Irritable Bowel SyndromeNCT00844961
Effectiveness of Internet Delivered Cognitive Behavior Therapy (CBT) for Irritable Bowel Syndrome (IBS)
A study testing Internet delivered cognitive behavior therapy in people with Irritable Bowel Syndrome, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a gastroenterological clinic. The recruitment will be consecutive with all patients receiving the diagnosis being offered to participate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Internet delivered cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2008to Feb 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Irritable Bowel Syndrome according to Rome III criteria
Who cannot join
- History of inflammatory bowel disease (IBD)
- Symptom debut after age of 50
- Ongoing severe mental illness (psychosis, severe depression, suicidal ideation, bipolar disease)
- Inability to participate in internet delivered treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effectiveness of Internet Delivered Cognitive Behavior Therapy in a Sample of Consecutively Recruited Patients Diagnosed With Irritable Bowel Syndrome
The study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a gastroenterological clinic. The recruitment will be consecutive with all patients receiving the diagnosis being offered to participate. After recruitment and 3 week baseline measure of IBS symptoms they will be randomised to either 10 weeks of internet delivered CBT or waiting list. After treatment IBS-symptoms are measured again to assess treatment effectiveness. All patients on waiting list are offered the same treatment as patients randomised to treatment.
All patients are assessed 12 months after completion of treatment.
Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms and quality of life compared to patients on waiting list.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Internet delivered cognitive behavior therapy
- Keywords
- IBS, CBT, Internet treatment, Cognitive behavior therapy
- 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 cognitive behavior therapyBehavioural
Also called CBT
10 weeks of internet delivered cognitive behavior therapy targeted at reducing experience of IBS symptoms and improving quality of life. Patients are offered guidance via email by a therapist.
| Study group | Role | What they receive |
|---|---|---|
| Internet CBT | Experimental | 10 weeks of internet delivered cognitive behaviour therapy Receives: Behavioral: Internet delivered cognitive behavior therapy |
| Waiting list | No intervention | Waiting list which is offered treatment after completion of post intervention assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
Measured: Before treatment
The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
Measured: After treatment
The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionFeb 2011
- Study completionFeb 2011
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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Allmänna arvsfonden, Region Stockholm, Königska-Söderströmska sjukhemmet, Aleris Helse
- Investigators
- Nils Lindefors, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844961
- Sponsor's protocol ID
- IBS-K
- Status last verified
- Feb 2009
- First submitted
- 13 Feb 2009
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ljotsson B, Andersson G, Andersson E, Hedman E, Lindfors P, Andreewitch S, Ruck C, Lindefors N. Acceptability, effectiveness, and cost-effectiveness of internet-based exposure treatment for irritable bowel syndrome in a clinical sample: a randomized controlled trial. BMC Gastroenterol. 2011 Oct 12;11:110. doi: 10.1186/1471-230X-11-110.
PubMed 21992655
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of Internet Delivered Cognitive Behavior Therapy in a Sample of Consecutively Recruited Patients Diagnosed With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00844961
- Acronym / sponsor ID
- IBS-K
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, CBT, Internet treatment, Cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Allmänna arvsfonden, Region Stockholm, Königska-Söderströmska sjukhemmet, Aleris Helse
- Study start
- Nov 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 16 Feb 2009 (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 study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a gastroenterological clinic. The recruitment will be consecutive with all patients receiving the diagnosis being offered to participate. After recruitment and 3 week baseline measure of IBS symptoms they will be randomised to either 10 weeks of internet delivered CBT or waiting list. After treatment IBS-symptoms are measured again to assess treatment effectiveness. All patients on waiting list are offered the same treatment as patients randomised to treatment.
All patients are assessed 12 months after completion of treatment.
Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms 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 |
|---|---|---|
| Internet CBT | Experimental | Behavioral: Internet delivered cognitive behavior therapy10 weeks of internet delivered cognitive behaviour therapy |
| Waiting list | No intervention | –Waiting list which is offered treatment after completion of post intervention assessments |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Irritable Bowel Syndrome according to Rome III criteria
Key exclusion criteria (4 listed)
- History of inflammatory bowel disease (IBD)
- Symptom debut after age of 50
- Ongoing severe mental illness (psychosis, severe depression, suicidal ideation, bipolar disease)
- Inability to participate in internet delivered treatment
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 cognitive behavior therapyAlso: CBT10 weeks of internet delivered cognitive behavior therapy targeted at reducing experience of IBS symptoms and improving quality of life. Patients are offered guidance via email by a therapist. | Behavioural | Internet CBT |
Primary outcome
The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
Time frame: Before treatment
The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
Time frame: After treatment
The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS)
Time frame: 12 months after treatment
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 9 Nov 2011.
- Derived from this study: PubMed 21992655Ljotsson B, Andersson G, Andersson E, Hedman E, Lindfors P, Andreewitch S, Ruck C, Lindefors N. Acceptability, effectiveness, and cost-effectiveness of internet-based exposure treatment for irritable bowel syndrome in a clinical sample: a randomized controlled trial. BMC Gastroenterol. 2011 Oct 12;11:110. doi: 10.1186/1471-230X-11-110.
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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 cognitive behavior therapy 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 1 inclusion and 4 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 9 Nov 2011. 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. 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?
The Gastrointestinal Symptom Rating Scale - IBS Version (GSRS-IBS) (time frame: Before treatment). The study lists 3 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 NCT00844961, 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 9 Nov 2011.