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ID
Source
Brief title
Health condition
Irritable Bowel Syndrome
Sponsors and support
A research grant (5000 euros) has been awarded by the Vereniging EMDR Nederland (VEN).
Another research grant will be applied for at the sience-desk at the Diakonessenhuis Utrecht.
Intervention
Outcome measures
Primary outcome
Pain score 0-10 reported by subject; reported daily during 2 weeks, three times: directly after inclusion (T1), 6 weeks after that (T2, after treatment period for the treatment group) and 10 weeks after that (T3,follow up). In total 42 reported scores.
Secondary outcome
Diary reports (exactly like the primary outcome) for:
- two IBS complaints other than pain (chosen by the subjects as the most burdensome)
- hindrance experienced by subjects (caused by IBS) in two valued activities (chosen by subjects as 'most interfered with')
And at the end of all three diary periods:
Total score on the Irritable Bowel Syndrome- Severity Scoring System (IBS-SSS)
Total score on the Irritable Bowel Syndrome- Quality of Life measurement (IBS-QOL)
Adequate relief question
Background summary
Many patients with Irritable Bowel Syndrome (IBS) suffer from severe and frequent abdominal pain. Eye Movement Desensitization and Reprocessing (EMDR) is an evidence based, standard treatment for PTSD and for psychopathology in which unresolved unpleasant experiences play a role in the development and / or maintenance of complaints. In recent years, increasing scientific evidence has been found that EMDR as a treatment can also be effective for chronic pain. To date, no scientific research has been conducted to investigate the effect of EMDR on abdominal pain (in IBS). Results with individual patients in clinical practice are promising.
It is hypothesized that EMDR treatment will reduce abdominal pain in patients with Irritable Bowel Syndrome (IBS). In addition, the effect of EMDR treatment on IBS complaints other than pain is examined, as well as the effect of EMDR treatment on the quality of life of patients with IBS.
It is a randomized clinical trial, in which the control group is 'wait list' (e.g. receives treatment after their participation in the trial has finished).
Study objective
Abdominal pain in patients in the intervention group (EMDR) will be reduced more than patients in the control group.
Study design
as described above (see: 'primary outcome' and 'secondary outcome')
Intervention
Intake and 6 weekly sessions of 90 minutes of EMDR standard protocol
Inclusion criteria
Adult
Meets ROME IV criteria for IBS
Pain intensity score on IBS-SSS at least 60
Reports on IBS-SSS a frequency of pain at least 5 out of 10 days
(IBS-SSS= Irritable Bowel Syndrome- Severity Scoring System)
Exclusion criteria
Other somatic conditions associated with abdominal pain such as ulcerative colitis and Crohn's disease.
Other pain symptoms that are more prominent than abdominal pain.
Insufficient command of the Dutch language to complete questionnaires (or other circumstances that seriously hinder communication).
Age under 18 or above 65
Psychiatric problems that require immediate treatment (such as psychosis, depression, suicidality)
Ongoing psychotrauma treatment.
Substance abuse
Pregnancy (to prevent confusion about the cause of abdominal sensations).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8894 |
| CCMO | NL71740.100.20 |
| OMON | NL-OMON49387 |