Irritable Bowel Syndrome
Conditions
Interventions
Group 1 will receive 12 weeks treatment with online psychoeducation, group 2
will receive 12 weeks treatment with individual face-to-face hypnotherapy (6
individual, bi-weekly sessions), group 3 wil
Sponsors
Universiteit Maastricht
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| According to FDA recommendation: 1. Abdominal pain response rate after 12 weeks of treatment. a. A responder is defined as a patient who experiences at least a 30 percent decrease in the weekly average of worst daily abdominal pain (measured daily, on an 11 point NRS) compared to baseline weekly average in at least 50 percent of the weeks in which the treatment in given. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Degree of relief response rate after 12 weeks of treatment, according to EMA recommendation: *A responder is defined as a patient who experiences a weekly relief of 1 or 2 (on a 7 point NRS) in at least 50 percent of the weeks in which treatment is given.* - Response rate directly after completion of the 12-week treatment period - Improvement of symptom severity as determined by the IBS-SSS by 50 points or more - Longitudinal change in IBS-SSS at baseline (run-in), t=12 weeks, t=16 weeks, t=6 months follow-up and t=1 year follow-up - Cost-utility, as determined by calculations incorporating total treatment costs and changes in EQ-5D-5L (QALYs gained) and MCQ/PCQ results (savings from reduced medical resource use and increased work productivity respectively) - Quality of life, as determined by the EQ-5D-5L and IBS-QoL (change from baseline) - Use of OTC and rescue medication - Adherence to therapy - Response rates in relation to patient expectation prior to the start of treatment - Response rates in relation to comorbid anxiety and/or depression- Number and severity of adverse events | — |
Countries
Netherlands
Outcome results
None listed