The proposed study is a competitive renewal of the investigators' NINR funded study entitled """"""""nursing Study of IBS: Improving Outcomes."""""""" The current study builds directly on the investigator's study of a non-pharmacologic intervention entitled individualized comprehensive self-management to reduce GI symptoms and enhance quality of life in women (ages 20-45) with IBS. In that study women with IBS who received a comprehensive self-management program had significant reductions in GI symptoms, psychological distress, and improved quality of life compared to women in the usual care and brief educational intervention groups. Despite the positive outcomes associated with the intervention, the results may not be generalizable to men or to women of peri-menopausal and post-menopausal age.
The aims of the proposed study are to 1) test the effectiveness of the face-to-face individualized comprehensive self-management program and a telephone version of the instrument relative to a usual care group in men and women with IBS. Outcome measures will be GI symptoms, sleep disturbance, psychological distress, sickness impact, and health related quality of life (HRQOL) and 2) explore the relationship between GI symptom improvement and a decrease in psychological distress as measured by prospective reports of anxiety and depression, and retrospective reports of global psychological distress and explore the relationship between decrease in physiological arousal as measured by basal catecholamine levels and basal cortisol levels in both men and women. A three group randomized clinical trial with longitudinal follow-up will be used to test the effectiveness of face to face (n=60) versus telephone comprehensive self-management program (n=60), relative to a usual care control group (n=60). Outcome measures will be measured during the baseline assessment phase, and at 3, 6, and 12 months following randomization. This study is important because health care providers working with patients with IBS are challenged in that the underlying pathology is not well defined and there are limited drug treatments available. To date, non-pharmacological intervention trials have been limited by small sample size, lack of attention to gender specific issues, and only a few included long-term follow-ups.
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