Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia: a Multicenter, Single-blinded, Randomized Controlled Trial
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)
RECRUITING
Haikou
Mianyang Third Hospital
RECRUITING
Mianyang
Air Force Military Medical University, China
RECRUITING
Xi'an
Shaanxi Second People's Hospital
RECRUITING
Xi'an
Tangdu Hospital
NOT_YET_RECRUITING
Xi'an
Xi'an 986 Hospital
RECRUITING
Xi'an
Xi'an People's Hospital
NOT_YET_RECRUITING
Xi'an
Contact Information
Primary
Yanglin Pan, Professor
yanglinpan@hotmail.com
13991811225
Backup
Xiaoyu Kang, MD, Ph.D
kangxiaoyu@hotmail.com
15291680602
Time Frame
Start Date:2024-11-01
Estimated Completion Date:2025-11-01
Participants
Target number of participants:88
Treatments
Experimental: Cognitive behavioural therapy mobile application
All patients received standard first-line treatment for FD, including PPIs and/or prokinetics, which was at the discretion of physicians. Additionally, patients underwent mobile app (named LotusHope)-based CBT to learn or practice the skills of acceptance, cognition, values, goal-setting and behavioral exercises. It takes approximately 15-20 minutes to complete one CBT treatment per day. The mobile app-based interference will last for 8 weeks.
Placebo_comparator: Flupentixol and Melitracen Tablets
All patients received standard first-line treatment for FD, including PPIs and/or prokinetics, which was at the discretion of physicians. Patients also took 1-2 tablets of deanxit (a compound preparation of tricyclic antidepressant (melitracen) and antipsychotic drug(flupentixol)) orally for 8 weeks.