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Sleep to Reduce Incident Depression Effectively (STRIDE)

睡眠可有效减少抑郁事件 (STRIDE)

基本信息

批准号：
10348176
负责人：
CHRISTOPHER L DRAKE
金额：
$ 60.73万
依托单位：
HENRY FORD HEALTH SYSTEM
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-04-01 至 2024-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10348176
关键词：
Accidents Address Behavior Behavioral Caring Chronic Clinical Clinical Trials Cognitive Cognitive Therapy Data Detection Development Disease Disease remission Dissemination and Implementation Effectiveness Exposure to Future Goals Health Services Accessibility Impairment Improve Access Incidence Individual Injury Intervention Major Depressive Disorder Mediating Mediator of activation protein Mental Depression Mental Health Modeling Online Systems Outcome Participant Patients Pharmaceutical Preparations Plant Roots Population Populations at Risk Predictive Value Prevention Prevention strategy Preventive care Preventive measure Primary Health Care Provider Randomized Recurrence Reduce health disparities Relapse Research Residual state Resistance Resources Risk Risk Factors Safety Sampling Sequential Multiple Assignment Randomized Trial Sleep Sleeplessness Specialist Symptoms Testing Therapeutic Thinking Time Training Treatment Efficacy Treatment outcome abuse liability base care systems clinical care clinical practice clinically significant critical period depression prevention depressive symptoms digital disorder prevention disorder risk effectiveness evaluation evidence base expectation falls flexibility follow up assessment follow-up high risk hypnotic improved innovation low socioeconomic status medical specialties mobile application modifiable risk prevent preventive intervention primary care setting public health priorities racial minority recruit relapse prediction risk stratification rumination sedative sleep health targeted treatment treatment effect treatment response trial design

项目摘要

Prevention of major depressive disorder (MDD) is a public health priority. Innovative strategies to identify those at-risk for MDD are in critical need to appropriately direct preventive care. Individuals with insomnia are >3 times more likely to develop depression than normal sleepers. Insomnia precedes ~50% of all incident and relapse depression cases. Thus, insomnia may serve as an entry point for preventing MDD. Our preliminary data not only show that insomnia treatment alleviates depressive symptoms, but may also reduce likelihood of future depression development, thereby identifying insomnia a viable target for depression prevention. Identification and treatment of insomnia typically occurs in primary care and is commonly treated with hypnotic medications. However, hypnotics have significant limitations, including residual impairment, injury due to falls and accidents, and abuse potential. Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as first-line treatment for its safety advantages and superior treatment efficacy. Unfortunately, widespread implementation of CBT-I is severely limited by the national shortage of trained practitioners in clinical practice. Innovative stepped care approaches rooted in primary care hold potential to increase access to care, which may improve insomnia therapeutics and reduce rates of MDD by targeting a robust yet modifiable risk factor in insomnia. Our proposal uses digital CBT-I (dCBT-I) as a widely available first-line intervention to increase care access and reduce need for specialist resources. Our proposal also adds clinician-based face-to-face CBT-I only for treatment-resistant patients who need a more personalized and flexible approach from specialty care. We propose a large-scale stepped care clinical trial in the primary care setting that utilizes sequential, multiple assignment, randomized trial (SMART) design to determine the effectiveness of dCBT-I alone and in combination with face-to-face CBT-I for insomnia and the prevention of MDD. An important innovative component of the trial is the 1- and 2-year follow-up assessments to determine the durability of effectiveness over time and assess the impact on MDD incidence and relapse. Early risk-detection and prevention is especially critical in those at elevated risk for depression to reduce health disparities. Thus, individuals with elevated vulnerability to MDD (e.g., low socioeconomic status and racial minorities) will be included in significant numbers to test for potential moderation of treatment effects stratified by risk. Finally, dCBT-I and CBT-I have been shown to reduce rumination (negative repetitive thinking), which may help mitigate MDD development. As such, we will determine whether changes in rumination (a modifiable risk- factor and potential key therapy target) mediates the effects of our stepped care model on MDD prevention. This project will test a highly scalable model of sleep care in a large primary care system to determine the potential for wide dissemination and implementation to address the high volume of population need for safe and effective insomnia treatment and associated prevention of depression.

预防重度抑郁症（MDD）是公共卫生的首要任务。创新策略识别那些有 MDD 风险的人迫切需要适当指导预防性护理。患有失眠症的人有患抑郁症的可能性是正常睡眠者的 3 倍以上。约 50% 的事件发生之前都是失眠抑郁症复发病例。因此，失眠可以作为预防MDD的切入点。我们的初步数据表明，失眠治疗不仅可以缓解抑郁症状，还可以降低患上抑郁症的可能性未来抑郁症的发展，从而确定失眠是预防抑郁症的可行目标。失眠的识别和治疗通常发生在初级保健中，通常采用以下方法治疗：安眠药。然而，催眠药有很大的局限性，包括残余损伤、因催眠引起的损伤等。跌倒和事故以及滥用潜力。推荐针对失眠的认知行为疗法（CBT-I）因其安全性优势和优越的治疗效果而成为一线治疗。不幸的是，广泛传播由于全国缺乏经过培训的临床实践人员，CBT-I 的实施受到严重限制。植根于初级保健的创新阶梯式护理方法有可能增加获得护理的机会，这可以通过针对一个强大但可改变的危险因素来改善失眠疗法并降低MDD的发生率失眠。我们的提案使用数字 CBT-I (dCBT-I) 作为广泛使用的一线干预措施来加强护理访问并减少对专业资源的需求。我们的提案还增加了基于临床医生的面对面 CBT-I 仅适用于需要专业护理更加个性化和灵活方法的难治性患者。我们建议在初级保健环境中进行一项大规模的阶梯式护理临床试验，该试验利用顺序、多重分配、随机试验 (SMART) 设计，以确定单独使用 dCBT-I 以及联合使用 dCBT-I 的有效性与面对面 CBT-I 结合治疗失眠和预防 MDD。一项重要的创新该试验的组成部分是一年和两年的后续评估，以确定有效性的持久性随着时间的推移，评估对 MDD 发病率和复发的影响。早期风险检测和预防是对于那些抑郁症风险较高的人来说，减少健康差距尤其重要。因此，具有以下特征的个体 MDD 的脆弱性较高（例如社会经济地位低下和少数族裔）将被纳入显着的数字来测试按风险分层的治疗效果的潜在调节。最后，dCBT-I 和 CBT-I 已被证明可以减少反刍（消极的重复思维），这可能帮助减轻 MDD 的发展。因此，我们将确定沉思是否发生变化（可改变的风险- 因素和潜在的关键治疗目标）介导我们的阶梯式护理模式对 MDD 预防的影响。该项目将在大型初级保健系统中测试高度可扩展的睡眠护理模型，以确定广泛传播和实施的潜力，以满足大量人口的安全需求以及有效的失眠治疗和抑郁症的相关预防。