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

NCT06756139 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-07-01

No results posted yet for this 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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Xi'an 986 Hospital

    collaborator UNKNOWN

  • Shaanxi Second People's Hospital

    collaborator UNKNOWN

  • Xi'an People's Hospital (Xi'an Fourth Hospital)

    collaborator OTHER

  • Tang-Du Hospital

    collaborator OTHER

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

    collaborator UNKNOWN

  • Mianyang Third Hospital

    collaborator UNKNOWN

  • Air Force Military Medical University, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-11-01
Completion
2025-11-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06756139 on ClinicalTrials.gov