Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cognitive behavioural therapy mobile application, Flupentixol and Melitracen Tablets.
- Who it may be relevant to
- Registry conditions: Functional Dyspepsia, Self-help Mobile Cognitive Behavioral Therapy, Antipsychotic Drug. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia: a Multicenter, Single-blinded, Randomized Controlled Trial
Overview
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.
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
Primary outcome measures
- 1. The primary endpoint was the change in GOSS scores from baseline to week 8 after treatment. [Time frame: 8weeks]
Secondary outcome measures (9)
- 5-Likert score [Time frame: 4 weeks, 8weeks, 12 weeks]
- Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) [Time frame: 4 weeks, 8weeks, 12 weeks]
- GOSS score [Time frame: 4 weeks, 8weeks, 12 weeks]
- Short Form of Nepean Dyspepsia Index (SF-NDI) [Time frame: 4 weeks, 8weeks, 12 weeks]
- Patient Health Questionnaire-9(PHQ-9) [Time frame: 4 weeks, 8weeks, 12 weeks]
- Generalized Anxiety Disorder-7(GAD-7) [Time frame: 4 weeks, 8weeks, 12 weeks]
- HAM-D17 [Time frame: 4 weeks, 8weeks, 12 weeks]
- HAMA-14A [Time frame: 4 weeks, 8weeks, 12 weeks]
- Treatment adherence [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- Age 18-80
- 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)
- 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
- Severe mental illness (PHQ-9 ≥20 or GAD-7 ≥15) or suicidal ideation;
- Known hp infection, active gastrointestinal peptic ulcer, cholecystitis, gallstones, suspected or known bowel obstruction, gastroparesis, major gastrointestinal surgery etc.;
- 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;
- Known or suspected drug-related FD (e.g.NSAIDs-related FD);
- Unable to access to mobile networks or unable to manage mobile APP properly.
- Allergy or other contradictions to flupenthixol or melitracen
- Taking any antipsychotics drugs or CBT interference within 12 weeks
- Pregnant or lactating women;
- Unable to provide informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 7 centers
- Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University) — Haikou
- Air Force Military Medical University, China — Xi'an
- Shaanxi Second People's Hospital — Xi'an
- Tangdu Hospital — Xi'an
- Xi'an 986 Hospital — Xi'an
- Xi'an People's Hospital — Xi'an
- Mianyang Third Hospital — Mianyang
Identifiers
NCT: NCT06756139 · KY20242333-C-1