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

February 14, 2013 updated by: Brjann Ljotsson, Karolinska Institutet
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CBT without exposure
Behavioral: Cognitive Behavioral Therapy without exposure
10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, and guided behavioral change aiming to increase quality of life and flexibility.
EXPERIMENTAL: CBT with exposure
Behavioral: Cognitive Behavioral Therapy with exposure
10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, guided behavioral change aiming to increase quality of life and flexibility, and systematic exposure to IBS symptoms and aversive situations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gastrointestinal symptom rating scale
Time Frame: 1 week before randomization
1 week before randomization
Gastrointestinal symptom rating scale
Time Frame: 10 weeks after randomization (i.e. after conclusion of treatment)
10 weeks after randomization (i.e. after conclusion of treatment)
Gastrointestinal symptom rating scale
Time Frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
36 weeks after randomization (i.e. 6 months after conclusion of treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Time Frame: 1 week before randomization
1 week before randomization
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Time Frame: 10 weeks after randomization (i.e. after conclusion of treatment)
10 weeks after randomization (i.e. after conclusion of treatment)
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Time Frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
36 weeks after randomization (i.e. 6 months after conclusion of treatment)
Visceral Sensitivity Index (VSI)
Time Frame: 1 week before randomization
1 week before randomization
Visceral Sensitivity Index (VSI)
Time Frame: 10 weeks after randomization (i.e. after conclusion of treatment)
10 weeks after randomization (i.e. after conclusion of treatment)
Visceral Sensitivity Index (VSI)
Time Frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
36 weeks after randomization (i.e. 6 months after conclusion of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (ESTIMATE)

February 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBS-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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