irritable bowel syndrome
Conditions
Interventions
In this study, the efficacy of a CBT program using a smartphone app (the App) for IBS is evaluated. The App, under development by MICIN Co., Ltd., consists of a patient-side app and a doctor-side app
Sponsors
Yoshiuchi Kazuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Individual diagnosed with IBS based on the Rome IV criteria. (2) Those who, despite initiating the first-stage treatment (diet therapy/behavioral modification, gastrointestinal motility modifiers, probiotics, bulking polymer, 5-HT3 antagonists, intestinal secretagogues, etc.) or the second-stage treatment (administration of psychotropic drugs, etc.) as outlined in the "Evidence-based clinical practice guidelines for irritable bowel syndrome 2020" (The Japanese Society of Gastroenterology), have not seen sufficient improvement in symptoms (falling between 3-7 on the Global Improvement Scale) after 8 weeks or more. (3) Those who possess a smartphone capable of using the application and is able to operate this application. (4) Age: Those aged between 18 and 75 at the time of consent acquisition. (5) Gender: Not specified. (6) Those who, after receiving a thorough explanation about the study, have given their informed written consent of their own free will. (7) Individuals able to attend outpatient visits according to the research schedule.
Exclusion criteria
Exclusion criteria: (1) Patients who are pregnant or may become pregnant. (2) Patients who have a malignant tumor or other disease that should be prioritized over treatment of irritable bowel syndrome (3) Patients who, at the time of consent acquisition, have participated in another clinical trial or clinical research within the past 3 months. (4) Other patients whom the principal investigator or co-investigator deems unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the IBSSI-J score from baseline at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change in the IBSSI-J score from baseline at 4 and 8 weeks. (2) Change in the IBS-QOL-J score from baseline at 4, 8, and 12 weeks. (3) Change in the EQ-5D-5L score from baseline at 4, 8, and 12 weeks. (4) Change in the HADS score from baseline at 2, 4, 8, and 12 weeks. (5) Change in daily symptom records (number of symptoms per day, maximum severity of symptoms in a day) from baseline at 2, 4, 8, and 12 weeks. (6) Adherence (quantitative evaluation during the study period: login rate, daily symptom recording rate, relaxation technique execution recording rate.). (7) Usability (qualitative & quantitative evaluation based on post-study questionnaire). (8) Treatment satisfaction (qualitative & quantitative evaluation based on post-study questionnaire). | — |
Contacts
Public ContactKazuhiro Yoshiuchi
The University of Tokyo Hospital
Outcome results
None listed