Irritable Bowel SyndromeM-IBSNCT00680693
Mindfulness vs. Support Groups for Irritable Bowel Syndrome
A study testing Mindfulness training and Psycho-educational support group for women with IBS in people with Irritable Bowel Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Irritable bowel syndrome (IBS) is a common and disabling functional disorder characterized by significant abdominal discomfort and disturbed defecation. It affects over 10% of U.S. adults (14% women, 8% men), resulting in major disability, impaired quality of life, and a significant health-care burden. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Mindfulness training and Psycho-educational support group for women with IBS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older, female, English-speaking, confirmed IBS meeting Rome II criteria with a minimum duration of symptoms of six months and under the care of a physician for IBS; able to provide informed consent; willing and able to document IBS symptoms and use of medications, as well as complete the assessment instruments. Subjects must be willing to attend and participate in 8 weekly Mindfulness Program or Support Group sessions.
Who cannot join
- Evidence of severe neuropsychological impairment or psychosis, significant depression, anxiety, a history of an inpatient admission for psychiatric disorder within the past two years; pregnancy or anticipated pregnancy; undergoing active treatment for a major medical illness such as malignancy, diabetes, autoimmune or immune deficiency disorder; a history of inflammatory bowel disease, gastrointestinal malignancy, active liver or pancreatic disease including diabetes, uncontrolled lactose intolerance, celiac disease, a history of abdominal trauma or surgery, cognitive impairment that prevents understanding or responding to study questions; prior history of mindfulness meditation training. Given the highly verbal nature of the interventions, otherwise eligible patients who do not speak or write English will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Mindfulness for Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a common and disabling functional disorder characterized by significant abdominal discomfort and disturbed defecation. It affects over 10% of U.S. adults (14% women, 8% men), resulting in major disability, impaired quality of life, and a significant health-care burden. Conventional management of IBS is only partially effective in some patients and includes use of medications, behavioral modification, dietary approaches, and lifestyle changes such as exercise and stress reduction. Although behavioral treatments such as cognitive behavioral therapy and hypnosis have been among the most effective treatments, they are costly to deliver.
Mindfulness meditation, a complementary/alternative medicine (CAM) therapy taught in groups, is a unique self-regulatory, mind-body approach in which practitioners learn to attend to present-moment experiences, letting go of fixation on negative emotions and thoughts of past and future. It has been found to be effective in reducing chronic pain and stress and in ameliorating disorders with similarities to IBS, including fibromyalgia, headache, and depression.
The overall goals of this exploratory, pilot study of women with IBS are to compare mindfulness meditation training to a patient support group (a previously validated control condition) in a small, randomized controlled clinical trial, in order to assess the feasibility of a larger, definitive trial. Specific aims are to evaluate primary and secondary outcome measures, to assess expectancy of benefit and scales measuring mindfulness (process measures), and to identify barriers to conducting such a trial in our setting. Sixty women meeting Rome II diagnostic criteria for IBS will be randomly assigned to one of two treatments - mindfulness meditation training or a support group - and will undergo 8 weekly group sessions plus a single day-long session. The primary outcome measure is improvement on the validated Irritable Bowel Symptom Severity Scale from pretreatment to the end of treatment, with follow-up at 3, 6, and 12 months. Additional variables address alternative endpoints (e.g., Adequate Relief of IBS symptoms, disease specific quality of life) and mechanism of treatment effects (e.g., coping scales, psychological symptoms, Visceral Sensitivity Scale). The multidisciplinary research team includes physicians, psychologists, and educators.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Mindfulness training, Psycho-educational support group for women with IBS
- Keywords
- IBS, functional gastrointestinal disease
- Medical subject headings
- Irritable Bowel Syndrome, Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
8 weekly 2-hour classes
Psycho-educational support group for women with IBSBehavioural
8 weekly 2-hour meetings
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Mindfulness-based stress management 8-week program Receives: Behavioral: Mindfulness training |
| 2 | Active comparator | Psycho-educational support group for women with IBS Receives: Behavioral: Psycho-educational support group for women with IBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-S
Measured: 3 months
Secondary outcomes (8)
Visceral Sensitivity Index
Measured: 3 months
Work Productivity and Activity Impairment for IBS (WPAI:IBS)
Measured: 3 months
Recent Physical Symptoms Questionnaire (RPSQ)
Measured: 3 months
Brief Symptom Inventory (BSI)
Measured: 3 months
State Trait-Anger Expression Inventory (STAXI)
Measured: 3 months
Coping Strategies Questionnaire (CSQ)
Measured: 3 months
IBS QOL
Measured: 3 months
Daily Symptom Diary
Measured: Daily x 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startOct 2006
- Primary completionAug 2010
- Study completionAug 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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Susan Gaylord, University of North Carolina, Chapel Hill
- Investigators
- Susan A Gaylord, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680693
- Sponsor's protocol ID
- R21AT003619-02
- Other IDs
- R21AT003619-02
- Acronym
- M-IBS
- Status last verified
- Feb 2010
- First submitted
- 15 May 2008
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gaylord SA, Whitehead WE, Coble RS, Faurot KR, Palsson OS, Garland EL, Frey W, Mann JD. Mindfulness for irritable bowel syndrome: protocol development for a controlled clinical trial. BMC Complement Altern Med. 2009 Jul 28;9:24. doi: 10.1186/1472-6882-9-24.
