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

Official title

Effects of an Online Mindfulness-Based Emotion Intervention on Symptoms and Emotional Distress in Patients With Gastroesophageal Reflux Disease: A Multicenter Randomized Waitlist-Controlled Trial

Overview

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.

Interventions

• Other TAU
  Participants will continue usual GERD treatment and health management during the 49-day observation period. They will not receive MIED, mindfulness training, or other structured psychological interventions during this period. Usual care may include medication, lifestyle advice, and necessary follow-up as determined by clinicians. The waitlist control group will complete assessments at the same time points as the MIED group. After the 2-year follow-up, participants in the waitlist control group w
• Other MIED
  The intervention is delivered via the internet and is grounded in the psychopathological diamond model of emotional distress proposed by Liu and colleagues. The program is supported by a MIED knowledge base, the Mindfulness Study public account, supervision and question-answer records, and official materials from Liu Xinghua and the MIED team. These resources are integrated into a WeChat self-help mini-program and the MIED Mindfulness Assistant, an artificial intelligence-supported system develo

Primary outcome measures

• GERD-HRQL [Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.]

Secondary outcome measures (8)

• Overall Anxiety Severity and Impairment Scale (OASIS) [Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.]
• Overall Depression Severity and Impairment Scale (ODSIS) [Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.]
• Gastroesophageal Reflux Disease Questionnaire (GERD-Q) [Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.]
• Reflux Symptom Index (RSI) [Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.]
• Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.]
• Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.]
• Treatment Inventory of Costs in Patients with Psychiatric Disorders (TIC-P) [Time frame: Baseline (T0); immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.]
• EuroQol 5-Dimension 5-Level (EQ-5D-5L) [Time frame: Baseline (T0); Week 3 (T1) and Week 5 (T2) during the intervention; immediately post-intervention at Week 8 (T3); and 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention.]

Eligibility criteria

Inclusion criteria

Participants must meet all of the following criteria:

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

Exclusion criteria

Participants meeting any of the following criteria will be excluded:

• 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.
• Current or previous severe esophageal organic disease or gastrointestinal malignancy.
• History of anti-reflux surgery, partial gastrectomy, or other upper gastrointestinal surgery that may substantially affect reflux symptom assessment.
• 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.
• Current uncontrolled severe mental disorder, such as schizophrenia, manic episode of bipolar disorder, acute severe depressive episode, or severe substance use disorder.
• Current suicide risk, operationalized as a score greater than 1 on item 9 of the PHQ-9.
• Previous systematic participation in MIED, mindfulness-based stress reduction, mindfulness-based cognitive therapy, or another structured mindfulness program.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 15 centers

• Being Haidian Hospital — Beijing
• PLA Rocket Force Characteristic Medical Center — Beijing
• Peking University — Beijing
• Baiyin Central Hospital — Baiyin
• Peking University Shenzhen Hospital — Shenzhen
• the first affiliated hospital of GuiZhou medical university — Guiyang
• Center Hospital Qinghe County — Xingtai
• Xinle City Hospital — Xinle
• … and 7 more centers

Identifiers

NCT: NCT07667894 · E20260611

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