No registrations found.
ID
Source
Brief title
Health condition
Irritable Bowel Syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
IBS-symptoms
The primary outcome of this study is IBS-symptoms, as measured with the Irritable Bowel Severity Scoring System (IBS-SSS), developed by Francis, Morris and Whorwell (1997).
Secondary outcome
IBS-quality of life, as measured with the Irritable Bowel Syndrome-Quality of Life Measure (IBS-QOL), developed by Patrick, Drossman, Frederick, Dicesare en Puder (1998).
Gastrointestinal specific anxiety (GSA), as measured with the Visceral Sensitivity Index (VSI), developed by Labus, Bolus, Chang, Wiklund, Naesdal, Mayer en Naliboff (2004).
Patient demographics: gender, age, education, years and months since debut IBS-symptoms and diagnosed IBS, treatment history, medical health.
Treatment expectation (one question), treatment and therapist satisfaction, suggestions for improving the treatment.
Participants who decide to stop the treatment, will be asked for what reason.
Background summary
The Irritable Bowel Syndrome is a chronic gastrointestinal affliction and with a prevalence of 10-20% one of the most diagnosed gastrointestinal conditions (in the general population). Physical as well as psychological factors could be in play in IBS. Besides being a burden for the patient, it could also be a burden for society. Multidisciplinary guidelines for IBS aim to minimize restrictions in daily life as treatment goal. Given that anxiety for symptoms is seen as a maintaining factor in IBS, this is the key feature of the treatment.
The proposed study is a randomized controlled trial (RCT), based on a guided online treatment for IBS which has been previously studied by Ljótsson et al., 2010, namely cognitive behaviour therapy (CBT) including exposure- en mindfulness exercises. Besides a decrease of IBS-symptoms a decrease of restrictions in daily life and anxiety is the treatment goal. Hypotheses are that the guided online treatment, based on CGT (exposure- en mindfulness exercises) as compared to a waiting list control group will leads to 1) a bigger decrease in IBS-symptoms, 2) a bigger increase in IBS-specific quality of life, 3) a bigger decrease in IBS- specific anxiety. Finally, it is expected that IBS- specific anxiety has a mediating effect in the treatment results.
Study objective
Hypotheses are that the guided online treatment, based on CGT (exposure- en mindfulness exercises) as compared to a waiting list control group will leads to 1) a bigger decrease in IBS-symptoms, 2) a bigger increase in IBS-specific quality of life, 3) a bigger decrease in IBS- specific anxiety. Finally, it is expected that IBS- specific anxiety has a mediating effect in the treatment results.
Study design
3
Intervention
Guided online treatment, based on CGT (exposure- en mindfulness exercises)
Inclusion criteria
• 18 years and over
• IBS diagnosed by general practitioner or physician, meeting the Rome-IV-criteria
• Having access to internet, a tablet/computer/laptop/telephone
• Proficient in the Dutch language
Exclusion criteria
• Medical intervention for IBS started in the 6 months preceding
• Already, for any reason, in concurrent psychological treatment
• Bowel disease other than IBS
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 | NL8275 |
| CCMO | NL68331.078.19 |
| OMON | NL-OMON48448 |