Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-60
SponsorChina Academy of Chinese Medical Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Vascular-Psychological Triage Workflow
Diagnostic testParticipants 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.
Treatment groups
520 Participants
are divided into 1 treatment groupGroup A: Patients with Chronic Atrophic Gastritis (CAG)1 intervention
Trial outcomes
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.
Time frame
Baseline (Day 0)Secondary outcomes
1
Screening Completion Rate
The proportion of eligible patients consenting to assessment.
Time frame
Up to 3 months2
Referral Uptake Rate
The proportion of screen-positive patients completing mental health consultation.
Time frame
Up to 3 months3
Dorsalis Pedis Artery Resistive Index (RI)
A calculated flow parameter reflecting vascular resistance measured via Doppler ultrasound.
Time frame
Baseline (Day 0)4
Dorsalis Pedis Artery Pulsatility Index (PI)
A calculated flow parameter reflecting vascular pulsatility measured via Doppler ultrasound.
Time frame
Baseline (Day 0)Sponsors and contacts
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China Academy of Chinese Medical Sciences
Lead sponsor
Beijing Anzhen Hospital
Collaborator
Hengshui Hospital of Traditional Chinese Medicine
Collaborator
Liyang Hospital of Traditional Chinese Medicine
Collaborator
Source ClinicalTrials.gov
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