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

未提供0 个研究点目标入组 20 人开始时间: 待定最近更新: 2025年3月31日

适应症

试验速览

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•(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

Change in the IBSSI-J score from baseline at 12 weeks

发起方

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