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

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ClinicalTrials.gov Identifier: NCT03899779
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Face-to-face hypnotherapy Other: Online hypnotherapy Other: Online psychoeducation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Active Comparator: Face-to-face hypnotherapy
12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
Other: Face-to-face hypnotherapy
12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)

Experimental: Online hypnotherapy
12 weeks treatment with online hypnotherapy
Other: Online hypnotherapy
12 weeks treatment with online hypnotherapy

Active Comparator: Online psychoeducation
12 weeks treatment with online psychoeducation
Other: Online psychoeducation
12 weeks treatment with online psychoeducation




Primary Outcome Measures :
  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 Outcome Measures :
  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]



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age 16-65 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899779


Contacts
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Contact: Anke Snijkers, MD 0031433882952 fortitude-intmed@maastrichtuniversity.nl
Contact: Daniel Keszthelyi, MD, PhD daniel.keszthelyi@maastrichtuniversity.nl

Locations
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Netherlands
Medisch Centrum Leeuwarden Not yet recruiting
Leeuwarden, Friesland, Netherlands
Contact: H.J.A. Jebbink         
Rijnstate Not yet recruiting
Arnhem, Gelderland, Netherlands
Contact: D.P. Hirsch         
Gelderse Vallei Not yet recruiting
Ede, Gelderland, Netherlands
Contact: B.J.M. Witteman         
Maastricht University Medical Center Not yet recruiting
Maastricht, Limburg, Netherlands
Contact: Daniel Keszthelyi         
Jeroen Bosch Ziekenhuis Not yet recruiting
Den Bosch, Noord-Brabant, Netherlands
Contact: K. van Hee         
Bernhoven Not yet recruiting
Uden, Noord-Brabant, Netherlands
Contact: B.J.T. Haarhuis         
Maxima Medisch Centrum Not yet recruiting
Veldhoven, Noord-Brabant, Netherlands
Contact: J.W.A. Straathof         
AMC Not yet recruiting
Amsterdam, Noord-Holland, Netherlands
Contact: A.J. Bredenoord         
VU Medisch Centrum Not yet recruiting
Amsterdam, Noord-Holland, Netherlands
Contact: R.J.F. Felt-Bersma         
Tergooi Hilversum Not yet recruiting
Hilversum, Noord-Holland, Netherlands
Contact: B.D.J. van den Elzen         
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
Alrijne Ziekenhuis Not yet recruiting
Leiden, Zuid-Holland, Netherlands
Contact: C.H.M. Clemens         
Martini Ziekenhuis Not yet recruiting
Groningen, Netherlands
Contact: L.A. van der Waaij         
Diakonessenhuis Not yet recruiting
Utrecht, Netherlands
Contact: A.H. Obernhoff-Klein Woolthuis         
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: A.A.M. Masclee, Prof., MD Maastricht University Medical Center

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03899779     History of Changes
Other Study ID Numbers: NL67607.068.18
852001924 ( Other Grant/Funding Number: ZonMw )
METC18-037 ( Other Identifier: METC azM/UM )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases