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

Last updated: June 27, 2025
Sponsor: Air Force Military Medical University, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heartburn (Pediatric)

Bowel Dysfunction

Colic

Treatment

Flupentixol and Melitracen Tablets

cognitive behavioural therapy mobile application

Clinical Study ID

NCT06756139
KY20242333-C-1
  • Ages 18-80
  • All Genders

Study 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

Inclusion Criteria:

  1. Age 18-80

  2. Refractory functional dyspepsia (patients with Rome IV functional dyspepsia remainedsymptomatic after treatment of 8 weeks of proton pump inhibitor and 4 weeks ofprokinetics)

  3. Negative or unrelated-to-FD symptom findings of gastroscopy, upper abdominalultrasound, Hp test and routine blood tests within the past 1 year.

Exclusion

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 surgeryetc.;

  3. Known or suspected malignant tumor, significant heart/brain/liver/kidney diseases,obvious hematologic abnormalities or endocrine diseases etc., which may be -relatedto 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.

Study Design

Total Participants: 88
Treatment Group(s): 2
Primary Treatment: Flupentixol and Melitracen Tablets
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
November 01, 2025

Connect with a study center

  • Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)

    Haikou, Hainan 570000
    China

    Active - Recruiting

  • Hainan People's Hospital

    Haikou, Hainan 570000
    China

    Active - Recruiting

  • Air Force Military Medical University, China

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

  • Shaanxi Second People's Hospital

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

  • Tangdu Hospital

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Xi'an 986 Hospital

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

  • Xi'an People's Hospital

    Xi'an, Shaanxi 710032
    China

    Site Not Available

  • Mianyang Third Hospital

    Mianyang, Sichuan 621000
    China

    Active - Recruiting

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