Clinical Effectiveness of Exposure Based Cognitive Behavioral Group Therapy for IBS

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effects of a specific Cognitive Behavioral treatment protocol for patients with IBS used in routine care at a gastroenterology unit in Stockholm. The research question is whether the treatment has the same effects in routine care as it has had in efficacy studies. The treatment is given by licenced psychologists (with CBT training) face-to-face in groups of 4-7 participants and lasts for ten sessions (ten weeks, normally).

Detailed Description
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IBS is a debilitating condition that affects approximately one out of eleven persons world wide. It is often called a functional disorder, a term used to characterize painful conditions, whose biological mechanisms are not fully understood. Diagnosis is made based on symptoms and exclusion of other conditions rather than specific tests or biological markers. Treatment usually starts with diet counselling and a change of eating habits. If symptoms persist, a physician can prescribe medication of different types. But for some patients neither change of diet, nor medication is sufficient. Some of these patients may benefit from psychological treatment. There are a few different psychological treatments that have been proven efficacious in clinical trials. Most researched is Cognitive Behavior Therapy (CBT). Our study is a clinical effectiveness trial without a control group. The data comes from a gastroenterology clinic in Stockholm and is collected as part of the work with continous improvement at the clinic. Patients with diagnosed IBS are offered group treatment with a specific CBT protocol developed by our research group at Karolinska Institutet. The treatment comprises 6 different modules and stretches over ten sessions. The modules are: 1. Information regarding the treatment, IBS and mindfulness. 2 Hypervigilance and anxiety. 3. Behaviors and thoughts. 4. Behavior change part one - toilet habits including exposure to feared situations. 5. Behavior change part two - exposure to symptoms and avoidance/control behaviors. 6. Summary and relapse prevention. Group sizes range from 4-7 patients and the treatment is given by licenced psychologists who are employed at the clinic.

Official Title
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Clinical Effectiveness of Exposure Based Cognitive Behavioral Group Therapy for IBS

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Exposure based face-to-face Cognitive Behavior Group Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Diagnosed with IBS Exclusion Criteria: Severe psychiatric condition (for example severe depression, self injuring, psychosis, PTSD) Unable or unwilling to participate in group therapy

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Patients recieve treatment from standard protocol at a gastroenterology unit. No specific adjustments is made for study purposes. Baseline data is collected before treatment and then again after treatment (POST). | Behavioral: Exposure based face-to-face Cognitive Behavior Group Therapy<br>* See under detailed description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastro-Intestinal Symptom Rating Scale for IBS Gastrointestinal Symptom Rating Scale - IBS version | Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, and from baseline to 9 months for analysis of effect.The GSRS-IBS have 13 items about weekly gastrointestinal symptoms like bloating, hard stool, abdominal pain etc. It is a seven-point Likert scale from 1 (no discomfort at all) to 7 (very severe discomfort). The GSRS-IBS has excellent psychometric properties with internal consistency between α = .74 (for abdominal pain) to α = .85 (for satiety). | Baseline to 10 veeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life in persons with Irritable Bowel Syndrome (QOL-IBS) | QOL-IBS consists of 34 items scored between 1 and 6 and the total score is transformed to a 0-100 scale, where 0 represents minimum quality of life and 100 represents maximum quality of life. The IBS-QOL shows high internal consistency (Cronbach's a = .95) and test-retest reliability. r = .86 | Baseline to 10 veeks | 
| Visceral Sensitivity Index (VSI) | VSI is a measure of gastro-intestinal anxiety (i.e., distress, avoidance, and safety behaviors in response to IBS-related stimuli). The VSI contains 15 items, which are scored between 1 and 6, 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 CBT on IBS symptoms. | Baseline to 10 veeks | 
| The Montgomery-Åsberg Depression Rating Scale (MADRS-S) | MADRS-S consists of 9 items that can be rated between 0 and 6, yielding a result between 0 and 54, where a higher number indicates more severe symptoms of depression. The scale was developed in 1993 and has been widely used. It has demonstrated good psychometric properties with an internal consistency between Cronbach's a = .84-.91 | Baseline to 10 veeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavior Therapy, IBS, Group Therapy, Exposure,