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

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.