The research questions this study aims to answer are: What is the effect of a Mindfulness Based Stress Reduction (MBSR) training on IBS in terms of quality of life. It is hypothesised that participation in a MBSR-training will improve quality of…
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is the statistical change in quality of life as measured
with the Irritable Bowel Syndrome Quality of Life queastionnaire (IBS-QOL).
Secondary outcome
Secondary parameters are the statistical change in symptom severity as measured
with the Irritable Bowel Syndrome - Symptom Severity Scale (IBS-SSS).
Background summary
Quality of life is shown to be low in patients with irritable bowel syndrome
(IBS) while a pathophysiological mechanism behind the syndrome has never been
demonstrated. There is a considerable body of evidence for socio-psychological
factors having some role in IBS. Catastrophizing, a maladaptive cognitive
coping style characterized by ruminations about the significance of symptoms,
also seems to play a part. Patients with IBS, through a learning process and
under the influence of state and trait characteristics, are not only
hypervigilant or hypersensitive regarding interoceptive (i.e. visceral)
signals, but are also prone to catastrophize these signals. Mindfulness
increases sensory processing of interoceptive signals and decreases emotional
and cognitive processing of these signals, thereby theoretically reducing
catastrophizing.
Study objective
The research questions this study aims to answer are: What is the effect of a
Mindfulness Based Stress Reduction (MBSR) training on IBS in terms of quality
of life. It is hypothesised that participation in a MBSR-training will improve
quality of life in IBS-patients. Secondary this study aims to prove an effect
of mindfulness on severity of symptoms in IBS, the hypothesis being that
participation in MBSR lowers the severity of IBS symptoms.
Study design
The study design is a Randomized Controlled Trial (RCT).
Intervention
The intervention group will receive a ten week Mindfulness program according to
a standard protocol (MBSR), administered by a certified Mindfulness instructor.
The waiting list group will be tested (i.e. fill out a set of questionnaires
two times) while waiting for treatment at a later date.
Study burden and risks
The intervention protocol includes eight weekly training sessions of 135
minutes each and one four-hour intensive training session (retreat).
Furthermore participants are required to commit to self-study and exercises for
approximately one hour each day during the training. Research assessment for
all participants consists of four questionnaires filled out two (control-group)
or three times (Intervention-group) during the study the total time needed to
fill out these forms is approximately 30-45 minutes each assessment. No adverse
events are to be expected.
Boerhaavelaan 22
Haarlem 2035 RC
NL
Boerhaavelaan 22
Haarlem 2035 RC
NL
Listed location countries
Age
Inclusion criteria
(1) IBS diagnosis by the gastroenterologist through Rome III criteria (Nederlands Huisartsen Genootschap, 2011)
(2) Age 18-65 years
(3) Sufficient comprehension of the Dutch language
(4) Willingness to attend an eight week training program consisting of 135 contact minutes per week and one hour of self-study a day
(5) Willingness to fill-out the questionnaires used to assess the outcome measurements;
(6) An obtained signed informed consent.
Exclusion criteria
(1) Diagnoses of mental illness with psychosis
(2) A psychiatric illness of which the treatment takes priority over the treatment of IBS with psychological methods.
(3) A history of in-patient psychiatric treatment within the last two years
(4) A history or current diagnosis of inflammatory bowel disease or gastrointestinal malignancy
(5) A malignant co morbidity
(6) Active liver or pancreatic disease
(7) A history of abdominal trauma or surgery involving gastrointestinal resection
(8) Pregnancy
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 | NL43532.094.13 |