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

催眠改善更年期睡眠：最佳剂量和方法的确定

• 批准号: 8851523
• 负责人: Gary R Elkins
• 金额: $ 20.83万
• 依托单位: BAYLOR UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8851523
• 关键词: Address; Adherence; Adverse effects; Adverse event; Affect; Age; American; Cardiovascular Diseases; Clinical Trials; Collaborations; Data; Diabetes Mellitus; Dose; Dropout; Emergency department visit; Endogenous Factors; Enrollment; Environment; Ethnic Origin; Exogenous Factors; Goals; Health; Healthcare; Home environment; Hot flushes; Hour; Human Resources; Hypnosis; Intervention; Knowledge; Laboratories; Life; Link; Measurement; Measures; Menopausal Status; Menopausal Symptom; Menopause; Methods; Morbidity - disease rate; National Center for Complementary and Alternative Medicine; Pain; Participant; Patient Self-Report; Pharmaceutical Preparations; Postmenopause; Prevalence; Productivity; Public Health; Quality of life; Questionnaires; Race; Randomized Clinical Trials; Randomized Controlled Trials; Recording of previous events; Reporting; Research; Research Design; Risk; Severities; Site; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Socioeconomic Status; Staging; Symptoms; Testing; Treatment Protocols; Woman; Work; Wrist; actigraphy; alternative treatment; design; diaries; hormone therapy; improved; innovation; malignant breast neoplasm; middle age; mortality; obesity risk; post intervention; primary outcome; programs; public health relevance; satisfaction; secondary outcome; statistics; success; trend

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.

描述（由申请人提供）：睡眠不佳是更年期过渡期间女性最常见但却最少被关注的健康问题之一，而且睡眠不佳的患病率随着年龄的增长而增加。此外，睡眠不足还会增加其他健康问题的风险、处方睡眠药物的不良影响和死亡率；影响中年妇女的生活质量和健康。我们的实验室已经确定，当治疗师提供五(5)个体化催眠诱导时，可以改善以潮热为主诉的绝经后妇女自我报告的睡眠质量。然而，按照目前的发展，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。如果能开发出一种人员密集程度较低、更容易传播的催眠项目，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得到检验，而且几乎没有效应大小估计的数据。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给药方法，以显示可行性，可接受的依从性，以及对睡眠（主要结果）和其他次要结果（睡眠质量，失眠症状严重程度，白天嗜睡，更年期症状和疼痛）的初步影响。我们将80名绝经期妇女纳入2X2因子设计，比较两种剂量（3次与5次）和两种催眠递送方式（录音与治疗师递送诱导），并在基线和干预后4、6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大小，包括达到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、更年期症状和疼痛等次要结局的初始效应量；(4)潜在协变量的趋势，包括内源性因素（如年龄、种族/民族、绝经期）和外源性因素（如睡眠环境、社会经济地位）。统计分析将确定可行性（< 25%的辍学率；该计划的“良好”或更好评级，不良事件<5%）和依从性（每天在家练习的依从性≥75%）。将使用标准方法计算主要和次要结果的估计效应大小，并确定最佳方案（例如，a b> b>c>d）。对于连续协变量（如年龄），将使用Pearson相关性分析潜在协变量的趋势，对于分类协变量（如人口统计学/环境变量），将酌情进行t检验或方差分析。研究结果将提供必要的数据，以计划后续的R01应用于多地点、大规模、随机对照试验。