Sara Nowakowski, Ph.D. - US grants

DESCRIPTION (provided by applicant): 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.

PROJECT SUMMARY/ABSTRACT Consistent with NINR and NCMRR priorities to address sleep disorders in the context of rehabilitation, this proposal aims to evaluate the efficacy of a nonpharmacological intervention for insomnia among older patients recovering from hip or knee arthroplasty. Almost half of the 15 million older patients hospitalized each year report disrupted sleep during their hospital visit. Sleep complaints can persist for several months following hospitalization and are associated with functional impairment during and following discharge. Further, daytime sequela of insomnia, such as diminished attention/concentration and fatigue, may serve to undermine and limit the effectiveness of rehabilitation. Thus, the proposed study aims to evaluate a much-needed safe treatment for insomnia (cognitive behavioral therapy for insomnia) in conjunction with medical rehabilitation to manage insomnia symptoms and promote functional health. Improving sleep is expected to enhance rehabilitation, by increasing patients' abilities to attend and adhere to rehabilitation recommendations. 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 and physical and occupational therapists hospital bedside and in the home environment. The central hypothesis is that tailored CBTI delivered during and following hospitalization will improve sleep and functional outcomes in older adults receiving medical rehabilitation and is guided by the following aims: (1) to evaluate the efficacy of CBTI in a randomized, placebo-controlled trial, and (2) to determine the effectiveness of CBTI on rehabilitation and health outcomes. Primary outcomes, for which the study is optimally designed and sufficiently powered, are subjectively- and objectively-measured sleep. Secondary outcomes, for which we are unable to estimate power are functional (motor, cognition, independence) outcomes. We will also explore the relationship of treatment response to other health outcomes, including level of inflammation, medication use, fatigue, pain intensity, and depressive symptom severity. Our team has extensive experience in designing and implementing behavioral health clinical trials for older adults within hospital and community-based settings. If effective the sleep intervention has the potential to optimize functional gains in rehabilitation and reduce adverse health outcomes, thereby improving quality of life and reducing significant costs to society.