Irritable Bowel SyndromeFORTITUDENCT03899779
Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome
A study testing Face-to-face hypnotherapy, Online hypnotherapy and Online psychoeducation in people with Irritable Bowel Syndrome, run by Maastricht University Medical Center at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Face-to-face hypnotherapy, Online hypnotherapy and Online psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 6 sitesNetherlands
- Study dates
- 8 Jul 2019to 29 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 12Show fewer
- 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 (only be allowed as specific rescue medication)
- Hypnotherapy treatment received in the last 3 months prior to inclusion
- Using more than 20 units of alcohol per week
- Using drugs of abuse
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant
Gelderse Vallei
Ede, Gelderland
Martini Ziekenhuis
Groningen, Provincie Groningen
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland
Maastricht University Medical Center
Maastricht, Limburg
Bernhoven
Uden, North Brabant
About this study
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.
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Face-to-face hypnotherapy, Online hypnotherapy, Online psychoeducation
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face hypnotherapyOther
12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
Online hypnotherapyOther
12 weeks treatment with online hypnotherapy
Online psychoeducationOther
12 weeks treatment with online psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face hypnotherapy | Active comparator | 12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions) Receives: Other: Face-to-face hypnotherapy |
| Online hypnotherapy | Experimental | 12 weeks treatment with online hypnotherapy Receives: Other: Online hypnotherapy |
| Online psychoeducation | Active comparator | 12 weeks treatment with online psychoeducation Receives: Other: Online psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (11)
Degree of relief response rate after 12 weeks of treatment
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.
Measured: 12 weeks
Improvement of symptom severity
determined by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) by 50 points or more [IBS-SSS, minimum score 0, maximum score 500]
Measured: 16 weeks
Indirect costs
determined by Productivity Cost Questionnaire (PCQ) (savings from increased work productivity)
Measured: 16 weeks and after 6 months and 1 year follow-up
Direct costs
determined by Medical Consumption Questionnaire (MCQ) (savings from reduced medical resource use)
Measured: 16 weeks and after 6 months and 1 year follow-up
General Quality of life (by EQ-5D)
Determined by the Euro-Quality of Life - 5 domains (EQ-5D-5L) (change from baseline)
Measured: 16 weeks and after 6 months and 1 year follow-up
IBS related Quality of life (by IBS-QoL)
Determined by IBS Quality of Life (IBS-QoL) (change from baseline) [IBS-QoL, minimum score: 0, maximum score 100]
Measured: 16 weeks and after 6 months and 1 year follow-up
Use of over the counter medication and rescue medication
As reported via digital diary (mobile phone application)
Measured: 12 and 16 weeks
Number and severity of side effects
As reported via digital diary (mobile phone application)
Measured: 12 and 16 weeks
Expectation
Response rates in relation to patient expectation prior to the start of treatment
Measured: 16 weeks
Response rates in relation to comorbid anxiety
Assessed with the use of the Generalized Anxiety Disorder-7 (GAD-7). [GAD-7 minimum score: 0, maximum score: 21]
Measured: 16 weeks and after 6 months and 1 year follow-up
Response rates in relation to comorbid depression
Assessed with the use of the Patient Health Questionnaire-9 (PHQ-9). [PHQ-9 minimum score: 0, maximum score: 21]
Measured: 16 weeks and after 6 months and 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start8 Jul 2019
- Primary completion29 Dec 2024
- Study completion29 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Daniel Keszthelyi, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899779
- Sponsor's protocol ID
- NL67607.068.18
- Other IDs
- 852001924, METC18-037
- Acronym
- FORTITUDE
- Status last verified
- Jul 2025
- First submitted
- 13 Feb 2019
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Snijkers JTW, Bosman MHMA, Winkens B, Haarhuis BJT, Witteman BJM, Pijnenborg N, de Ruiter AS, van der Waaij LA, Bours AMH, Elderson C, van Rood YR, de Wit N, Flik CE, Masclee AAM, Keszthelyi D. In-person therapist-delivered hypnotherapy versus smartphone-based self-guided hypnotherapy in IBS: a multicentre three-armed randomised controlled trial. Gut. 2026 Jul 25:gutjnl-2026-338385. doi: 10.1136/gutjnl-2026-338385. Online ahead of print.
PubMed 42502003
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03899779
- Acronym / sponsor ID
- FORTITUDE / NL67607.068.18
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 29 Jun 2025 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face-to-face hypnotherapy | Active comparator | Other: Face-to-face hypnotherapy12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions) |
| Online hypnotherapy | Experimental | Other: Online hypnotherapy12 weeks treatment with online hypnotherapy |
| Online psychoeducation | Active comparator | Other: Online psychoeducation12 weeks treatment with online psychoeducation |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-face hypnotherapy12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions) | Other | Face-to-face hypnotherapy |
| Online hypnotherapy12 weeks treatment with online hypnotherapy | Other | Online hypnotherapy |
| Online psychoeducation12 weeks treatment with online psychoeducation | Other | Online psychoeducation |
Primary outcome
Abdominal pain response rate after 12 weeks of treatment
Time frame: 12 weeks
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.
11 secondary outcomes
Degree of relief response rate after 12 weeks of treatment
Time frame: 12 weeks
Improvement of symptom severity
Time frame: 16 weeks
Indirect costs
Time frame: 16 weeks and after 6 months and 1 year follow-up
Direct costs
Time frame: 16 weeks and after 6 months and 1 year follow-up
General Quality of life (by EQ-5D)
Time frame: 16 weeks and after 6 months and 1 year follow-up
IBS related Quality of life (by IBS-QoL)
Time frame: 16 weeks and after 6 months and 1 year follow-up
Use of over the counter medication and rescue medication
Time frame: 12 and 16 weeks
Number and severity of side effects
Time frame: 12 and 16 weeks
Expectation
Time frame: 16 weeks
Response rates in relation to comorbid anxiety
Time frame: 16 weeks and after 6 months and 1 year follow-up
Response rates in relation to comorbid depression
Time frame: 16 weeks and after 6 months and 1 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Derived from this study: PubMed 42502003Snijkers JTW, Bosman MHMA, Winkens B, Haarhuis BJT, Witteman BJM, Pijnenborg N, de Ruiter AS, van der Waaij LA, Bours AMH, Elderson C, van Rood YR, de Wit N, Flik CE, Masclee AAM, Keszthelyi D. In-person therapist-delivered hypnotherapy versus smartphone-based self-guided hypnotherapy in IBS: a multicentre three-armed randomised controlled trial. Gut. 2026 Jul 25:gutjnl-2026-338385. doi: 10.1136/gutjnl-2026-338385. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Keszthelyi, MD, PhD principal investigator
Maastricht University Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face hypnotherapy, Online hypnotherapy and Online psychoeducation in people with Irritable Bowel Syndrome, run by Maastricht University Medical Center at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal pain response rate after 12 weeks of treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.