Cognitive Behavior Therapy (CBT) Compared to Stress Management for Irritable Bowel Syndrome
Internet-delivered Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 19, 2010
CompletedFirst Posted
Study publicly available on registry
January 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 5, 2012
January 1, 2012
1.2 years
January 19, 2010
January 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Level of IBS symptoms
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
During 4 consecutive weeks before randomization
Level of IBS symptoms
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
During 4 consecutive weeks after treatment completion (10 weeks after randomization)
Level of IBS symptoms
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
During 4 consecutive weeks 6 months after treatment completion
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Cognitive behavior therapy
EXPERIMENTALStress management
ACTIVE COMPARATORInterventions
A 10-week treatment based on exposure to symptoms and related feelings.
A 10-week stress management treatment including applied relaxation and dietary advice.
Eligibility Criteria
You may qualify if:
- Diagnosis of IBS given by physician
- At screening fulfilling Rome III-criteria for IBS
You may not qualify if:
- Severe depression
- Suicidal ideation
- Presence of unexplained IBS alarm symptoms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Region Stockholmcollaborator
Study Sites (1)
Internetpsykatrienheten, M57, Psykiatri sydväst
Stockholm, 181 86, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nils Lindefors, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
January 19, 2010
First Posted
January 20, 2010
Study Start
October 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 5, 2012
Record last verified: 2012-01