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

April 8, 2026 updated by: wei zhao, The First Affiliated Hospital of Air Force Medicial University

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months post-trauma

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baselin and 6 months post-trauma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Air Force Medicial University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20252601-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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