Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia

Launched by AIR FORCE MILITARY MEDICAL UNIVERSITY, CHINA · Dec 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective a mobile app for Cognitive Behavioral Therapy (CBT) can be in helping patients with a condition called refractory functional dyspepsia (FD). FD is a common digestive issue that causes discomfort in the stomach and can significantly affect a person's quality of life. The trial aims to see if using this smartphone-based therapy for 8 weeks can help reduce the symptoms of FD just as well as traditional medications, like antipsychotic drugs, which can have unpleasant side effects.

To participate, individuals need to be between 18 and 80 years old and must have been experiencing symptoms of FD that haven’t improved after other treatments. They should also have undergone certain medical tests within the past year that ruled out other serious health problems related to their symptoms. Participants will learn how to use the mobile app and will take part in guided therapy sessions over the 8 weeks. Overall, this trial could provide a new, safer way to manage FD symptoms without relying solely on medications.

Gender

ALL

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.