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

Karolinska Institute

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: Cognitive Behavioral Therapy without exposure; Behavioral: Cognitive Behavioral Therapy with exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT01529567

IBS-0

Details and patient eligibility

About

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.

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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311 participants in 2 patient groups

CBT without exposure

Active Comparator group

Treatment:

Behavioral: Cognitive Behavioral Therapy without exposure

CBT with exposure

Experimental group

Treatment:

Behavioral: Cognitive Behavioral Therapy with exposure