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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01529567
First Posted: February 9, 2012
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brjann Ljotsson, Karolinska Institutet
  Purpose
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.

Condition Intervention
Irritable Bowel Syndrome Behavioral: Cognitive Behavioral Therapy without exposure Behavioral: Cognitive Behavioral Therapy with exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Brjann Ljotsson, Karolinska Institutet:

Primary Outcome Measures:
  • Gastrointestinal symptom rating scale [ Time Frame: 1 week before randomization ]
  • Gastrointestinal symptom rating scale [ Time Frame: 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) ]

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

Enrollment: 311
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529567


Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Brjánn Ljótsson, PhD Karolinska Institutet
  More Information

Responsible Party: Brjann Ljotsson, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01529567     History of Changes
Other Study ID Numbers: IBS-0
First Submitted: February 6, 2012
First Posted: February 9, 2012
Last Update Posted: February 15, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases