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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 520
- 试验地点
- 4
- 主要终点
- Depressive Symptom Screening-Positive Status (PHQ-9 ≥10)
研究概览
简要总结
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.
详细描述
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:
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Gastrointestinal evaluation: Endoscopy and histopathology (OLGA/OLGIM staging), and symptom scoring (GSRS).
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Peripheral vascular assessment: High-frequency ultrasound of the dorsalis pedis artery (measuring Resistive Index [RI], Pulsatility Index [PI], and waveform classification).
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Arterial stiffness and autonomic function: Brachial-ankle pulse wave velocity (baPWV), Ankle-Brachial Index (ABI), and Heart Rate Variability (HRV).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Depressive Symptom Screening-Positive Status (PHQ-9 ≥10)
时间窗: 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.
次要结局
- Screening Completion Rate(Up to 3 months)
- Referral Uptake Rate(Up to 3 months)
- Dorsalis Pedis Artery Pulsatility Index (PI)(Baseline (Day 0))
- Dorsalis Pedis Artery Resistive Index (RI)(Baseline (Day 0))
- Dorsalis Pedis Artery Flow Waveform Classification(Baseline (Day 0))
- Brachial-Ankle Pulse Wave Velocity (baPWV)(Baseline (Day 0))
- Generalized Anxiety Disorder-7 (GAD-7) Score(Baseline (Day 0))
- Time Burden(Up to 3 months)
研究者
Meng Wang
Principal Investigator
China Academy of Chinese Medical Sciences