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

Irritable Bowel Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529567
• Other study ID #: IBS-0
• Status: Completed
• Phase: N/A
• First received: February 6, 2012
• Last updated: February 14, 2013
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal symptom rating scale		1 week before randomization	No
Primary	Gastrointestinal symptom rating scale		10 weeks after randomization (i.e. after conclusion of treatment)	No
Primary	Gastrointestinal symptom rating scale		36 weeks after randomization (i.e. 6 months after conclusion of treatment)	No
Secondary	Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)		1 week before randomization	No
Secondary	Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)		10 weeks after randomization (i.e. after conclusion of treatment)	No
Secondary	Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)		36 weeks after randomization (i.e. 6 months after conclusion of treatment)	No
Secondary	Visceral Sensitivity Index (VSI)		1 week before randomization	No
Secondary	Visceral Sensitivity Index (VSI)		10 weeks after randomization (i.e. after conclusion of treatment)	No
Secondary	Visceral Sensitivity Index (VSI)		36 weeks after randomization (i.e. 6 months after conclusion of treatment)	No