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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brjann Ljotsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01529567
First received: February 6, 2012
Last updated: February 14, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Gastrointestinal symptom rating scale [ Time Frame: 1 week before randomization ] [ Designated as safety issue: No ]
  • Gastrointestinal symptom rating scale [ Time Frame: 10 weeks after randomization (i.e. after conclusion of treatment) ] [ Designated as safety issue: No ]
  • Gastrointestinal symptom rating scale [ Time Frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) [ Time Frame: 1 week before randomization ] [ Designated as safety issue: No ]
  • Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) [ Time Frame: 10 weeks after randomization (i.e. after conclusion of treatment) ] [ Designated as safety issue: No ]
  • Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) [ Time Frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment) ] [ Designated as safety issue: No ]
  • Visceral Sensitivity Index (VSI) [ Time Frame: 1 week before randomization ] [ Designated as safety issue: No ]
  • Visceral Sensitivity Index (VSI) [ Time Frame: 10 weeks after randomization (i.e. after conclusion of treatment) ] [ Designated as safety issue: No ]
  • Visceral Sensitivity Index (VSI) [ Time Frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529567

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

No publications provided

Responsible Party: Brjann Ljotsson, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01529567     History of Changes
Other Study ID Numbers: IBS-0
Study First Received: February 6, 2012
Last Updated: February 14, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014