BACKGROUND & AIMS: A randomized clinical trial was used to test the effectiveness of an 8-session multicomponent program (Comprehensive) compared to a Brief (single session) version and Usual Care for women with irritable bowel syndrome. METHODS:Menstruating women, ages 18-48 years, were recruited from a health maintenance organization as well as community advertisements. Psychiatric nurse practitioners delivered both programs. The primary outcomes were improved symptoms, psychological distress, health-related quality of life, and indicators of stress-related hormones. Outcome indicators were measured at 3 points: (1) immediately after the Comprehensive program or 9 weeks after entry into the Usual Care and Brief Self-Management groups, (2) at 6 months, and (3) at 12 months. RESULTS: Compared to Usual Care, women in the Comprehensive program had reduced gastrointestinal symptoms, psychological distress indicators, interruptions in activities because of symptoms, and enhanced quality of life that persisted at the 12-month follow-up evaluation. Women in the Brief group also demonstrated statistically significant improvements in quality of life and smaller nonsignificant improvements in other outcome variables than observed in the Comprehensive group. There were no group differences in urine catecholamines and cortisol levels. CONCLUSIONS: A comprehensive self-management program is an important therapy approach for women with irritable bowel syndrome. The Brief 1-session version is also moderately helpful for some women with IBS.
RCT Entities:
BACKGROUND & AIMS: A randomized clinical trial was used to test the effectiveness of an 8-session multicomponent program (Comprehensive) compared to a Brief (single session) version and Usual Care for women with irritable bowel syndrome. METHODS: Menstruating women, ages 18-48 years, were recruited from a health maintenance organization as well as community advertisements. Psychiatric nurse practitioners delivered both programs. The primary outcomes were improved symptoms, psychological distress, health-related quality of life, and indicators of stress-related hormones. Outcome indicators were measured at 3 points: (1) immediately after the Comprehensive program or 9 weeks after entry into the Usual Care and Brief Self-Management groups, (2) at 6 months, and (3) at 12 months. RESULTS: Compared to Usual Care, women in the Comprehensive program had reduced gastrointestinal symptoms, psychological distress indicators, interruptions in activities because of symptoms, and enhanced quality of life that persisted at the 12-month follow-up evaluation. Women in the Brief group also demonstrated statistically significant improvements in quality of life and smaller nonsignificant improvements in other outcome variables than observed in the Comprehensive group. There were no group differences in urine catecholamines and cortisol levels. CONCLUSIONS: A comprehensive self-management program is an important therapy approach for women with irritable bowel syndrome. The Brief 1-session version is also moderately helpful for some women with IBS.
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