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

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.

NCT Number	NCT06756139
Lead Sponsor	Air Force Military Medical University, China Collaborators: Xi'an 986 Hospital, Shaanxi Second People's Hospital, Xi'an People's Hospital (Xi'an Fourth Hospital), Tang-Du Hospital, Hainan General Hospital, Mianyang Third Hospital
Conditions	Functional Dyspepsia, Self-help Mobile Cognitive Behavioral Therapy, Antipsychotic Drug
Enrollment	88 participants
Start Date	2024-11-01
Primary Completion	2025-11-01 (estimated)
Study Completion	2025-11-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-01