To study the effectiveness of gut-directed hypnotherapy in the treatment of IBS-like symptoms in patients with inflammatory bowel disease.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the number of patients with > 50% reduction in
intensity and frequency of abdominal pain.
Secondary outcome
Secondary outcomes include the change in pain scores during follow-up, IBD
disease activity score, quality of life scores, depression and anxiety scores,
use of additional medication, health utility, societal costs, school absence
and absence of work, measured after treatment and at 3 and 6 months follow-up.
Background summary
30-50% of patients with inflammatory bowel disease (IBD) in remission have
irritable bowel syndrome(IBS)-like symptoms for which treatment options are
limited. Often these complaints result in additional health care use.
Gut-directed hypnotherapy has been effective in the treatment of patients with
IBS only.
Study objective
To study the effectiveness of gut-directed hypnotherapy in the treatment of
IBS-like symptoms in patients with inflammatory bowel disease.
Study design
Patients (age > 11 years) with IBD in remission and in addition IBS-like
symptoms will be randomly allocated to either 6 sessions of hypnotherapy or
standard medical care and 6 sessions of supportive therapy.
Intervention
Patients in the hypnotherapy group will receive 6 sessions of 50 minutes
therapy over a 3-months period. The hypnotherapy-protocol used is based on the
Manchester protocol of gut-directed hypnotherapy and will consist of general
relaxation, visualisations aiming at control of abdominal pain, gut and immune
functions, and ego-strengthening suggestions.
Patients in the standard medical care group will receive standard care for IBS
consisting of explanation of the cause and origin of the IBS-like complaints by
their treating physician and reassurance that the complaints are not related to
inflammatory bowel disease, cancer or other life threatening diseases. If
considered necessary pain medications, spasmolytic agents, proton-pump
inhibitors will be prescribed. Moreover, patients in this group will receive 6
half-hour sessions of supportive therapy over a 3-month period. In these
sessions, given by the physician, symptoms of the previous weeks will be
discussed and if possible, contributory triggers, such as dietary products,
emotional problems, and stressful events, will be explored
Study burden and risks
None
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients with inflammatory bowel disease and IBS-like symptoms, age >11 years will be recruited. Patients have to be in remission of their inflammatory bowel disease as defined as no signs of inflammatory bowel disease, low inflammatory markers in laboratory tests and no disease activity on imaging studies of the intestine. IBS-like symptoms are defined as abdominal pain for at least two months, fulfilling the pediatric and adult Rome-III criteria for IBS
Exclusion criteria
Exclusion criteria are a concomitant organic gastrointestinal disease, treatment by another health care professional for abdominal symptoms, mental retardation, insufficient knowledge of the Dutch language and previous hypnotherapy treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33724.018.10 |