An observational study in Chronic Atrophic Gastritis, Depressive Symptoms and Depression, sponsored by China Academy of Chinese Medical Sciences. Not yet recruiting at 4 sites in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by China Academy of Chinese Medical Sciences · Observational
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.
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).
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.
75 studies on the registry are indexed under Gastritis, Atrophic; 37 are open to participants now.
This study's planned enrollment of 520 is close to the median of 509 across 54 observational studies indexed under Gastritis, Atrophic.
Browse Gastritis, Atrophic studies →China Academy of Chinese Medical Sciences is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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)
Screening Completion Rate
The proportion of eligible patients consenting to assessment.
Time frame: Up to 3 months
Referral Uptake Rate
The proportion of screen-positive patients completing mental health consultation.
Time frame: Up to 3 months
Dorsalis Pedis Artery Resistive Index (RI)
A calculated flow parameter reflecting vascular resistance measured via Doppler ultrasound.
Time frame: Baseline (Day 0)
Dorsalis Pedis Artery Pulsatility Index (PI)
A calculated flow parameter reflecting vascular pulsatility measured via Doppler ultrasound.
Time frame: Baseline (Day 0)
Dorsalis Pedis Artery Flow Waveform Classification
Flow waveforms classified into three categories: triphasic, biphasic, or monophasic via Doppler ultrasound assessment.
Time frame: Baseline (Day 0)
Brachial-Ankle Pulse Wave Velocity (baPWV)
Measured to assess arterial stiffness.
Time frame: Baseline (Day 0)
Generalized Anxiety Disorder-7 (GAD-7) Score
Anxiety symptom severity assessed using the GAD-7 scale. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: Baseline (Day 0)
Time Burden
The median time added to routine workflow (measured in minutes)
Time frame: Up to 3 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months and ending 5 years following article publication.
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.
Start is estimated for Feb 2026; primary completion for Jun 2026, 4 months later.
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This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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China Academy of Chinese Medical Sciences