Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome
FORTITUDE
3 other identifiers
interventional
282
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedStudy Start
First participant enrolled
July 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2025
CompletedJuly 18, 2025
July 1, 2025
5.5 years
February 13, 2019
July 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Abdominal pain response rate after 12 weeks of treatment
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.
12 weeks
Secondary Outcomes (11)
Degree of relief response rate after 12 weeks of treatment
12 weeks
Improvement of symptom severity
16 weeks
Indirect costs
16 weeks and after 6 months and 1 year follow-up
Direct costs
16 weeks and after 6 months and 1 year follow-up
General Quality of life (by EQ-5D)
16 weeks and after 6 months and 1 year follow-up
- +6 more secondary outcomes
Study Arms (3)
Face-to-face hypnotherapy
ACTIVE COMPARATOR12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
Online hypnotherapy
EXPERIMENTAL12 weeks treatment with online hypnotherapy
Online psychoeducation
ACTIVE COMPARATOR12 weeks treatment with online psychoeducation
Interventions
12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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. 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
- Use of over-the-counter or prescription antidiarrheals, analgesics and laxatives (only be allowed as specific rescue medication)
- Using more than 20 units of alcohol per week
- Using drugs of abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Gelderse Vallei
Ede, Gelderland, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands
Bernhoven
Uden, North Brabant, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
Martini Ziekenhuis
Groningen, Provincie Groningen, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Keszthelyi, MD, PhD
Maastricht University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2019
First Posted
April 2, 2019
Study Start
July 8, 2019
Primary Completion
December 29, 2024
Study Completion
June 29, 2025
Last Updated
July 18, 2025
Record last verified: 2025-07