Effectiveness of Internet Delivered Cognitive Behavior Therapy (CBT) for Irritable Bowel Syndrome (IBS)

November 8, 2011 updated by: Karolinska Institutet

Study of the Effectiveness of Internet Delivered Cognitive Behavior Therapy in a Sample of Consecutively Recruited Patients Diagnosed With Irritable Bowel Syndrome

The study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a gastroenterological clinic. The recruitment will be consecutive with all patients receiving the diagnosis being offered to participate. After recruitment and 3 week baseline measure of IBS symptoms they will be randomised to either 10 weeks of internet delivered CBT or waiting list. After treatment IBS-symptoms are measured again to assess treatment effectiveness. All patients on waiting list are offered the same treatment as patients randomised to treatment.

All patients are assessed 12 months after completion of treatment.

Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms and quality of life compared to patients on waiting list.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 181 86
        • Internetpsykatrienheten, M57, Psykiatri sydväst

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Irritable Bowel Syndrome according to Rome III criteria

Exclusion Criteria:

  • History of inflammatory bowel disease (IBD)
  • Symptom debut after age of 50
  • Ongoing severe mental illness (psychosis, severe depression, suicidal ideation, bipolar disease)
  • Inability to participate in internet delivered treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Internet CBT
10 weeks of internet delivered cognitive behaviour therapy
Behavioral: Internet delivered cognitive behavior therapy
10 weeks of internet delivered cognitive behavior therapy targeted at reducing experience of IBS symptoms and improving quality of life. Patients are offered guidance via email by a therapist.
Other Names:
  • CBT
NO_INTERVENTION: Waiting list
Waiting list which is offered treatment after completion of post intervention assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
Time Frame: Before treatment
Before treatment
The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
Time Frame: After treatment
After treatment
The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
Time Frame: 12 months after treatment
12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm
Aleris Helse
Allmänna arvsfonden
Königska-Söderströmska sjukhemmet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (ESTIMATE)

February 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 9, 2011

Last Update Submitted That Met QC Criteria

November 8, 2011

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBS-K

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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