact
li18089193316@163.com
+86 18089193316

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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