Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome

Study Overview
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Brief Summary
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Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral. They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both programs include mindfulness training, education about how excessive avoidant and control behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One of the programs also includes instructions on how to perform systematic exposure. The hypothesis of the study is while both groups will show improvement in terms of IBS symptom severity and quality of life, the addition of systematic exposure will lead to more improvement in symptoms.

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy without exposure
* Behavioral: Cognitive Behavioral Therapy with exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fluency in Swedish IBS-diagnosis established by physician Fulfillment of Rome III criteria for IBS Exclusion Criteria: Diarrhea predominance with no colonoscopy performed Blood in stool without benign medical explanation Rapid weight loss without benign medical explanation Ongoing alcohol or drug abuse Suicidal ideation

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 |
| --- | --- |
| Active Comparator: CBT without exposure<br> | Behavioral: Cognitive Behavioral Therapy without exposure<br>* 10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, and guided behavioral change aiming to increase quality of life and flexibility.<br>|
| Experimental: CBT with exposure<br> | Behavioral: Cognitive Behavioral Therapy with exposure<br>* 10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, guided behavioral change aiming to increase quality of life and flexibility, and systematic exposure to IBS symptoms and aversive situations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptom rating scale |  | 1 week before randomization | 
| Gastrointestinal symptom rating scale |  | 10 weeks after randomization (i.e. after conclusion of treatment) | 
| Gastrointestinal symptom rating scale |  | 36 weeks after randomization (i.e. 6 months after conclusion of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) |  | 1 week before randomization | 
| Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) |  | 10 weeks after randomization (i.e. after conclusion of treatment) | 
| Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) |  | 36 weeks after randomization (i.e. 6 months after conclusion of treatment) | 
| Visceral Sensitivity Index (VSI) |  | 1 week before randomization | 
| Visceral Sensitivity Index (VSI) |  | 10 weeks after randomization (i.e. after conclusion of treatment) | 
| Visceral Sensitivity Index (VSI) |  | 36 weeks after randomization (i.e. 6 months after conclusion of treatment) |