Primary objective:Is guided online treatment, based on CGT with mindfull- and exposure exercises, with minimal patient contact, effective for IBS-patients as compared to a waiting list?Secondary objectives: Will the guided online treatment lead to…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Somatic symptom and related disorders
Synonym
Research involving
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
Primary objective:
Is guided online treatment, based on CGT with mindfull- and exposure exercises,
with minimal patient contact, effective for IBS-patients as compared to a
waiting list?
Secondary
objectives:
Will the guided online treatment lead to a significant improvement of in
IBS-specific quality of life, as compared to a waiting list?
Will the guided online treatment lead to a significant decrease of IBS-
specific anxiety, as compared to a waiting list?
Is IBS- specific anxiety a mediator in the treatment effect in terms of
IBS-symptoms?
Study design
The study is a randomized controlled trial (RCT), with pre- and post-test (ten
weeks between) and a waiting list as control group.
Intervention
The treatment group receives an online CGT-treatment, based on mindfulness- and
exposure-exercises, with a duration of ten weeks and consisting of five steps.
The last step (exposure) takes six weeks. Every week the participant gets
access to a new step consisting of psycho education (video and text) and
homework. Once per week (at least), there will be contact at email for
questions and the homework.
The control group is a waiting list. After ten
weeks, the participants are offered the same treatment as the treatment
condition.
Study burden and risks
Risks during the study are not expected and participants are expected to
benefit from the treatment.
Kanaalweg 33
Capelle aan den IJssel 2903LR
NL
Kanaalweg 33
Capelle aan den IJssel 2903LR
NL
Listed location countries
Age
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 CBT Six
months or less started with
another (medical) intervention for IBS
* Already, for any reason, in concurrent psychological treatment
* Bowel disease other than IBS
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 | NL68331.078.19 |
| OMON | NL-OMON29140 |