Mindfulness Intervention for Emotional Distress (MIED) in Patients With GERD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXinghua Liu
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
TAU
Other interventionParticipants 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.
MIED
Other interventionThe 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: MIEDExperimental treatment 2 interventions
Group B: WLActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
GERD-HRQL
The GERD-HRQL is a self-report questionnaire used to assess the impact of gastroesophageal reflux symptoms on health-related quality of life. It evaluates symptom burden and the degree to which reflux symptoms affect daily functioning. Higher scores indicate poorer reflux-related quality of life.
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 outcomes
1
Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS is a 5-item self-report measure designed to assess the frequency and severity of anxiety symptoms, as well as the extent of anxiety-related functional impairment and avoidance, over the past week. Each item is rated on a 5-point scale from 0 to 4, with total scores ranging from 0 to 20. Higher scores indicate greater overall anxiety severity and impairment. The OASIS has demonstrated good reliability and validity in both clinical and nonclinical samples (Norman et al., 2006).
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.2
Overall Depression Severity and Impairment Scale (ODSIS)
The ODSIS is a 5-item self-report measure designed to assess the frequency and severity of depressive symptoms, as well as depression-related functional impairment and avoidance, over the past week. Each item is rated on a 5-point scale from 0 to 4, with total scores ranging from 0 to 20. Higher scores indicate greater overall depression severity and impairment. The ODSIS has demonstrated good reliability and validity in both clinical and nonclinical samples (Bentley et al., 2014).
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.3
Gastroesophageal Reflux Disease Questionnaire (GERD-Q)
The GERD-Q is a 6-item self-report questionnaire used to assess the frequency and severity of gastroesophageal reflux symptoms and to monitor treatment response. Total scores range from 0 to 18, with higher scores indicating more severe reflux-related symptoms.
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.4
Reflux Symptom Index (RSI)
The RSI is a 9-item self-report questionnaire used to assess symptoms related to laryngopharyngeal reflux, including chronic cough, hoarseness, throat clearing, and globus sensation. Total scores range from 0 to 45, with higher scores indicating more severe reflux-related throat symptoms.
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.Other outcomes
1
Short Form-8 Health Survey (SF-8)
The SF-8 is a brief self-report questionnaire used to assess general health-related quality of life. It measures physical and mental health domains and provides summary indicators of overall health status. Higher scores indicate better health-related quality of life.
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.2
Insomnia Severity Index (ISI)
The ISI is a 7-item self-report questionnaire used to assess the severity of insomnia symptoms and the degree of sleep-related impairment. Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.
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.3
Connor-Davidson Resilience Scale (CD-RISC)
The CD-RISC is a self-report questionnaire used to assess psychological resilience and the ability to cope with stress and adversity. Higher scores indicate greater resilience.
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.4
Chinese Perceived Stress Scale (CPSS)
The Chinese Perceived Stress Scale (CPSS) will be used to assess participants' subjective perception of life stress. This scale is derived from the Perceived Stress Scale developed by Cohen et al., and primarily assesses the extent to which individuals perceive life events over the past month as unpredictable, uncontrollable, and overwhelming (Cohen et al., 1983). The Chinese version of the CPSS has been applied and validated in Chinese populations, with studies demonstrating good internal consistency, structural validity, and criterion-related validity, supporting its use for assessing subjective stress levels (Leung et al., 2010; Ng, 2013).
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xinghua Liu
Lead sponsor
Peking University
Sponsor institution
Source ClinicalTrials.gov