Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome
Key facts
- Who runs it
- Maastricht University Medical Center
- Where
- Netherlands6 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 282 people enrolled
- Started
- 8 Jul 2019
- Ended
- 29 Jun 2025
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Face-to-face hypnotherapy
- Online hypnotherapy
- Online psychoeducation
- Record updated
- 18 July 2025
Who can take part
- Age
- 16 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
- Women in fertile age must use contraception or be postmenopausal for at least two years
Who cannot take part
- 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
- 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 (only be allowed as specific rescue medication)
- Hypnotherapy treatment received in the last 3 months prior to inclusion
- Using drugs of abuse
- Evidence of current anxiety and/or depression disorder as defined by a score ≥10 on the GAD-7 and/or PHQ-9 questionnaire. 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
- Insufficient command of the Dutch language
- No access to internet
- Current pregnancy or lactation
- Using more than 20 units of alcohol per week
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Psychological therapies are effective in reducing irritable bowel syndrome (IBS) symptom severity and increasing quality of life and are recommended for the management of IBS by guidelines. Evidence appears strongest for the efficacy of hypnotherapy as psychological treatment. However, therapist-led interventions are time consuming and relatively costly. Approaches based on e-health are cost saving and appear more attractive to patients as no visits to a therapist are necessary. Therefore, the investigators plan to conduct a multicentre randomised controlled trial to examine whether the effectiveness of online hypnotherapy is non-inferior compared to individual face-to-face hypnotherapy delivered by a therapist, according to current FDA guidelines. Online psychoeducation will be used as control condition. In addition, the investigators hypothesize that treatment with online hypnotherapy is a more cost-effective therapy than face-to-face hypnotherapy in IBS patients.
The 3 groups in the trial
- Face-to-face hypnotherapyExisting treatment, for comparison
12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
- Online hypnotherapyTreatment being tested
12 weeks treatment with online hypnotherapy
- Online psychoeducationExisting treatment, for comparison
12 weeks treatment with online psychoeducation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome, According to a Non-inferiority Design. Three-armed Randomized Controlled Trial.
- Publications
- Record updated
- 18 July 2025