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

Karolinska Institute

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: Cognitive behavior therapy; Behavioral: Stress management

Study type: Interventional

Funder types: Other

Identifiers

NCT01051973

IBS-X

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Cognitive behavior therapy

Experimental group

Treatment:

Behavioral: Cognitive behavior therapy

Stress management

Active Comparator group

Treatment:

Behavioral: Stress management