Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 311
- Primary Endpoint
- Gastrointestinal symptom rating scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CBT without exposure
Intervention: Cognitive Behavioral Therapy without exposure (Behavioral)
CBT with exposure
Intervention: Cognitive Behavioral Therapy with exposure (Behavioral)
Outcomes
Primary Outcomes
Gastrointestinal symptom rating scale
Time Frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
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)
Secondary Outcomes
- Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)(36 weeks after randomization (i.e. 6 months after conclusion of treatment))
- Visceral Sensitivity Index (VSI)(36 weeks after randomization (i.e. 6 months after conclusion of treatment))
- Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)(1 week before randomization)
- Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)(10 weeks after randomization (i.e. after conclusion of treatment))
- Visceral Sensitivity Index (VSI)(1 week before randomization)
- Visceral Sensitivity Index (VSI)(10 weeks after randomization (i.e. after conclusion of treatment))
Investigators
Brjann Ljotsson
Principal Investigator
Karolinska Institutet