Irritable Bowel SyndromeNCT01171053
Internet-delivered CBT for Irritable Bowel Syndrome
A study testing Internet-delivered CBT and Therapist support in people with Irritable Bowel Syndrome, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Internet-delivered CBT and Therapist support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of IBS given by physician
- At screening fulfilling Rome III-criteria for IBS
Who cannot join
- Severe depression
- Suicidal ideation
- Presence of unexplained IBS alarm symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Internet-delivered CBT, Therapist support
- Keywords
- Cognitive behavior therapy, Internet, Cost-effectiveness, Irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered CBTBehavioural
Internet-delivered cognitive behavioral therapy with therapist support.
Therapist supportBehavioural
Weekly therapist support without CBT-interventions
| Study group | Role | What they receive |
|---|---|---|
| Attention control | Placebo comparator | Weekly support from therapist without CBT-interventions Receives: Behavioral: Therapist support |
| Internet CBT | Experimental | Internet-delivered cognitive behavioral therapy with therapist support Receives: Behavioral: Internet-delivered CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptoms
Gastrointestinal Symptom rating scale (GSRS)
Measured: One week before the treatment starts
Gastrointestinal symptoms
Gastrointestinal Symptom rating scale (GSRS)
Measured: 10 weeks after the treatment started
Gastrointestinal symptoms
Gastrointestinal Symptom rating scale (GSRS)
Measured: 3 months after the treatment ended
Gastrointestinal symptoms
Gastrointestinal Symptom rating scale (GSRS)
Measured: One year after the treatment ended
Secondary outcomes (20)
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.
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.
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.
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.
Measured: One year after the treatment ended
Quality of life
The Irritable Bowel Syndrome Quality of Life Instrument
Measured: One week before the treatment starts
Quality of life
The Irritable Bowel Syndrome Quality of Life Instrument
Measured: 10 weeks after the treatment started
Quality of life
The Irritable Bowel Syndrome Quality of Life Instrument
Measured: 3 months after the treatment ended
Quality of life
The Irritable Bowel Syndrome Quality of Life Instrument
Measured: One year after the treatment ended
Gastrointestinal symptom-specific anxiety
Visceral Sensitivity Index
Measured: One week before the treatment starts
Gastrointestinal symptom-specific anxiety
Visceral Sensitivity Index
Measured: 10 weeks after the treatment started
Gastrointestinal symptom-specific anxiety
Visceral Sensitivity Index
Measured: 3 months after the treatment ended
Gastrointestinal symptom-specific anxiety
Visceral Sensitivity Index
Measured: One year after the treatment ended
Depressive symptoms
The Montgomery Åsberg Depression Rating Scale
Measured: One week before the treatment starts
Depressive symptoms
The Montgomery Åsberg Depression Rating Scale
Measured: 10 weeks after the treatment started
Depressive symptoms
The Montgomery Åsberg Depression Rating Scale
Measured: 3 months after the treatment ended
Depressive symptoms
The Montgomery Åsberg Depression Rating Scale
Measured: One year after the treatment ended
Functional impairments in work, social and family life
Sheenan Disability Scale (DSD)
Measured: One week before the treatment starts
Functional impairments in work, social and family life
Sheenan Disability Scale (DSD)
Measured: 10 weeks after the treatment started
Functional impairments in work, social and family life
Sheenan Disability Scale (DSD)
Measured: 3 months after the treatment ended
Functional impairments in work, social and family life
Sheenan Disability Scale (DSD)
Measured: One year after the treatment ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJun 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Investigators
- Nils Lindefors, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171053
- Sponsor's protocol ID
- IBS-S
- Status last verified
- Jul 2010
- First submitted
- 26 Jul 2010
- Last updated
- 28 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20362976
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Exposure and Mindfulness Based Therapy for Irritable Bowel Syndrome - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01171053
- Acronym / sponsor ID
- IBS-S
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Cognitive behavior therapy, Internet, Cost-effectiveness, Irritable bowel syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Jun 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention control | Placebo comparator | Behavioral: Therapist supportWeekly support from therapist without CBT-interventions |
| Internet CBT | Experimental | Behavioral: Internet-delivered CBTInternet-delivered cognitive behavioral therapy with therapist support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of IBS given by physician
- At screening fulfilling Rome III-criteria for IBS
Key exclusion criteria (3 listed)
- Severe depression
- Suicidal ideation
- Presence of unexplained IBS alarm symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered CBTInternet-delivered cognitive behavioral therapy with therapist support. | Behavioural | Internet CBT |
| Therapist supportWeekly therapist support without CBT-interventions | Behavioural | Attention control |
Primary outcome
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)
Gastrointestinal symptoms
Time frame: One year after the treatment ended
Gastrointestinal Symptom rating scale (GSRS)
20 secondary outcomes
Health economic data
Time frame: One week before the treatment starts
Health economic data
Time frame: 10 weeks after the treatment started
Health economic data
Time frame: 3 months after the treatment ended
Health economic data
Time frame: One year after the treatment ended
Quality of life
Time frame: One week before the treatment starts
Quality of life
Time frame: 10 weeks after the treatment started
Quality of life
Time frame: 3 months after the treatment ended
Quality of life
Time frame: One year after the treatment ended
Gastrointestinal symptom-specific anxiety
Time frame: One week before the treatment starts
Gastrointestinal symptom-specific anxiety
Time frame: 10 weeks after the treatment started
Gastrointestinal symptom-specific anxiety
Time frame: 3 months after the treatment ended
Gastrointestinal symptom-specific anxiety
Time frame: One year after the treatment ended
Depressive symptoms
Time frame: One week before the treatment starts
Depressive symptoms
Time frame: 10 weeks after the treatment started
Depressive symptoms
Time frame: 3 months after the treatment ended
Depressive symptoms
Time frame: One year after the treatment ended
Functional impairments in work, social and family life
Time frame: One week before the treatment starts
Functional impairments in work, social and family life
Time frame: 10 weeks after the treatment started
Functional impairments in work, social and family life
Time frame: 3 months after the treatment ended
Functional impairments in work, social and family life
Time frame: One year after the treatment ended
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2010.
- Results publication: PubMed 20362976Ljotsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils Lindefors, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered CBT and Therapist support in people with Irritable Bowel Syndrome, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal symptoms (time frame: One week before the treatment starts). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01171053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2010; AzTrials last refreshed its copy on 6 Nov 2026.