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

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: Cognitive behavior therapy; Behavioral: Stress management

• Registration Number: NCT01051973
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-03
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavior therapy	Cognitive behavior therapy	-
Stress management	Stress management	-

Primary Outcome Measures

Name	Time	Method
Level of IBS symptoms	During 4 consecutive weeks 6 months after treatment completion	The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Internetpsykatrienheten, M57, Psykiatri sydväst; 🇸🇪 Stockholm, Sweden