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

NCT06756139 | Recruiting

• 1 other identifier: KY20242333-C-1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 1. The primary endpoint was the change in GOSS scores from baseline to week 8 after treatment.

  GOSS (7-point Global Overall Symptom Scale) is a scoring system composed of ten primary symptom ratings. The main symptoms include upper abdominal pain, early satiety, postprandial fullness discomfort, bloating, nausea, acid reflux, heartburn, excessive belching, upper abdominal discomfort, and other upper abdominal discomforts. Each item is scored from 1 to 7, with 7 representing the most severe symptom. The total score is the sum of the scores for the ten symptoms.

  8weeks

Secondary Outcomes (9)

• 5-Likert score

  4 weeks, 8weeks, 12 weeks

• Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)

  4 weeks, 8weeks, 12 weeks

• GOSS score

  4 weeks, 8weeks, 12 weeks

• Short Form of Nepean Dyspepsia Index (SF-NDI)

  4 weeks, 8weeks, 12 weeks

• Patient Health Questionnaire-9(PHQ-9)

  4 weeks, 8weeks, 12 weeks

Study Arms (2)

Cognitive behavioural therapy mobile application

EXPERIMENTAL

All patients received standard first-line treatment for FD, including PPIs and/or prokinetics, which was at the discretion of physicians. Additionally, patients underwent mobile app (named LotusHope)-based CBT to learn or practice the skills of acceptance, cognition, values, goal-setting and behavioral exercises. It takes approximately 15-20 minutes to complete one CBT treatment per day. The mobile app-based interference will last for 8 weeks.

Procedure: cognitive behavioural therapy mobile application

Flupentixol and Melitracen Tablets

PLACEBO COMPARATOR

All patients received standard first-line treatment for FD, including PPIs and/or prokinetics, which was at the discretion of physicians. Patients also took 1-2 tablets of deanxit (a compound preparation of tricyclic antidepressant (melitracen) and antipsychotic drug(flupentixol)) orally for 8 weeks.

Drug: Flupentixol and Melitracen Tablets

Interventions

cognitive behavioural therapy mobile application PROCEDURE

The CBT mobile application enables patients to conduct cognitive therapy independently.

Cognitive behavioural therapy mobile application

Flupentixol and Melitracen Tablets DRUG

patients take Flupentixol and Melitracen Tablets

Flupentixol and Melitracen Tablets

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead
• Xi'an 986 Hospital: collaborator
• Shaanxi Second People's Hospital: collaborator
• Xi'an People's Hospital (Xi'an Fourth Hospital): collaborator
• Tang-Du Hospital: collaborator
• Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University): collaborator
• Mianyang Third Hospital: collaborator

Study Sites (7)

Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)

Haikou, Hainan, 570000, China

RECRUITING

Air Force Military Medical University, China

Xi'an, Shaanxi, 710032, China

RECRUITING

Shaanxi Second People's Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Tangdu Hospital

Xi'an, Shaanxi, 710032, China

NOT YET RECRUITING

Xi'an 986 Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Xi'an People's Hospital

Xi'an, Shaanxi, 710032, China

NOT YET RECRUITING

Mianyang Third Hospital

Mianyang, Sichuan, 621000, China

RECRUITING

MeSH Terms

Interventions

Flupenthixol

Intervention Hierarchy (Ancestors)

Thioxanthenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Yanglin Pan, Professor

CONTACT

13991811225; yanglinpan@hotmail.com

Xiaoyu Kang, MD, Ph.D

CONTACT

15291680602; kangxiaoyu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 1, 2025
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

CN (7)