Analysis of Influencing Factors for the Development of PTSD in Emergency Department Trauma Patients
Conditions: Trauma Patients, PTSD
Sponsor: The First Affiliated Hospital of Air Force Medicial University

Analysis of Influencing Factors for PTSD in
Emergency Department Trauma Patients
Sponsor：Department of Emergency Medicine, The First Affiliated
Hospital of Air Force Medical University
Principal Investigator: Wei Zhao
Contact Information: 18681850922
Study Period：September 1, 2025 - June 30, 2027
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Protocol Summary
Item
Analysis of Influencing Factors for PTSD in Emergency Department
Trauma Patients
Study
Objectives
To determine the incidence of PTSD within 6 months in emergency
department
trauma
patients
and
identify
the
sociodemographic,
trauma-related, and psychosocial high-risk factors associated with the
development of PTSD.
To explore the interaction pathways among various factors and reveal the
mediating or moderating roles of relevant factors in the occurrence of
PTSD.
Study Design
Single-center prospective cohort study
Total Sample
Size
250 cases
Case Selection
Inclusion Criteria
①Aged 18-65 years (inclusive of boundary values);
②Experienced life-threatening major traumatic events, confirmed by
clinical diagnosis;
③Able to communicate normally with medical staff;
④Provided full informed consent and voluntarily signed the Informed
Consent Form (ICF).
Exclusion Criteria
①History of mental illness or current use of psychotropic drugs;
②Previous cognitive impairment (e.g., dementia, Alzheimer's disease);
③Terminal diseases (e.g., advanced malignant tumors, end-stage organ
failure, advanced neurological diseases, or any other diseases with an
expected survival time of less than 6 months as judged by the attending

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physician);
④Unable to cooperate with follow-up.
Study Protocol
1.
Study
Subjects:
Trauma
patients
admitted
to
the
Emergency
Department of Xijing Hospital from January 2026 to June 2027.
2.
Assessment Items
（1）Sociodemographic Factors: Basic information including age, gender,
occupation, marital status, educational level, and income status.
（2）Trauma-Related Factors: Injury mechanism, trauma severity, time to
first effective analgesia (minutes), morphine equivalent of analgesic drugs
(mg), vital signs, length of stay in the emergency department, and whether
emergency surgery/procedure was performed.
（3）Physiological Indicators: White blood cell count, neutrophil count,
lymphocyte count, platelet count, lactic acid, blood glucose, serum
albumin, serum cortisol, interleukin-6 (IL-6), and C-reactive protein.
（4）Cranial Magnetic Resonance Imaging (MRI)
（5）Psychosocial Factors:
①General Information Questionnaire
②Injury Severity Score (ISS)
③Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
④Acute Stress Disorder Scale (ASDS)
⑤Social Support Rating Scale (SSRS)
⑥Connor-Davidson Resilience Scale (CD-RISC 10)
⑦Cognitive Flexibility Inventory (CFI)
⑧Hospital Anxiety and Depression Scale (HADS)

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Outcome
Assessment
评价指标
Incidence of PTSD as determined by the PCL-5 scale within 6 months after
trauma.
Point prevalence of PTSD at 1 month and 3 months after trauma; dynamic
changes in psychosocial indicators such as social support, anxiety and
depression, psychological resilience, and cognitive flexibility.
Statistical
Methods
Descriptive statistics will first be used to summarize all study variables.
Continuous variables will be expressed as mean ± standard deviation or
median (interquartile range), and categorical variables as frequency and
percentage. The point prevalence of PTSD at 1 month, 3 months, and 6
months after trauma, as well as the 6-month cumulative incidence and their
95% confidence intervals, will be calculated respectively.
Univariate analysis will be used to screen factors associated with PTSD
occurrence: chi-square test or Fisher's exact test for categorical variables,
and independent samples t-test or Mann-Whitney U test for continuous
variables.
Variables with statistical significance (P<0.05) or clinical significance in
univariate analysis will be included in a multivariate binary Logistic
regression model to identify independent influencing factors of PTSD.
Adjusted odds ratios and their 95% confidence intervals will be calculated,
and goodness-of-fit and multicollinearity diagnostics will be performed for
the model.
Amos 21.0 software will be used to construct a structural equation model of
PTSD occurrence to analyze the relationships among observed variables. A
model will be considered well-fitted if the ratio of chi-square to degrees of
freedom, comparative fit index, incremental fit index, and goodness-of-fit
index are >0.900, and the root mean square error of approximation is <0.05.
The significance level α=0.05.
Study Duration
September 2025 - June 2027

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I. Research Background
1. Research Significance
Post-Traumatic Stress Disorder (PTSD) is a common and severe mental disorder
following exposure to traumatic events, characterized by intrusive memories,
avoidance behaviors, negative cognitions and emotions, and increased arousal. It not
only significantly impairs patients' mental health but also leads to long-term
functional disabilities, imposing a heavy burden on public health
[1]. As a key
first-contact site for trauma patients, emergency departments receive individuals who
have experienced sudden, life-threatening events such as traffic accidents, violent
assaults, work-related injuries, and natural disasters. The incidence of PTSD in this
population is significantly higher than in the general public[2, 3]. Globally, the lifetime
prevalence of PTSD among trauma-exposed individuals is approximately 3.9%, while
in emergency department trauma patients, it ranges from 14.1% to 36.0%. When
symptoms persist for more than 1 month, patients face an increased risk of
comorbidities such as chronic pain, depression, and substance abuse, which
significantly reduce their quality of life and increase medical costs[1, 4, 5]. Therefore,
identifying the influencing factors of PTSD in emergency department trauma patients
is of great clinical and public health significance for early identification of high-risk
groups and development of targeted prevention and intervention strategies.
The development of PTSD in emergency department trauma patients is closely
associated with neurocognitive dysfunction[6, 7]. Studies have shown that patients with
better cognitive flexibility within 1 month after trauma exhibit significantly milder
PTSD symptoms at 13 months; moreover, early neurocognitive interventions such as
working memory training and task-switching training can improve cognitive
flexibility, thereby reducing PTSD symptoms at 6 months[2]. This finding suggests
that cognitive flexibility, as a core dimension of neurocognitive function, may be a
key protective factor against PTSD in emergency department trauma patients. By
helping patients flexibly adjust cognitive strategies, distinguish between threatening

