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A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women.
Sleep Medicine ( IF 4.8 ) Pub Date : 2020-03-21 , DOI: 10.1016/j.sleep.2020.03.016
David A Kalmbach 1 , Philip Cheng 1 , Louise M O'Brien 2 , Leslie M Swanson 3 , Roopina Sangha 4 , Srijan Sen 3 , Constance Guille 5 , Andrea Cuamatzi-Castelan 1 , Alasdair L Henry 6 , Thomas Roth 1 , Christopher L Drake 1
Affiliation  

Objective

Despite high rates of prenatal insomnia, efficacious treatment options for this population are quite limited. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy internet-based digital CBTI in pregnant women with insomnia.

Methods

Single-site RCT. A total of 91 pregnant women (29.03 ± 4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C) served as study outcomes, which were collected before treatment and after treatment during pregnancy, then six weeks after childbirth.

Results

From pre to posttreatment, CBTI patients reported reductions in ISI (−4.91 points, p < 0.001) and PSQI (−2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008). Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 min per night (p = 0.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed.

Conclusions

Digital CBTI improves sleep quality and sleep duration during pregnancy and after childbirth. To better optimize outcomes, CBTI should be tailored to meet the changing needs of women as the progress through pregnancy and early parenting.

Name

Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression.

URL

clinicaltrials.gov. Registration: NCT03596879.



中文翻译:

一项针对孕妇失眠的数字认知行为疗法的随机对照试验。

客观的

尽管产前失眠率很高,但针对这一人群的有效治疗选择非常有限。来自随机对照试验 (RCT) 的早期证据支持失眠的面对面认知行为疗法 (CBTI) 对产前失眠的疗效。然而,由于许多患者无法获得这种专家驱动的护理,因此迫切需要增加其可及性。该随机对照试验检查了基于互联网的数字 CBTI 对失眠孕妇的疗效。

方法

单站点 RCT。共有 91 名接近/进入妊娠晚期的孕妇(29.03 ± 4.16 岁)在失眠严重程度指数 (ISI) 中筛查出临床失眠阳性,被随机分配到数字 CBTI 或数字睡眠教育控制组。ISI、匹兹堡睡眠质量指数(PSQI)、爱丁堡产后抑郁量表(EPDS)和睡前觉醒量表的认知因素(PSAS-C)作为研究结果,在治疗前和治疗后在怀孕期间收集,然后六分娩后数周。

结果

从治疗前到治疗后,CBTI 患者报告 ISI(-4.91 分,p < 0.001)和 PSQI(-2.98 分,p < 0.001)降低,夜间睡眠持续时间增加 32 分钟(p = 0.008)。对照组的睡眠症状在怀孕期间没有变化。分娩后,与对照组相比,CBTI 患者每晚的睡眠时间延长了 40 分钟(p = 0.01),并报告了更好的睡眠维持。未观察到产前或产后治疗对抑郁或认知唤醒的影响。

结论

数字 CBTI 可改善怀孕期间和分娩后的睡眠质量和睡眠时间。为了更好地优化结果,CBTI 应量身定制,以满足女性在怀孕和早期育儿过程中不断变化的需求。

名称

妊娠晚期失眠和反刍以及产后抑郁症的风险。

网址

临床试验.gov. 注册:NCT03596879。

更新日期:2020-03-21
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