JPRN-jRCTs032230498招募中2 期
The Efficacy of a Cognitive Behavioral Therapy (CBT) Application for Irritable Bowel Syndrome (IBS): A Multicenter, Single-Arm, Pilot study.
Yoshiuchi Kazuhiro0 个研究点目标入组 20 人开始时间: 2023年12月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old(—)
- 性别
- All
入选标准
- •(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.
排除标准
- •(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
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