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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01529567

Enrollment

311

Registered

2012-02-09

Start date

2011-11-30

Completion date

2012-12-31

Last updated

2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

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.

Interventions

BEHAVIORALCognitive 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.

BEHAVIORALCognitive 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Gastrointestinal symptom rating scale	1 week before randomization

Secondary

Measure	Time frame
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)	1 week before randomization
Visceral Sensitivity Index (VSI)	1 week before randomization

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026