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NCT Number: NCT06756139

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

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.

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Key information

Conditions

Functional Dyspepsia Antipsychotic Drug Self-help Mobile Cognitive Behavioral Therapy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hainan General Hospital (Hainan Affifiliated Hospital ofHainan Medical University), Haikou, Hainan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

cognitive behavioural therapy mobile application

Procedure

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

Flupentixol and Melitracen Tablets

Drug

patients take Flupentixol and Melitracen Tablets

Primary outcomes

  1. 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.

Secondary outcomes

  1. 5-Likert score

    Time frame: 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.

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

    Time frame: 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.

  3. GOSS score

    Time frame: 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.

  4. Short Form of Nepean Dyspepsia Index (SF-NDI)

    Time frame: 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.

  5. Patient Health Questionnaire-9(PHQ-9)

    Time frame: 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."

  6. Generalized Anxiety Disorder-7(GAD-7)

    Time frame: 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."

  7. HAM-D17

    Time frame: 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.

  8. HAMA-14A

    Time frame: 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.

  9. Treatment adherence

    Time frame: 12 weeks

    The treatment adherence to the treatment will be evaluated by the completion of drug or the core modules of APP.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoyu Kang, MD, Ph.D

CONTACT

[email protected]

15291680602

Yanglin Pan, Professor

CONTACT

[email protected]

13991811225

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Collaborators

  • Hainan General Hospital
  • Mianyang Third Hospital
  • Shaanxi Second People's Hospital
  • Tang-Du Hospital
  • Xi'an 986 Hospital
  • Xi'an People's Hospital (Xi'an Fourth Hospital)

Registry information

Official study title

Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia: a Multicenter, Single-blinded, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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