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and safe situations, and promote the extinction of fear memories, cognitive flexibility
reduces the consolidation of trauma-related negative cognitions, thereby lowering the
risk of PTSD[2]. Additionally, neuroimaging studies have confirmed that PTSD
patients exhibit abnormal prefrontal network function, and improved cognitive
flexibility can enhance prefrontal regulation of the limbic system, reducing
hyperarousal caused by excessive amygdala activation—further supporting the role of
neurocognitive function in the development of PTSD in emergency department
trauma patients[2].
Psychological and social factors are also important influencing variables for PTSD in
emergency department trauma patients. As a classic protective factor, the negative
correlation between social support and PTSD has been confirmed by numerous
studies: a meta-analysis including 62,803 trauma-exposed individuals showed that
higher levels of social support (especially perceived support) are associated with
lower PTSD symptom scores, and this association is more pronounced in emergency
department trauma patients[8]. Specifically, after experiencing sudden trauma,
emotional support from family, friends, or the medical team can alleviate patients'
loneliness and helplessness, reducing avoidance behaviors; instrumental support (e.g.,
provision of medical information, practical life assistance) can reduce patients' sense
of loss of control over the post-traumatic environment, thereby mitigating stress
responses[8]. Conversely, negative social reactions (e.g., blame, neglect) significantly
exacerbate trauma-related negative cognitions, increasing the risk of PTSD, and their
association with PTSD is even stronger than that of positive social support[8].
Furthermore, coping styles also affect the development of PTSD in emergency
department trauma patients: patients adopting positive coping strategies have a
significantly lower incidence of PTSD than those using negative coping strategies,
and coping styles play a mediating role between psychological resilience and
PTSD—i.e., psychological resilience indirectly reduces PTSD risk by promoting
positive coping[9].
Abnormal physiological stress responses and inflammatory mechanisms are also
involved in the development of PTSD in emergency department trauma patients.

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Dysfunction of the hypothalamic-pituitary-adrenal (HPA) axis after trauma is an
important physiological basis for PTSD: emergency department trauma patients with
abnormal cortisol responses in the early post-traumatic period (e.g., delayed cortisol
peak, reduced basal cortisol levels) have a significantly higher incidence of PTSD at 3
months[4]. This is because cortisol, a key hormone in the stress response, can reduce
the release of inflammatory factors by inhibiting the nuclear factor-κB (NF-κB)
pathway, while HPA axis dysfunction leads to uncontrolled inflammatory responses.
Studies have found that among emergency department trauma patients, those with
PTSD have significantly higher levels of peripheral blood IL-1β, IL-6, TNF-α, and
C-reactive protein (CRP) than non-PTSD patients. These inflammatory factors can
cross the blood-brain barrier to activate microglia and astrocytes in the brain,
triggering
neuroinflammation,
which
further
exacerbates
prefrontal-amygdala
network dysfunction and promotes the development of PTSD symptoms[1,
10].
Additionally, early post-traumatic pain is closely associated with PTSD: a study of
663 emergency department trauma patients showed that pain within 1 month after
trauma is positively correlated with PTSD symptom scores at 1 year, and anxiety and
depression play a complete mediating role—pain intensifies patients' negative
emotional experiences, strengthens trauma-related fear memories, and thereby
increases PTSD risk[11].
Sociodemographic and trauma characteristics of emergency department trauma
patients also affect the risk of PTSD. From a sociodemographic perspective, female
patients have a significantly higher incidence of PTSD after emergency department
trauma than male patients, which may be related to women's greater sensitivity to
emotional processing of trauma and stronger HPA axis stress responses[8]. younger
patients (e.g., 18-30 years old) also face a higher PTSD risk due to immature
neurodevelopment and limited psychological resources for coping with trauma[8].
From a trauma characteristic perspective, trauma type is an important influencing
factor: emergency department patients who experience interpersonal violence (e.g.,
assault, sexual abuse) or terrorist attacks have a significantly higher incidence of
PTSD (approximately 30%-40%) than those who experience traffic accidents or

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work-related injuries (approximately 15%-20%). This is because interpersonal trauma
involves intentional harm, which is more likely to cause patients to lose trust in others
and suffer long-term lack of sense of security[10]. Furthermore, trauma severity (e.g.,
ISS score ≥16) and post-traumatic coma duration are positively correlated with
PTSD risk: physiological damage caused by severe trauma exacerbates stress
responses, while coma may affect the integration of trauma memories, increasing the
occurrence of intrusive memories[12].
2. Domestic and Foreign Research Status
2.1 Domestic Research Status
Domestic research on the influencing factors of PTSD in emergency department
trauma patients mainly focuses on local prevalence surveys and exploration of
individual influencing factors. Although some key variables have been initially
identified, there are limitations such as limited sample representativeness and
insufficient analysis of multi-factor interactions.
Regarding the association between prevalence and trauma type, regional studies have
shown significant differences in PTSD incidence among emergency department
trauma patients based on trauma type. A study of 326 emergency department trauma
patients in the Pearl River Delta region reported an overall PTSD incidence of 18.2%,
with violent assault (31.5%) and traffic accidents (22.3%) as the main triggers, while
work-related injuries (12.7%) and accidental falls (10.5%) had relatively lower
incidences—suggesting that interpersonal violence-related trauma may be a high-risk
trigger for PTSD in domestic emergency department patients[13]. Another study on
severely traumatized patients further confirmed that the incidence of PTSD at 3
months after trauma was 29.6% in patients with an ISS score
≥16 (mostly
high-energy trauma such as traffic accidents and falls from heights), significantly
higher than that in patients with an ISS score <16 (13.8%), and the risk was further
increased in those with a coma duration >24 hours—indicating that trauma severity
and physiological damage are important risk markers for PTSD in domestic
emergency department patients[12].

