Clinical trial Recruiting at 5 sites Interventional Ages 18 to 80

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 typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment88 (estimated)
SponsorAir Force Military Medical University, China
Academic / other
Locations7 sites (Haikou, Hainan and 6 other locations)
StatusRecruiting
StartedNovember 1, 2024
Main results expectedNovember 1, 2025
Study endsNovember 1, 2025
Registry record updatedJuly 1, 2025
Trial IDNCT06756139 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

  • 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
  • Xi'an People's Hospital
    Xi'an, Shaanxi, China
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.