Functional DyspepsiaNCT06756139
Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia
A study testing cognitive behavioural therapy mobile application and Flupentixol and Melitracen Tablets in people with Functional Dyspepsia and Self-help Mobile Cognitive Behavioral Therapy, run by Air Force Military Medical University, China at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Dyspepsia, Self-help Mobile Cognitive Behavioral Therapy, Antipsychotic Drug
- What is being tested?
- cognitive behavioural therapy mobile application and Flupentixol and Melitracen Tablets
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 7 sitesChina
- Study dates
- 1 Nov 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Taking any antipsychotics drugs or CBT interference within 12 weeks
- Pregnant or lactating women;
- Unable to provide informed consent.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)
Haikou, Hainan, 570000
Na Liu, MD, Ph.D
- Recruiting
Mianyang Third Hospital
Mianyang, Sichuan, 621000
Long Zou, Ph.D
- Recruiting
Air Force Military Medical University, China
Xi'an, Shaanxi, 710032
Yanglin Pan, MD, 13991811225, yanglinpan@hotmail.com
- Recruiting
Shaanxi Second People's Hospital
Xi'an, Shaanxi, 710032
Limei Wang, MD, Ph.D
- Not yet recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710032
Zhenxiong Liu, MD, Ph.D
- Recruiting
Xi'an 986 Hospital
Xi'an, Shaanxi, 710032
Jun Wang, MD, Ph.D
- Not yet recruiting
Xi'an People's Hospital
Xi'an, Shaanxi, 710032
Rui Huang, MD, Ph.D
About this study
Official title: Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia: a Multicenter, Single-blinded, Randomized Controlled Trial
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.
- Being tested
- cognitive behavioural therapy mobile application, Flupentixol and Melitracen Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioural therapy mobile applicationProcedure or surgery
The CBT mobile application enables patients to conduct cognitive therapy independently.
Flupentixol and Melitracen TabletsDrug
patients take Flupentixol and Melitracen Tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Flupentixol and Melitracen Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8weeks
Secondary outcomes (9)
5-Likert score
The patients were interviewed to answer the question "Compared with the condition before receiving treatment, how about your gut condition now?" The following questions were chosen: (1) extremely worse, (2) slightly worse, (3) same as before, (4) slightly better, (5) much better.
Measured: 4 weeks, 8weeks, 12 weeks
Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)
PROMIS (Patient-Reported Outcomes Measurement Information System) Global-10, also known as the Global Quality of Life Score, is a patient-reported questionnaire consisting of 10 items. The responses are rated on a scale of 1-5 (with an additional 0-10 rating scale for a single item), and the final outputs are two standardized scores: the global physical health score and the global mental health score. Higher scores indicate better quality of life for the patient.
Measured: 4 weeks, 8weeks, 12 weeks
GOSS score
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.
Measured: 4 weeks, 8weeks, 12 weeks
Short Form of Nepean Dyspepsia Index (SF-NDI)
The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50.
Measured: 4 weeks, 8weeks, 12 weeks
Patient Health Questionnaire-9(PHQ-9)
For the PHQ-9: Scores of 0-4 indicate "Minimal Depression," 5-9 indicate "Mild Depression," 10-14 indicate "Moderate Depression," 15-19 indicate "Moderately Severe Depression," and 20-27 indicate "Severe Depression."
Measured: 4 weeks, 8weeks, 12 weeks
Generalized Anxiety Disorder-7(GAD-7)
For the GAD-7: Scores of 0-4 indicate "Minimal Anxiety," 5-9 indicate "Mild Anxiety," 10-14 indicate "Moderate Anxiety," and 15-21 indicate "Severe Anxiety."
Measured: 4 weeks, 8weeks, 12 weeks
HAM-D17
The Hamilton Depression Rating Scale, 17-item version (HAM-D17) consists of 17 items, each of which is rated on a scale of 0 to 2 or 0 to 4, depending on the severity of the symptom. For scoring, a HAM-D17 score of 0-7 is generally accepted as within the normal range or in clinical remission, while a score of 20 or higher indicates at least moderate severity and is often required for entry into a clinical trial.
Measured: 4 weeks, 8weeks, 12 weeks
HAMA-14A
The Hamilton Anxiety Rating Scale (HAMA-14A) probes 14 parameters, each scored on a 5-point scale ranging from 0 (not present) to 4 (severe). For scoring, a HAMA-14A score of 14-17 indicates mild anxiety, 18-24 indicates moderate anxiety, and 25-30 indicates severe anxiety.
Measured: 4 weeks, 8weeks, 12 weeks
Treatment adherence
The treatment adherence to the treatment will be evaluated by the completion of drug or the core modules of APP.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Nov 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756139
- Sponsor's protocol ID
- KY20242333-C-1
- Status last verified
- Jun 2025
- First submitted
- 20 Dec 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia: a Multicenter, Single-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06756139
- Acronym / sponsor ID
- KY20242333-C-1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- 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
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioural therapy mobile application | Experimental | Procedure: cognitive behavioural therapy mobile applicationAll 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. |
| Flupentixol and Melitracen Tablets | Placebo comparator | Drug: Flupentixol and Melitracen TabletsAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioural therapy mobile applicationThe CBT mobile application enables patients to conduct cognitive therapy independently. | Procedure or surgery | Cognitive behavioural therapy mobile application |
| Flupentixol and Melitracen Tabletspatients take Flupentixol and Melitracen Tablets | Drug | Flupentixol and Melitracen Tablets |
Primary outcome
1. The primary endpoint was the change in GOSS scores from baseline to week 8 after treatment.
Time frame: 8weeks
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
Related trials for Functional Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioural therapy mobile application and Flupentixol and Melitracen Tablets in people with Functional Dyspepsia and Self-help Mobile Cognitive Behavioral Therapy, run by Air Force Military Medical University, China at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanglin Pan, Professor (13991811225, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. The primary endpoint was the change in GOSS scores from baseline to week 8 after treatment. (time frame: 8weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.