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

RecruitingNA

Sponsor: Xinghua Liu

Conditions: Gastroesophageal Reflux Disease, Emotional Distress

Interventions: TAU, MIED

Countries: China

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 participants receiving online MIED with participants in a waitlist control group receiving usual medical care and health management to determine whether online MIED leads to greater improvement over time. Participants will: complete screening and baseline assessments; be randomly assigned to either the online MIED intervention group or the waitlist control group; if assigned to the intervention group, complete an 8-week online MIED program with one session per week; continue necessary usual medical care during the study, while keeping medication use stable when possible; complete online questionnaires at baseline, during the intervention, after the intervention, and at 3, 6, 12, and 24 months after the intervention; report information on reflux symptoms, emotional distress, quality of life, sleep, stress, resilience, life satisfaction, healthcare use, intervention adherence, and adverse events.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (15)

Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Baiyin, Gansu, China
Shenzhen, Guangdong, China
Guiyang, Guizhou, China
Xingtai, Hebei, China
Xinle, Hebei, China
Chifeng, Inner Mongolia, China
Hohhot, Inner Mongolia, China
Nanjing, Jiangsu, China
Jinan, Shandong, China
Liaocheng, Shandong, China
Shanghai, Shanghai Municipality, China
Changzhi, Shanxi, China