Actively Recruiting
Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia
Led by Air Force Military Medical University, China · Updated on 2025-07-01
88
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Air Force Military Medical University, China
Lead Sponsor
X
Xi'an 986 Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years
- Diagnosed with refractory functional dyspepsia after 8 weeks of proton pump inhibitor and 4 weeks of prokinetics without symptom relief
- Normal or unrelated findings on gastroscopy, upper abdominal ultrasound, Hp test, and blood tests within the past year
You will not qualify if you...
- Severe mental illness with PHQ-9 score 20 or higher or GAD-7 score 15 or higher, or suicidal thoughts
- Known or active gastrointestinal diseases including Hp infection, peptic ulcer, cholecystitis, gallstones, bowel obstruction, or gastroparesis
- Known or suspected cancer or serious heart, brain, liver, kidney, blood, or endocrine diseases related to FD symptoms
- Drug-related functional dyspepsia such as from NSAIDs
- Unable to access mobile networks or use the mobile app
- Allergy or contraindications to flupenthixol or melitracen
- Use of any antipsychotic drugs or CBT in the past 12 weeks
- Pregnant or breastfeeding women
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)
Haikou, Hainan, China, 570000
Actively Recruiting
2
Air Force Military Medical University, China
Xi'an, Shaanxi, China, 710032
Actively Recruiting
3
Shaanxi Second People's Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
4
Tangdu Hospital
Xi'an, Shaanxi, China, 710032
Not Yet Recruiting
5
Xi'an 986 Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
6
Xi'an People's Hospital
Xi'an, Shaanxi, China, 710032
Not Yet Recruiting
7
Mianyang Third Hospital
Mianyang, Sichuan, China, 621000
Actively Recruiting
Research Team
Y
Yanglin Pan, Professor
CONTACT
X
Xiaoyu Kang, MD, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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