Cognitive Behavioral Therapy via Mobile App for Functional Dyspepsia

Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia: a Multicenter, Single-blinded, Randomized Controlled Trial

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Air Force Military Medical University, China (Academic / other)
• Locations: 7 sites (Haikou, Hainan and 6 other locations)
• Trial ID: NCT06756139 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with refractory functional dyspepsia who have not responded to previous treatments.

Not a fit: Patients with severe mental illness, significant gastrointestinal diseases, or those unable to use mobile technology may not benefit from this study.

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 performed: Previous studies have shown positive outcomes for psychological interventions in treating dyspepsia, suggesting potential success for this mobile CBT approach.

Eligibility 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 this trial is running

Haikou, Hainan and 6 other locations

• 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)
• Tangdu Hospital — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Xi'an 986 Hospital — Xi'an, Shaanxi, China (Recruiting)
• Xi'an People's Hospital — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Mianyang Third Hospital — Mianyang, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Yanglin Pan, Professor

Conditions Functional Dyspepsia; Self-help Mobile Cognitive Behavioral Therapy; Antipsychotic Drug