Mindfulness Intervention for Emotional Distress in GERD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial compares online Mindfulness-Based Intervention for Emotional Distress (MIED) against a waitlist control in adults with GERD. Participants will complete online assessments and engage in a mindfulness course while maintaining their usual treatment unless medically required changes. The study looks at changes in emotional distress, reflux-related symptoms, and quality of life, as well as related psychological processes. It uses a waitlist design to determine whether MIED provides benefits beyond standard care. Enrollment targets adults aged 18–65 with GERD symptoms and internet access.

Why it matters

Who can join: the full rules

Inclusion Criteria

Participants must meet all of the following criteria:

1. Aged 18 to 65 years.
2. GERD-Q score of 8 or higher.
3. Willingness to maintain a relatively stable usual treatment regimen during the study unless medically indicated changes are required.
4. Ability to use a smartphone, computer, or tablet to participate in the online program and complete online questionnaires.
5. Willingness to comply with course training and follow-up assessments.
6. Ability to understand the study and provide written or electronic informed consent.

Exclusion Criteria

Participants meeting any of the following criteria will be excluded:

1. Alarm symptoms or high suspicion of serious organic disease, including but not limited to progressive dysphagia, hematemesis, melena, unexplained weight loss, anemia, recurrent vomiting, or persistent chest pain without exclusion of cardiovascular risk.
2. Current or previous severe esophageal organic disease or gastrointestinal malignancy.
3. History of anti-reflux surgery, partial gastrectomy, or other upper gastrointestinal surgery that may substantially affect reflux symptom assessment.
4. GERD-Q score greater than 15, or symptoms judged by the study physician to be extremely severe and requiring priority medical evaluation or intensified treatment.
5. Current uncontrolled severe mental disorder, such as schizophrenia, manic episode of bipolar disorder, acute severe depressive episode, or severe substance use disorder.
6. Current suicide risk, operationalized as a score greater than 1 on item 9 of the PHQ-9.
7. Previous systematic participation in MIED, mindfulness-based stress reduction, mindfulness-based cognitive therapy, or another structured mindfulness program.

Where it's running

• Being Haidian Hospital
  Beijing, Beijing Municipality, China Recruiting
• PLA Rocket Force Characteristic Medical Center
  Beijing, Beijing Municipality, China Recruiting
• Peking University
  Beijing, Beijing Municipality, China Recruiting
• Baiyin Central Hospital
  Baiyin, Gansu, China Recruiting
• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting
• Center Hospital Qinghe County
  Xingtai, Hebei, China Recruiting

Study contacts

• Principal investigator: Xinghua Liu, Dr. — Peking University
• Study coordinator: Yinan Zhang, PHD Candidate
• Email: yinanzhang25@stu.pku.edu.cn
• Phone: 8615823339524

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Mindfulness for Emotional Distress: An EEG-Based Trial in Adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.