This study has two main objectives:1. To assess the efficacy of hypnotherapy on symptoms and quality of life in IBS patients;2. To compare the efficacy of individual hypnotherapy with a group application of hypnotherapy in IBS treatment.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy parameter is the responder rate for IBS symptoms based on
a weekly assessment of Adequate Relief (AR) score.
Secondary outcome
Secondary efficacy parameters are changes in the IBS Symptom Severity Score
(IBS-SSS) and Quality of Life (IBS-Qol), cognitions, self-efficacy,
psychological complaints and direct and indirect costs of the disease, measured
as the costs of visits to doctors and alternative healers, use of medicines and
loss of labour productiveness.
Background summary
Rationale: Irritable Bowel Syndrome (IBS) is a common gastro-intestinal
disorder in primary and secondary care. IBS is a chronic functional
gastro-intestinal disorder, characterized by recurrent periods of abdominal
pain, discomfort, altered bowel habits and/or symptoms of bloating and
distension. In general the efficacy of drug therapies is weak. Several reviews
have been written on the effectiveness of psychological therapeutic
interventions for these complaints. According to the Clinical practice
guideline from the National Institute for Health and Clinical Excellence(NICE)
(1), Hypnotherapy as well as Cognitive Behaviour Therapy and short
Psychodynamic Therapy are useful options for patients with refractory IBS in
secondary care and for this group of patients the therapies are cost-effective.
Hypnotherapy may be considered a promising intervention for IBS, but the
evidence is still too limited. Further research is recommended, with special
focus on the potential of this intervention as a first line therapy option,
with long term follow-up(1).
Study objective
This study has two main objectives:
1. To assess the efficacy of hypnotherapy on symptoms and quality of life in
IBS patients;
2. To compare the efficacy of individual hypnotherapy with a group application
of hypnotherapy in IBS treatment.
Study design
We propose a randomised placebo-controlled trial to evaluate the effects of
individual - and group hypnotherapy in the treatment of IBS patients in primary
and secondary care. To this end, we assess the efficacy of hypnotherapy
compared to control therapy and compare the efficacy of group-hypnotherapy to
individual hypnotherapy. Follow-up for all patients is 9 months post treatment.
In the study period of two years a total of 354 IBS patients will be included
in primary and secondary care.
Intervention
Patients will be randomly allocated to 6 sessions of individual hypnotherapy, 6
sessions of group-hypnotherapy or 6 sessions of educational-supportive therapy
in a group (placebo).
Study burden and risks
The patient will visit the therapist 7 times (intake + 6 sessions) during
treatment, to practice at home (hypnotherapy) or do home-work assignments
(EOT-group) as well as being asked to fill in questionnaires, three times. No
adverse events of hypnotherapy in literature have been reported (2).
Universiteitsweg 100
Utrecht 3584 CG
NL
Universiteitsweg 100
Utrecht 3584 CG
NL
Listed location countries
Age
Inclusion criteria
Patients aged 18-65 years in primary and secondary care , who are diagnosed with IBS (Rome III criteria)
Exclusion 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL30698.041.10 |
| OMON | NL-OMON27823 |