Vascular-Psychological Triage Workflow: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
20 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age between 20 and 60 years, regardless of sex.
2. Diagnosed with chronic atrophic gastritis (CAG) confirmed by upper gastrointestinal endoscopy and histopathology within the past 6 months.
3. Ability to comprehend and voluntarily complete psychological assessments and multimodal vascular examinations.
4. Willingness to provide written informed consent.
Exclusion Criteria:
1. History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder) or currently experiencing an acute psychotic episode.
2. Major cardiovascular or cerebrovascular events (e.g., acute myocardial infarction, stroke) within the past 3 months.
3. Severe peripheral artery disease or major anatomical abnormalities in the lower extremities (e.g., Fontaine stage III-IV, diabetic foot with ulcers) that would preclude reliable dorsalis pedis artery ultrasound assessment.
4. Severe hepatic or renal dysfunction, or malignancy with a limited life expectancy.
5. Current use of systemic corticosteroids or potent immunosuppressants.
6. Pregnancy or lactation.
7. Any other condition deemed by the investigators to interfere with study participation or cooperation.
Primary outcome measure(s)
Depressive Symptom Screening-Positive Status (PHQ-9 ≥10) — Baseline (Day 0) 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.
Trial sites (4)
Facility
City
Region
Status
China Academy of Chinese Medical Sciences
Beijing
Beijing Municipality
Beijing Anzhen Hospital, Capital Medical University
Beijing
Beijing Municipality
Hengshui Hospital of Traditional Chinese Medicine
Hengshui
Hebei
Liyang Hospital of Chinese Medicine
Changzhou
Jiangsu
More China Academy of Chinese Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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