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

基本信息

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
项目类别：
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

项目摘要

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妊娠并发症之一，美国有近 60 万名女性患有产后抑郁症的影响是深远的，包括：母亲自杀、功能障碍、后代发育障碍和精神疾病。患病率高且后果严重，在目前的治疗模式下，不到 16% 患有产后抑郁症的女性接受治疗，只有 3.2% 的患者获得缓解。该人群的吸收受到哺乳期和护理期间对药物治疗的担忧的影响对新生儿的需求，消除了获得护理固有的重大障碍。产后迫切需要在家中进行非药物治疗。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-觉醒周期的一致性（称为相位角差）代表了一部有前途的小说早晨强光疗法可改善昼夜节律，是一种有效的抗抑郁药。重要的是，强光疗法是一种非药物干预。然而，它对产后抑郁症的功效和作用机制已经被证实。此外，通过灯箱进行的传统光疗对产后的效用有限。女性，因为用户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。最近的技术创新，可穿戴强光治疗设备（即 Re-Timer®）现已上市；对产后妇女的优势包括治疗期间的活动自由和有针对性的光照仅限于用户的眼部区域，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（可信且无生物活性）安慰剂光的对照试验针对产后抑郁症，具有以下具体目标：目标 1：确定可穿戴早晨的效果强光疗法 (n = 60) 与弱光安慰剂 (n = 60) 对临床医生评定的产后抑郁症状的影响。目标 2：建立相位角差（睡眠与昼夜节律之间的关系）的变化作为产后抑郁症改善的预测指标目标 3：测试晨光疗法对产后抑郁症的影响。次要结果（自我报告的抑郁症和母亲功能）。客观评估，对睡眠和昼夜节律时间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强光疗法治疗产后抑郁症的功效并建立睡眠昼夜节律调整作为治疗机制，这将为整合睡眠奠定基础。将晨光疗法纳入产后抑郁症的标准护理，以及个性化应用该提案涉及 NIMH 围产期心理健康的高度优先领域——测试创新。在 RDoC 框架内，非药物干预作为传统干预的替代方案。