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NCT Number: NCT07319338

Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Screening Completion Rate

    Time frame: Up to 3 months

    The proportion of eligible patients consenting to assessment.

  2. Referral Uptake Rate

    Time frame: Up to 3 months

    The proportion of screen-positive patients completing mental health consultation.

  3. Dorsalis Pedis Artery Resistive Index (RI)

    Time frame: Baseline (Day 0)

    A calculated flow parameter reflecting vascular resistance measured via Doppler ultrasound.

  4. Dorsalis Pedis Artery Pulsatility Index (PI)

    Time frame: Baseline (Day 0)

    A calculated flow parameter reflecting vascular pulsatility measured via Doppler ultrasound.

  5. 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.

  6. Brachial-Ankle Pulse Wave Velocity (baPWV)

    Time frame: Baseline (Day 0)

    Measured to assess arterial stiffness.

  7. 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.

  8. Time Burden

    Time frame: Up to 3 months

    The median time added to routine workflow (measured in minutes)

Study contacts

Contact information is provided by the study sponsor or research team.

Meng Wang, PhD

CONTACT

[email protected]

+86 18852096726

Sponsors and collaborators

Lead sponsor

China Academy of Chinese Medical Sciences

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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