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

可穿戴晨光疗法治疗产后抑郁症：确认疗效和机制

• 批准号: 10330019
• 负责人: Leslie M Swanson
• 金额: $ 54.3万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-01 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10330019
• 关键词: Address; Affect; Aftercare; Antidepressive Agents; Area; Arousal and Regulatory Systems; Cessation of life; Child; Circadian Rhythms; Circadian desynchrony; Clinic; Development; Devices; Disease remission; Estrogens; Excessive Daytime Sleepiness; Exposure to; Foundations; Freedom; Gold; Hamilton Rating Scale for Depression; Health Services Accessibility; High Prevalence; Home; Hour; Impairment; Infant; Infant Care; Intervention; Lactation; Light; Measures; Mediating; Mediator of activation protein; Melatonin; Mental Depression; Mental disorders; Mothers; Movement; Napping; National Institute of Mental Health; Newborn Infant; Nonpharmacologic Therapy; Participant; Pharmacotherapy; Phase; Phototherapy; Placebos; Population; Postpartum Depression; Postpartum Period; Postpartum Women; Pregnancy Complications; Pregnancy Rate; Progesterone; Randomized Controlled Trials; Recurrence; Research Domain Criteria; Salivary; Sleep; Sleep Wake Cycle; Social Functioning; Suicide; System; Testing; Time; Travel; United States; Woman; Work; Wrist; actigraphy; barrier to care; base; caregiving; circadian; depressive symptoms; efficacy testing; functional disability; improved; improved outcome; innovation; novel; offspring; perinatal mental health; pilot test; primary outcome; response; satisfaction; secondary outcome; self-reported depression; side effect; standard care; technological innovation; treatment adherence; treatment effect; treatment response; uptake

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.

摘要 作为最常见的妊娠并发症之一，美国有近60万女性患有 产后抑郁症每年产后抑郁症的后果是深远的，包括 母亲自杀，功能障碍，发育障碍和后代的精神疾病。尽管 在目前的治疗模式下， 患有产后抑郁症的妇女接受治疗，只有3.2%的妇女得到缓解。治疗 这一人群的摄取受哺乳期和哺乳期药物治疗问题的影响 对新生儿的要求新的治疗方法，消除了获得护理固有的重大障碍， 迫切需要产后期的非药物治疗，例如在家中提供的非药物治疗。内 唤醒/调节系统的研究领域标准（RDoC）领域，昼夜节律计时系统和 它与睡眠-觉醒周期的对齐-称为相位角差-代表了一种有前途的新方法， 治疗目标早晨明亮的光线疗法推进昼夜节律，是一种有效的抗抑郁药， 季节性和非季节性抑郁症重要的是，明亮的光疗法是一种非药物干预 在家中进行。然而，其对产后抑郁症的疗效和作用机制， 尚未得到证实。此外，经由灯箱递送的传统光疗法对于产后具有有限的效用。 女性，因为使用者在治疗期间必须保持静止，并且它可能使婴儿暴露在光下。通过 最近的技术创新，可佩戴的亮光治疗设备（即，Re-Timer®）现已推出; 对产后妇女的好处包括治疗期间的活动自由和有针对性的光照 仅限于使用者的眼部区域，因此婴儿不会暴露在光线下。拟议的研究是一项随机研究， Re-Timer®亮光疗法相对于昏暗（可靠且无生物活性）安慰剂光的对照试验 针对产后抑郁症，有以下具体目标：目的1：建立可穿戴早晨的效果 强光疗法（n = 60）与暗光安慰剂（n = 60）对临床医师评定的产后抑郁症状的影响。 目的2：建立相位角差的变化（睡眠和昼夜节律定时之间的关系）， 产后抑郁症改善的预测因素。目的3：测试早晨明亮的光疗法对 次要结局（自我报告的抑郁和母亲功能）。治疗依从性将是 客观地评估，并且睡眠和昼夜节律定时的客观评估将允许机械测试。 该项目将是第一个测试可穿戴强光疗法对产后抑郁症的疗效， 建立睡眠-昼夜节律调整作为治疗机制。它将为整合 早晨明亮的光疗法纳入产后抑郁症的标准护理，并为个性化的应用， 治疗该提案涉及NIMH的围产期精神健康测试创新的高度优先领域 在RDoC框架内，非药物干预作为传统干预的替代方案。