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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051973
• Other study ID #: IBS-X
• Status: Completed
• Phase: N/A
• First received: January 19, 2010
• Last updated: January 3, 2012
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Cognitive behavior therapy
A 10-week treatment based on exposure to symptoms and related feelings.
• Stress management
A 10-week stress management treatment including applied relaxation and dietary advice.

Locations

Country	Name	City	State
Sweden	Internetpsykatrienheten, M57, Psykiatri sydväst	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of IBS symptoms	The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.	During 4 consecutive weeks before randomization	No
Primary	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)
Primary	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	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	No
Secondary	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	No
Secondary	Level of IBS-symptoms	IBS-Severity Scoring System	Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion	No
Secondary	Anxiety related to gastrointestinal symptoms	Visceral Sensitivity Index	Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion	No
Secondary	Level of daily stress	Perceived stress scale	Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion	No
Secondary	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