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

Summary

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.

Conditions

• Gastroesophageal Reflux Disease
• Emotional Distress

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 who wish to receive the program will be offered the same MIED course.

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 developed using large language models such as Tencent Hunyuan and DeepSeek R1. Together, these tools support participants' learning and practice over a continuous 49-day training period.

Sponsors & Collaborators

• Xinghua Liu

  lead OTHER

Principal Investigators

• Xinghua Liu, Dr. · Peking University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-05-15

Completion

2028-05-15

Countries

• China

Study Locations