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In terms of psychosocial influencing factors, domestic research has focused on the
role of social support and coping styles, and most have confirmed their close
association with PTSD. A cross-sectional study of 287 emergency department trauma
patients found that the incidence of PTSD in patients with insufficient social support
(SSRS score <20) was 35.2%, 2.9 times that of patients with sufficient social support
(12.1%). Family support and friend support had the most significant protective effects,
and this association was stable across different trauma types such as traffic accidents
and violent assaults—suggesting that lack of social support may be a universal risk
factor for PTSD in domestic emergency department patients[14]. The mediating effect
of coping styles has also been confirmed by multiple studies: a follow-up study of 198
emergency department trauma patients showed that negative coping (e.g., avoidance,
denial) indirectly exacerbates PTSD symptoms by reducing psychological resilience
(mediation effect accounting for 35.7%), while positive coping can reduce PTSD risk
by 40%, and this effect is more pronounced in young patients (18-30 years
old)—reflecting the regulatory role of psychological resilience in the development of
PTSD in domestic emergency department patients[9].
In terms of physiological indicators and intervention exploration, domestic research
has initially focused on the predictive value of inflammatory and nutritional indicators
and attempted early nursing interventions. An analysis of 215 emergency department
trauma patients showed that the incidence of PTSD at 3 months was 32.8% and 30.5%
in patients with a C-reactive protein/albumin ratio >0.15 and a procalcitonin/albumin
ratio >0.02 within 24 hours after trauma, respectively, significantly higher than that in
patients
with
normal
ratios
(11.2%
and
10.8%)—suggesting
that
such
inflammatory-nutritional indicators may serve as convenient screening markers for
PTSD in domestic emergency department patients[15]. At the intervention level, a
single-center controlled study (n=156) showed that implementing an integrated
nursing intervention of "early psychological counseling + pain management + social
support linkage" for emergency department trauma patients reduced the incidence of
PTSD at 3 months from 28.2% to 19.2% and increased patient satisfaction to 92.3%,
providing practical evidence for early PTSD intervention in domestic emergency

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departments. However, the study had a small sample size and did not involve
mechanism-level interventions such as neurocognition[16].
2.2 Foreign Research Status
Foreign research on the influencing factors of PTSD in emergency department trauma
patients
is
characterized
by
neurocognitive
mechanisms,
physiological
stress
pathways,
and
large-sample
meta-analyses,
with
an
emphasis
on
verifying
intervention effects. However, there are limitations such as neglect of emergency
department setting specificity and insufficient representativeness of non-Western
populations.
In terms of neurocognitive mechanisms and predictive value, foreign studies have
clearly identified cognitive flexibility as a core protective factor against PTSD in
emergency department trauma patients. Two longitudinal studies of Israeli emergency
department trauma patients showed that patients with higher cognitive flexibility
scores at 1 month after trauma had significantly lower CAPS-5 scores at 13 months,
even after adjusting for age, trauma type, and initial symptoms; further intervention
studies confirmed that 30-day online cognitive training can significantly improve
patients'
cognitive
flexibility
and
reduce
PTSD
symptoms
by
23.1%
at
6
months—suggesting that cognitive flexibility is not only a predictor but also a
modifiable target[2]. Additionally, a study of 198 male veterans (though not in an
emergency setting) verified the consistency of cognitive assessment tools: the
correlation coefficient between CAPS-5 (clinical interview) and PCL-5 (self-report)
in assessing changes in PTSD symptoms was 0.878, and their association patterns
with depression and social function were similar—providing a reference for the
selection of PTSD assessment tools in emergency department trauma patients[1].
In terms of meta-analysis and heterogeneity exploration of social support, foreign
studies have revealed the association between social support and PTSD and moderator
effects through large-sample integration. A meta-analysis including 139 studies
showed a significant negative correlation between social support and PTSD symptoms,
with significant heterogeneity in this association: the association strength of negative
social reactions (e.g., blame, neglect) was significantly higher than that of perceived

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support and structural support; the veteran population had a significantly higher
association than the general population; the natural disaster trauma group had a
significantly lower association than the combat and interpersonal violence groups[8].
This result suggests that social support interventions for foreign emergency
department trauma patients need to be tailored to trauma types and population
characteristics rather than a "one-size-fits-all" approach.
In terms of physiological stress and inflammatory mechanisms, foreign studies have
delved into the mediating roles of the HPA axis, inflammatory factors, and pain. A
meta-analysis of 7 emergency trauma studies showed that patients with delayed
cortisol peak (>40 minutes) or reduced basal cortisol levels (<10μg/dL) within 72
hours after trauma had a 2.1-fold increased risk of PTSD at 3-6 months, and the
predictive value of blood cortisol was significantly higher than that of urine and
salivary cortisol[17]. A cohort study of 5703 Vietnam War veterans further extended to
inflammation and pain: even after controlling for Criterion A trauma history, PTSD
symptoms were significantly positively correlated with pain intensity, and IL-6 and
TNF-α levels played a partial mediating role—suggesting that inflammation may be a
key link between PTSD and pain comorbidity in emergency department trauma
patients[10]. Additionally, a randomized controlled trial showed that repeated
intravenous
ketamine
administration
can
rapidly
reduce
symptom
scores
in
emergency department trauma patients with chronic PTSD, with significantly better
efficacy than midazolam, but the median response duration was only 27.5
days—indicating that drug interventions need to be combined with maintenance
regimens[18].
In terms of assessment tools and setting adaptation, foreign studies have focused on
the impact of the emergency environment on PTSD assessment. A study of 65 female
PTSD patients found that a machine learning model based on functional connectivity
MRI can predict 24% of the variance in dissociative symptoms, and this prediction is
independent of childhood trauma and total PTSD symptoms—providing a new idea
for the objective assessment of PTSD subtypes (e.g., with dissociative symptoms) in
emergency department trauma patients. However, the study did not include acute

