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

This study has been completed.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Brjann Ljotsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01051973
First received: January 19, 2010
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Irritable Bowel Syndrome Behavioral: Cognitive behavior therapy Behavioral: Stress management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-delivered Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.

Further study details as provided by Brjann Ljotsson, Karolinska Institutet:

Primary Outcome Measures:
  • Level of IBS symptoms [ Time Frame: During 4 consecutive weeks before randomization ]
    The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

  • Level of IBS symptoms [ Time Frame: During 4 consecutive weeks after treatment completion (10 weeks after randomization) ]
    The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.

  • Level of IBS symptoms [ Time Frame: During 4 consecutive weeks 6 months after treatment completion ]
    The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion ]
    The Irritable Bowel Syndrome Quality of Life Instrument

  • Use of health care resources and societal production loss because of illness [ Time Frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion ]
    Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry

  • Level of IBS-symptoms [ Time Frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion ]
    IBS-Severity Scoring System

  • Anxiety related to gastrointestinal symptoms [ Time Frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion ]
    Visceral Sensitivity Index

  • Level of daily stress [ Time Frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion ]
    Perceived stress scale

  • Subjective relief of IBS-symptoms [ Time Frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion ]
    One question: "In the past week, have you had adequate relief from IBS pain or discomfort?"


Estimated Enrollment: 200
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive behavior therapy Behavioral: Cognitive behavior therapy
A 10-week treatment based on exposure to symptoms and related feelings.
Active Comparator: Stress management Behavioral: Stress management
A 10-week stress management treatment including applied relaxation and dietary advice.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01051973

Locations
Sweden
Internetpsykatrienheten, M57, Psykiatri sydväst
Stockholm, Sweden, 181 86
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Nils Lindefors, PhD Karolinska Institutet
  More Information

Responsible Party: Brjann Ljotsson, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01051973     History of Changes
Other Study ID Numbers: IBS-X
Study First Received: January 19, 2010
Last Updated: January 3, 2012

Keywords provided by Brjann Ljotsson, Karolinska Institutet:
Cognitive behavior therapy
exposure
stress management

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 September 19, 2017