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

改善失眠带来的负面压力，让准妈妈恢复活力（INSPIRE）

• 批准号: 10508947
• 负责人: David Addison Kalmbach
• 金额: $ 28.08万
• 依托单位: HENRY FORD HEALTH SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10508947
• 关键词: Address; Aftercare; Arousal; Awareness; Behavioral; Chronic; Client satisfaction; Clinic; Clinical; Cognitive; Cognitive Therapy; DSM-V; Data; Disease remission; Effectiveness; Elements; Ensure; Etiology; Evaluation; Exacerbated Insomnia; Feedback; Fetal health; Goals; Health system; Hybrids; Intervention; Investigational Therapies; Link; Maintenance; Maternal Health; Mediator of activation protein; Mental Depression; Mental disorders; Midwife; Moods; National Institute of Mental Health; Outcome; Participant; Patients; Perinatal; Phase; Physicians; Placebos; Postpartum Depression; Postpartum Period; Predictive Factor; Pregnancy; Pregnant Women; Prenatal care; Process; Public Health; Randomized; Randomized Controlled Trials; Refractory; Reporting; Severities; Sleep; Sleeplessness; Symptoms; Telemedicine; Testing; Thinking; Third Pregnancy Trimester; Time; Translating; Woman; Women' s Health; acceptability and feasibility; antidepressant effect; barrier to care; base; comorbid depression; depressed patient; depressive symptoms; design; diagnostic criteria; effectiveness implementation study; effectiveness testing; effectiveness-implementation RCT; efficacious treatment; feasibility testing; fetal; follow-up; implementation outcomes; improved; meetings; mindfulness; mindfulness intervention; operation; pandemic disease; patient expectation; perinatal intervention; perinatal women; pregnant; prenatal; response; retention rate; rumination; sleep difficulty; therapy development; treatment effect; treatment response

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).

项目摘要。 在妊娠晚期，每两名妇女中就有一名患有神经功能障碍， 失眠症支持抑郁症共病。虽然失眠的认知行为疗法（CBTI） 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，预测失眠的次优反应 治疗：高认知唤醒，提高认知活动的transdiagnosis现象，特别是在 持续思考的形式（忧虑、沉思）。几乎所有患有失眠症的孕妇都有高血压。 在失眠治疗之前，认知唤醒，但CBTI对这些症状的影响很小。怀孕 失眠治疗后认知唤醒程度高的女性，失眠缓解的可能性要低4倍， 与接受治疗后性唤起降低的女性相比，患抑郁症的可能性要高出一倍。为努力 增强缓解认知唤醒，以优化临床结果，我们将有效的行为睡眠 在正念干预框架内制定专门针对孕妇的失眠治疗策略 围产期对睡眠正念意识的理解（Perinatal Understanding of Mindful Awareness for Sleep，PUMAS）与CBTI不同，疗效数据显示， 与对照组相比，PUMAS可大幅减少失眠、抑郁和认知唤醒。此外，委员会认为， 有效性数据表明，减少认知唤醒可能代表PUMAS减少的机制， 失眠和抑郁。干预发展的NIMH阶段的下一步是将这些 将疗效数据转化为实际应用。评估的可接受性，可行性和初步有效性， 在现实世界的诊所中实施的PUMAS绝对至关重要，并且具有巨大的潜力，可以减轻患者的负担。 母亲的精神疾病与NIMH强调实验治疗方法相一致，我们将研究 认知唤醒的减少是PUMAS减轻失眠和抑郁的关键机制。我们 提出了一项有效性-实施混合1型试点RCT，其中100名患有DSM-5的孕妇 将失眠症随机分为远程医疗PUMAS或假治疗对照。我们将实施PUMAS 位于底特律市中心的亨利福特医疗系统的所有23家女性健康诊所。 实施将反映现实世界的诊所运作，如妇女接受产前护理谁报告睡眠 妇产科医生和助产士将把这些困难转介给妇女健康诊所的治疗师 进行评估和治疗。治疗后，我们将评估产后第一年的参与者， 初步评价临床结局的持久性。该项目不仅将测试PUMAS初步 有效性失眠和抑郁症，但也将调查是否PUMAS从事一个关键的候选人 有效缓解这些临床结局的机制（高认知唤醒） 上下文（PAR-21-131）。