NCT06756139

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Functional Dyspepsia
• Self-help Mobile Cognitive Behavioral Therapy
• Antipsychotic Drug

Interventions

Type	Name	Description
PROCEDURE	cognitive behavioural therapy mobile application	The CBT mobile application enables patients to conduct cognitive therapy independently.
DRUG	Flupentixol and Melitracen Tablets	patients take Flupentixol and Melitracen Tablets

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-01-01
• Last updated: 2025-07-01

Locations

7 sites across 1 country: China