Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

描述(由申请人提供)：根据NINR 2011年的战略计划，将睡眠受损作为提高患者生活质量的优先事项，并使用行为策略来管理包括睡眠障碍在内的慢性病，本提案旨在开发和评估针对围绝经期和绝经后女性失眠和夜间潮热(NHF)的初级保健干预。与更年期相关的失眠与不良后果相关，包括生活质量下降、卫生保健利用率增加以及精神疾病和医疗状况的风险。雌激素和黄体酮替代疗法的低收益/风险比，以及对镇静催眠药的长期影响的担忧，让女性迫切需要新的方法来解决与更年期相关的健康问题，包括睡眠不佳。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治疗失眠和潮热的认知行为疗法。为了最大限度地影响公共健康，改善获得机会，并减少治疗障碍(耻辱和交通问题)，我们建议评估妇科诊所护士提供的干预的有效性和有效性，妇女在那里接受常规护理。这项研究的主要结果是主观和客观测量的睡眠和NHF，这项研究经过了优化设计和充分的动力。这项研究的目的是：1)在一项随机、安慰剂对照的先导研究中，探讨CBTMI和改良对照疗法伪脱敏疗法治疗更年期相关失眠(DTMI)的可行性、可接受性(随机化意愿和辍学率)，以及CBTMI疗效/有效性的适应症；2)探索CBTMI对nHFs后觉醒/觉醒的次数和持续时间的影响。如果有效，这种干预措施有可能改善围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者所建议的培训。如《职业发展计划》所述，多学科专家小组将在几个领域为候选人提供高级培训和指导，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。这一职业发展奖的重点是帮助申请者建立新的专业知识，同时建立在先前的非临床睡眠和更年期研究培训的基础上。这些领域的高级培训将为候选人继续她的研究计划并促进她作为一名独立研究人员的发展奠定良好的基础。

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.