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

This study has been completed.
Sponsor:
Collaborators:
Allmänna arvsfonden
Stockholm County Council, Sweden
Königska-Söderströmska sjukhemmet
Aleris Helse
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00844961
First received: February 13, 2009
Last updated: November 8, 2011
Last verified: February 2009
  Purpose

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.


Condition Intervention
Irritable Bowel Syndrome
Behavioral: Internet delivered cognitive behavior therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Effectiveness of Internet Delivered Cognitive Behavior Therapy in a Sample of Consecutively Recruited Patients Diagnosed With Irritable Bowel Syndrome

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS) [ Time Frame: Before treatment ] [ Designated as safety issue: No ]
  • The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS) [ Time Frame: After treatment ] [ Designated as safety issue: No ]
  • The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS) [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: November 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CBT
No Intervention: Waiting list
Waiting list which is offered treatment after completion of post intervention assessments

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844961

Locations
Sweden
Internetpsykatrienheten, M57, Psykiatri sydväst
Stockholm, Sweden, 181 86
Sponsors and Collaborators
Karolinska Institutet
Allmänna arvsfonden
Stockholm County Council, Sweden
Königska-Söderströmska sjukhemmet
Aleris Helse
Investigators
Principal Investigator: Nils Lindefors, PhD Karolinska Institutet
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nils Lindefors, Psykiatri Sydväst, Stockholms läns landsting
ClinicalTrials.gov Identifier: NCT00844961     History of Changes
Other Study ID Numbers: IBS-K
Study First Received: February 13, 2009
Last Updated: November 8, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
IBS
CBT
Internet treatment
Cognitive behavior therapy

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 16, 2014