Depressive symptoms are highly prevalent in patients with chronic atrophic gastritis (CAG) but are frequently under-detected due to stigma and reliance on subjective questionnaires. This multicenter, cross-sectional observational study aims to validate a novel clinical triage workflow. It repurposes routine vascular assessments (specifically dorsalis pedis artery ultrasound and arterial stiffness metrics) as objective "biological entry points" to facilitate mental health referrals. The study will enroll approximately 450-520 adults with histologically confirmed CAG across four clinical centers in China. The primary objective is to determine the diagnostic accuracy of these vascular biomarkers for identifying patients with moderate-to-severe depressive symptoms (PHQ-9 score \>= 10). Secondary objectives include evaluating the implementation feasibility (e.g., referral uptake, screening completion rate) of this integrated care model in routine gastroenterology practice.
Current screening for depression in gastroenterology relies heavily on self-report scales, which are often limited by somatization and cultural stigma in Asian populations. This study proposes a "vascular-gut-brain" framework to bridge this service gap. Participants will undergo a standardized multimodal assessment comprising: * Gastrointestinal evaluation: Endoscopy and histopathology (OLGA/OLGIM staging), and symptom scoring (GSRS). * Peripheral vascular assessment: High-frequency ultrasound of the dorsalis pedis artery (measuring Resistive Index \[RI\], Pulsatility Index \[PI\], and waveform classification). * Arterial stiffness and autonomic function: Brachial-ankle pulse wave velocity (baPWV), Ankle-Brachial Index (ABI), and Heart Rate Variability (HRV). * Psychological assessment: PHQ-9, GAD-7, and PSQI scales. The study employs a hybrid effectiveness-implementation design. In addition to validating the diagnostic accuracy of vascular markers, the study will assess the feasibility of the workflow. A subset of participants will be re-contacted at 3 months to evaluate referral completion and retention rates. The ultimate goal is to establish a non-stigmatizing, objective triage protocol to improve mental health resource utilization in digestive clinics.
Study Type
OBSERVATIONAL
Enrollment
520
Participants undergo a multimodal assessment including high-frequency ultrasound of the dorsalis pedis artery, measurement of brachial-ankle pulse wave velocity (baPWV), and completion of the PHQ-9 depression screening scale.
China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Hengshui Hospital of Traditional Chinese Medicine
Hengshui, Hebei, China
Liyang Hospital of Chinese Medicine
Changzhou, Jiangsu, China
Depressive Symptom Screening-Positive Status (PHQ-9 ≥10)
The primary outcome is the binary classification of depressive symptom burden. Participants are categorized as "screen-positive" if their 9-item Patient Health Questionnaire (PHQ-9) total score is ≥10, indicating moderate-to-severe depressive symptoms warranting referral. The PHQ-9 scores range from 0 to 27, with higher scores indicating greater symptom severity.
Time frame: Baseline (Day 0)
Screening Completion Rate
The proportion of eligible patients consenting to assessment.
Time frame: Up to 3 months
Referral Uptake Rate
The proportion of screen-positive patients completing mental health consultation.
Time frame: Up to 3 months
Dorsalis Pedis Artery Resistive Index (RI)
A calculated flow parameter reflecting vascular resistance measured via Doppler ultrasound.
Time frame: Baseline (Day 0)
Dorsalis Pedis Artery Pulsatility Index (PI)
A calculated flow parameter reflecting vascular pulsatility measured via Doppler ultrasound.
Time frame: Baseline (Day 0)
Dorsalis Pedis Artery Flow Waveform Classification
Flow waveforms classified into three categories: triphasic, biphasic, or monophasic via Doppler ultrasound assessment.
Time frame: Baseline (Day 0)
Brachial-Ankle Pulse Wave Velocity (baPWV)
Measured to assess arterial stiffness.
Time frame: Baseline (Day 0)
Generalized Anxiety Disorder-7 (GAD-7) Score
Anxiety symptom severity assessed using the GAD-7 scale. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: Baseline (Day 0)
Time Burden
The median time added to routine workflow (measured in minutes)
Time frame: Up to 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.