Effectiveness of Internet Delivered Cognitive Behavior Therapy (CBT) for Irritable Bowel Syndrome (IBS)

Study Overview
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Brief Summary
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The study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a gastroenterological clinic. The recruitment will be consecutive with all patients receiving the diagnosis being offered to participate. After recruitment and 3 week baseline measure of IBS symptoms they will be randomised to either 10 weeks of internet delivered CBT or waiting list. After treatment IBS-symptoms are measured again to assess treatment effectiveness. All patients on waiting list are offered the same treatment as patients randomised to treatment. All patients are assessed 12 months after completion of treatment. Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms and quality of life compared to patients on waiting list.

Official Title
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Study of the Effectiveness of Internet Delivered Cognitive Behavior Therapy in a Sample of Consecutively Recruited Patients Diagnosed With Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Internet delivered cognitive behavior therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Irritable Bowel Syndrome according to Rome III criteria Exclusion Criteria: History of inflammatory bowel disease (IBD) Symptom debut after age of 50 Ongoing severe mental illness (psychosis, severe depression, suicidal ideation, bipolar disease) Inability to participate in internet delivered treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet CBT<br>10 weeks of internet delivered cognitive behaviour therapy | Behavioral: Internet delivered cognitive behavior therapy<br>* 10 weeks of internet delivered cognitive behavior therapy targeted at reducing experience of IBS symptoms and improving quality of life. Patients are offered guidance via email by a therapist.<br>* Other names: CBT;|
| No Intervention: Waiting list<br>Waiting list which is offered treatment after completion of post intervention assessments | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS) |  | Before treatment | 
| The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS) |  | After treatment | 
| The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS) |  | 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, CBT, Internet treatment, Cognitive behavior therapy