Internet-delivered CBT for Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Internet-delivered CBT
* Behavioral: Therapist support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Attention control<br>Weekly support from therapist without CBT-interventions | Behavioral: Therapist support<br>* Weekly therapist support without CBT-interventions<br>|
| Experimental: Internet CBT<br>Internet-delivered cognitive behavioral therapy with therapist support | Behavioral: Internet-delivered CBT<br>* Internet-delivered cognitive behavioral therapy with therapist support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms | Gastrointestinal Symptom rating scale (GSRS) | One week before the treatment starts | 
| Gastrointestinal symptoms | Gastrointestinal Symptom rating scale (GSRS) | 10 weeks after the treatment started | 
| Gastrointestinal symptoms | Gastrointestinal Symptom rating scale (GSRS) | 3 months after the treatment ended | 
| Gastrointestinal symptoms | Gastrointestinal Symptom rating scale (GSRS) | One year after the treatment ended | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health economic data | Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry. In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured. | One week before the treatment starts | 
| Health economic data | Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry. In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured. | 10 weeks after the treatment started | 
| Health economic data | Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry. In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured. | 3 months after the treatment ended | 
| Health economic data | Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry. In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured. | One year after the treatment ended | 
| Quality of life | The Irritable Bowel Syndrome Quality of Life Instrument | One week before the treatment starts | 
| Quality of life | The Irritable Bowel Syndrome Quality of Life Instrument | 10 weeks after the treatment started | 
| Quality of life | The Irritable Bowel Syndrome Quality of Life Instrument | 3 months after the treatment ended | 
| Quality of life | The Irritable Bowel Syndrome Quality of Life Instrument | One year after the treatment ended | 
| Gastrointestinal symptom-specific anxiety | Visceral Sensitivity Index | One week before the treatment starts | 
| Gastrointestinal symptom-specific anxiety | Visceral Sensitivity Index | 10 weeks after the treatment started | 
| Gastrointestinal symptom-specific anxiety | Visceral Sensitivity Index | 3 months after the treatment ended | 
| Gastrointestinal symptom-specific anxiety | Visceral Sensitivity Index | One year after the treatment ended | 
| Depressive symptoms | The Montgomery Åsberg Depression Rating Scale | One week before the treatment starts | 
| Depressive symptoms | The Montgomery Åsberg Depression Rating Scale | 10 weeks after the treatment started | 
| Depressive symptoms | The Montgomery Åsberg Depression Rating Scale | 3 months after the treatment ended | 
| Depressive symptoms | The Montgomery Åsberg Depression Rating Scale | One year after the treatment ended | 
| Functional impairments in work, social and family life | Sheenan Disability Scale (DSD) | One week before the treatment starts | 
| Functional impairments in work, social and family life | Sheenan Disability Scale (DSD) | 10 weeks after the treatment started | 
| Functional impairments in work, social and family life | Sheenan Disability Scale (DSD) | 3 months after the treatment ended | 
| Functional impairments in work, social and family life | Sheenan Disability Scale (DSD) | One year after the treatment ended | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavior therapy, Internet, Cost-effectiveness, Irritable bowel syndrome