Irritable Bowel SyndromeNCT00880256
Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data
A study testing mindfulness-based stress reduction in people with Irritable Bowel Syndrome, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
Trial summary
Irritable bowel syndrome (IBS) is a very common, chronic disorder that significantly affects quality of life, and results in enormous expenditures each year in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- mindfulness-based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patient who enroll in a MBSR course
Who cannot join
- Psychosis, borderline personality, active substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Irritable bowel syndrome (IBS) is a very common, chronic disorder that significantly affects quality of life, and results in enormous expenditures each year in the United States. Therapy for IBS is generally unsatisfactory, and takes an additive approach whereby medications are prescribed according to each type of symptom the patient experiences. Accumulating evidence indicates that persons with IBS have a heightened perception of stress, and chronic stress has been shown to have a significant impact on IBS symptomatology. Mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health and decreased stress perception. The clinical literature suggests that mindfulness-based interventions may lead to improvement in many disorders including chronic pain, stress, anxiety, eating disorders and depressive relapse. The purpose of this study is to collect survey pilot data to determine whether an 8-week program of mindfulness-based stress reduction (MBSR) improves symptoms and quality of life for persons with IBS. Patients in the 8-week MBSR program are referred as part of their clinical care, and we seek approval only to collect survey data before and after the MBSR course. This study will evaluate whether there is sufficient evidence of efficacy to warrant a full clinical trial of MBSR.
Read the detailed description
Aim 1: Apply measures of IBS symptom severity, depression and quality of life before and after the MBSR course, to assess whether there is evidence of benefit, and allow calculation of standardized effect sizes. Aim 2: Apply a validated measure of mindfulness before and after treatment. Aim 3: Explore the relationship between IBS symptoms, mindfulness score, and frequency of mindfulness practice.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- mindfulness-based stress reduction
- Keywords
- irritable bowel, mindfulness, stress, meditation
- 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.
mindfulness-based stress reductionBehavioural
An 8-week course in mindfulness training
| Study group | Role | What they receive |
|---|---|---|
| MBSR | Experimental | Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course. Receives: Behavioral: mindfulness-based stress reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score)
The Irritable Bowel Severity Scoring System (IBSSS) provides a measure of the severity of IBS. The measure consists of five questions, which assess severity of abdominal pain, number of days with abdominal pain in past 10 days, severity of abdominal distension, satisfaction with bowel habits, and impact of IBS on life in general. The score on each of the 5 questions ranges from 0 to 100, and the scores are summed with a range of total possible scores from 0 to 500. Higher scores reflect more severe IBS. Total score was used in the analyses.
Measured: 6 months
Secondary outcomes (1)
Irritable Bowel Syndrome (IBS) Quality of Life
The IBS-QOL is a disease specific Quality-of-Life Measure for IBS. IBS-QOL has been shown have a high level of content validity and to be responsive to change, and has been used in several outcome studies and clinical drug trials throughout the world. It consists of 34 questions that assess the influence of bowel habits on daily life. The response to each question is rated on a 5-point scale. A lower score indicates worse bowel-related quality of life. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startSep 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kearney, Seattle Institute for Biomedical and Clinical Research
- Investigators
- David Kearney, MD, Principal investigator, VA Puget Sound Heatlh Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880256
- Sponsor's protocol ID
- 0013
- Status last verified
- Jan 2012
- First submitted
- 10 Apr 2009
- Last updated
- 27 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Stress Reduction for Bowel Symptoms: Collection of Pilot Survey Data
- ClinicalTrials.gov ID
- NCT00880256
- Acronym / sponsor ID
- 0013
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel, mindfulness, stress, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Posted 27 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Irritable bowel syndrome (IBS) is a very common, chronic disorder that significantly affects quality of life, and results in enormous expenditures each year in the United States. Therapy for IBS is generally unsatisfactory, and takes an additive approach whereby medications are prescribed according to each type of symptom the patient experiences. Accumulating evidence indicates that persons with IBS have a heightened perception of stress, and chronic stress has been shown to have a significant impact on IBS symptomatology. Mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health and decreased stress perception. The clinical literature suggests that mindfulness-based interventions may lead to improvement in many disorders including chronic pain, stress, anxiety, eating disorders and depressive relapse. The purpose of this study is to collect survey pilot data to determine whether an 8-week program of mindfulness-based stress reduction (MBSR) improves symptoms and quality of life for persons with IBS. Patients in the 8-week MBSR program are referred as part of their clinical care, and we seek approval only to collect survey data before and after the MBSR course. This study will evaluate whether there is sufficient evidence of efficacy to warrant a full clinical trial of MBSR.
Detailed description
Aim 1: Apply measures of IBS symptom severity, depression and quality of life before and after the MBSR course, to assess whether there is evidence of benefit, and allow calculation of standardized effect sizes. Aim 2: Apply a validated measure of mindfulness before and after treatment. Aim 3: Explore the relationship between IBS symptoms, mindfulness score, and frequency of mindfulness practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBSR | Experimental | Behavioral: mindfulness-based stress reductionPatients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patient who enroll in a MBSR course
Key exclusion criteria (1 listed)
- Psychosis, borderline personality, active substance abuse
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 |
|---|---|---|
| mindfulness-based stress reductionAn 8-week course in mindfulness training | Behavioural | MBSR |
Primary outcome
IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score)
Time frame: 6 months
The Irritable Bowel Severity Scoring System (IBSSS) provides a measure of the severity of IBS. The measure consists of five questions, which assess severity of abdominal pain, number of days with abdominal pain in past 10 days, severity of abdominal distension, satisfaction with bowel habits, and impact of IBS on life in general. The score on each of the 5 questions ranges from 0 to 100, and the scores are summed with a range of total possible scores from 0 to 500. Higher scores reflect more severe IBS. Total score was used in the analyses.
1 secondary outcome
Irritable Bowel Syndrome (IBS) Quality of Life
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
David Kearney, MD principal investigator
VA Puget Sound Heatlh Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based stress reduction in people with Irritable Bowel Syndrome, run by Seattle Institute for Biomedical and Clinical Research at 1 site in United States.
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 1 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 27 Feb 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score) (time frame: 6 months). 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 27 Feb 2012.