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NCT07319338

Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis

Sponsor: China Academy of Chinese Medical Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

520

Start Date

2026-02-01

Completion Date

2026-08-30

Last Updated

2026-01-06

Healthy Volunteers

No

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.

Locations (4)

China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Hengshui Hospital of Traditional Chinese Medicine

Hengshui, Hebei, China

Liyang Hospital of Chinese Medicine

Changzhou, Jiangsu, China