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

描述(申请人提供)：睡眠不佳是更年期妇女中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，睡眠不佳还会增加其他健康问题的风险，处方睡眠药物的不良影响，以及死亡率；影响中年妇女的生活质量和健康。我们的实验室已经确定，当提供五(5)个治疗师提供的个性化催眠诱导时，可以改善以潮热为主诉的绝经后妇女的自我报告睡眠质量。然而，就目前的发展而言，催眠是劳动密集型的，而且不易传播，因此限制了其对公共健康的潜在影响。如果能开发出一种人员密集度较低、更容易传播的催眠计划，它可能会对中年女性的睡眠产生重大的公共健康影响。此外，任何催眠程序对客观测量的睡眠的潜在影响还没有被检查，而且几乎没有数据来估计效果大小。我们的长期目标是确定一种安全、有效和可广泛传播的催眠干预措施，用于治疗更年期过渡期间的睡眠问题。本申请的目的是确定催眠方案的最佳剂量和交付方法，该方案显示了可行性、可接受的坚持和对睡眠(主要结果)和其他次要结果(睡眠质量、失眠症状严重程度、日间嗜睡、更年期症状和疼痛)的初步影响。我们将80名更年期妇女纳入2X2析因设计，以比较两次剂量(三次与五次)和两种催眠方法(录音与治疗师提供的诱导)在基线以及干预后4、6和8周的评估。具体目标是(1)确定四种催眠方案的可行性和坚持；(2)确定客观测量的睡眠持续时间的主要结果的初始效果大小，包括临床上有意义的改善的女性的百分比；(3)确定睡眠质量、失眠症状严重程度、日间嗜睡、更年期症状和疼痛的次要结果的初始效果大小；以及(4)潜在协变量的趋势，包括内生因素(例如，年龄、种族/民族、绝经阶段)和外部因素(例如，睡眠环境、社会经济状况)。统计分析将确定可行性(&lt；25%的辍学；该计划的评级为“良好”或更好，以及&lt；5%的不良事件)和依从性(&gt；75%的日常在家实践)。将使用标准方法和确定的最佳方案(例如，a&gt；b&gt；c&gt；d)计算主要和次要结果的估计效果大小。将对连续协变量(如年龄)和分类协变量(如人口/环境变量)使用皮尔逊相关性分析潜在协变量的趋势，并将酌情进行t检验或ANOVA。研究结果将为多点、大规模、随机对照试验的后续R01应用计划提供必要的数据。

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.