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

NCT07667894 | Not Yet Recruiting

• 1 other identifier: E20260611
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 15

Brief 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

Keywords

Emotional Distress; Gastroesophageal Reflux Disease; Mindfulness Intervention for Emotional Distress

Outcome Measures

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.

  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 (8)

• Overall Anxiety Severity and Impairment Scale (OASIS)

  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)

  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)

  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)

  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)

  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 (12)

• Short Form-8 Health Survey (SF-8)

  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.

• Insomnia Severity Index (ISI)

  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.

• Connor-Davidson Resilience Scale (CD-RISC)

  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.

Study Arms (2)

MIED

EXPERIMENTAL

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.

Other: TAU; Other: MIED

WL

ACTIVE COMPARATOR

Participants in the waitlist control group 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: TAU

Interventions

TAU OTHER

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.

MIED; WL

MIED OTHER

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.

MIED

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• 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.

Sponsors & Collaborators

• Xinghua Liu: lead

Study Sites (15)

Being Haidian Hospital

Beijing, Beijing Municipality, 100080, China

Location

PLA Rocket Force Characteristic Medical Center

Beijing, Beijing Municipality, 100088, China

Location

Peking University

Beijing, Beijing Municipality, 100871, China

Location

Baiyin Central Hospital

Baiyin, Gansu, 730913, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

Location

the first affiliated hospital of GuiZhou medical university

Guiyang, Guizhou, 550004, China

Location

Center Hospital Qinghe County

Xingtai, Hebei, 054899, China

Location

Xinle City Hospital

Xinle, Hebei, 050700, China

Location

Affiliated Houspital of Chifeng University

Chifeng, Inner Mongolia, 024000, China

Location

Xilingol League Mongolian Medicine Hospital

Hohhot, Inner Mongolia, 026000, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Shandong Second Provincial General Hospital

Jinan, Shandong, 250022, China

Location

the Second People's Hospital of Liaocheng

Liaocheng, Shandong, 252600, China

Location

Shanghai sixth people's hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Changzhi People'S Hospital

Changzhi, Shanxi, 046000, China

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Xinghua Liu, Dr.

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinan Zhang, PHD Candidate

CONTACT

8615823339524; yinanzhang25@stu.pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (15)