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 the
pain component of the IBS severity scoring system (IBS-SSS) score.
Secondary outcome
Secondary outcomes are the effects of therapy on pain scores, adequate relief,
health related quality of life, IBD disease activity, health utility index,
depression, anxiety and somatisation, abdominal pain related cognitions,
absence of school or work, use of health care resources and additional costs,
use of IBD medication, colonic sensitivity to distension, cortisol level in
hair, faecal protease activity and microbiota and the ability of patient*s
faecal supernatant to induce colonic hypersensitivity to distension in rats by
colonic infusion.
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 (aged > 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 a
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
There are no risks related to the rectal barostat. The burden is considered
minimal. The introduction of the rectal balloon can be uncomfortable. The
duration (around 2 hours) can also be considered uncomfortable. Most of these 2
hours, the patient will be lying on a bed comfortably. Controlled distension of
the intra-rectal balloon will be done and the threshold for pain or discomfort
will be determined, to evaluate the sensitivity of the colon. Previous
comparable studies in patients with inflammatory bowel disease or irritable
bowel syndrome, were well tolerated.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with inflammatory bowel disease and IBS-like symptoms, aged >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, faecal calprotectin levels either below 50, or between 50-200 in combination with a recent (up to 6 months) normal colonoscopy. IBS-like symptoms are defined as abdominal pain for at least two months, fulfilling the pediatric or adult Rome-III criteria for IBS.
Exclusion criteria
Exclusion criteria are a concomitant organic gastrointestinal disease, stenotic IBD, complicated IBD that had required surgery more than once, another coexisting complicated disease (e.g. malignancy, unstable cardiovascular, hepatic or renal 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
In other registers
| Register | ID |
|---|---|
| CCMO | NL39964.018.12 |
| OMON | NL-OMON22531 |