Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis

NCT07319338 | Not Yet Recruiting

• 2 other identifiers: 2025-EC-KY-004Other Identifier
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Atrophic Gastritis; Depressive Symptoms; Depression; Gastrointestinal Diseases

Keywords

Vascular biomarkers; Dorsalis pedis artery ultrasound; Triage workflow; Implementation science; Stigma; Screening; Gut-brain axis

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

• Screening Completion Rate

  Up to 3 months

• Referral Uptake Rate

  Up to 3 months

• Dorsalis Pedis Artery Resistive Index (RI)

  Baseline (Day 0)

• Dorsalis Pedis Artery Pulsatility Index (PI)

  Baseline (Day 0)

• Dorsalis Pedis Artery Flow Waveform Classification

  Baseline (Day 0)

Study Arms (1)

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.

Diagnostic Test: Vascular-Psychological Triage Workflow

Interventions

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.

Patients with Chronic Atrophic Gastritis (CAG)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hengshui Hospital of Traditional Chinese Medicine: collaborator
• Liyang Hospital of Traditional Chinese Medicine: collaborator
• China Academy of Chinese Medical Sciences: lead
• Beijing Anzhen Hospital: collaborator

Study Sites (4)

China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100700, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Hengshui Hospital of Traditional Chinese Medicine

Hengshui, Hebei, 053000, China

Location

Liyang Hospital of Chinese Medicine

Changzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Gastritis, Atrophic; Depression; Gastrointestinal Diseases; Social Stigma

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Digestive System Diseases; Stomach Diseases; Behavioral Symptoms; Behavior; Social Behavior

Central Study Contacts

Meng Wang, PhD

CONTACT

+86 18852096726; nzzywm@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: 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.

Locations

CN (4)