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Not yet recruiting NCT07530432

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

Observational Trauma Patients PTSD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Trauma Patients, PTSD. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • PTSD Incidence as Assessed by the PTSD Checklist for DSM-5 (PCL-5) [Time frame: 6 months post-trauma]
Secondary outcome measures (1)
  • Association of Sociodemographic, Trauma-Related, and Psychosocial Factors with PTSD Status [Time frame: Baselin and 6 months post-trauma]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07530432 · KY20252601-F-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