Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis

December 21, 2025 updated by: Meng Wang, China Academy of Chinese Medical Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Meng Wang, PhD
  • Phone Number: +86 18852096726
  • Email: nzzywm@163.com

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Beijing AnZhen Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing Municipality, China, 100700
        • China Academy of Chinese Medical Sciences
        • Contact:
    • Hebei
      • Hengshui, Hebei, China, 053000
        • Hengshui Hospital of Traditional Chinese Medicine
        • Contact:
    • Jiangsu
      • Changzhou, Jiangsu, China
        • Liyang Hospital of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptom Screening-Positive Status (PHQ-9 ≥10)
Time Frame: 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.
Baseline (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening Completion Rate
Time Frame: Up to 3 months
The proportion of eligible patients consenting to assessment.
Up to 3 months
Referral Uptake Rate
Time Frame: Up to 3 months
The proportion of screen-positive patients completing mental health consultation.
Up to 3 months
Dorsalis Pedis Artery Resistive Index (RI)
Time Frame: Baseline (Day 0)
A calculated flow parameter reflecting vascular resistance measured via Doppler ultrasound.
Baseline (Day 0)
Dorsalis Pedis Artery Pulsatility Index (PI)
Time Frame: Baseline (Day 0)
A calculated flow parameter reflecting vascular pulsatility measured via Doppler ultrasound.
Baseline (Day 0)
Dorsalis Pedis Artery Flow Waveform Classification
Time Frame: Baseline (Day 0)
Flow waveforms classified into three categories: triphasic, biphasic, or monophasic via Doppler ultrasound assessment.
Baseline (Day 0)
Brachial-Ankle Pulse Wave Velocity (baPWV)
Time Frame: Baseline (Day 0)
Measured to assess arterial stiffness.
Baseline (Day 0)
Generalized Anxiety Disorder-7 (GAD-7) Score
Time Frame: 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.
Baseline (Day 0)
Time Burden
Time Frame: Up to 3 months
The median time added to routine workflow (measured in minutes)
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Academy of Chinese Medical Sciences

Collaborators

Beijing Anzhen Hospital
Hengshui Hospital of Traditional Chinese Medicine
Liyang Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-EC-KY-004
  • Other Identifier (Other Identifier: Research Ethics Committee, College of Nursing, Univ. of Baghdad, Min. of Higher Educ. & Sci. Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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