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

September 2, 2020 updated by: Maastricht University Medical Center

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

285

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Groningen, Netherlands
        • Recruiting
        • Martini Ziekenhuis
        • Contact:
          • L.A. van der Waaij
    • Friesland
      • Leeuwarden, Friesland, Netherlands
        • Recruiting
        • Medisch Centrum Leeuwarden
        • Contact:
          • A.S. de Ruiter
    • Gelderland
      • Ede, Gelderland, Netherlands
        • Recruiting
        • Gelderse Vallei
        • Contact:
          • B.J.M. Witteman
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Recruiting
        • Maastricht University Medical Center
        • Contact:
          • Daniel Keszthelyi
    • Noord-Brabant
      • Den Bosch, Noord-Brabant, Netherlands
        • Not yet recruiting
        • Jeroen Bosch Ziekenhuis
        • Contact:
          • K. van Hee
      • Uden, Noord-Brabant, Netherlands
        • Recruiting
        • Bernhoven
        • Contact:
          • B.J.T. Haarhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Face-to-face hypnotherapy
12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
Experimental: Online hypnotherapy
12 weeks treatment with online hypnotherapy
12 weeks treatment with online hypnotherapy
Active Comparator: Online psychoeducation
12 weeks treatment with online psychoeducation
12 weeks treatment with online psychoeducation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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]
16 weeks
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)
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
determined by Medical Consumption Questionnaire (MCQ) (savings from reduced medical resource use)
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
Determined by the Euro-Quality of Life - 5 domains (EQ-5D-5L) (change from baseline)
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
Determined by IBS Quality of Life (IBS-QoL) (change from baseline) [IBS-QoL, minimum score: 0, maximum score 100]
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
As reported via digital diary (mobile phone application)
12 and 16 weeks
Number and severity of side effects
Time Frame: 12 and 16 weeks
As reported via digital diary (mobile phone application)
12 and 16 weeks
Expectation
Time Frame: 16 weeks
Response rates in relation to patient expectation prior to the start of treatment
16 weeks
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]
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
Assessed with the use of the Patient Health Questionnaire-9 (PHQ-9). [PHQ-9 minimum score: 0, maximum score: 21]
16 weeks and after 6 months and 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: A.A.M. Masclee, Prof., MD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2019

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

February 13, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • NL67607.068.18
  • 852001924 (Other Grant/Funding Number: ZonMw)
  • METC18-037 (Other Identifier: METC azM/UM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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