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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
88
The CBT mobile application enables patients to conduct cognitive therapy independently.
patients take Flupentixol and Melitracen Tablets
Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University)
Haikou, Hainan, China
RECRUITINGAir Force Military Medical University, China
Xi'an, Shaanxi, China
RECRUITINGShaanxi Second People's Hospital
Xi'an, Shaanxi, China
RECRUITINGTangdu Hospital
Xi'an, Shaanxi, China
NOT_YET_RECRUITINGXi'an 986 Hospital
Xi'an, Shaanxi, China
RECRUITINGXi'an People's Hospital
Xi'an, Shaanxi, China
NOT_YET_RECRUITINGMianyang Third Hospital
Mianyang, Sichuan, China
RECRUITING1. 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.
Time frame: 8weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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."
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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