Expired Study
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Chapel Hill, North Carolina 27599


Purpose:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


Study is Available At:


Original ID:

R21 AT003619-02


NCT ID:

NCT00680693


Secondary ID:

R21AT003619-02


Study Acronym:

M-IBS


Brief Title:

Mindfulness vs. Support Groups for Irritable Bowel Syndrome


Official Title:

Mindfulness for Irritable Bowel Syndrome


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of North Carolina, Chapel Hill


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

75


Enrollment Type:

Actual


Overall Contact Information

Official Name:Susan A Gaylord, PhD
Principal Investigator
University of North Carolina, Chapel Hill

Study Dates

Start Date:October 2006
Completion Date:August 2010
Completion Type:Actual
Primary Completion Date:August 2010
Primary Completion Type:Actual
Verification Date:February 2010
Last Changed Date:November 17, 2011
First Received Date:May 15, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Daily Symptom Diary
Time Frame:Daily x 10 weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:IBS QOL
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Coping Strategies Questionnaire (CSQ)
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:State Trait-Anger Expression Inventory (STAXI)
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Brief Symptom Inventory (BSI)
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Recent Physical Symptoms Questionnaire (RPSQ)
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Work Productivity and Activity Impairment for IBS (WPAI:IBS)
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Visceral Sensitivity Index
Time Frame:3 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:IBS-S
Time Frame:3 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Mindfulness training
Description:8 weekly 2-hour classes
Arm Name:1
Intervention Type:Behavioral
Name:Psycho-educational support group for women with IB
Description:8 weekly 2-hour meetings
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Mindfulness-based stress management 8-week program
Study Arm Type:Active Comparator
Arm Name:2
Description:Psycho-educational support group for women with IBS

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of North Carolina, Chapel Hill
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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