Antipsychotic Drug, Functional Dyspepsia, Self-help Mobile Cognitive Behavioral Therapy
Conditions
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.
Interventions
PROCEDUREcognitive behavioural therapy mobile application
The CBT mobile application enables patients to conduct cognitive therapy independently.
DRUGFlupentixol and Melitracen Tablets
patients take Flupentixol and Melitracen Tablets
Sponsors
Xi'an 986 Hospital
Shaanxi Second People's Hospital
Xi'an People's Hospital (Xi'an Fourth Hospital)
Tang-Du Hospital
Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)
Mianyang Third Hospital
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. The primary endpoint was the change in GOSS scores from baseline to week 8 after treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) | 4 weeks, 8weeks, 12 weeks | 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. |
| GOSS score | 4 weeks, 8weeks, 12 weeks | 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. |
| Short Form of Nepean Dyspepsia Index (SF-NDI) | 4 weeks, 8weeks, 12 weeks | 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. |
| Patient Health Questionnaire-9(PHQ-9) | 4 weeks, 8weeks, 12 weeks | 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. |
| 5-Likert score | 4 weeks, 8weeks, 12 weeks | 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. |
| HAM-D17 | 4 weeks, 8weeks, 12 weeks | 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. |
| HAMA-14A | 4 weeks, 8weeks, 12 weeks | 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. |
| Treatment adherence | 12 weeks | The treatment adherence to the treatment will be evaluated by the completion of drug or the core modules of APP. |
| Generalized Anxiety Disorder-7(GAD-7) | 4 weeks, 8weeks, 12 weeks | 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. |
Countries
China
Contacts
Primary ContactYanglin Pan, Professor
Backup ContactXiaoyu Kang, MD, Ph.D
Outcome results
None listed