A Wearable Morning Light Treatment for Postpartum Depression: Confirming Efficacy and Mechanisms

摘要 作为最常见的妊娠并发症之一，美国近60万女性患有 每年都有产后抑郁症。产后抑郁症的后果是深远的，包括 母亲自杀、功能障碍、子代发育受损和精神疾病。尽管 在目前的治疗模式下，高患病率和严重后果不到16% 患有产后抑郁症的妇女接受了治疗，总共只有3.2%的人得到了缓解。治疗 对哺乳期和哺乳期间药物治疗的担忧影响了这一人群的摄取率 对新生儿的需求。新的治疗方法消除了获得医疗保健固有的重大障碍 产后期，例如家庭提供的非药物治疗，是迫切需要的。在 觉醒/调节系统的研究领域标准(RDoC)领域，昼夜节律系统和 它与睡眠-觉醒周期的对准--称为相角差--代表了一种很有前途的新奇事物 治疗目标。早晨的强光疗法提前了昼夜节律，是一种有效的抗抑郁剂 季节性和非季节性抑郁症。重要的是，强光疗法是一种非药物干预。 这是在家中管理的。然而，它对产后抑郁症的疗效和作用机制 没有得到确认。此外，通过灯箱提供的传统光疗对产后的效用有限。 妇女，因为使用者在治疗过程中必须保持静止，这可能会使婴儿暴露在光线下。穿过 最近的技术创新，可穿戴的强光治疗设备(即Re-Timer®)现已面市； 产后妇女的优势包括治疗期间的行动自由和有针对性的光线照射 仅限于使用者的眼睛区域，因此婴儿不会暴露在光线下。建议的研究是一项随机研究 Re-Timer®强光疗法与暗光(可信的和生物上无效的)安慰剂的对照试验 针对产后抑郁症的具体目标如下：目标1：建立可穿戴的早晨的效果 强光疗法(n=60)与弱光安慰剂(n=60)治疗临床医生评定的产后抑郁症状。 目的2：建立相角差的变化(睡眠和昼夜节律之间的关系)作为 产后抑郁症改善的预测因子。目的3：检测晨光疗法对糖尿病患者的影响。 次要结果(自我报告的抑郁和产妇功能)。治疗依从性将是 客观地评估，客观地评估睡眠和昼夜节律将允许进行机械性测试。 该项目将首次测试可穿戴式强光疗法对产后抑郁症的疗效，并将 建立睡眠-昼夜节律调整作为一种治疗机制。它将为整合 将晨光疗法纳入产后抑郁症的标准护理，并用于个性化应用 心理治疗。这项建议解决了NIMH围产期心理健康测试的高度优先领域-创新 作为传统干预措施替代品的非药物干预措施--在RDoC框架内。

ABSTRACT As one of the most common pregnancy complications, nearly 600,000 women in the United States suffer from postpartum depression annually. Consequences of postpartum depression are far-reaching and include maternal suicide, functional impairment, and impaired development and psychiatric illness in offspring. Despite the high prevalence and significant consequences, under current treatment paradigms less than 16% of women with postpartum depression receive treatment and only 3.2% in total achieve remission. Treatment uptake in this population is influenced by concerns regarding pharmacotherapy during lactation and caregiving demands for a newborn. Novel treatments that remove the significant obstacles to accessing care inherent to the postpartum period, such as non-pharmacological therapies delivered in-home, are urgently needed. Within the Research Domain Criteria (RDoC) domain of arousal/regulatory systems, the circadian timing system and its alignment with the sleep-wake cycle—called the phase angle difference—represents a promising novel treatment target. Morning bright light therapy advances circadian timing, and is an effective antidepressant for seasonal and non-seasonal depression. Importantly, bright light therapy is a non-pharmacological intervention that is administered in-home. However, its efficacy in postpartum depression, and mechanism of action, have not been confirmed. Further, traditional light therapy delivered via light box has limited utility for postpartum women, as the user must remain stationary during the treatment and it may expose the infant to light. Through recent technological innovations, wearable bright light therapy devices (i.e., Re-Timer®) are now available; advantages for postpartum women include freedom of movement during treatment and targeted light exposure limited to the user’s ocular area, so infants are not exposed to the light. The proposed study is a randomized controlled trial of Re-Timer® bright light therapy relative to dim (credible and biologically inactive) placebo light for postpartum depression with the following specific aims: AIM 1: Establish the effect of a wearable morning bright light therapy (n = 60) vs. dim light placebo (n = 60) on clinician-rated postpartum depression symptoms. AIM 2: Establish changes in phase angle difference (relationship between sleep and circadian timing) as a predictor of improvement in postpartum depression. AIM 3: Test the effect of morning bright light therapy on secondary outcomes (self-reported depression and maternal functioning). Treatment adherence will be objectively assessed, and objective assessment of sleep and circadian timing will allow for mechanistic testing. This project will be the first to test the efficacy of wearable bright light therapy for postpartum depression and to establish sleep-circadian alignment as a mechanism of treatment. It will lay the foundation for integration of morning bright light therapy into standard care for postpartum depression, and for personalized applications of the therapy. This proposal addresses NIMH’s high priority area for perinatal mental health—testing innovative non-pharmacological interventions as alternatives to traditional interventions—within the RDoC framework.