Face-to-face versus online hypnotherapy for the treatment of Irritable Bowel Syndrome, according to a non-inferiority design. Three-armed randomized controlled trial. (FORTITUDE) - FORTITUDE

niversiteit Maastricht0 个研究点目标入组 285 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- Age 16-75 years
•- A diagnosis of IBS according to the Rome IV criteria
•- In the presence of alarm symptoms, such as rectal blood loss, weight loss,
•anemia, first onset of symptoms above 50 years of age, patients will be first
•referred for further investigation by their treating physician to exclude
•organic disorders, conform current Dutch guidelines for IBS.(15)
•- Women in fertile age must use contraception or be postmenopausal for at least

•- Insufficient command of the Dutch language
•- No access to internet
•- Evidence of current anxiety and/or depression disorder as defined by a score
•>=10 on the GAD-7 and/or PHQ-9 questionnaire, supported by a detailed interview
•by the investigator. In this case it is conceivable that the IBS symptoms are
•strongly related to psychopathology for which different treatment might be more
•appropriate.
•- History of ulcerative colitis, Crohn*s disease, coeliac disease or
•significant liver disease
•- Major surgery to the lower gastrointestinal tract, such as partial or total
•colectomy, small bowel resection or partial or total gastrectomy
•- Past or present radiotherapy to the abdomen
•- Current pregnancy or lactation
•- Using of psychoactive medication in case there*s no stable dose for at least
•3 months prior to inclusion
•- Use of over-the-counter or prescription antidiarrheals, analgesics and
•laxatives in case there*s no stable dose during the study period
•- Hypnotherapy treatment received in the last 3 months prior to inclusion
•- Using more than 20 units of alcohol per week
•- Using drugs of abuse

发起方