Irritable Bowel SyndromeNCT01529567
Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome
A study testing Cognitive Behavioral Therapy without exposure and Cognitive Behavioral Therapy with exposure in people with Irritable Bowel Syndrome, run by Karolinska Institutet.
Trial summary
Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral. They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. 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 Behavioral Therapy without exposure and Cognitive Behavioral Therapy with exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Dec 2012
- 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
- Fluency in Swedish
- IBS-diagnosis established by physician
- Fulfillment of Rome III criteria for IBS
Who cannot join
- Diarrhea predominance with no colonoscopy performed
- Blood in stool without benign medical explanation
- Rapid weight loss without benign medical explanation
- Ongoing alcohol or drug abuse
- Suicidal ideation
About this study
Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral. They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both programs include mindfulness training, education about how excessive avoidant and control behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One of the programs also includes instructions on how to perform systematic exposure. The hypothesis of the study is while both groups will show improvement in terms of IBS symptom severity and quality of life, the addition of systematic exposure will lead to more improvement in symptoms.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Cognitive Behavioral Therapy without exposure, Cognitive Behavioral Therapy with exposure
- 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 Behavioral Therapy without exposureBehavioural
10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, and guided behavioral change aiming to increase quality of life and flexibility.
Cognitive Behavioral Therapy with exposureBehavioural
10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, guided behavioral change aiming to increase quality of life and flexibility, and systematic exposure to IBS symptoms and aversive situations.
| Study group | Role | What they receive |
|---|---|---|
| CBT without exposure | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Therapy without exposure |
| CBT with exposure | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy with exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptom rating scale
Measured: 1 week before randomization
Gastrointestinal symptom rating scale
Measured: 10 weeks after randomization (i.e. after conclusion of treatment)
Gastrointestinal symptom rating scale
Measured: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
Secondary outcomes (6)
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Measured: 1 week before randomization
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Measured: 10 weeks after randomization (i.e. after conclusion of treatment)
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Measured: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
Visceral Sensitivity Index (VSI)
Measured: 1 week before randomization
Visceral Sensitivity Index (VSI)
Measured: 10 weeks after randomization (i.e. after conclusion of treatment)
Visceral Sensitivity Index (VSI)
Measured: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
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
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brjann Ljotsson, Karolinska Institutet
- Investigators
- Brjánn Ljótsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529567
- Sponsor's protocol ID
- IBS-0
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2012
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wallen H, Lindfors P, Andersson E, Hedman-Lagerlof E, Hesser H, Lindefors N, Svanborg C, Ljotsson B. Return on investment of internet delivered exposure therapy for irritable bowel syndrome: a randomized controlled trial. BMC Gastroenterol. 2021 Jul 13;21(1):289. doi: 10.1186/s12876-021-01867-6.
PubMed 34256715
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01529567
- Acronym / sponsor ID
- IBS-0
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Feb 2012 (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.
Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral. They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both programs include mindfulness training, education about how excessive avoidant and control behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One of the programs also includes instructions on how to perform systematic exposure. The hypothesis of the study is while both groups will show improvement in terms of IBS symptom severity and quality of life, the addition of systematic exposure will lead to more improvement in symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT without exposure | Active comparator | Behavioral: Cognitive Behavioral Therapy without exposure |
| CBT with exposure | Experimental | Behavioral: Cognitive Behavioral Therapy with exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fluency in Swedish
- IBS-diagnosis established by physician
- Fulfillment of Rome III criteria for IBS
Key exclusion criteria (5 listed)
- Diarrhea predominance with no colonoscopy performed
- Blood in stool without benign medical explanation
- Rapid weight loss without benign medical explanation
- Ongoing alcohol or drug abuse
- Suicidal ideation
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 Behavioral Therapy without exposure10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, and guided behavioral change aiming to increase quality of life and flexibility. | Behavioural | CBT without exposure |
| Cognitive Behavioral Therapy with exposure10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, guided behavioral change aiming to increase quality of life and flexibility, and systematic exposure to IBS symptoms and aversive situations. | Behavioural | CBT with exposure |
Primary outcome
Gastrointestinal symptom rating scale
Time frame: 1 week before randomization
Gastrointestinal symptom rating scale
Time frame: 10 weeks after randomization (i.e. after conclusion of treatment)
Gastrointestinal symptom rating scale
Time frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
6 secondary outcomes
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Time frame: 1 week before randomization
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Time frame: 10 weeks after randomization (i.e. after conclusion of treatment)
Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)
Time frame: 36 weeks after randomization (i.e. 6 months after conclusion of treatment)
Visceral Sensitivity Index (VSI)
Time frame: 1 week before randomization
Visceral Sensitivity Index (VSI)
Time frame: 10 weeks after randomization (i.e. after conclusion of treatment)
Visceral Sensitivity Index (VSI)
Time frame: 36 weeks after randomization (i.e. 6 months after conclusion of 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 15 Feb 2013.
- Derived from this study: PubMed 34256715Wallen H, Lindfors P, Andersson E, Hedman-Lagerlof E, Hesser H, Lindefors N, Svanborg C, Ljotsson B. Return on investment of internet delivered exposure therapy for irritable bowel syndrome: a randomized controlled trial. BMC Gastroenterol. 2021 Jul 13;21(1):289. doi: 10.1186/s12876-021-01867-6.
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NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
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.
Brjánn Ljótsson, PhD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy without exposure and Cognitive Behavioral Therapy with exposure in people with Irritable Bowel Syndrome, run by Karolinska Institutet.
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 3 inclusion and 5 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 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Gastrointestinal symptom rating scale (time frame: 1 week 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?
On the ClinicalTrials.gov record for NCT01529567, 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 15 Feb 2013.