Gastroesophageal Reflux DiseaseNCT07667894
Mindfulness Intervention for Emotional Distress (MIED) in Patients With GERD
A study testing TAU and MIED in people with Gastroesophageal Reflux Disease and Emotional Distress, run by Xinghua Liu at 15 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Emotional Distress
- What is being tested?
- TAU and MIED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 15 sitesChina
- Study dates
- 29 Jun 2026to 15 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Baiyin Central Hospital
Baiyin, Gansu, 730913
Junhong Yang, MBBS, 86+13893031337, 13893031337@139.com
- Recruiting
Being Haidian Hospital
Beijing, Beijing Municipality, 100080
Yuqing Huang, MMed, 86+13371735630, huangyuqing555@qq.com
- Recruiting
PLA Rocket Force Characteristic Medical Center
Beijing, Beijing Municipality, 100088
Jimin Wu, MMed, 86+13691300588, 18810647108@163.com
- Recruiting
Peking University
Beijing, Beijing Municipality, 100871
- Not yet recruiting
Changzhi People'S Hospital
Changzhi, Shanxi, 046000
Caiwen Yan, MBBS, 86+13994613311, yancw401@sina.com
- Recruiting
Affiliated Houspital of Chifeng University
Chifeng, Inner Mongolia, 024000
Yilei Zhang, MMed, 86+18648117300, zhangyl1213@sina.com
- Not yet recruiting
the first affiliated hospital of GuiZhou medical university
Guiyang, Guizhou, 550004
Jie Yang, PhD, 86+18984812272, 458571933@qq.com
- Recruiting
Xilingol League Mongolian Medicine Hospital
Hohhot, Inner Mongolia, 026000
Yinghai Yang, MBBS, 86+13947955766, yyh0479@163.com
- Recruiting
Shandong Second Provincial General Hospital
Jinan, Shandong, 250022
Zhi Wei, PhD, 86+18753110926, chenjixindyx@126.com
- Recruiting
the Second People's Hospital of Liaocheng
Liaocheng, Shandong, 252600
Shuliang Li, PhD, 86+15163550161, lishuliang110@163.com
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Liuqin Jiang, PhD, 86+13951017379, jiangliuqin@163.com
- Recruiting
Shanghai sixth people's hospital
Shanghai, Shanghai Municipality, 200233
Yang Xia, PhD, 86+18930172923, xiayang9999@sina.cn
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Junping Wang, PhD, 86+13510076860, wjp2006sz@aliyun.com
- Recruiting
Center Hospital Qinghe County
Xingtai, Hebei, 054899
Ruijia Niu, 86+13932929522, niuruijia@yeah.net
- Recruiting
Xinle City Hospital
Xinle, Hebei, 050700
Lin Wang, MBBS, 86+18931197177, 1261980387@qq.com
About this study
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
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:
Read more
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.
- Being tested
- TAU, MIED
- Keywords
- Emotional Distress, Gastroesophageal Reflux Disease, Mindfulness Intervention for Emotional Distress
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAUOther
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.
MIEDOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: 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)
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
The GAD-7 is a 7-item self-report questionnaire used to assess the severity of anxiety symptoms over the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity. The GAD-7 has demonstrated good reliability and validity in both clinical and general populations (Spitzer et al., 2006).
Measured: 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)
The PHQ-9 is a 9-item self-report questionnaire used to assess the severity of depressive symptoms over the past 2 weeks. Each item is rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate greater depression severity. The PHQ-9 has demonstrated good reliability and validity in both clinical and general populations (Kroenke et al., 2001).
Measured: 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)
TIC-P is a widely used health economic instrument in mental health research for assessing psychiatric healthcare use and societal costs, including service utilization, medication use, and productivity losses (Bouwmans et al., 2013). In this study, TIC-P will be used to record healthcare resource consumption during the trial, including outpatient visits, medication costs, and other healthcare-related expenditures. To capture healthcare utilization more comprehensively, a self-developed healthcare utilization questionnaire will also be administered.
Measured: 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)
This is one of the most widely used instruments in health economic evaluation for measuring health-related quality of life and includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five response levels (Devlin \& Brooks, 2017; Herdman et al., 2011). The health utility values derived from EQ-5D-5L will be used to calculate Quality-Adjusted Life Years (QALYs) for cost-utility analysis (Drummond et al., 2015; Group, 1990).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start29 Jun 2026
- Primary completion15 May 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinghua Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xinghua Liu, Peking University
- Investigators
- Xinghua Liu, Dr., Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667894
- Sponsor's protocol ID
- E20260611
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) underlying the results reported in the main publication will be available upon reasonable request after publication of the primary trial results. The shared data will include deidentified participant-level data used in the primary and secondary analyses, including baseline characteristics, group allocation, outcome measures, follow-up assessments, adherence indicators, and safety outcomes. Directly or indirectly identifiable information will not be shared. Access will be provided to qualified researchers with a methodologically sound proposal, subject to approval by the principal investigator and relevant ethics requirements, and after completion of a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07667894
- Acronym / sponsor ID
- E20260611
- Keywords
- Emotional Distress, Gastroesophageal Reflux Disease, Mindfulness Intervention for Emotional Distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xinghua LiuUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIED | Experimental | Other: TAU, Other: MIEDThe 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. |
| WL | Active comparator | Other: TAUParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAUParticipants 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, WL |
| MIEDThe 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 | MIED |
Primary outcome
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.
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.
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) underlying the results reported in the main publication will be available upon reasonable request after publication of the primary trial results. The shared data will include deidentified participant-level data used in the primary and secondary analyses, including baseline characteristics, group allocation, outcome measures, follow-up assessments, adherence indicators, and safety outcomes. Directly or indirectly identifiable information will not be shared. Access will be provided to qualified researchers with a methodologically sound proposal, subject to approval by the principal investigator and relevant ethics requirements, and after completion of a data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinghua Liu, Dr. principal investigator
Peking University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAU and MIED in people with Gastroesophageal Reflux Disease and Emotional Distress, run by Xinghua Liu at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yinan Zhang, PHD Candidate (8615823339524, yinanzhang25@stu.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.