Chronic Atrophic Gastritis, Depression, Depressive Symptoms, Gastrointestinal Diseases
Conditions
Keywords
Vascular biomarkers, Dorsalis pedis artery ultrasound, Triage workflow, Implementation science, Stigma, Screening, Gut-brain axis
Brief 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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTVascular-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.
Sponsors
Beijing Anzhen Hospital
Hengshui Hospital of Traditional Chinese Medicine
Liyang Hospital of Traditional Chinese Medicine
China Academy of Chinese Medical Sciences
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
20 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Referral Uptake Rate | Up to 3 months | The proportion of screen-positive patients completing mental health consultation. |
| Dorsalis Pedis Artery Resistive Index (RI) | Baseline (Day 0) | A calculated flow parameter reflecting vascular resistance measured via Doppler ultrasound. |
| Dorsalis Pedis Artery Pulsatility Index (PI) | Baseline (Day 0) | A calculated flow parameter reflecting vascular pulsatility measured via Doppler ultrasound. |
| Screening Completion Rate | Up to 3 months | The proportion of eligible patients consenting to assessment. |
| Brachial-Ankle Pulse Wave Velocity (baPWV) | Baseline (Day 0) | Measured to assess arterial stiffness. |
| Generalized Anxiety Disorder-7 (GAD-7) Score | Baseline (Day 0) | 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 Burden | Up to 3 months | The median time added to routine workflow (measured in minutes) |
| Dorsalis Pedis Artery Flow Waveform Classification | Baseline (Day 0) | Flow waveforms classified into three categories: triphasic, biphasic, or monophasic via Doppler ultrasound assessment. |
Countries
China
Contacts
Primary ContactMeng Wang, PhD
Outcome results
None listed