Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Gastrointestinal symptoms
Study Overview
Brief Summary
The aim of this study is to investigate the efficacy of a 10 week Internet-delivered CBT treatment for patients diagnosed with IBS. The patients' work with the treatment and is supported through online contact with a therapist.
Approximately 86 patients will be included in the study and randomized to either condition.
All included patients are assessed one week before the treatment starts. After 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months follow-up after treatment.
Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms, societal costs and quality of life compared to patients on waiting list.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Attention control
Weekly support from therapist without CBT-interventions
Intervention: Therapist support (Behavioral)
Internet CBT
Internet-delivered cognitive behavioral therapy with therapist support
Intervention: Internet-delivered CBT (Behavioral)
Outcomes
Primary Outcomes
Gastrointestinal symptoms
Time Frame: One year after the treatment ended
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms
Time Frame: One week before the treatment starts
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms
Time Frame: 10 weeks after the treatment started
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms
Time Frame: 3 months after the treatment ended
Gastrointestinal Symptom rating scale (GSRS)
Secondary Outcomes
- Health economic data(One year after the treatment ended)
- Quality of life(One year after the treatment ended)
- Gastrointestinal symptom-specific anxiety(One year after the treatment ended)
- Functional impairments in work, social and family life(One year after the treatment ended)
- Depressive symptoms(One year after the treatment ended)
- Quality of life(3 months after the treatment ended)
- Gastrointestinal symptom-specific anxiety(One week before the treatment starts)
- Health economic data(One week before the treatment starts)
- Health economic data(10 weeks after the treatment started)
- Health economic data(3 months after the treatment ended)
- Quality of life(One week before the treatment starts)
- Quality of life(10 weeks after the treatment started)
- Gastrointestinal symptom-specific anxiety(10 weeks after the treatment started)
- Gastrointestinal symptom-specific anxiety(3 months after the treatment ended)
- Depressive symptoms(One week before the treatment starts)
- Depressive symptoms(10 weeks after the treatment started)
- Depressive symptoms(3 months after the treatment ended)
- Functional impairments in work, social and family life(One week before the treatment starts)
- Functional impairments in work, social and family life(10 weeks after the treatment started)
- Functional impairments in work, social and family life(3 months after the treatment ended)