Fibromyalgia Clinical Trial
Official title:
Health Promotion for Women With Fibromyalgia
Women with chronic disabling conditions such as fibromyalgia syndrome (FMS) must manage a wide variety of disease-related, intrapersonal, and environmental demands to maintain their health and quality of life. Engaging in health-promoting behaviors is one strategy recommended to manage disease symptoms and enhance quality of life (USDHHS, 2000). The purpose of this four-year study is to refine and test a theoretically and empirically based intervention to promote the health and well being of women with the chronic disabling condition of fibromyalgia. We hypothesize that women who participate in the "Lifestyle Counts" Intervention will report more greater self-efficacy for health behaviors, more frequent health behaviors and more positive health and quality of life than women in the comparison group.
This wellness intervention, originally developed and tested in a randomized clinical trial
of women with MS (N=113), resulted in significant improvements in self-efficacy, health
behaviors and improvements in pain, social functioning, mental health and emotional
role-functioning. The specific aims of this study are to examine the effects of the adapted
wellness intervention on self-efficacy, resources, barriers, health behaviors and health
outcomes for women with fibromyalgia.
A sample of 160 women with FMS will be recruited to participate in a randomized clinical
study to determine the effects of this wellness intervention that includes an eight week
health promotion/behavior change component and 3 months of follow-up phone support. Content
regarding stress management, lifestyle adjustment, physical activity, nutrition and women's
health issues will be presented with an emphasis on the unique adaptations and associated
skills required to empower women with the tools for exercising personal control over their
health behaviors. The effects of the intervention on outcome variables will be assessed over
an 8-month period with measurements at baseline, 2 months (immediately after the
educational/skill-building component), 5 months (after 3 months of phone support) and at 8
months.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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