The cyclicity of menstruation has a profound effect on women's lives and maladaptation to normal menstrual cyclicity, or disregulation of the menstrual cycle, has been found to result in disease and illness. In this study, a randomized clinical trial design will be used to determine the effectiveness of an experimental treatment aimed at relieving the symptom and stress experience associated with Premenstrual Syndrome (PMS), a chronically recurring and complex women's health problem. This study builds upon previous work of the investigator to develop nursing interventions and test the effectiveness of symptom management, stress reduction, and health promoting strategies for perimenstrual negative affect (PNA) symptoms, the most distressing type of PMS.
Specific aims of this study are: (1) to determine the short-term effectiveness of a multi-modal, prescriptive treatment aimed at reducing PNA symptom severity, decreasing stress perception and response, and improving health practices for women experiencing PMS. Symptomatic women with high severity PNA symptoms will be randomized to a treatment group and a delayed treatment (control) group, (2) to determine the intermediate and long-term effectiveness of the prescriptive treatment aimed at maintaining reduced PNA symptom severity, decreased stress perception and response, and improved health practices in the women experiencing PNA symptoms, and (3) to describe the intraindividual differences in the choice of elements from the experimental treatment package (self-monitoring, self-regulatory, self-modification, and/or environmental modification strategies). A staged screening, randomization, and treatment process will randomize 50 women to the experimental group (the PMS-Symptom Management Program) and 50 women to a delayed treatment control group. Daily hormone measures will be obtained during 4 menstrual cycles (baseline, 3 post-treatment cycles). Repeated behavioral measures will be obtained on multiple occasions: baseline (3 menstrual cycles) and 5 occasions post-- treatment. Treatment effects will be assessed by clinical indicators that address the following outcome measures: PNA severity, stress response (salivary cortisol), stress perception, health practices (nutrition, exercise, self-care activities), and health service utilization. Data analysis will include a between-group comparison of experimental and delayed treatment (control) groups across time, and a within-group analysis of treatment choice and effects.
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