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

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: Cognitive Behavioral Therapy without exposure; Behavioral: Cognitive Behavioral Therapy with exposure

• Registration Number: NCT01529567
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT without exposure	Cognitive Behavioral Therapy without exposure	-
CBT with exposure	Cognitive Behavioral Therapy with exposure	-

Primary Outcome Measures

Name	Time	Method
Gastrointestinal symptom rating scale	36 weeks after randomization (i.e. 6 months after conclusion of treatment)

Secondary Outcome Measures

Name	Time	Method
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)	36 weeks after randomization (i.e. 6 months after conclusion of treatment)