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)
- Conditions
- Irritable Bowel Syndrome10018012
- Registration Number
- NL-OMON55898
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 285
- 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
two years.
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>According to FDA recommendation:<br /><br>1. Abdominal pain response rate after 12 weeks of treatment.<br /><br>a. A responder is defined as a patient who experiences at least a 30 percent<br /><br>decrease in the weekly average of worst daily abdominal pain (measured daily,<br /><br>on an 11 point NRS) compared to baseline weekly average in at least 50 percent<br /><br>of the weeks in which the treatment in given.</p><br>
- Secondary Outcome Measures
Name Time Method