Individual or Group Hypnotherapy in the treatment of Irritable Bowel Syndrome in primary and secondary care.
- Conditions
- Irritable Bowel Syndromeunexplained abdominal symptoms10017977
- Registration Number
- NL-OMON39767
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 354
Patients aged 18-65 years in primary and secondary care , who are diagnosed with IBS (Rome III criteria)
Patients unable to understand the content of the sessions, because of insufficient command of the Dutch language.
Patients unable to fill in the questionnaires.
Patients unable (for example: too aggressive) or unwilling to function in a group.
Patients in whom a` psychiatric condition needs attention first (for example severe depression or psychosis).
Patients who have IBS and other chronic bowel diseases, as far as they are already diagnosed, such as ulcerative colitis, Crohn*s disease or coeliac disease.
Patients who have undergone major surgery to the lower gastrointestinal tract, such as partial or total colectomy, small bowel resection or partial or total gastrectomy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy parameter is the responder rate for IBS symptoms based on<br /><br>a weekly assessment of Adequate Relief (AR) score.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy parameters are changes in the IBS Symptom Severity Score<br /><br>(IBS-SSS) and Quality of Life (IBS-Qol), cognitions, self-efficacy,<br /><br>psychological complaints and direct and indirect costs of the disease, measured<br /><br>as the costs of visits to doctors and alternative healers, use of medicines and<br /><br>loss of labour productiveness.</p><br>