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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• GERD-HRQL [Срок оценки: 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.]

Вторичные конечные точки (8)

• Overall Anxiety Severity and Impairment Scale (OASIS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 15 центров

• Being Haidian Hospital — Пекин
• PLA Rocket Force Characteristic Medical Center — Пекин
• Peking University — Пекин
• Baiyin Central Hospital — Baiyin
• Peking University Shenzhen Hospital — Шэньчжэнь
• the first affiliated hospital of GuiZhou medical university — Guiyang
• Center Hospital Qinghe County — Xingtai
• Xinle City Hospital — Xinle
• … и ещё 7 центров

Идентификаторы

NCT: NCT07667894 · E20260611

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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