Cognitive Behavior Therapy (CBT) Compared to Stress Management for Irritable Bowel Syndrome

Study Overview
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Brief Summary
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The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks. Approximately 200 patients will be included in the study and randomized to either condition. The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.

Official Title
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Internet-delivered Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Cognitive behavior therapy
* Behavioral: Stress management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of IBS given by physician At screening fulfilling Rome III-criteria for IBS Exclusion Criteria: Severe depression Suicidal ideation Presence of unexplained IBS alarm symptoms

Ages Eligible for Study
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Minimum Age: 18 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: Cognitive behavior therapy<br> | Behavioral: Cognitive behavior therapy<br>* A 10-week treatment based on exposure to symptoms and related feelings.<br>|
| Active Comparator: Stress management<br> | Behavioral: Stress management<br>* A 10-week stress management treatment including applied relaxation and dietary advice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of IBS symptoms | The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment. | During 4 consecutive weeks before randomization | 
| Level of IBS symptoms | The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment. | During 4 consecutive weeks after treatment completion (10 weeks after randomization) | 
| Level of IBS symptoms | The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment. | During 4 consecutive weeks 6 months after treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | The Irritable Bowel Syndrome Quality of Life Instrument | Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion | 
| Use of health care resources and societal production loss because of illness | Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry | Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion | 
| Level of IBS-symptoms | IBS-Severity Scoring System | Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion | 
| Anxiety related to gastrointestinal symptoms | Visceral Sensitivity Index | Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion | 
| Level of daily stress | Perceived stress scale | Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion | 
| Subjective relief of IBS-symptoms | One question: In the past week, have you had adequate relief from IBS pain or discomfort? | Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavior therapy, exposure, stress management