Internet-delivered Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- Karolinska Institutet
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Level of IBS symptoms
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Brjann Ljotsson
PhD
Karolinska Institutet
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- Quality of life(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)
- Use of health care resources and societal production loss because of illness(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)
- Level of IBS-symptoms(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)
- Anxiety related to gastrointestinal symptoms(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)
- Level of daily stress(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)
- Subjective relief of IBS-symptoms(Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion)