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| ID | Type | Description | Link |
|---|---|---|---|
| 852001924 | Other Grant/Funding Number | ZonMw | |
| METC18-037 | Other Identifier | METC azM/UM |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-to-face hypnotherapy | Active Comparator | 12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions) |
|
| Online hypnotherapy | Experimental | 12 weeks treatment with online hypnotherapy |
|
| Online psychoeducation | Active Comparator | 12 weeks treatment with online psychoeducation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face-to-face hypnotherapy | Other | 12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions) |
|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Keszthelyi, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gelderse Vallei | Ede | Gelderland | Netherlands | |||
| Maastricht University Medical Center |
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| Online hypnotherapy | Other | 12 weeks treatment with online hypnotherapy |
|
| Online psychoeducation | Other | 12 weeks treatment with online psychoeducation |
|
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 |
| Maastricht |
| Limburg |
| Netherlands |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | North Brabant | Netherlands |
| Bernhoven | Uden | North Brabant | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | Provincie Friesland | Netherlands |
| Martini Ziekenhuis | Groningen | Provincie Groningen | Netherlands |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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