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emergency patients, and the setting applicability needs to be verified[19]. Most foreign
emergency trauma studies use "1 month after trauma" as the assessment node, which
may miss early stress responses during emergency department stay, and insufficiently
consider
environmental
factors
such
as
emergency
department
noise
and
doctor-patient communication—limiting the direct application of conclusions in the
emergency setting[20].
Although existing studies have initially identified some influencing factors of PTSD
in emergency department trauma patients, there are still shortcomings: most studies
focus on individual factors, lacking exploration of multi-factor interactions; moreover,
there are few studies on the impact of the specific emergency department environment
on PTSD. Therefore, systematically sorting out the physiological, psychological,
social, and trauma-related influencing factors of PTSD in emergency department
trauma patients can provide a theoretical basis for the subsequent development of
multi-dimensional risk assessment tools and early intervention studies, ultimately
improving the long-term prognosis of emergency department trauma patients.
II. Research Objectives
To determine the incidence of PTSD within 6 months in emergency department
trauma patients and identify the sociodemographic, trauma-related, and psychosocial
high-risk factors associated with the development of PTSD.
To explore the interaction pathways among various factors and reveal the mediating
or moderating roles of relevant factors in the occurrence of PTSD.
III. Study Design Type, Principles, and Trial Procedures
1. Study Design
This study is a single-center prospective cohort study.
Sampling Method: Consecutive enrollment
Sample Size Calculation: According to "Wu Minglong. Structural Equation Modeling:
Application of SIMPLIS", the sample size should be 10-15 times the number of
observed variables. This study is expected to have 20 observed variables, requiring a

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sample size of 200-300 cases. Considering a 20% non-compliance rate, the planned
sample size is 250 cases.
2. Study Procedures
(1) Baseline Assessment (T0, <24 hours):
Conduct interviews with patients using a self-designed structured questionnaire to
collect
comprehensive
sociodemographic
information
including
age,
gender,
occupation, marital status, educational level, and income status.
Record trauma type and injury site in detail based on medical records and assessment
by trained researchers, and calculate the Injury Severity Score (ISS) using the ISS
system.
Accurately extract the "time to first effective analgesia" (in minutes) from emergency
nursing records and electronic medical records, and record the name, dosage, and
route of administration of all analgesic drugs used. Pharmacists or researchers will
convert them into "morphine equivalent (mg)" according to standard conversion
tables.
Perform cranial Magnetic Resonance Imaging (MRI) to collect brain structural
imaging data, assess the direct impact of acute trauma on brain tissue, and use it as a
baseline for comparison at subsequent time points.
For psychological scales: ASDS, HADS, SSRS, CD-RISC, and CFI should be
completed when the patient is conscious (GCS ≥15 points); if the patient has visual or
educational limitations, researchers will read the items one-on-one, and the patient
will verbally report the answers (ensuring the "self-report" nature). All scale data will
be double-entered and verified.
Simultaneously collect 5mL of venous blood into EDTA anticoagulant tubes, record
the blood collection time, centrifuge at 3000g for 15 minutes using a 4℃
low-temperature centrifuge, then aliquot the plasma into cryovials and store at -80℃
in an ultra-low temperature refrigerator.
(2) T1 (1 month ±1 week):
Conduct follow-up using PCL-5, HADS, SSRS, CD-RISC, and CFI. The main
method is outpatient visit, supplemented by telephone follow-up or electronic

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questionnaire link filling according to the patient's actual situation. The assessment
method is the same as the baseline period. Patients may optionally undergo a repeat
cranial MRI to track the recovery or changes in brain structure and function 1 month
after trauma.
(3) T2 (3 months ±2 weeks):
Continue follow-up using the same methods as T1 (outpatient visit as the main
method, supplemented by telephone follow-up or electronic questionnaire), and use
the same scales for assessment. Patients may optionally undergo a repeat cranial MRI
to track the recovery or changes in brain structure and function 3 months after trauma.
(4) T3 (6 months ±2 weeks):
Continue follow-up using the same methods as T1, and use the same scales for
assessment. Patients may optionally undergo a repeat cranial MRI to track the
recovery or changes in brain structure and function 6 months after trauma.
(5) Follow-up Strategy
Record multiple contact methods (telephone, WeChat, address, etc.) of the patient and
at least 1 emergency contact person in detail at enrollment, and establish a follow-up
calendar and reminder system.
Adopt flexible follow-up methods such as telephone, electronic questionnaire, and
outpatient visit, and provide appropriate transportation/communication subsidies to
encourage patient cooperation. Record the reasons for loss to follow-up in detail for
dropouts.
IV. Case Selection
1. Inclusion Criteria
(1) Aged 18-65 years (inclusive of boundary values);
(2) Experienced life-threatening major traumatic events, confirmed by clinical
diagnosis;
(3) Able to communicate normally with medical staff;
(4) Provided full informed consent and voluntarily signed the Informed Consent Form
(ICF).