PubMed 19638214
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00680693
- Acronym / sponsor ID
- M-IBS / R21AT003619-02
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, functional gastrointestinal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Oct 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 20 May 2008 (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.
Irritable bowel syndrome (IBS) is a common and disabling functional disorder characterized by significant abdominal discomfort and disturbed defecation. It affects over 10% of U.S. adults (14% women, 8% men), resulting in major disability, impaired quality of life, and a significant health-care burden. Conventional management of IBS is only partially effective in some patients and includes use of medications, behavioral modification, dietary approaches, and lifestyle changes such as exercise and stress reduction. Although behavioral treatments such as cognitive behavioral therapy and hypnosis have been among the most effective treatments, they are costly to deliver.
Mindfulness meditation, a complementary/alternative medicine (CAM) therapy taught in groups, is a unique self-regulatory, mind-body approach in which practitioners learn to attend to present-moment experiences, letting go of fixation on negative emotions and thoughts of past and future. It has been found to be effective in reducing chronic pain and stress and in ameliorating disorders with similarities to IBS, including fibromyalgia, headache, and depression.
The overall goals of this exploratory, pilot study of women with IBS are to compare mindfulness meditation training to a patient support group (a previously validated control condition) in a small, randomized controlled clinical trial, in order to assess the feasibility of a larger, definitive trial. Specific aims are to evaluate primary and secondary outcome measures, to assess expectancy of benefit and scales measuring mindfulness (process measures), and to identify barriers to conducting such a trial in our setting. Sixty women meeting Rome II diagnostic criteria for IBS will be randomly assigned to one of two treatments - mindfulness meditation training or a support group - and will undergo 8 weekly group sessions plus a single day-long session. The primary outcome measure is improvement on the validated Irritable Bowel Symptom Severity Scale from pretreatment to the end of treatment, with follow-up at 3, 6, and 12 months. Additional variables address alternative endpoints (e.g., Adequate Relief of IBS symptoms, disease specific quality of life) and mechanism of treatment effects (e.g., coping scales, psychological symptoms, Visceral Sensitivity Scale). The multidisciplinary research team includes physicians, psychologists, and educators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Mindfulness trainingMindfulness-based stress management 8-week program |
| 2 | Active comparator | Behavioral: Psycho-educational support group for women with IBSPsycho-educational support group for women with IBS |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older, female, English-speaking, confirmed IBS meeting Rome II criteria with a minimum duration of symptoms of six months and under the care of a physician for IBS; able to provide informed consent; willing and able to document IBS symptoms and use of medications, as well as complete the assessment instruments. Subjects must be willing to attend and participate in 8 weekly Mindfulness Program or Support Group sessions.
Key exclusion criteria (1 listed)
- Evidence of severe neuropsychological impairment or psychosis, significant depression, anxiety, a history of an inpatient admission for psychiatric disorder within the past two years; pregnancy or anticipated pregnancy; undergoing active treatment for a major medical illness such as malignancy, diabetes, autoimmune or immune deficiency disorder; a history of inflammatory bowel disease, gastrointestinal malignancy, active liver or pancreatic disease including diabetes, uncontrolled lactose intolerance, celiac disease, a history of abdominal trauma or surgery, cognitive impairment that prevents understanding or responding to study questions; prior history of mindfulness meditation training. Given the highly verbal nature of the interventions, otherwise eligible patients who do not speak or write English will be excluded from this study.
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 training8 weekly 2-hour classes | Behavioural | 1 |
| Psycho-educational support group for women with IBS8 weekly 2-hour meetings | Behavioural | 2 |
Primary outcome
IBS-S
Time frame: 3 months
8 secondary outcomes
Visceral Sensitivity Index
Time frame: 3 months
Work Productivity and Activity Impairment for IBS (WPAI:IBS)
Time frame: 3 months
Recent Physical Symptoms Questionnaire (RPSQ)
Time frame: 3 months
Brief Symptom Inventory (BSI)
Time frame: 3 months
State Trait-Anger Expression Inventory (STAXI)
Time frame: 3 months
Coping Strategies Questionnaire (CSQ)
Time frame: 3 months
IBS QOL
Time frame: 3 months
Daily Symptom Diary
Time frame: Daily x 10 weeks
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 18 Nov 2011.
- Derived from this study: PubMed 19638214Gaylord SA, Whitehead WE, Coble RS, Faurot KR, Palsson OS, Garland EL, Frey W, Mann JD. Mindfulness for irritable bowel syndrome: protocol development for a controlled clinical trial. BMC Complement Altern Med. 2009 Jul 28;9:24. doi: 10.1186/1472-6882-9-24.
Related trials for Irritable Bowel Syndrome
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Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
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The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
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Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
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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.
Susan A Gaylord, PhD principal investigator
University of North Carolina, Chapel Hill
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 training and Psycho-educational support group for women with IBS in people with Irritable Bowel Syndrome, run by University of North Carolina, Chapel Hill 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 18 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 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?
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?
IBS-S (time frame: 3 months). 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 NCT00680693, 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 18 Nov 2011.