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

NCT ID: NCT01529567

Last Updated: 2013-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT without exposure

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy without exposure

Intervention Type BEHAVIORAL

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.

CBT with exposure

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy with exposure

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Brjann Ljotsson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brjánn Ljótsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

References

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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.

Reference Type DERIVED
PMID: 34256715 (View on PubMed)

Other Identifiers

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IBS-0

Identifier Type: -

Identifier Source: org_study_id

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