Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)

项目摘要。 失眠障碍影响每两名妇女中的一名在她们的第三个月末，有一半的孕妇患有 失眠是共病抑郁的代名词。虽然认知行为疗法(CBTI)对失眠有疗效 在怀孕期间，与非围产期患者相比，CBTI对失眠和抑郁的影响较小。 我们的团队已经确定了一个有希望的候选因素，可以预测对失眠的次优反应 治疗：高认知唤醒，一种认知活动增强的跨诊断现象，尤其是在 持之以恒的思维方式(担心、沉思)。几乎所有患有失眠症的孕妇都有很高的 认知唤醒在失眠治疗之前，但CBTI对这些症状的影响很小。怀孕了 失眠治疗后认知唤醒程度高的女性从失眠中缓解的可能性降低4倍，3 与性欲随着治疗而降低的女性相比，患抑郁症的可能性要高出一倍。为了努力 加强认知觉醒的缓解以优化临床结果，我们放置了有效的行为睡眠 正念干预框架内的策略，以开发一种专门针对孕妇的失眠疗法 女性：围产期对睡眠意识的理解(美洲狮)。与CBTI不同，疗效数据表明 与对照组相比，美洲狮能显著减少失眠、抑郁和认知唤醒。此外， 功效数据表明，减少认知唤醒可能代表了美洲狮减少 失眠和抑郁。干预开发的NIMH阶段的下一步是将这些 将功效数据转化为现实世界的实践。评估以下项目的可接受性、可行性和初步有效性 在现实世界的诊所中实施美洲狮是绝对关键的，并具有巨大的潜力来减轻 母亲的精神疾病。结合NIMH对实验治疗方法的强调，我们将调查 认知唤醒的减少是美洲狮缓解失眠和抑郁的关键机制。我们 提出一种有效性-实施混合型1型试验性随机对照试验，其中100名患有DSM-5的孕妇 失眠症被随机分为远程医疗美洲狮或假治疗对照组。我们将实施美洲狮 在位于底特律大都会中心的亨利·福特健康系统的所有23家妇女健康诊所。 实施将反映真实世界的诊所操作，以便报告睡眠的妇女接受产前护理 困难将由产科医生和助产士转介给嵌入妇女健康诊所的治疗师 用于评估和治疗。治疗后，我们将在产后第一年对参与者进行评估 初步评估临床结果的持久性。该项目不仅将对美洲狮进行初步测试 对失眠和抑郁症有效，但也将调查美洲狮是否聘用了关键候选人 有效缓解这些临床结果的机制(高认知唤醒) 上下文(PAR-21-131)。

Project Abstract. Insomnia disorder impacts one in two women by the end of their 3rd trimester, and half of pregnant women with insomnia endorse comorbid depression. Though cognitive-behavioral therapy for insomnia (CBTI) has efficacy in pregnancy, CBTI produces smaller effects on insomnia and depression as compared to non-perinatal patients. Our team has identified a promising candidate factor that predicts suboptimal response to insomnia therapy: high cognitive arousal, a transdiagnostic phenomenon of heightened cognitive activity, particularly in the form of perseverative thinking (worry, rumination). Nearly all pregnant women with insomnia have high cognitive arousal before insomnia therapy, but CBTI produces minimal effect on these symptoms. Pregnant women with high cognitive arousal after insomnia therapy are 4 times LESS likely to remit from insomnia, and 3 times MORE likely to have depression relative to women whose arousal decreases with therapy. In effort to enhance alleviation of cognitive arousal to optimize clinical outcomes, we placed efficacious behavioral sleep strategies within a mindfulness intervention framework to develop an insomnia therapy specifically for pregnant women: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS). Unlike CBTI, efficacy data show that PUMAS produces large reductions in insomnia, depression, and cognitive arousal relative to control. Moreover, efficacy data suggest that reducing cognitive arousal may represent a mechanism by which PUMAS reduces insomnia and depression. The next step in the NIMH phase of intervention development is to translate these efficacy data into real-world practice. Evaluating the acceptability, feasibility, and preliminary effectiveness of PUMAS implemented in real-world clinics is absolutely critical and has immense potential to reduce burden of maternal mental illness. Aligned with NIMH emphasis on experimental therapeutics approach, we will investigate reductions in cognitive arousal as a key mechanism by which PUMAS alleviates insomnia and depression. We propose an effectiveness-implementation hybrid type 1 pilot RCT wherein 100 pregnant women with DSM-5 insomnia disorder are randomized to telemedicine PUMAS or sham therapy control. We will implement PUMAS in all 23 women’s health clinics across Henry Ford Health System, centrally located in Metro Detroit. Implementation will reflect real-world clinic operations such that women receiving prenatal care who report sleep difficulties will be referred by OB physicians and midwifes to therapists embedded in the women’s health clinics for evaluation and treatment. After treatment, we will assess participants across the first postpartum year to preliminarily evaluate the durability of clinical outcomes. This project will not only test PUMAS preliminary effectiveness for insomnia and depression, but will also investigate whether PUMAS engages a key candidate mechanism (high cognitive arousal) that is operative for alleviating these clinical outcomes in the effectiveness context (PAR-21-131).