Internet-delivered Exposure-based Cognitive Behavior Therapy for Irritable Bowel Syndrome - a Cohort Effectiveness Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of Internet-delivered Exposure-based Cognitive Behavior Therapy for Irritable Bowel Syndrome - a Cohort Study

Conditions
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Irritable Bowel Syndrome

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS) | 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 | pre treatment (same day as treatment starts), | 
| Change from baseline IBS-symptoms measured with The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS) | 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 | weekly during treatment (ten times in total, during the ten week long treatment) | 
| The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS) | 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 | post treatment (same day as treatment ends). 10 weeks after treatment start. | 
| The Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS) | 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 | follow-up (six months after the treatment ended), | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ) | 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 | pre treatment (same day as treatment starts) | 
| Change from baseline avoidance behaviors measured with The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ) | 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 | weekly during treatment (ten times in total, during the ten week long treatment) | 
| The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ) | 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 | post treatment (same day as treatment ends), ten weeks after treatment start | 
| The Irritable bowel Syndrome - Behavioral Responses Questionnaire (IBS-BRQ) | 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 | follow-up (six months after the treatment ended), | 
| Visceral Sensitivity Index (VSI) | 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 | pre treatment (same day as treatment starts) | 
| Visceral Sensitivity Index (VSI) | 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 | post treatment (same day as treatment ends), ten weeks after treatment start. | 
| Visceral Sensitivity Index (VSI) | 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 | follow-up (six months after the treatment ended) | 
| EuroQoL (EQ-5D) | 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. | pre treatment (same day as treatment starts) | 
| EuroQoL (EQ-5D) | 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. | post treatment (same day as treatment ends), ten weeks after treatment start. | 
| EuroQoL (EQ-5D) | 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. | follow-up (six months after the treatment ended) | 
| Short Form Health Survey (SF-12) | 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). | pre treatment (same day as treatment starts) | 
| Short Form Health Survey (SF-12) | 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). | post treatment (same day as treatment ends), ten weeks after treatment start. | 
| Change from baseline health status measured with Short Form Health Survey (SF-12) | 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). | weekly during treatment (ten times in total, during the ten week long treatment) | 
| Short Form Health Survey (SF-12) | 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). | follow-up (six months after the treatment ended) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Effectiveness, Cognitive Behavioral Therapy, Exposure, Internet, Mediation