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| ID | Type | Description | Link |
|---|---|---|---|
| Other Identifier | Other Identifier | 2025-KY-18 |
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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
| Hengshui Hospital of Traditional Chinese Medicine | UNKNOWN |
| Liyang Hospital of Traditional Chinese Medicine | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Chronic Atrophic Gastritis (CAG) | Adults (aged 20-60 years) with histologically confirmed chronic atrophic gastritis diagnosed via upper gastrointestinal endoscopy within the past 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular-Psychological Triage Workflow | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Screening Completion Rate | The proportion of eligible patients consenting to assessment. | Up to 3 months |
| Referral Uptake Rate | The proportion of screen-positive patients completing mental health consultation. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult patients (aged 20-60 years) with histologically confirmed chronic atrophic gastritis (CAG). Participants are recruited from the gastroenterology outpatient clinics of four participating centers in Northern and Eastern China (including China Academy of Chinese Medical Sciences, Beijing Anzhen Hospital, Hengshui Hospital of TCM, and Liyang Hospital of TCM). All participants must have undergone upper gastrointestinal endoscopy within the past 6 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Wang, PhD | Contact | +86 18852096726 | nzzywm@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | 100700 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42164162 | Derived | Wang M, Jiang S, Jin Z, Pan X, Xu S, Wang C. Vascular and autonomic correlates of screening-positive depressive symptom burden in chronic atrophic gastritis: a multicenter observational study protocol. Front Med (Lausanne). 2026 May 5;13:1842882. doi: 10.3389/fmed.2026.1842882. eCollection 2026. |
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Individual participant data that underlie the results reported in this article, after de-identification, may be shared with researchers who provide a methodologically sound proposal and obtain necessary ethical approvals. Data sharing is subject to the rules and regulations of the participating institutions and the Data Security Law of China.
Beginning 3 months and ending 5 years following article publication.
Proposals should be directed to the corresponding author (wangchao19891216@163.com). To gain access, data requestors will need to sign a data access agreement and provide ethical approval from their institution.
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| Up to 3 months |
| Dorsalis Pedis Artery Resistive Index (RI) | A calculated flow parameter reflecting vascular resistance measured via Doppler ultrasound. | Baseline (Day 0) |
| Dorsalis Pedis Artery Pulsatility Index (PI) | A calculated flow parameter reflecting vascular pulsatility measured via Doppler ultrasound. | Baseline (Day 0) |
| Dorsalis Pedis Artery Flow Waveform Classification | Flow waveforms classified into three categories: triphasic, biphasic, or monophasic via Doppler ultrasound assessment. | Baseline (Day 0) |
| Brachial-Ankle Pulse Wave Velocity (baPWV) | Measured to assess arterial stiffness. | 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. | Baseline (Day 0) |
| Time Burden | The median time added to routine workflow (measured in minutes) | Up to 3 months |
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
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| Hengshui Hospital of Traditional Chinese Medicine | Hengshui | Hebei | 053000 | China |
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| Liyang Hospital of Chinese Medicine | Changzhou | Jiangsu | China |
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| ID | Term |
|---|---|
| D005757 | Gastritis, Atrophic |
| D003863 | Depression |
| D005767 | Gastrointestinal Diseases |
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
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