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2. Exclusion Criteria
(1) History of mental illness or current use of psychotropic drugs;
(2) Previous cognitive impairment (e.g., dementia, Alzheimer's disease);
(3) Terminal diseases (e.g., advanced malignant tumors, end-stage organ failure,
advanced neurological diseases, or any other diseases with an expected survival time
of less than 6 months as judged by the attending physician);
(4) Unable to cooperate with follow-up.
V. Research Methods and Technical Route
(I) Research Methods
(1) Measuring PTSD Incidence
This study targets emergency department trauma patients, focusing on the occurrence
of PTSD within 6 months after trauma, and systematically assesses and measures the
incidence of PTSD through multiple time points. Trauma survivors are included in the
cohort, and the PCL-5 scale is used as the core assessment tool. Follow-up
assessments are conducted at three key time points: 1 month (T1), 3 months (T2), and
6 months (T3) after enrollment. Flexible methods such as outpatient visits, telephone
follow-up, and electronic questionnaires are used to ensure the completeness of data
collection. Statistical analysis is performed to calculate the 6-month cumulative
incidence of PTSD and its corresponding 95% confidence interval (95%CI), and the
prevalence is calculated separately at T1, T2, and T3 to clearly present the overall
level of PTSD incidence and the dynamic changes at different stages in emergency
department trauma patients.
(2) Identifying Relevant Influencing Factors of PTSD Occurrence
This study systematically identifies factors associated with the occurrence of PTSD in
emergency department trauma patients from four aspects: sociodemographic,
trauma-related, physiological biomarkers, and psychosocial factors.
Sociodemographic factors: Collected using a self-designed structured questionnaire,
including basic information such as age, gender, occupation, marital status,
educational level, and income status.

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Trauma-related factors: Obtained based on medical records and researcher assessment,
specifically including injury mechanism (traffic accidents, falls, violence, etc.),
trauma severity (calculated using the ISS scoring system), time to first effective
analgesia (minutes) and morphine equivalent of analgesic drugs (mg), vital signs
(heart rate, blood pressure, respiratory rate, blood oxygen saturation), cranial MRI,
length of stay in the emergency department (time from admission to discharge,
transfer, or leaving the emergency department, reflecting the duration of acute stress
exposure),
and
whether
emergency
surgery/procedure
was
performed
(e.g.,
debridement and suture, closed thoracic drainage, laparotomy, etc.).
Physiological biomarkers: Venous blood is collected at baseline (T0, <24 hours) to
detect indicators such as white blood cell count, neutrophil count, lymphocyte count,
platelet count, lactic acid, blood glucose, serum albumin, serum cortisol, interleukin-6
(IL-6), and C-reactive protein, to reflect the dynamic changes in stress and
inflammatory levels. Among them, serum cortisol reflects the immediate stress
function of the HPA axis, and blood collection time is crucial—it is recommended to
fix it in the early morning (e.g., 6:00-10:00 AM).
Psychosocial factors: Obtained through scale assessment, including the Acute Stress
Disorder Scale (ASDS), Social Support Rating Scale (SSRS), Hospital Anxiety and
Depression Scale (HADS), Connor-Davidson Resilience Scale (CD-RISC 10),
Cognitive Flexibility Inventory (CFI), and PTSD Checklist for DSM-5 (PCL-5).
In statistical analysis, univariate analysis (chi-square test or Fisher's exact test for
categorical variables, independent samples t-test or Mann-Whitney U test for
continuous variables, etc.) is first used to compare differences in each factor between
the PTSD group and the non-PTSD group. Then, variables with statistical or clinical
significance are included in a multivariate binary Logistic regression model to screen
for independent risk factors for PTSD occurrence.
(3) Exploring the Mediating or Moderating Roles of Various Factors in PTSD
Occurrence
On the basis of identifying independent influencing factors, this study will further use
Structural Equation Modeling (SEM) to deeply explore the complex mechanism of
action of key variables in the pathway of PTSD occurrence.

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1) Proposing Hypothetical Models
Based on literature review and theoretical basis, hypothetical models including
mediating and moderating effects are constructed.
Mediating Effect Hypotheses:
H1: Trauma severity and time to first effective analgesia positively affect the
occurrence of PTSD at 6 months by exacerbating acute stress responses.
H2: Early post-traumatic inflammatory levels and trauma severity positively affect the
occurrence of PTSD at 6 months by impairing psychological resilience.
H3a: Early post-traumatic inflammatory levels and trauma-related characteristics
positively affect the occurrence of PTSD at 6 months by reducing social support
levels.
H4: Trauma severity exacerbates acute stress responses by reducing cognitive
flexibility, ultimately positively affecting the occurrence of PTSD at 6 months.
Moderating Effect Hypotheses:
H5: Psychological resilience plays a moderating role between trauma severity and
PTSD at 6 months. Specifically, for patients with high psychological resilience, the
positive impact of trauma severity on PTSD is weaker.
H6: Social support plays a moderating role between acute stress responses and PTSD
at 6 months. Specifically, for patients with high social support levels, the positive
impact of acute stress responses on PTSD is weaker.
H7: Time to first effective analgesia plays a moderating role between trauma severity
and acute stress responses. Specifically, the shorter the analgesia time, the weaker the
positive impact of trauma severity on acute stress responses.
H8: Cognitive flexibility plays a moderating role between trauma-related cues and
PTSD symptoms. Specifically, for patients with high cognitive flexibility, the
association between trauma exposure and PTSD re-experiencing symptoms is weaker.
2) Variable Definition
Mediating Variables: Mainly include psychosocial variables and physiological
variables.

