In accord with the NINR 2011 strategic plan to address impaired sleep as a priority for advancing patients' quality of life and using behavioral strategies for the management of chronic diseases, including disturbed sleep, this proposal aims to develop and evaluate a primary care-based intervention for insomnia and nocturnal hot flashes (nHF) in peri- and postmenopausal women. Menopause-associated insomnia is associated with adverse consequences including reduced quality of life, increased health care utilization, and risk for psychiatric disorders and medical conditions. The poor benefit/risk ratioof estrogen and progesterone replacement therapy and concerns about long-term effects of sedative hypnotics has left women desperate for new approaches to resolve menopause-related health problems, including poor sleep. The proposed intervention aims to develop and evaluate a much-needed safe treatment of menopause-associated insomnia that combines and enhances cognitive behavioral therapies for insomnia and hot flashes. To maximize the public health impact, improve access, and reduce treatment barriers (stigma and transportation issues), we propose to evaluate the efficacy and effectiveness of the intervention delivered by nurses in gynecology clinics, where women receive routine care. Primary outcomes, for which the study is optimally designed and sufficiently powered, are subjectively- and objectively-measured sleep and nHF.
The Aims of this research are to: 1) To explore feasibility, acceptability (willingness to be randomized and dropout rates) of CBTMI and modified control therapy Pseudo-Desensitization Treatment for menopause-associated insomnia (DTMI), and indications of efficacy/effectiveness of CBTMI in a randomized, placebo-controlled, pilot study; 2) explore the effects of CBTMI on the number and duration of arousals/awakenings that follow nHFs. If effective, the intervention has the potential to improve the quality of life in peri- and postmenopausal women and reduce the significant costs to society. Successful completion of this research is contingent upon the applicant's proposed training. As outlined in the Career Development Plan, a multidisciplinary team of experts will provide the candidate with advanced training and mentoring in several areas, including: treatment development, design and implementation of clinical trials, primary care delivery models, physiological measurement of hot flashes, and advance qualitative and quantitative methods. This career development award focuses on assisting the applicant in establishing new expertise while building upon prior research training in nonclinical sleep and menopause. Advanced training in these areas will serve as an excellent foundation for the candidate to continue her program of research and foster her development as an independent researcher.
The reduction of bothersome menopausal symptoms and associated long-term adverse consequences is a high priority in NIH. Poor sleep is one such health issue of menopause, associated with adverse consequences including reduced quality of life, increased health care utilization and costs, and risk for psychiatric disorders (e.g., depression) and medical conditions (e.g., obesity, cardiovascular disease). We propose to test the effectiveness of a primary care based, nurse-delivered, non-pharmacological intervention to improve menopause-associated insomnia, thereby improving quality of life and reducing costs to society.
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