Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Other: Online hypnotherapyOther: Online psychoeducationOther: Face-to-face hypnotherapy
- Registration Number
- NCT03899779
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 285
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Online hypnotherapy Online hypnotherapy 12 weeks treatment with online hypnotherapy Online psychoeducation Online psychoeducation 12 weeks treatment with online psychoeducation Face-to-face hypnotherapy Face-to-face hypnotherapy 12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
- Primary Outcome Measures
Name Time Method Abdominal pain response rate after 12 weeks of treatment 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
Name Time Method Indirect costs 16 weeks and after 6 months and 1 year follow-up determined by Productivity Cost Questionnaire (PCQ) (savings from increased work productivity)
General Quality of life (by EQ-5D) 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)
Use of over the counter medication and rescue medication 12 and 16 weeks As reported via digital diary (mobile phone application)
Response rates in relation to comorbid depression 16 weeks and after 6 months and 1 year follow-up Assessed with the use of the Patient Health Questionnaire-9 (PHQ-9). \[PHQ-9 minimum score: 0, maximum score: 21\]
Improvement of symptom severity 16 weeks determined by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) by 50 points or more \[IBS-SSS, minimum score 0, maximum score 500\]
Expectation 16 weeks Response rates in relation to patient expectation prior to the start of treatment
Response rates in relation to comorbid anxiety 16 weeks and after 6 months and 1 year follow-up Assessed with the use of the Generalized Anxiety Disorder-7 (GAD-7). \[GAD-7 minimum score: 0, maximum score: 21\]
Degree of relief response rate after 12 weeks of treatment 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.
IBS related Quality of life (by IBS-QoL) 16 weeks and after 6 months and 1 year follow-up Determined by IBS Quality of Life (IBS-QoL) (change from baseline) \[IBS-QoL, minimum score: 0, maximum score 100\]
Number and severity of side effects 12 and 16 weeks As reported via digital diary (mobile phone application)
Direct costs 16 weeks and after 6 months and 1 year follow-up determined by Medical Consumption Questionnaire (MCQ) (savings from reduced medical resource use)
Trial Locations
- Locations (6)
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Friesland, Netherlands
Jeroen Bosch Ziekenhuis
🇳🇱Den Bosch, Noord-Brabant, Netherlands
Gelderse Vallei
🇳🇱Ede, Gelderland, Netherlands
Martini Ziekenhuis
🇳🇱Groningen, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands
Bernhoven
🇳🇱Uden, Noord-Brabant, Netherlands