Clinical trial NCT06756139: Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia
Official title: Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia: a Multicenter, Single-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Dyspepsia
Self-help Mobile Cognitive Behavioral Therapy
Antipsychotic Drug
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: Xi'an 986 Hospital
name: Shaanxi Second People's Hospital
name: Xi'an People's Hospital (Xi'an Fourth Hospital)
name: Tang-Du Hospital
name: Hainan People's Hospital
name: Mianyang Third Hospital
First posted: 2025-01-01
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: 1. The primary endpoint was the change in GOSS scores from baseline to week 8 after treatment.
timeFrame: 8weeks
Secondary outcomes:
measure: 5-Likert score
timeFrame: 4 weeks, 8weeks, 12 weeks
measure: Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)
timeFrame: 4 weeks, 8weeks, 12 weeks
measure: GOSS score
timeFrame: 4 weeks, 8weeks, 12 weeks
measure: Short Form of Nepean Dyspepsia Index (SF-NDI)
timeFrame: 4 weeks, 8weeks, 12 weeks
measure: Patient Health Questionnaire-9(PHQ-9)
timeFrame: 4 weeks, 8weeks, 12 weeks
measure: Generalized Anxiety Disorder-7(GAD-7)
timeFrame: 4 weeks, 8weeks, 12 weeks
measure: HAM-D17
timeFrame: 4 weeks, 8weeks, 12 weeks
measure: HAMA-14A
timeFrame: 4 weeks, 8weeks, 12 weeks
measure: Treatment adherence
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan People's Hospital
state: Hainan
city: Xi'an
country: China
facility: Air Force Military Medical University, China
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Second People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an 986 Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an People's Hospital
state: Shaanxi
city: Mianyang
country: China
facility: Mianyang Third Hospital
state: Sichuan
Study officials:
References: