Hypnosis to improve sleep in menopause: Determination of optimal dose and method

描述（由申请人提供）：睡眠不佳是绝经过渡期妇女最常见但最不受关注的健康问题之一，睡眠不佳的患病率随着年龄的增长而增加。此外，睡眠不佳与其他健康问题的风险增加，处方睡眠药物的不良影响和死亡率有关;影响中年妇女的生活质量和健康。我们的实验室已经确定，催眠，当提供五（5），治疗师提供，个性化的催眠诱导可以改善自我报告的睡眠质量绝经后妇女提出的主要投诉潮热。然而，就目前的发展而言，催眠是劳动密集型的，不容易传播，因此限制了其潜在的公共卫生影响。如果能够开发出一种人员密集度更低、更容易传播的催眠程序，它可能会对中年妇女的睡眠产生巨大的公共卫生影响。此外，任何催眠程序对客观测量的睡眠的潜在影响尚未被研究，并且几乎没有数据用于估计效应大小。我们的长期目标是确定一种安全，有效，广泛传播的催眠干预治疗更年期过渡期的睡眠问题。本申请的目的是确定催眠程序的最佳剂量和递送方法，该催眠程序显示可行性、可接受的依从性以及对睡眠（主要结局）和其他次要结局（睡眠质量、失眠症状严重程度、白天嗜睡、更年期症状和疼痛）的初步影响。我们将招募80名绝经期女性进入2X2析因设计，以比较两种剂量（三次与五次）和两种催眠方法（录音与治疗师提供的诱导），并在基线和干预后4周，6周和8周进行评估。具体目标是：（1）确定四种催眠方案的可行性和依从性;（2）确定客观测量的睡眠持续时间的主要结局的初始效应量，包括实现临床有意义改善的妇女的百分比;（3）确定睡眠质量、失眠症状严重程度、白天嗜睡、更年期症状和疼痛的次要结局的初始效应量;和（4）潜在协变量的趋势，包括内源性因素（例如，年龄、种族/民族、绝经阶段）和外源性因素（例如，睡眠环境、社会经济状况）。统计分析将确定可行性（< 25%的脱落率;该计划的“良好”或更好的评级，以及<5%的不良事件）和依从性（> 75%的日常在家实践依从性）。主要和次要结局的估计效应量将使用标准方法和确定的最佳程序（例如，a >B>c>d）。对于连续协变量，将使用Pearson相关性分析潜在协变量的趋势（例如，年龄），以及分类协变量（例如，人口统计学/环境变量）t检验或方差分析。研究结果将提供必要的数据，以计划随后的R 01应用于多中心，大规模，随机对照试验。

DESCRIPTION (provided by applicant): Poor sleep is among the most frequent, yet least addressed, health concern among women during the menopause transition and the prevalence of poor sleep increases with age. In addition, poor sleep has been associated with increased risks for other health problems, adverse effects of prescription sleep medications, and mortality; affecting the quality of life and health of midlife women. Our laboratory has identified that hypnosis, when delivered with five (5), therapist delivered, individualized hypnosis inductions can improve self- reported sleep quality among postmenopausal women presenting with a primary complaint of hot flashes. However, as currently developed, hypnosis is labor intensive and not easily disseminable, thus, limiting its potential public health impact. If a hypnosis program could be developed that is less personnel-intensive and more easily disseminable, it could have a large public health impact on the sleep of midlife women. In addition, the potential impact of any hypnosis program on objectively measured sleep has not yet been examined and there is little data for effect size estimates. Our long range goal is to identify a safe, efficacius, and widely disseminable hypnosis intervention for the treatment of sleep problems during the menopause transition. The purpose of this application is to determine the optimal dose and delivery method for a hypnosis program that shows feasibility, acceptable adherence, and preliminary effects on sleep (primary outcomes) and other secondary outcomes (sleep quality, insomnia symptom severity, daytime sleepiness, menopausal symptoms, and pain). We will enroll 80 menopausal women into a 2X2 factorial design to compare two dosing (three vs. five sessions) and two delivery methods of hypnosis (audio recorded vs. therapist delivered inductions) with assessments at baseline and four, six, and eight weeks post-intervention. Specific aims are to (1) Determine the feasibility of and adherence to the four hypnosis programs; (2) Determine initial effect sizes for the primary outcome of objectively measured sleep duration, including the percent of women who achieve a clinically meaningful improvement; (3) Determine initial effect sizes for secondary outcomes of sleep quality, insomnia symptom severity, daytime sleepiness, menopausal symptoms, and pain; and (4) Trends in potential covariates including endogenous factors (e.g., age, race/ethnicity, menopausal stage) and exogenous factors (e.g., sleep environment, socioeconomic status). Statistical analysis will determine feasibility (< 25% dropout; rating of "good" or better for the program, and <5% adverse events) and adherence (> 75% compliance with daily at-home practice). Estimated effect sizes for primary and secondary outcomes will be calculated using standard methods and the optimal programs identified (e.g., a >b>c>d). Trends in potential covariates will be analyzed using Pearson correlations for continuous covariates (e.g., age), and for categorical covariates (e.g., demographic/environment variables) t tests or ANOVAs will be conducted, as appropriate. Findings will provide the requisite data to plan a subsequent R01 application for a multi-site, large-scale, randomized controlled trial.