Functional dyspepsia (FD) is a common gastrointestinal disease, which is associated with decreased life quality and increased medical cost. Antipsychotic drugs were demonstrated to be effective in relieving symptoms in FD patients, especially for patients with refractory FD. However, the use of those drugs was associated with obvious adverse events. Cognitive behavioral therapy (CBT) has extensive applications and exhibited potential treatment effects in clinical practices, especially for treating anxiety, depression, pain or stress disorders. Several previous RCT studies have confirmed the effects of psychological intervention on improving dyspepsia in FD patients. Our hypothesis was that 8-week smartphone-based CBT would be non-inferior to conventional pharmacotherapy in reducing FD-related symptoms in patients with refactory FD.
Age 18-80
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)
Negative or unrelated-to-FD symptom findings of gastroscopy, upper abdominal ultrasound, Hp test and routine blood tests within the past 1 year.
Severe mental illness (PHQ-9 ≥20 or GAD-7 ≥15) or suicidal ideation;
Known hp infection, active gastrointestinal peptic ulcer, cholecystitis, gallstones, suspected or known bowel obstruction, gastroparesis, major gastrointestinal surgery etc.;
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;
Known or suspected drug-related FD (e.g.NSAIDs-related FD);
Air Force Military Medical University, China
Lead sponsor
Xi'an 986 Hospital
Collaborator
Shaanxi Second People's Hospital
Collaborator
Xi'an People's Hospital (Xi'an Fourth Hospital)
Collaborator
Tang-Du Hospital
Collaborator
Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)
Collaborator
Mianyang Third Hospital
Collaborator