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

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated July 1, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study sites revised (7)
    • Collaborators revised (6)
    v5
  2. Study sites: 6 to 7
    • Collaborators: 5 to 6
    v4
  3. Site details revised at 1 of 6 sitesv3
  4. Site details revised at 2 of 6 sitesv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06756139
Lead Sponsor Air Force Military Medical University, China
Collaborators: Xi'an 986 Hospital, Shaanxi Second People's Hospital, Xi'an People's Hospital (Xi'an Fourth Hospital), Tang-Du Hospital, Hainan General Hospital, Mianyang Third Hospital
Conditions
(from sponsor)		 Functional Dyspepsia, Self-help Mobile Cognitive Behavioral Therapy, Antipsychotic Drug
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov