Internet-delivered CBT for Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered CBT
Therapist support
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Cognitive behavior therapy, Internet, Cost-effectiveness, Irritable bowel syndrome
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
Sites / Locations
- Internetpsykatrienheten, M46, Psykiatri sydväst
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Attention control
Internet CBT
Arm Description
Weekly support from therapist without CBT-interventions
Internet-delivered cognitive behavioral therapy with therapist support
Outcomes
Primary Outcome Measures
Gastrointestinal symptoms
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms
Gastrointestinal Symptom rating scale (GSRS)
Gastrointestinal symptoms
Gastrointestinal Symptom rating scale (GSRS)
Secondary Outcome Measures
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.
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.
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.
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.
Quality of life
The Irritable Bowel Syndrome Quality of Life Instrument
Quality of life
The Irritable Bowel Syndrome Quality of Life Instrument
Quality of life
The Irritable Bowel Syndrome Quality of Life Instrument
Quality of life
The Irritable Bowel Syndrome Quality of Life Instrument
Gastrointestinal symptom-specific anxiety
Visceral Sensitivity Index
Gastrointestinal symptom-specific anxiety
Visceral Sensitivity Index
Gastrointestinal symptom-specific anxiety
Visceral Sensitivity Index
Gastrointestinal symptom-specific anxiety
Visceral Sensitivity Index
Depressive symptoms
The Montgomery Åsberg Depression Rating Scale
Depressive symptoms
The Montgomery Åsberg Depression Rating Scale
Depressive symptoms
The Montgomery Åsberg Depression Rating Scale
Depressive symptoms
The Montgomery Åsberg Depression Rating Scale
Functional impairments in work, social and family life
Sheenan Disability Scale (DSD)
Functional impairments in work, social and family life
Sheenan Disability Scale (DSD)
Functional impairments in work, social and family life
Sheenan Disability Scale (DSD)
Functional impairments in work, social and family life
Sheenan Disability Scale (DSD)
Full Information
NCT ID
NCT01171053
First Posted
July 26, 2010
Last Updated
July 27, 2010
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT01171053
Brief Title
Internet-delivered CBT for Irritable Bowel Syndrome
Official Title
Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Cognitive behavior therapy, Internet, Cost-effectiveness, Irritable bowel syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Attention control
Arm Type
Placebo Comparator
Arm Description
Weekly support from therapist without CBT-interventions
Arm Title
Internet CBT
Arm Type
Experimental
Arm Description
Internet-delivered cognitive behavioral therapy with therapist support
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered CBT
Intervention Description
Internet-delivered cognitive behavioral therapy with therapist support.
Intervention Type
Behavioral
Intervention Name(s)
Therapist support
Intervention Description
Weekly therapist support without CBT-interventions
Primary Outcome Measure Information:
Title
Gastrointestinal symptoms
Description
Gastrointestinal Symptom rating scale (GSRS)
Time Frame
One week before the treatment starts
Title
Gastrointestinal symptoms
Description
Gastrointestinal Symptom rating scale (GSRS)
Time Frame
10 weeks after the treatment started
Title
Gastrointestinal symptoms
Description
Gastrointestinal Symptom rating scale (GSRS)
Time Frame
3 months after the treatment ended
Title
Gastrointestinal symptoms
Description
Gastrointestinal Symptom rating scale (GSRS)
Time Frame
One year after the treatment ended
Secondary Outcome Measure Information:
Title
Health economic data
Description
"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.
Time Frame
One week before the treatment starts
Title
Health economic data
Description
"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.
Time Frame
10 weeks after the treatment started
Title
Health economic data
Description
"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.
Time Frame
3 months after the treatment ended
Title
Health economic data
Description
"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.
Time Frame
One year after the treatment ended
Title
Quality of life
Description
The Irritable Bowel Syndrome Quality of Life Instrument
Time Frame
One week before the treatment starts
Title
Quality of life
Description
The Irritable Bowel Syndrome Quality of Life Instrument
Time Frame
10 weeks after the treatment started
Title
Quality of life
Description
The Irritable Bowel Syndrome Quality of Life Instrument
Time Frame
3 months after the treatment ended
Title
Quality of life
Description
The Irritable Bowel Syndrome Quality of Life Instrument
Time Frame
One year after the treatment ended
Title
Gastrointestinal symptom-specific anxiety
Description
Visceral Sensitivity Index
Time Frame
One week before the treatment starts
Title
Gastrointestinal symptom-specific anxiety
Description
Visceral Sensitivity Index
Time Frame
10 weeks after the treatment started
Title
Gastrointestinal symptom-specific anxiety
Description
Visceral Sensitivity Index
Time Frame
3 months after the treatment ended
Title
Gastrointestinal symptom-specific anxiety
Description
Visceral Sensitivity Index
Time Frame
One year after the treatment ended
Title
Depressive symptoms
Description
The Montgomery Åsberg Depression Rating Scale
Time Frame
One week before the treatment starts
Title
Depressive symptoms
Description
The Montgomery Åsberg Depression Rating Scale
Time Frame
10 weeks after the treatment started
Title
Depressive symptoms
Description
The Montgomery Åsberg Depression Rating Scale
Time Frame
3 months after the treatment ended
Title
Depressive symptoms
Description
The Montgomery Åsberg Depression Rating Scale
Time Frame
One year after the treatment ended
Title
Functional impairments in work, social and family life
Description
Sheenan Disability Scale (DSD)
Time Frame
One week before the treatment starts
Title
Functional impairments in work, social and family life
Description
Sheenan Disability Scale (DSD)
Time Frame
10 weeks after the treatment started
Title
Functional impairments in work, social and family life
Description
Sheenan Disability Scale (DSD)
Time Frame
3 months after the treatment ended
Title
Functional impairments in work, social and family life
Description
Sheenan Disability Scale (DSD)
Time Frame
One year after the treatment ended
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Lindefors, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internetpsykatrienheten, M46, Psykiatri sydväst
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
20362976
Citation
Ljotsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Ruck C, Hursti T, Andreewitch S, Jansson L, Lindefors N, Andersson G. Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome--a randomized controlled trial. Behav Res Ther. 2010 Jun;48(6):531-9. doi: 10.1016/j.brat.2010.03.003. Epub 2010 Mar 16.
Results Reference
result
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Internet-delivered CBT for Irritable Bowel Syndrome
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