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Completed

NCT Number: NCT03899779

Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome

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.

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Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gelderse Vallei, Ede, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Women in fertile age must use contraception or be postmenopausal for at least two years.

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. 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 (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

Treatment and study plan

Face-to-face hypnotherapy

Other

12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)

Online hypnotherapy

Other

12 weeks treatment with online hypnotherapy

Online psychoeducation

Other

12 weeks treatment with online psychoeducation

Primary outcomes

  1. 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.

Secondary outcomes

  1. Degree of relief response rate after 12 weeks of treatment

    Time frame: 12 weeks

    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.

  2. Improvement of symptom severity

    Time frame: 16 weeks

    determined by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) by 50 points or more [IBS-SSS, minimum score 0, maximum score 500]

  3. Indirect costs

    Time frame: 16 weeks and after 6 months and 1 year follow-up

    determined by Productivity Cost Questionnaire (PCQ) (savings from increased work productivity)

  4. Direct costs

    Time frame: 16 weeks and after 6 months and 1 year follow-up

    determined by Medical Consumption Questionnaire (MCQ) (savings from reduced medical resource use)

  5. General Quality of life (by EQ-5D)

    Time frame: 16 weeks and after 6 months and 1 year follow-up

    Determined by the Euro-Quality of Life - 5 domains (EQ-5D-5L) (change from baseline)

  6. IBS related Quality of life (by IBS-QoL)

    Time frame: 16 weeks and after 6 months and 1 year follow-up

    Determined by IBS Quality of Life (IBS-QoL) (change from baseline) [IBS-QoL, minimum score: 0, maximum score 100]

  7. Use of over the counter medication and rescue medication

    Time frame: 12 and 16 weeks

    As reported via digital diary (mobile phone application)

  8. Number and severity of side effects

    Time frame: 12 and 16 weeks

    As reported via digital diary (mobile phone application)

  9. Expectation

    Time frame: 16 weeks

    Response rates in relation to patient expectation prior to the start of treatment

  10. Response rates in relation to comorbid anxiety

    Time frame: 16 weeks and after 6 months and 1 year follow-up

    Assessed with the use of the Generalized Anxiety Disorder-7 (GAD-7). [GAD-7 minimum score: 0, maximum score: 21]

  11. Response rates in relation to comorbid depression

    Time frame: 16 weeks and after 6 months and 1 year follow-up

    Assessed with the use of the Patient Health Questionnaire-9 (PHQ-9). [PHQ-9 minimum score: 0, maximum score: 21]

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study 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.

Acronym: FORTITUDE

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Apr 2, 2019
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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