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Moderating Variables: Mainly include cognitive flexibility, social support level, etc.
Outcome Variable: Binary variable indicating whether PTSD occurs.
3) Statistical Analysis Steps:
Amos 21.0 software is used to construct a structural equation model of PTSD
occurrence to analyze the relationships among observed variables. A model is
considered well-fitted if the ratio of chi-square to degrees of freedom, comparative fit
index, incremental fit index, and goodness-of-fit index are >0.900, and the root mean
square error of approximation is <0.05. The significance level α=0.05. First, centering
processing is performed on the continuous variables involved in the model to reduce
the impact of multicollinearity.
Through the above analysis, this study aims to reveal the psychosocial and
physiological pathways influencing PTSD in emergency department trauma patients,
clarify how various factors interact (mediation) and when the effect is stronger or
weaker (moderation), thereby providing key theoretical and empirical basis for
constructing multi-dimensional and precise early psychological crisis intervention
programs.
(IV) Technical Route
1.Preparation
Stage:
Literature
review,
protocol
finalization,
definition
of
inclusion/exclusion criteria.
2.Enrollment: Consecutive enrollment of 250 eligible patients.
3.Data Collection:
Baseline (T0): Collection of sociodemographic data, trauma clinical characteristics,
physiological biomarkers, and psychological scales (ASDS, SSRS, HADS, CD-RISC
10, CFI).
Follow-up Assessments:
T1 (1 month ±1 week): Scales (PCL-5, SSRS, HADS, CD-RISC 10, CFI).
T2 (3 months ±2 weeks): Same scales as T1.
T3 (6 months ±2 weeks): Same scales as T1.

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4.Data Collation and Management: Double data entry, logical verification, blind
linking of serum data and clinical database.
5.Statistical Analysis:
Descriptive statistics.
Univariate analysis (t-test/U test/chi-square test).
Multivariate analysis (binary Logistic regression).
Structural equation modeling (confirmatory factor analysis, path analysis, mediating
effect test).
6.Results and Conclusions: Summary of research findings, conclusion formulation,
and paper writing.
VI. Observation Items and Observation Time Points
(I) Observation Items
1. Sociodemographic Factors
Collected using a self-designed structured questionnaire, including basic information
such as age, gender, occupation, marital status, educational level, and income status.
(1) General Information Questionnaire
Designed based on extensive literature review and data collection, including age,
gender, occupation, marital status, educational level, and income status.
2. Trauma-Related Factors
Obtained based on medical records and researcher assessment, specifically including
injury mechanism (traffic accidents, falls, violence, etc.), trauma severity (calculated
using the ISS scoring system), time to first effective analgesia (minutes) and
morphine equivalent of analgesic drugs (mg), vital signs (heart rate, blood pressure,
respiratory rate, blood oxygen saturation), cranial MRI, length of stay in the
emergency department (time from admission to discharge, transfer, or leaving the
emergency department, reflecting the duration of acute stress exposure), and whether

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emergency surgery/procedure was performed (e.g., debridement and suture, closed
thoracic drainage, laparotomy, etc.).
(1) Injury Severity Score (ISS)
The ISS score correlates the Abbreviated Injury Scale (AIS) score with patient
prognosis. It is calculated as the sum of the squares of the AIS scores of the three most
severely injured body regions. The maximum score of this indicator is 75 points: ISS
≥16 and <25 points is defined as severe injury, with a mortality risk of less than 10%;
ISS ≥25 and <50 points is defined as critical injury, with a certain mortality risk; ISS
≥50 points is defined as life-threatening injury, with a very low survival probability
and the patient is nearly dying.
The Abbreviated Injury Scale (AIS) is a scoring system derived from anatomy and
global consensus on severe trauma. The body is divided into 6 regions based on
anatomy, and the severity of injury to the corresponding body regions is scored from 1
to 6 points, representing mild injury, moderate injury, moderately severe injury, severe
injury, life-threatening critical injury, and untreatable extreme injury, respectively.
3. Physiological Biomarkers
Venous blood is collected at baseline (T0, <24 hours) to detect indicators such as
white blood cell count, neutrophil count, lymphocyte count, platelet count, lactic acid,
blood glucose, serum albumin, serum cortisol, interleukin-6 (IL-6), and C-reactive
protein, to reflect the dynamic changes in stress and inflammatory levels. Among
them, serum cortisol reflects the immediate stress function of the HPA axis, and blood
collection time is crucial—it is recommended to fix it in the early morning (e.g.,
6:00-10:00 AM).
4. Psychosocial Factors
Obtained through the following scale assessments:
(1) PTSD Checklist for DSM-5 (PCL-5): Strictly formulated in accordance with the
criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
(DSM-5) issued by the American Psychiatric Association. This scale is specifically

