孕期正念睡眠理解研究（PUMAS）：一项针对孕期 DSM-5 失眠障碍的基于正念的干预措施的单臂概念验证临床试验。
Perinatal Understanding of Mindful Awareness for Sleep (PUMAS): A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for DSM-5 insomnia disorder during pregnancy.
机构信息
Thomas Roth Sleep Disorders & Research Center, Henry Ford Health, Detroit, MI, USA; Department of Obstetrics, Gynecology, and Reproductive Biology, Michigan State University College of Human Medicine, East Lansing, MI, USA.
Thomas Roth Sleep Disorders & Research Center, Henry Ford Health, Detroit, MI, USA.
出版信息
Sleep Med. 2023 Aug;108:79-89. doi: 10.1016/j.sleep.2023.05.026. Epub 2023 Jun 10.
OBJECTIVES
Cognitive-behavioral therapy is effective for prenatal insomnia, but unresolved cognitive arousal limits patient outcomes. Therapies aimed at reducing cognitive arousal may benefit pregnant women with insomnia. This proof-of-concept trial evaluated Perinatal Understanding of Mindful Awareness for Sleep (PUMAS, which combines mindfulness with behavioral sleep strategies) on insomnia, depression, and cognitive arousal.
METHODS
A single-arm trial of 12 pregnant women with DSM-5 insomnia disorder (n = 5/12 with comorbid depression) who received six sessions of PUMAS delivered individually via telemedicine. Pretreatment and posttreatment outcomes included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), pre-sleep arousal scale's cognitive factor (PSASC; nocturnal cognitive arousal), perinatal-focused rumination (appended to PSASC), and Glasgow sleep effort scale.
RESULTS
Eleven of 12 patients completed all sessions. Intent-to-treat analyses revealed a 10.83-point reduction in ISI (Cohen's dz = 3.05), resulting in 83.3% insomnia remission. PUMAS produced large reductions in EPDS (Cohen's dz = 2.76 in depressed group), resulting in all five baseline depressed patients remitting from depression. PUMAS produced large reductions in nocturnal cognitive arousal, perinatal-focused rumination, and sleep effort (all Cohen's dzs>2.00). Patients were highly satisfied with PUMAS and identified the telemedicine format and meditation app as positive features of its delivery. Patients rated sleep restriction and guided meditations as the most helpful treatment components.
CONCLUSION
Prenatal insomnia patients were highly engaged in PUMAS, which produced large acute reductions in insomnia, depression, and cognitive arousal. These findings support the concept and feasibility of PUMAS for pregnant women with insomnia who present with or without comorbid depression.
GOV ID
NCT04443959.
目的
认知行为疗法对产前失眠有效，但未解决的认知觉醒会限制患者的治疗效果。旨在降低认知觉醒的治疗方法可能使失眠的孕妇受益。本概念验证试验评估了 Perinatal Understanding of Mindful Awareness for Sleep（PUMAS，将正念与行为睡眠策略相结合）对失眠、抑郁和认知觉醒的影响。
方法
一项对 12 名患有 DSM-5 失眠症（5/12 例合并抑郁）的孕妇进行的单臂试验，这些孕妇通过远程医疗接受了六次 PUMAS 个体治疗。治疗前后的结局指标包括失眠严重指数（ISI）、爱丁堡产后抑郁量表（EPDS）、睡前觉醒量表认知因子（PSASC；夜间认知觉醒）、围产期关注性反刍（附加于 PSASC）和格拉斯哥睡眠努力量表。
结果
12 名患者中有 11 名完成了所有疗程。意向治疗分析显示，ISI 降低了 10.83 分（Cohen's dz=3.05），83.3%的失眠患者得到缓解。PUMAS 使 EPDS 大幅降低（抑郁组的 Cohen's dz=2.76），使基线时的所有 5 名抑郁患者都从抑郁中缓解。PUMAS 使夜间认知觉醒、围产期关注性反刍和睡眠努力均显著降低（所有 Cohen's dzs>2.00）。患者对 PUMAS 非常满意，并认为远程医疗形式和冥想应用程序是其优点。患者认为睡眠限制和引导冥想是最有帮助的治疗内容。
结论
产前失眠患者对 PUMAS 高度投入，PUMAS 使失眠、抑郁和认知觉醒在急性治疗中显著降低。这些发现支持了 PUMAS 对患有或不伴有共病抑郁的失眠孕妇的概念和可行性。
GOV ID
NCT04443959。
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