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）是公共卫生的优先事项。识别的创新策略那些高危的MDD迫切需要适当指导预防保健。失眠的人是抑郁症的可能性是正常卧铺的可能性的3倍。失眠占所有事件的约50％，并且复发抑郁案病例。因此，失眠可以作为预防MDD的切入点。我们的初步数据不仅表明失眠治疗可以减轻抑郁症状，而且还可能降低未来的抑郁症发育，从而确定失眠是预防抑郁症的可行目标。失眠症的识别和治疗通常发生在初级保健中，通常由催眠药。但是，催眠药有重大局限性，包括残留损害，应付伤害跌倒和事故，以及滥用潜力。建议对失眠症（CBT-I）进行认知行为疗法作为其安全优势和出色治疗功效的一线治疗。不幸的是，普遍存在 CBT-I的实施受到临床实践中训练有素的从业人员短缺的严重限制。植根于初级护理的创新阶梯护理方法具有增加获得护理的潜力，这可以通过针对强大但可修改的危险因素来改善失眠症的治疗剂并降低MDD的速率失眠。我们的建议使用数字CBT-I（DCBT-I）作为广泛可用的一线干预措施来增加护理访问并减少对专业资源的需求。我们的建议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中更个性化和灵活方法的耐药患者。我们在初级保健环境中提出了一项大规模的阶梯护理临床试验，该试验利用顺序的，多次任务，随机试验（智能）设计，以确定DCBT-I的有效性结合面对面的CBT-I用于失眠和预防MDD。重要的创新该试验的组成部分是1年和2年的随访评估，以确定有效性的持久性随着时间的流逝，并评估对MDD发病率和复发的影响。早期风险检测和预防是对于抑郁症风险升高的人尤其至关重要。因此，有个人较高的MDD脆弱性（例如，社会经济地位低下和少数群体）将包括在内大量数量以测试由风险分层的潜在适度治疗效应。最后，已证明DCBT-I和CBT-I可以减少反省（负重复思维），这可能帮助减轻MDD开发。因此，我们将确定是否反省变化（可改变的风险 - 因子和潜在的关键疗法靶标）介导了我们阶梯护理模型对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，以满足人口大量安全需求以及有效的失眠治疗以及相关的抑郁症。