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Mindfulness Intervention for Emotional Distress (MIED) in Patients With GERD

RecruitingNAAges 18 Years - 65 YearsAllXinghua Liu
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In plain words

What the trial is, and whether it could suit you

The goal of this multicenter randomized waitlist-controlled clinical trial is to evaluate whether an online Mindfulness-Based Intervention for Emotional Distress (MIED) can reduce emotional distress and reflux-related symptoms in adults with gastroesophageal reflux disease (GERD). GERD is a common chronic gastrointestinal condition that is frequently accompanied by anxiety, depressive symptoms, stress, and impaired quality of life. The main questions this study aims to answer are: Can online MIED reduce emotional distress in patients with GERD? Can online MIED reduce reflux-related symptoms and improve reflux-related quality of life? Are changes in psychological processes, such as distress tolerance, cognitive flexibility, experiential avoidance, emotional behaviors, and life engagement, associated with improvements in emotional distress and reflux symptoms? Researchers will compare

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • TAU
  • MIED
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Where

15 sites
Being Haidian Hospital
Beijing, China
PLA Rocket Force Characteristic Medical Center
Beijing, China
Peking University
Beijing, China
Baiyin Central Hospital
Baiyin, China
Peking University Shenzhen Hospital
Shenzhen, China
the first affiliated hospital of GuiZhou medical university
Guiyang, China
Center Hospital Qinghe County
Xingtai, China
Xinle City Hospital
Xinle, China

โ€ฆand 7 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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