RCT of the Effectiveness of Stepped-Care Sleep Therapy In General Practice (RESTING)

一般实践中分级护理睡眠疗法 (RESTING) 有效性的随机对照试验 (RCT)

• 批准号: 10160730
• 负责人: RACHEL MANBER
• 金额: $ 43.8万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10160730
• 关键词: Adoption; Adult; Affect; Age; American; American College of Physicians; Beer; Behavior Therapy; Caring; Characteristics; Clinic; Cognitive Therapy; Data; Dissemination and Implementation; Effectiveness; Elderly; Elements; Future; General Practices; Guidelines; Health Services Accessibility; Hybrids; Impaired cognition; Individual; Intervention; Maintenance; Methods; Modeling; Outcome Measure; Participant; Patient Participation Rates; Patients; Personal Satisfaction; Persons; Pharmaceutical Preparations; Primary Health Care; Professional Organizations; Provider; Psychotherapy; Qualitative Methods; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Resources; Rest; Risk; Safety; Science; Secondary to; Severities; Site; Sleep; Sleeplessness; Societies; Testing; Time; Training; Treatment Cost; Treatment Step; Use Effectiveness; Visual impairment; age group; care delivery; care providers; comparative; comparative effectiveness; compare effectiveness; design; economic evaluation; effective therapy; effectiveness evaluation; experience; fall risk; formative assessment; hypnotic; implementation evaluation; implementation process; improved; individual patient; middle age; primary outcome; programs; response; service gap; success; therapy development; treatment arm; treatment duration; treatment effect; zolpidem

Insomnia and use of sleep medications increase around age 50 and affect approximately one in three middle aged and older adults. Untreated insomnia is associated with a range of negative sequelae, including several, such as visual impairment, cognitive impairment, imbalance, and greater risk for falls that are specific to this older age group. In primary care, insomnia is treated with hypnotics; but even the newer and safer hypnotics are associated with cognitive impairment and risk of falls. Cognitive behavioral therapy for insomnia (CBTi) offers a viable alternative to hypnotic medications and could reduce their use, as recommended by the American Geriatric Society Beers Criteria. CBTi is a brief insomnia-focused psychotherapy that is as efficacious as a variety of hypnotic medications in the short-term and superior over the long-term. Although it is the recommended first line treatment for insomnia by the American College of Physicians, access to this safe and effective treatment is limited by current models of therapist-led delivery. Broad long term objectives: This proposal aims to fill in the science-to-service gap between proven efficacy of CBTi and future large scale implementation. We have developed and propose to test a primary-care-friendly stepped-care CBTi model (STEPPED CARE) that offers an easy to use Decision Checklist for matching delivery of CBTi to individual patient characteristics so that patients will begin treatment with the appropriate delivery mode. Specific aims: We propose to compare STEPPED CARE to an ONLINE ONLY program. We will focus on comparative effectiveness (Aims 1) and testing the Decision Checklist (Aim 2), as well as evaluating other aspects of the two-steps STEPPED CARE program, including the specific Checklist Criteria and the added benefit of the second step for those with insufficient response to the first step (Aim 3). We will perform a rigorous mixed-methods formative evaluation to guide future implementation and dissemination potential (Aim 4). Results will yield a simple and effective way for primary care providers to prescribe CBTi to middle aged and older adults. Methods: Participants will be randomized to receive ONLINE ONLY or STEPPED CARE CBTi. Primary outcomes are insomnia severity and the amount of hypnotic medications used, assessed over a 12 month period. A mix of quantitative and qualitative methods will be used to collect data from multiple steak-holders about the potential for reach, adoption, implementation, and maintenance of the two approaches. Impact: The proposed STEPPED CARE model for delivering CBTi has the potential to improve sleep, reduce use of hypnotic medication, and promote safety and wellbeing of middle aged and older adults. Importantly, it offers convenient access to treatment for patients, while using resources efficiently. Efficient use of resources will result from provision of the less expensive online CBTi as a first line of treatment to those who are likely to benefit from it so that the limited therapist-led treatment resources can be focused on patients who are less likely to benefit from online CBTi and to those for whom online treatment was unsuccessful.

在50岁左右，失眠和使用睡眠药物的人数增加，大约三分之一的中年人受到影响。 老年人和老年人。未经治疗的失眠与一系列负面后遗症有关，包括几个， 如视力障碍、认知障碍、不平衡和更大福尔斯跌倒风险 年龄段在初级保健中，失眠是用催眠药治疗的;但即使是更新和更安全的催眠药， 与认知障碍和福尔斯风险相关。失眠症的认知行为疗法（CBTi）提供了一种 可行的替代催眠药物，并可以减少其使用，如美国建议， 老年医学协会啤酒标准。CBTi是一种以失眠为重点的简短心理治疗， 各种催眠药物在短期和上级超过长期。虽然是 推荐的第一线治疗失眠的美国医师学院，获得这种安全， 有效的治疗受到目前治疗师主导的提供模式的限制。 广泛的长期目标：该提案旨在填补科学与服务之间的差距， CBTi和未来的大规模实施。我们已经开发并建议测试一个初级保健友好型 阶梯式护理CBTi模型（阶梯式护理），提供了一个易于使用的决策检查表， CBTi符合个体患者特征，以便患者开始使用适当的输送模式进行治疗。 具体目标：我们建议将阶梯式护理与仅在线计划进行比较。我们将专注于 比较有效性（目标1）和测试决策清单（目标2），以及评估其他方面的 两步阶梯式护理计划，包括具体的检查表标准和第二步的额外好处 第一步：对第一步反应不足的人（目标3）。我们将执行严格的混合方法 形成性评价，以指导今后的实施和传播潜力（目标4）。结果将产生一个 初级保健提供者为中老年人开CBTi处方的简单有效的方法。 方法：受试者将随机接受ONLINE ONLY或STEPPED CARE CBTi治疗。初级 结果是失眠的严重程度和催眠药物的使用量，在12个月内进行评估 期将使用定量和定性相结合的方法来收集来自多个牛排持有者的数据 关于这两种方法的普及、采用、实施和维护的潜力。 影响：用于提供CBTi的拟议阶梯式护理模型有可能改善睡眠，减少 催眠药物的使用，促进中老年人的安全和健康。重要的是 为患者提供方便的治疗途径，同时有效利用资源。有效利用资源 将导致提供较便宜的在线CBTi作为第一线治疗的那些谁可能会 受益于它，以便有限的治疗师主导的治疗资源可以集中在患者谁是较少 可能受益于在线CBTi和那些在线治疗不成功的人。