Cognitive Behavioral Therapy via Mobile App for Functional Dyspepsia
Official title: Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia: a Multicenter, Single-blinded, Randomized Controlled Trial
Run by Air Force Military Medical University, China · NCT06756139 · Data updated 2026-11-12
This study tests if an 8-week mobile app program using cognitive behavioral therapy can help adults with stubborn stomach issues feel better, compared to traditional medications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | Air Force Military Medical University, China Academic / other |
| Locations | 7 sites (Haikou, Hainan and 6 other locations) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | November 1, 2025 |
| Study ends | November 1, 2025 |
| Registry record updated | July 1, 2025 |
| Trial ID | NCT06756139 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 with refractory functional dyspepsia who have not responded to previous treatments.
✕Probably not a fit
Patients with severe mental illness, significant gastrointestinal diseases, or those unable to use mobile technology may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of an 8-week smartphone-based cognitive behavioral therapy (CBT) program for patients suffering from refractory functional dyspepsia. The approach aims to determine if mobile CBT can reduce symptoms as effectively as conventional pharmacotherapy, specifically antipsychotic medications, which are associated with adverse effects. Participants will be monitored for symptom improvement and overall quality of life. The study includes patients aged 18-80 who have not responded to standard treatments for functional dyspepsia.
Why it matters
Potential benefit: If successful, this approach could provide a safer, non-pharmacological treatment option for patients with refractory functional dyspepsia.
How similar studies have gone: Previous studies have shown positive outcomes for psychological interventions in treating dyspepsia, suggesting potential success for this mobile CBT approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-80 2. Refractory functional dyspepsia (patients with Rome IV functional dyspepsia remained symptomatic after treatment of 8 weeks of proton pump inhibitor and 4 weeks of prokinetics) 3. Negative or unrelated-to-FD symptom findings of gastroscopy, upper abdominal ultrasound, Hp test and routine blood tests within the past 1 year. Exclusion Criteria: 1. Severe mental illness (PHQ-9 ≥20 or GAD-7 ≥15) or suicidal ideation; 2. Known hp infection, active gastrointestinal peptic ulcer, cholecystitis, gallstones, suspected or known bowel obstruction, gastroparesis, major gastrointestinal surgery etc.; 3. Known or suspected malignant tumor, significant heart/brain/liver/kidney diseases, obvious hematologic abnormalities or endocrine diseases etc., which may be -related to FD symptoms; 4. Known or suspected drug-related FD (e.g.NSAIDs-related FD); 5. Unable to access to mobile networks or unable to manage mobile APP properly. 6. Allergy or other contradictions to flupenthixol or melitracen 7. Taking any antipsychotics drugs or CBT interference within 12 weeks 8. Pregnant or lactating women; 9. Unable to provide informed consent.
Where it's running
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Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)
Haikou, Hainan, China Recruiting -
Air Force Military Medical University, China
Xi'an, Shaanxi, China Recruiting -
Shaanxi Second People's Hospital
Xi'an, Shaanxi, China Recruiting -
Xi'an 986 Hospital
Xi'an, Shaanxi, China Recruiting -
Mianyang Third Hospital
Mianyang, Sichuan, China Recruiting -
Tangdu Hospital
Xi'an, Shaanxi, China Not yet recruiting
Show 1 more location
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Xi'an People's Hospital
Xi'an, Shaanxi, China Not yet recruiting
Study contacts
- Study coordinator: Yanglin Pan, Professor
- Email: yanglinpan@hotmail.com
- Phone: 13991811225
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Low-FODMAP Diet vs Standard Dietary Advice for Functional Dyspepsia
This study tests whether a low-FODMAP diet helps adults with functional dyspepsia compared with standard dietary advice.
-
Pain Reprocessing Therapy for Functional Dyspepsia
A small pilot test to see if a psychological therapy that uses exposure techniques can lessen digestive symptoms and help daily functioning in people with functional dyspepsia.
-
Identifying Signatures of Gut Interoception in Functional Dyspepsia and Anorexia Nervosa
This study tests how the gut-brain connection works in people with functional dyspepsia or anorexia nervosa using brain imaging.
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Prevalence and possible role of non-H. pylori Helicobacter species in gastric conditions and cancers
Researchers will test stomach tissue from people with functional dyspeasia, various gastritis conditions, gastric cancer, and bariatric patients to see if non-H. pylori Helicobacter species are present.
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Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity
This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.
-
Prevalence of Functional Dyspepsia in a Rural Community in Bangladesh
This study tests how common functional dyspepsia is in a rural Bangladeshi community among adults who live there.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.