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

NCT07530432 | Not Yet Recruiting

• 1 other identifier: KY20252601-F-1
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Trauma Patients; PTSD

Outcome Measures

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).

  6 months post-trauma

Secondary Outcomes (1)

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

  Baselin and 6 months post-trauma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Air Force Medicial University: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

yang li, Master's Student

CONTACT

+86 18089193316; li18089193316@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 15, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share