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: 10553095
• 负责人: Leslie M Swanson
• 金额: $ 53.56万
• 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/10553095
• 关键词: Address; Affect; Aftercare; Antidepressive Agents; Area; Arousal and Regulatory Systems; Cessation of life; Child; Child Care; Circadian Rhythms; Circadian desynchrony; Clinic; Development; Devices; Disease remission; Estrogens; Excessive Daytime Sleepiness; Exposure to; Foundations; Freedom; Glass; Hamilton Rating Scale for Depression; Health Services Accessibility; High Prevalence; Home; Hour; Impairment; Infant; Infant Care; Intervention; Lactation; Light; Measures; Mediating; Mediator; 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; Progesterone; Randomized, Controlled Trials; Recurrence; Research Domain Criteria; Salivary; Seasons; Sleep; Sleep Wake Cycle; Social Functioning; Suicide; System; Testing; Time; Travel; United States; Woman; Work; Wrist; actigraphy; barrier to care; 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.

抽象的 作为最常见的怀孕并发症之一，美国近60万妇女患有 产后抑郁。产后抑郁症的后果是深远的，包括 后代的孕产妇自杀，功能障碍以及发育和精神病受损。尽管 在当前治疗范例下，高患病率和重大后果少于16％ 产后抑郁症的妇女接受治疗，总成绩缓解只有3.2％。治疗 该人群的吸收受到哺乳和护理期间药物治疗的关注 对新生儿的需求。消除获得继承护理的重大障碍的新颖治疗方法 迫切需要产后时期，例如在家中提供的非药物疗法。之内 唤醒/监管系统的研究领域标准（RDOC）域，昼夜节律系统和 它与睡眠觉醒周期的一致性 - 称为相角差 - 代表了有希望的小说 治疗目标。早晨明亮的光疗法可以提高昼夜节律的时间，并且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 这是在家中管理的。但是，其在产后抑郁症和作用机理方面的效率具有 没有得到确认。此外，通过灯箱提供的传统轻疗法的产后有限 妇女，因为用户在治疗过程中必须保持静止，并且可能会使婴儿暴露在光线下。通过 现在可以使用最近的技术创新，可穿戴明亮的光线治疗设备（即Re-Timer®）； 产后妇女的优势包括治疗期间的运动自由和目标光暴露 仅限于用户的眼部区域，因此婴儿不暴露于光线。拟议的研究是随机的 Re-Timer®明亮光疗法的对照试验相对于昏暗（可信和生物学上的）安慰剂光 对于带有以下特定目的的产后抑郁症：目标1：确定可穿戴早晨的效果 明亮的光治疗（n = 60）与临床产后抑郁符号上的昏暗光安慰剂（n = 60）。 目标2：确定相角差异（睡眠和昼夜节律之间的关系）作为一个 AIM 3：测试早晨明亮光治疗对 次要结果（自我报告的抑郁和母体功能）。治疗依从性将是 客观评估，对睡眠和昼夜节律的客观评估将允许进行机械测试。 该项目将是第一个测试可穿戴明亮光疗法对产后抑郁症的效率和 建立睡眠环对准作为治疗机制。它将为整合的基础 早晨明亮的光疗法进入产后抑郁症的标准护理，并为个性化应用 疗法。该提案涉及NIMH的围产期心理健康的高优先领域 - 测试创新性 非药理学干预措施是传统干预措施的替代方法 - 在RDOC框架中。