NCT06756139 Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia
| NCT ID | NCT06756139 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Air Force Military Medical University, China |
| Condition | Functional Dyspepsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 88 participants in total. It began in 2024-11-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age 18-80 2. 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) 3. Negative or unrelated-to-FD symptom findings of gastroscopy, upper abdominal ultrasound, Hp test and routine blood tests within the past 1 year. Exclusion Criteria: 1. Severe mental illness (PHQ-9 ≥20 or GAD-7 ≥15) or suicidal ideation; 2. Known hp infection, active gastrointestinal peptic ulcer, cholecystitis, gallstones, suspected or known bowel obstruction, gastroparesis, major gastrointestinal surgery etc.; 3. 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; 4. Known or suspected drug-related FD (e.g.NSAIDs-related FD); 5. Unable to access to mobile networks or unable to manage mobile APP properly. 6. Allergy or other contradictions to flupenthixol or melitracen 7. Taking any antipsychotics drugs or CBT interference within 12 weeks 8. Pregnant or lactating women; 9. Unable to provide informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06756139 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Functional Dyspepsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06756139 currently recruiting?
Yes, NCT06756139 is actively recruiting participants. Contact the research team at yanglinpan@hotmail.com for enrollment information.
Where is the NCT06756139 trial being conducted?
This trial is being conducted at Haikou, China, Xi'an, China, Xi'an, China, Xi'an, China and 3 additional locations.
Who is sponsoring the NCT06756139 clinical trial?
NCT06756139 is sponsored by Air Force Military Medical University, China. The trial plans to enroll 88 participants.