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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
A 10-week treatment based on exposure to symptoms and related feelings.
A 10-week stress management treatment including applied relaxation and dietary advice.
Internetpsykatrienheten, M57, Psykiatri sydväst
Stockholm, Sweden
Level of IBS symptoms
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
Time frame: During 4 consecutive weeks before randomization
Level of IBS symptoms
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
Time frame: 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.
Time frame: During 4 consecutive weeks 6 months after treatment completion
Quality of life
The Irritable Bowel Syndrome Quality of Life Instrument
Time frame: 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
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry
Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Level of IBS-symptoms
IBS-Severity Scoring System
Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Anxiety related to gastrointestinal symptoms
Visceral Sensitivity Index
Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
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Level of daily stress
Perceived stress scale
Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Subjective relief of IBS-symptoms
One question: "In the past week, have you had adequate relief from IBS pain or discomfort?"
Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion