Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

认知行为疗法治疗更年期失眠和夜间潮热

• 批准号: 8551712
• 负责人: Sara Nowakowski
• 金额: $ 12.48万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-27 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8551712
• 关键词: Address; Area; Arousal; Behavior; Behavior Therapy; Behavioral; Benefits and Risks; British; Cardiovascular Diseases; Chronic Disease; Clinic; Clinical Research; Clinical Trials; Cognitive Therapy; Consensus; Development; Development Plans; Dropout; Effectiveness; Effectiveness of Interventions; Electroencephalography; Elements; Eligibility Determination; Estrogens; Fostering; Foundations; Galvanic Skin Response; Goals; Gynecology; Health; Hormones; Hot flushes; Improve Access; Internet; Intervention; K-Series Research Career Programs; Knowledge; Left; Long-Term Effects; Measurement; Measures; Medical; Menopausal Symptom; Menopause; Mental Depression; Mental disorders; Mentors; Methods; Modeling; Monitor; Night Sweating; Nurses; Obesity; Patient Self-Report; Patients; Perimenopause; Pharmaceutical Preparations; Physiological; Pilot Projects; Placebo Control; Polysomnography; Postmenopause; Primary Health Care; Probability; Progesterone; Public Health; Publishing; Quality of life; Questionnaires; Randomized; Regimen; Replacement Therapy; Reporting; Research; Research Personnel; Research Training; Risk; Science; Severities; Sleep; Sleep disturbances; Sleeplessness; Societies; Strategic Planning; Symptoms; Testing; Time; Training; Transportation; United States; United States National Institutes of Health; Vasomotor; Weight; Woman; adverse outcome; awake; base; care delivery; career development; cost; depressive symptoms; desensitization; design; diaries; effective intervention; effective therapy; efficacy testing; follow-up; health care service utilization; hypnotic; improved; indexing; meetings; minimal risk; multidisciplinary; novel strategies; post intervention; primary outcome; programs; prospective; routine care; sedative; social stigma; symposium; therapy development; willingness

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.

描述（由申请人提供）：根据NINR 2011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估基于初级保健的干预措施，用于绝经前后妇女的失眠和夜间潮热（nHF）。更年期相关的失眠与不良后果相关，包括生活质量下降、医疗保健使用率增加、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长期影响的担忧，使妇女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。提出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影响，改善可及性，减少治疗障碍（污名化和运输问题），我们建议评估妇科诊所护士提供的干预措施的功效和效果。妇科诊所是妇女接受常规护理的地方。主要结果是主观和客观测量的睡眠和nHF，这项研究是经过优化设计和充分支持的。本研究的目的是：1)在一项随机、安慰剂对照的试点研究中，探讨CBTMI和改良对照疗法伪脱敏治疗绝经相关失眠（DTMI）的可行性、可接受性（随机化意愿和辍学率）以及CBTMI的疗效/有效性指证；2)探讨CBTMI对nHFs后唤醒/觉醒次数和持续时间的影响。如果有效，该干预措施有可能改善围绝经期和绝经后妇女的生活质量，并减少对社会的重大成本。这项研究的成功完成取决于申请人所建议的培训。正如职业发展计划中概述的那样，一个多学科专家团队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。这个职业发展奖项的重点是帮助申请人建立新的专业知识，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项目和培养她作为独立研究人员的发展奠定良好的基础。