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designed for screening PTSD patients and assessing changes in their symptoms before
and after treatment, providing strong reference for diagnostic work [63]. The scale
consists of 20 items, covering four core symptom clusters: intrusive re-experiencing
symptoms (Criterion B): Items 1-5; avoidance and numbing symptoms (Criterion C):
Items 6-7; negative cognitive symptoms (Criterion D): Items 8-14; and hyperarousal
symptoms (Criterion E): Items 15-20. Each item is scored on a 5-point Likert scale:
"Not at all" (0 points), "A little bit" (1 point), "Moderately" (2 points), "Quite a bit" (3
points), and "Extremely" (4 points). The total score of the scale ranges from 0 to 80
points, calculated by summing the scores of each item. Based on a comprehensive
analysis of relevant domestic and foreign literature, a PCL-5 score ≥33 points is set as
the positive criterion for screening PTSD symptoms. According to this criterion, the
higher an individual's PCL-5 score, the greater the likelihood of PTSD occurrence.
The scale has high reliability, with a Cronbach's α coefficient of 0.983, indicating
good internal consistency.
(2) Acute Stress Disorder Scale (ASDS): Compiled by Bryant et al., including 4
dimensions: dissociation, re-experiencing, avoidance, and hyperarousal. The total
score of the scale is 95 points, with 19 items, each scored from 1 to 5 points (1 point =
"Never", 5 points = "Always"). An ASDS score >56 points can be judged as Acute
Stress Disorder (ASD).
Acute Stress Disorder (ASD) refers to the immediate mental disorder response of
individuals suddenly encountering severe psychological traumatic stress events. If
ASD symptoms do not improve within weeks or months, they will eventually develop
into Post-Traumatic Stress Disorder.
(3) Social Support Rating Scale (SSRS): The scale includes 3 dimensions: objective
support (3 items), subjective support (4 items), and utilization of social support (3
items), totaling 10 items. The total score is the sum of the scores of each item: a total
score ≤22 points indicates a low level of social support, 23-44 points indicates a
moderate level, and 45-66 points indicates a high level. The Cronbach's α coefficient
of the scale is 0.92, and the Cronbach's α coefficient of each item ranges from 0.89 to
0.94, indicating good validity.。
(4) Connor-Davidson Resilience Scale (CD-RISC 10): Compiled by Connor et al.,
translated into Chinese and revised locally by Yu Xiaonan et al. The scale includes 3

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dimensions: tenacity, strength, and optimism, totaling 25 items, each scored from 0 to
4 points, with a total score of 100 points. A higher score indicates better psychological
resilience of the individual.
(5) Cognitive Flexibility Inventory (CFI): Compiled by DENNIS et al., translated and
revised by domestic scholar Wang Yang et al., used to assess an individual's ability to
freely change cognition to cope with different stimuli or environmental changes. The
scale includes 2 subscales: Alternatives and Control, totaling 20 items, 6 of which are
reverse-scored. A 5-point Likert scale is used, with a total score ranging from 20 to
100 points. A higher score indicates better cognitive flexibility of the subject.
(6) Hospital Anxiety and Depression Scale (HADS): HADS consists of two subscales:
HADS-A (Anxiety) and HADS-D (Depression), including 14 items (7 for A, 7 for D).
Each item is scored on a 4-point scale (0-3 points) based on the frequency of
occurrence in the past month. Thus, the anxiety score ranges from 0 to 21 points, and
the same applies to depression. A higher score indicates a greater tendency towards
anxiety or depression. The anxiety subscale score is obtained by summing the scores
of the 7 items marked A; the depression subscale score is obtained by summing the
scores of the 7 items marked D. According to the general scoring criteria of the scale,
0-7 points are normal, 8-10 points are mild, 11-14 points are moderate, and 15-21
points are severe.
(II) Observation Time Points
Baseline: The day of trauma occurrence.
T1: 1 month after trauma.
T2: 3 months after trauma.
T3: 6 months after trauma.。
VII. Statistical Analysis
(1) Data Management
A data management system is used for double data entry with logical verification
functions; meanwhile, the linking of serum data and clinical databases is performed
blindly by an independent biostatistician to avoid bias during data association.

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(2) Statistical Methods
Descriptive statistics will first be used to summarize all study variables. Continuous
variables will be expressed as mean ± standard deviation or median (interquartile
range), and categorical variables as frequency and percentage. The point prevalence of
PTSD at 1 month, 3 months, and 6 months after trauma, as well as the 6-month
cumulative incidence and their 95% confidence intervals, will be calculated
respectively.
Univariate analysis will be used to screen factors associated with PTSD occurrence:
chi-square test or Fisher's exact test for categorical variables, and independent
samples t-test or Mann-Whitney U test for continuous variables.
Variables with statistical significance (P<0.05) or clinical significance in univariate
analysis will be included in a multivariate binary Logistic regression model to identify
independent influencing factors of PTSD. Adjusted odds ratios and their 95%
confidence intervals will be calculated, and goodness-of-fit and multicollinearity
diagnostics will be performed for the model.
Amos 21.0 software will be used to construct a structural equation model of PTSD
occurrence to analyze the relationships among observed variables. A model will be
considered well-fitted if the ratio of chi-square to degrees of freedom, comparative fit
index, incremental fit index, and goodness-of-fit index are >0.900, and the root mean
square error of approximation is <0.05. The significance level α=0.05.
VIII. Ethics of Clinical Research
9.1 Investigator Responsibilities
Investigators commit to conducting this clinical trial in accordance with this study
protocol, Good Clinical Practice (GCP), ICH guidelines, and applicable laws and
regulations.
1) Have received training on GCP and this trial protocol, and have the time to
conduct the trial in accordance with the study protocol.
2) Provide patients with detailed information about the study before enrollment,
obtain their consent, and have them sign the Informed Consent Form (ICF).

