The Efficacy of a Cognitive Behavioral Therapy (CBT) Application for Irritable Bowel Syndrome (IBS): A Multicenter, Single-Arm, Pilot study.

Yoshiuchi Kazuhiro0 sites20 target enrollmentDecember 8, 2023

Overview

No summary available.

Registry

who.int

Start Date

December 8, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Yoshiuchi Kazuhiro

•(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.

•(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