MINDFULNESS or social support for irritable Bowel Syndrome
Women with irritable bowel syndrome (IBS) often have abdominal pain and other unpleasant bowel symptoms. To help them reduce or cope with their IBS symptoms, this research study will compare the value of two eight-week programs. In both programs, women of all ages will meet once per week in a group. The first group, a support group, will center on sharing information about successful strategies for coping with and reducing symptoms of IBS. The second, mindfulness, combines gentle yoga with a meditation technique. Both programs have shown promise for helping people with long-standing illnesses.
What Else Should I Know?
If you decide to join this study, you will join a group of women for two hours once each week and for 4 hours one Saturday. In addition, you will meet with the Study Coordinator to fill out questionnaires.
What will happen if i join the study?
Your group will be chosen for you randomly by a computer program. Both groups will be led by an experienced health coach and group facilitator. In the support group, she will first introduce the topic of the week and then encourage group discussion and sharing. In the mindfulness group, she will lead the training program. This includes awareness of breathing and working with emotions.
Are there any reasons i should not be in this study?
You should not be in this study if you are unable to attend a 2- hour meeting on a Monday afternoon or evening for 8 weeks. In addition, you should not participate if you are pregnant or you have one of the following disorders: severe mental illness; inflammatory bowel disease (ulcerative colitis or Crohn’s disease); cancer; active liver or pancreas disease; uncontrolled lactose intolerance; celiac disease; or a history of major abdominal surgery.
What are the possible benefits?
Research is designed to benefit society by gaining new knowledge. Being in this study may reduce your IBS symptoms themselves or reduce the stress those symptoms cause you. However, there is no guarantee that you will receive any benefit.
What are the possible risks?
Risks associated with mindfulness meditation or support group activity are minimal; there is no evidence that mindfulness or support group activities worsen the symptoms of IBS. However, the following may occur:
- transient sleepiness, lasting hours to up to a day (relaxation related to mindfulness);
- anxiety and mood swings (early in mindfulness training);
- mild soreness related to the gentle yoga postures (in mindfulness training); and
- awkwardness in discussing bowel symptoms with others (in the support group).
Sharing personal information is entirely up to you—it is never required.
Will i be paid?
To compensate you for your time, you will be receiving a $50 for each time you fill out a set of questionnaires, for a total of $250. If needed, parking vouchers will also be provided.
Will it cost me anything to be in this study?
It will not cost you anything in addition to be in the study.
Funded by NIH R21 AT003619-01
This flyer was approved by the University of North Carolina Biomedical Institutional Review Board for use from 4/ 24 /2006 to 4/ 24 /2007 |
