Sleep to Reduce Incident Depression Effectively (STRIDE)

预防严重抑郁障碍(MDD)是公共卫生的优先事项。创新战略，以确定 MDD高危人群迫切需要适当指导预防护理。失眠症患者有 患抑郁症的可能性是正常睡眠者的3倍。失眠在所有事故中约占50%， 复发性抑郁症病例。因此，失眠可以作为预防MDD的切入点。我们的预赛 数据显示，失眠治疗不仅可以缓解抑郁症状，还可能降低患上 未来抑郁症的发展，从而确定失眠是预防抑郁症的一个可行的目标。 失眠的识别和治疗通常发生在初级保健中，通常使用 催眠药。然而，催眠药有很大的局限性，包括残留损伤、应得的损伤 到跌倒和事故，还有滥用的可能性。失眠的认知行为疗法(CBT-I)是推荐的 作为一线治疗，以其安全的优势和优越的治疗效果。不幸的是，广泛的 CBT-I的实施受到国家临床实践中训练有素的从业人员短缺的严重限制。 创新的分级保健办法植根于初级保健，有可能增加获得保健的机会，这 可以改善失眠治疗并降低MDD的发生率，因为它针对的是 失眠。我们的方案使用数字CBT-I(dCBT-I)作为广泛使用的第一线干预措施，以增加护理 访问并减少对专家资源的需求。我们的建议还增加了基于临床医生的面对面CBT-I 仅适用于那些需要从专科护理中获得更个性化和更灵活的方法的难治性患者。 我们建议在初级保健环境中进行大规模阶梯式保健临床试验，利用序贯、 多分配随机试验(SMART)设计，以确定dCBT-I单独和联合用药的有效性 联合面对面CBT-I治疗失眠及预防MDD。一项重要的创新 试验的组成部分是为期一年和两年的跟踪评估，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。及早发现和预防风险是 对于那些抑郁风险较高的人来说尤其重要，以减少健康差距。因此，拥有 MDD易感性增加(例如，社会经济地位低和少数族裔)将列入 要测试按风险分层的治疗效果的潜在缓解程度的显著数字。 最后，dCBT-I和CBT-I已被证明可以减少沉思(消极的重复思维)，这可能 帮助缓解MDD开发。因此，我们将确定沉思的变化(一种可修改的风险- 因素和潜在的关键治疗目标)调节了我们的分级护理模式在MDD预防方面的效果。 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，以满足大量人口对安全的需求 并有效治疗失眠和联合预防抑郁症。

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.