Trauma PatientsNCT07530432
Analysis of Influencing Factors for the Development of PTSD in Emergency Department Trauma Patients
An observational study of Trauma Patients and PTSD, run by The First Affiliated Hospital of Air Force Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma Patients, PTSD
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Medical subject headings
- Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baselin and 6 months post-trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start20 Mar 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Air Force Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wei zhao, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530432
- Sponsor's protocol ID
- KY20252601-F-1
- Status last verified
- Dec 2025
- First submitted
- 19 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Influencing Factors for the Development of PTSD in Emergency Department Trauma Patients
- ClinicalTrials.gov ID
- NCT07530432
- Acronym / sponsor ID
- KY20252601-F-1
- Conditions
- Trauma Patients, PTSD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Air Force Medical UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Association of Sociodemographic, Trauma-Related, and Psychosocial Factors with PTSD Status
Time frame: Baselin and 6 months post-trauma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma Patients and PTSD, run by The First Affiliated Hospital of Air Force Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yang li, Master's Student (+86 18089193316, li18089193316@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Incidence as Assessed by the PTSD Checklist for DSM-5 (PCL-5) (time frame: 6 months post-trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.