Ignite Creation Date:
2024-05-05 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00680693
Status:
COMPLETED
Last Update Posted:
2011-11-18
First Post:
2008-05-15
Brief Title:
Mindfulness vs Support Groups for Irritable Bowel Syndrome
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Mindfulness for Irritable Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
M-IBS
Brief 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 US 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 complementaryalternative 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 eg Adequate Relief of IBS symptoms disease specific quality of life and mechanism of treatment effects eg coping scales psychological symptoms Visceral Sensitivity Scale The multidisciplinary research team includes physicians psychologists and educators
Mindfulness meditation a complementaryalternative 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 eg Adequate Relief of IBS symptoms disease specific quality of life and mechanism of treatment effects eg coping scales psychological symptoms Visceral Sensitivity Scale The multidisciplinary research team includes physicians psychologists and educators
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AT003619-02 | NIH | None | httpsreporternihgovquickSearchR21AT003619-02 |