Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, Effectiveness, Cognitive Behavioral Therapy, Exposure, Internet, Mediation
Brief summary
The main purpose of the study is to investigate the clinical real-world effectiveness of a specific exposure based psychological treatment for irritable bowel syndrome (IBS). A secondary aim of the study is to find mediators of the treatment effect and thereby learn something about the working mechanism of the treatment.
Detailed description
IBS is a debilitating disorder with a prevalence of 10% world wide. For patients with severe forms of IBS where medication and other interventions have failed it can be useful to try psychological treatment. National Institute for Health and Care Excellence (NICE) guidelines recommend cognitive behavior therapy or hypnotherapy. Our research group at the Karolinska Institute in Stockholm has developed a cognitive behavioral treatment protocol for IBS. This treatment contains exposure therapy and mindfulness based exercises alongside psychoeducation. The treatment has been tested in four earlier randomized controlled trials (RCT) and produced large effect sizes compared to wait-list and moderate effect sizes compared to other active treatments or placebo. The present study aims to examine the effectiveness of the treatment protocol under real-world circumstances at a secondary-care unit in Stockholm. The Internet psychiatry Unit (IPSY) has been operative since 2007 and is run by Region Stockholm (i.e. the responsible authority for all publicly-funded healthcare in Stockholm). Patients with IBS have been treated at the clinic since 2015 and the treatment is delivered via an online treatment platform. The study is based on the clinics own data that has been collected for quality improvement reasons. Another aim of the study is to find out more about the working mechanisms behind the treatment by examining the weekly reports on behavioral avoidance and and anxiety that the patients file during treatment. All patients that have been treated at the clinic so far will be included in the study (N=319). Data has been collected between April 2015 and January 2022. The study has an approved ethical permit from the Swedish Authority for Ethical Approvals. The first hypothesis is that the treatment will be as effective in clinical routine care as it has been in earlier trials with a moderate to large effect-size from pre treatment to follow-up, six month after treatment. A second hypothesis is that the treatment effect is mediated by a change in behavioral avoidance that precedes symptomatic improvement.
Interventions
None listed
Sponsors
Karolinska Institutet
Region Stockholm
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of IBS made by a licenced physician * Able to provide written certificate of the diagnosis * At least 16 years of age * Daily access to computer, mobile phone or tablet with internet * Account at health care guide 1177 * Proficient in Swedish
Exclusion criteria
* Considered having a high risk for suicide * Unable to read or communicate in written form * Do not understand Swedish language * has planned to be away for more than 2 weeks during the treatment period * suffers from another somatic or psychiatric condition needing to be prioritized or that might hinder treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS) | pre treatment (same day as treatment starts), | It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 \[17\] and test-retest reliability between .55 and .70 |
| Change from baseline IBS-symptoms measured with The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS) | weekly during treatment (ten times in total, during the ten week long treatment) | It is a self-rating scale with 13 questions regarding the severity of the IBS-symptoms. The questions can be rated from 1-7, where 1 represents no discomfort at all and 7 means very severe discomfort. The total score may range from 13-91. The GSRS-IBS has demonstrated good psychometric properties for the different symptoms that are assessed, with an internal consistency (Cronbach's a) of .88 \[17\] and test-retest reliability between .55 and .70 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visceral Sensitivity Index (VSI) | pre treatment (same day as treatment starts) | a scale designed to measure gastrointestinal specific anxiety (GSA; i.e., distress, avoidance, and safety behaviors in response to IBS-related stimuli). The VSI contains 15 items, which are scored between 0 and 5, rendering a total score between 0 (minimum GSA) and 75 (maximum GSA). The VSI has demonstrated high internal consistency (Cronbach's a = .90-.92) and has been shown to be associated with symptom severity and diagnostic status of IBS and also to be a mediator of the effect of exposure-based cognitive behavioral treatment on IBS symptoms |
| EuroQoL (EQ-5D) | pre treatment (same day as treatment starts) | The EQ-5D consists of two parts: the health states descriptive system and the visual analog rating scale (VAS). In our study we used only the VAS scale which can be rated from 0-100. The endpoints of the VAS are labeled best imaginable health state and worst imaginable health state anchored at 100 and 0, respectively. |
| The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ) | pre treatment (same day as treatment starts) | A scale measuring avoidance behavior and IBS-related anxiety'. The scale consists of 26 questions regarding food habits and toilet and social situations. The questions can be scored from 1-7 where 1 represents no control or avoidance behavior and 7 represents maximum avoidance or control, rendering a total score between 26 and 182. The IBS-BRQ has demonstrated excellent psychometric properties, with high internal consistency (Cronbach's alpha .86) and high correlations with measures of dysfunctional IBS-related cognitions, IBS impact and impairment, anxiety, and depression |
| Change from baseline health status measured with Short Form Health Survey (SF-12) | weekly during treatment (ten times in total, during the ten week long treatment) | This is a generic health status measure that includes both the physical domain and the mental domain of health. The scale has 12 items and has shown to be a reliable indicator of subjectively perceived health (Jenkinson C, et al., 1990). |
| Short Form Health Survey (SF-12) | pre treatment (same day as treatment starts) | This is a generic health status measure that includes both the physical domain and the mental domain of health. The scale has 12 items and has shown to be a reliable indicator of subjectively perceived health (Jenkinson C, et al., 1990). |
| Change from baseline avoidance behaviors measured with The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ) | weekly during treatment (ten times in total, during the ten week long treatment) | A scale measuring avoidance behavior and IBS-related anxiety'. The scale consists of 26 questions regarding food habits and toilet and social situations. The questions can be scored from 1-7 where 1 represents no control or avoidance behavior and 7 represents maximum avoidance or control, rendering a total score between 26 and 182. The IBS-BRQ has demonstrated excellent psychometric properties, with high internal consistency (Cronbach's alpha .86) and high correlations with measures of dysfunctional IBS-related cognitions, IBS impact and impairment, anxiety, and depression |
Outcome results
None listed