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3) Investigators are obligated to take necessary measures to ensure patient safety.
In case of adverse reactions, investigators shall immediately handle them in
accordance with relevant regulations and report to the principal investigator. Follow
up on serious adverse reactions.
4) Fill in the study medical records carefully and timely;
5) Actively cooperate with the clinical monitor's regular visits;
6) Retain complete records of laboratory tests, clinical records, and patients'
original medical records.
9.2 Ethics Committee or Institutional Review Board
The conduct of this trial complies with GCP, the Declaration of Helsinki, relevant
laws and regulations, and the review opinions of the Ethics Committee.
Investigators shall ensure that the trial is reviewed and approved by a qualified Ethics
Committee that meets GCP requirements. Before the start of the trial, investigators
shall submit the trial protocol, Informed Consent Form (ICF), and other necessary
materials to the Ethics Committee for review and approval. Investigators may only
provide the investigational product after receiving the approval from the Ethics
Committee. At the same time, the Ethics Committee must be informed of any
subsequent protocol amendments that may affect the safety of subjects and their
continued participation in the trial, as well as serious adverse events occurring during
the trial. Investigators are responsible for reporting the progress of the trial to the
Ethics Committee. When reviewing and approving the trial protocol, the Ethics
Committee must confirm the protocol title, protocol number, and indicate the
reviewed protocol documents and review date. During the trial, if there are any new
revisions to the trial protocol, Informed Consent Form, etc., written approval from the
relevant regulatory authorities must be obtained again in accordance with the law.
9.3 Ethical Conduct of Research and Ethical Approval
This study will be conducted in accordance with GCP and all relevant regulatory
requirements, including the current version of the Declaration of Helsinki.
Investigators are responsible for obtaining the Ethics Committee's review and

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approval of the study protocol, study center ICF, and any other information provided
to potential patients (e.g., advertisements or information supporting or supplementing
the ICF). Investigators agree that the Ethics Committee may directly access all
relevant documents. The composition of the Ethics Committee must comply with all
relevant regulatory requirements. Investigators provide the relevant documents/data
required by the Ethics Committee for reviewing and approving the study.
If revisions are made to the study protocol, ICF, or any other information approved by
the Ethics Committee for provision to potential patients during the study, investigators
are responsible for ensuring the Ethics Committee's approval of these revised
documents. Investigators must comply with all relevant regulatory requirements
regarding the use of revised ICFs, including obtaining the Ethics Committee's
approval of the revised ICF before using the new form to obtain consent from new
patients to participate in the study. The Ethics Committee's approval of the written
ICF/other information and copies of the approved revised ICF/other information must
be sent to the sponsor in a timely manner.
9.4 Informed Consent
The principal investigator of the study center will:
• Ensure that each patient is provided with comprehensive and sufficient oral or
written information about the nature, purpose, potential risks, and benefits of the
study;
•Ensure that each patient is aware that they may voluntarily withdraw from the study
at any time;
•Ensure that each patient has the opportunity to ask questions and is given sufficient
time to consider the provided information;
•Ensure that each patient provides a signed and dated ICF before any study-related
procedures are performed;
•Ensure that the original signed ICF is kept in the investigator's study files;
•Ensure that a copy of the signed ICF is provided to the patient;
• Ensure that the ICF approved by the Ethics Committee describes any benefits of

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participating in the study and the corresponding content of potential harm to the
patient from participating in the study.
9.5 Revisions to the Study Protocol and Informed Consent Form
If there are any important changes to the study protocol, these changes must be
recorded in the protocol amendment of the latest version of the clinical study protocol
(if necessary). The amendment must be approved by the corresponding Ethics
Committee before implementation. The latest version of the protocol and any
amendments will be distributed by the principal investigator.
If the study protocol amendment requires changes to the center ICF, the investigator
and the center Ethics Committee will first approve the ICF amendment before it can
be used. If required by local regulatory authorities, any administrative changes shall
be reported to and approved by each Ethics Committee.
9.6 Record Retention
Study data shall be retained in accordance with the following requirements:
Investigators must keep all study data;
Retention period: 5 years after the end of the trial.
9.7 Confidentiality of Personal Data
The ICF may contain content in line with relevant data protection and privacy rights.
In some cases, this content will be recorded in a separate accompanying document.
Investigators and other staff participating in the study shall strictly keep confidential
the patient's privacy, treatment, study protocol, study-related documents, and data.
Without the investigator's written permission, study information or data shall not be
disclosed to any unauthorized third party.
Study monitors, representatives of the Ethics Committee, and regulatory authorities
may inspect all documents and records required to be kept by investigators, including
but not limited to the medical records (clinic, outpatient, or hospital) and drug records
of study patients. The clinical research center will allow the above personnel to access
these records.
Each clinical center will strictly keep the contact information of study patients for

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internal use during the study. At the end of the study, all records will continue to be
kept in a secure location, and the retention period will be determined in accordance
with the requirements of the Ethics Committee and the center's system.
9.8 Privacy in Publication
All data and all data generated during the study (excluding patients' medical records)
shall be kept confidential. Investigators or other staff of the study center shall not use
the data, data, or records for any other purpose except for this study. These restrictions
do not apply to:
Data that has been publicly published not due to the error of the investigator
or the study center staff;
Data that must be disclosed for the purpose of convincing the academic
committee or the Ethics Committee to evaluate the study;
Data that must be disclosed to provide appropriate medical care to patients
participating in the study.
IX. Study Progress
September 2025 - December 2025: Research preparation stage, literature review, and
protocol finalization.
January 2026 - December 2026: Subject recruitment.
January 2027 - June 2027: Data entry, collation, analysis, and paper writing.
X. Participating Personnel
Name
Title/Specialty
Responsibilities
GCP Training
(Yes/No)
Wei
Zhao
Associate Chief
Physician/Emer
gency Medicine
Study design and quality control of
implementation
Yes
Min Cai
Associate Chief
Physician/Psych
Study design and quality control of
implementation
Yes

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iatry and Mental
Health
Yaochi
Zhang
Research
Assistant/Psychi
atry and Mental
Health
Study design and quality control of
implementation
Yes
Yang Li
Graduate
Student/Emerge
ncy Medicin
Data collection and analysis, paper
writing
Yes
Lin Wu
Associate Chief
Physician/Emer
gency Medicine
Enrollment and follow-up
Yes
Qianmei
Wang
Assistant
Researcher/Eme
rgency Medicine
Enrollment and follow-up
Yes
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