Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis

Official title

Implementing Objective Vascular Biomarkers as a Non-stigmatizing Triage Workflow for Depression in Gastroenterology Settings: a Multicenter Study Protocol for a Hybrid Effectiveness-implementation Study

Overview

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 test 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.

Primary outcome measures

• Depressive Symptom Screening-Positive Status (PHQ-9 ≥10) [Time frame: Baseline (Day 0)]

Secondary outcome measures (8)

• Screening Completion Rate [Time frame: Up to 3 months]
• Referral Uptake Rate [Time frame: Up to 3 months]
• Dorsalis Pedis Artery Resistive Index (RI) [Time frame: Baseline (Day 0)]
• Dorsalis Pedis Artery Pulsatility Index (PI) [Time frame: Baseline (Day 0)]
• Dorsalis Pedis Artery Flow Waveform Classification [Time frame: Baseline (Day 0)]
• Brachial-Ankle Pulse Wave Velocity (baPWV) [Time frame: Baseline (Day 0)]
• Generalized Anxiety Disorder-7 (GAD-7) Score [Time frame: Baseline (Day 0)]
• Time Burden [Time frame: Up to 3 months]

Eligibility criteria

Inclusion criteria

• Age between 20 and 60 years, regardless of sex.
• Diagnosed with chronic atrophic gastritis (CAG) confirmed by upper gastrointestinal endoscopy and histopathology within the past 6 months.
• Ability to comprehend and voluntarily complete psychological assessments and multimodal vascular examinations.
• Willingness to provide written informed consent.

Exclusion criteria

• History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder) or currently experiencing an acute psychotic episode.
• Major cardiovascular or cerebrovascular events (e.g., acute myocardial infarction, stroke) within the past 3 months.
• 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.
• Severe hepatic or renal dysfunction, or malignancy with a limited life expectancy.
• Current use of systemic corticosteroids or potent immunosuppressants.
• Pregnancy or lactation.
• Any other condition deemed by the investigators to interfere with study participation or cooperation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 4 centers

• China Academy of Chinese Medical Sciences — Beijing
• Beijing Anzhen Hospital, Capital Medical University — Beijing
• Hengshui Hospital of Traditional Chinese Medicine — Hengshui
• Liyang Hospital of Chinese Medicine — Changzhou

Publications

• 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. PMID 42164162

Identifiers

NCT: NCT07319338 · 2025-EC-KY-004 · Other Identifier

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