Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy without exposure
Cognitive Behavioral Therapy with exposure
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CBT without exposure
CBT with exposure
Arm Description
Outcomes
Primary Outcome Measures
Gastrointestinal symptom rating scale
Gastrointestinal symptom rating scale
Gastrointestinal symptom rating scale
Secondary Outcome Measures
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Visceral Sensitivity Index (VSI)
Visceral Sensitivity Index (VSI)
Visceral Sensitivity Index (VSI)
Full Information
NCT ID
NCT01529567
First Posted
February 6, 2012
Last Updated
February 14, 2013
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT01529567
Brief Title
Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
311 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT without exposure
Arm Type
Active Comparator
Arm Title
CBT with exposure
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy without exposure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy with exposure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gastrointestinal symptom rating scale
Time Frame
1 week before randomization
Title
Gastrointestinal symptom rating scale
Time Frame
10 weeks after randomization (i.e. after conclusion of treatment)
Title
Gastrointestinal symptom rating scale
Time Frame
36 weeks after randomization (i.e. 6 months after conclusion of treatment)
Secondary Outcome Measure Information:
Title
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Time Frame
1 week before randomization
Title
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Time Frame
10 weeks after randomization (i.e. after conclusion of treatment)
Title
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Time Frame
36 weeks after randomization (i.e. 6 months after conclusion of treatment)
Title
Visceral Sensitivity Index (VSI)
Time Frame
1 week before randomization
Title
Visceral Sensitivity Index (VSI)
Time Frame
10 weeks after randomization (i.e. after conclusion of treatment)
Title
Visceral Sensitivity Index (VSI)
Time Frame
36 weeks after randomization (i.e. 6 months after conclusion of treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brjánn Ljótsson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34256715
Citation
Wallen H, Lindfors P, Andersson E, Hedman-Lagerlof E, Hesser H, Lindefors N, Svanborg C, Ljotsson B. Return on investment of internet delivered exposure therapy for irritable bowel syndrome: a randomized controlled trial. BMC Gastroenterol. 2021 Jul 13;21(1):289. doi: 10.1186/s12876-021-01867-6.
Results Reference
derived
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Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome
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