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

Study Overview
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Brief Summary
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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.

Official Title
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Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome, According to a Non-inferiority Design. Three-armed Randomized Controlled Trial.

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Face-to-face hypnotherapy
* Other: Online hypnotherapy
* Other: Online psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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] | 16 weeks | 
| Indirect costs | determined by Productivity Cost Questionnaire (PCQ) (savings from increased work productivity) | 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) | 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) | 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] | 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) | 12 and 16 weeks | 
| Number and severity of side effects | As reported via digital diary (mobile phone application) | 12 and 16 weeks | 
| Expectation | Response rates in relation to patient expectation prior to the start of treatment | 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] | 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] | 16 weeks and after 6 months and 1 year follow-up |