Irritable Bowel SyndromeNCT01051973
Cognitive Behavior Therapy (CBT) Compared to Stress Management for Irritable Bowel Syndrome
A study testing Cognitive behavior therapy and Stress management in people with Irritable Bowel Syndrome, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks. 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?
- Cognitive behavior therapy and Stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2009to Dec 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 Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.
The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks.
Approximately 200 patients will be included in the study and randomized to either condition.
The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Cognitive behavior therapy, Stress management
- Keywords
- Cognitive behavior therapy, exposure, stress management
- 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.
Cognitive behavior therapyBehavioural
A 10-week treatment based on exposure to symptoms and related feelings.
Stress managementBehavioural
A 10-week stress management treatment including applied relaxation and dietary advice.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavior therapy | Experimental | Not described Receives: Behavioral: Cognitive behavior therapy |
| Stress management | Active comparator | Not described Receives: Behavioral: Stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of IBS symptoms
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
Measured: During 4 consecutive weeks before randomization
Level of IBS symptoms
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
Measured: During 4 consecutive weeks after treatment completion (10 weeks after randomization)
Level of IBS symptoms
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
Measured: During 4 consecutive weeks 6 months after treatment completion
Secondary outcomes (6)
Quality of life
The Irritable Bowel Syndrome Quality of Life Instrument
Measured: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Use of health care resources and societal production loss because of illness
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry
Measured: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Level of IBS-symptoms
IBS-Severity Scoring System
Measured: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Anxiety related to gastrointestinal symptoms
Visceral Sensitivity Index
Measured: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Level of daily stress
Perceived stress scale
Measured: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Subjective relief of IBS-symptoms
One question: "In the past week, have you had adequate relief from IBS pain or discomfort?"
Measured: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Brjann Ljotsson, Karolinska Institutet
- Investigators
- Nils Lindefors, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051973
- Sponsor's protocol ID
- IBS-X
- Status last verified
- Jan 2012
- First submitted
- 19 Jan 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT01051973
- Acronym / sponsor ID
- IBS-X
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Cognitive behavior therapy, exposure, stress management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Jan 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 study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks.
Approximately 200 patients will be included in the study and randomized to either condition.
The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavior therapy | Experimental | Behavioral: Cognitive behavior therapy |
| Stress management | Active comparator | Behavioral: Stress management |
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 |
|---|---|---|
| Cognitive behavior therapyA 10-week treatment based on exposure to symptoms and related feelings. | Behavioural | Cognitive behavior therapy |
| Stress managementA 10-week stress management treatment including applied relaxation and dietary advice. | Behavioural | Stress management |
Primary outcome
Level of IBS symptoms
Time frame: During 4 consecutive weeks before randomization
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
Level of IBS symptoms
Time frame: During 4 consecutive weeks after treatment completion (10 weeks after randomization)
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
Level of IBS symptoms
Time frame: During 4 consecutive weeks 6 months after treatment completion
The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment.
6 secondary outcomes
Quality of life
Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Use of health care resources and societal production loss because of illness
Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Level of IBS-symptoms
Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Anxiety related to gastrointestinal symptoms
Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Level of daily stress
Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
Subjective relief of IBS-symptoms
Time frame: Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion
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 5 Jan 2012.
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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 Cognitive behavior therapy and Stress management 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 5 Jan 2012. 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?
Level of IBS symptoms (time frame: During 4 consecutive weeks before randomization). 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?
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 5 Jan 2012.