Cognitive Behavior Therapy (CBT) Compared to Stress Management for Irritable Bowel Syndrome

NCT ID: NCT01051973

Last Updated: 2012-01-05

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks.

Approximately 200 patients will be included in the study and randomized to either condition.

The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.

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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Cognitive behavior therapy

Group Type EXPERIMENTAL

Cognitive behavior therapy

Intervention Type BEHAVIORAL

A 10-week treatment based on exposure to symptoms and related feelings.

Stress management

Group Type ACTIVE_COMPARATOR

Stress management

Intervention Type BEHAVIORAL

A 10-week stress management treatment including applied relaxation and dietary advice.

Interventions

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Cognitive behavior therapy

A 10-week treatment based on exposure to symptoms and related feelings.

Intervention Type BEHAVIORAL

Stress management

A 10-week stress management treatment including applied relaxation and dietary advice.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of IBS given by physician
* At screening fulfilling Rome III-criteria for IBS

Exclusion Criteria

* Severe depression
* Suicidal ideation
* Presence of unexplained IBS alarm symptoms
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Brjann Ljotsson

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nils Lindefors, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Internetpsykatrienheten, M57, Psykiatri sydväst

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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IBS-X

Identifier Type: -

Identifier Source: org_study_id

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