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

Internet-delivered Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Cognitive behavior therapy; Behavioral: Stress management

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 181 86
    • Internetpsykatrienheten, M57, Psykiatri sydväst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive behavior therapy	Behavioral: Cognitive behavior therapy; A 10-week treatment based on exposure to symptoms and related feelings.
Active Comparator: Stress management	Behavioral: Stress management; A 10-week stress management treatment including applied relaxation and dietary advice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of IBS symptoms	The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.	During 4 consecutive weeks before randomization
Level of IBS symptoms	The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.	During 4 consecutive weeks after treatment completion (10 weeks after randomization)
Level of IBS symptoms	The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.	During 4 consecutive weeks 6 months after treatment completion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 19, 2010
• First Submitted That Met QC Criteria: January 19, 2010
• First Posted (Estimate): January 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 3, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Cognitive behavior therapy; exposure; stress management
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: IBS-X