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

NCT ID: NCT06756139

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cognitive behavioural therapy mobile application

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.

Group Type: EXPERIMENTAL

cognitive behavioural therapy mobile application

Intervention Type: PROCEDURE

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

Flupentixol and Melitracen Tablets

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.

Group Type: PLACEBO_COMPARATOR

Flupentixol and Melitracen Tablets

Intervention Type: DRUG

patients take Flupentixol and Melitracen Tablets

Interventions

cognitive behavioural therapy mobile application

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

Intervention Type: PROCEDURE

Flupentixol and Melitracen Tablets

patients take Flupentixol and Melitracen Tablets

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xi'an 986 Hospital

UNKNOWN

Sponsor Role: collaborator

Shaanxi Second People's Hospital

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: collaborator

Tang-Du Hospital

OTHER

Sponsor Role: collaborator

Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)

UNKNOWN

Sponsor Role: collaborator

Mianyang Third Hospital

UNKNOWN

Sponsor Role: collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yanglin Pan

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)

Haikou, Hainan, China

Site Status: RECRUITING

Air Force Military Medical University, China

Xi'an, Shaanxi, China

Site Status: RECRUITING

Shaanxi Second People's Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Tangdu Hospital

Xi'an, Shaanxi, China

Site Status: NOT_YET_RECRUITING

Xi'an 986 Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Xi'an People's Hospital

Xi'an, Shaanxi, China

Site Status: NOT_YET_RECRUITING

Mianyang Third Hospital

Mianyang, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanglin Pan, Professor

Role: CONTACT

yanglinpan@hotmail.com

13991811225

Xiaoyu Kang, MD, Ph.D

Role: CONTACT

kangxiaoyu@hotmail.com

15291680602

Facility Contacts

Na Liu, MD, Ph.D

Role: primary

Yanglin Pan, MD

Role: primary

yanglinpan@hotmail.com

13991811225

Limei Wang, MD, Ph.D

Role: primary

Zhenxiong Liu, MD, Ph.D

Role: primary

Jun Wang, MD, Ph.D

Role: primary

Rui Huang, MD, Ph.D

Role: primary

Long Zou, Ph.D

Role: primary

Other Identifiers

KY20242333-C-1

Identifier Type: -

Identifier Source: org_study_id