Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

描述（由申请方提供）：雅阁NINR 2011年战略计划，将睡眠受损作为提高患者生活质量的优先事项，并使用行为策略管理慢性疾病，包括睡眠障碍，本提案旨在开发和评价绝经后和绝经后女性失眠和夜间潮热（nHF）的基于初级护理的干预措施。绝经期相关失眠与不良后果有关，包括生活质量降低，医疗保健利用增加，精神疾病和医疗条件的风险。雌激素和孕激素替代疗法的不良获益/风险比以及对镇静催眠药长期影响的担忧，使女性迫切需要新的方法来解决更年期相关的健康问题，包括睡眠不良。拟议的干预措施旨在开发和评估一种急需的安全治疗更年期相关失眠的方法，该方法结合并增强了失眠和潮热的认知行为疗法。为了最大限度地提高公共卫生的影响，改善访问，并减少治疗障碍（耻辱和交通问题），我们建议评估妇科诊所，妇女接受常规护理的护士提供的干预措施的疗效和有效性。主要结局是主观和客观测量的睡眠和nHF，研究设计最佳且有足够的把握度。本研究的目的是：1）在一项随机、安慰剂对照、初探性研究中，探索CBTMI和改良对照疗法假脱敏治疗绝经期相关失眠（DTMI）的可行性、可接受性（随机化意愿和脱落率），以及CBTMI的疗效/有效性指征; 2）探索CBTMI对nHF后觉醒/觉醒次数和持续时间的影响。如果有效，干预措施有可能改善绝经期和绝经后妇女的生活质量，并降低社会的重大成本。这项研究的成功完成取决于申请人提出的培训。正如职业发展计划所述，多学科专家团队将为候选人提供多个领域的高级培训和指导，包括：治疗开发，临床试验的设计和实施，初级保健提供模式，潮热的生理测量以及先进的定性和定量方法。这个职业发展奖的重点是帮助申请人建立新的专业知识，同时建立在非临床睡眠和更年期的研究培训。在这些领域的高级培训将作为候选人继续她的研究计划，并促进她作为一个独立的研究人员发展的良好基础。 公共卫生相关性：减少令人烦恼的更年期症状和相关的长期不良后果是NIH的高度优先事项。睡眠不佳是更年期的一个这样的健康问题，与不良后果相关，包括生活质量降低、医疗保健利用和成本增加以及精神疾病（例如，抑郁症）和医学状况（例如，肥胖、心血管疾病）。我们建议测试的有效性，初级保健为基础的，护士提供的，非药物干预，以改善更年期相关的失眠，从而提高生活质量，降低社会成本。

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. PUBLIC HEALTH RELEVANCE: 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.