Felder Jennifer N, Epel Elissa S, Neuhaus John, Krystal Andrew D, Prather Aric A
Osher Center for Integrative Medicine, University of California, San Francisco, San Francisco.
Department of Psychiatry, University of California, San Francisco, San Francisco.
JAMA Psychiatry. 2020 May 1;77(5):484-492. doi: 10.1001/jamapsychiatry.2019.4491.
Despite the prevalence and adverse consequences of prenatal insomnia, a paucity of research is available regarding interventions to improve insomnia symptoms during pregnancy.
To test the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) compared with standard treatment among pregnant women with insomnia symptoms.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial enrolled pregnant women from November 23, 2016, to May 22, 2018. Of the 2258 women assessed for eligibility using an online self-report questionnaire, 208 were randomized to receive digital CBT-I (n = 105) or standard treatment (n = 103) for insomnia. Participants were pregnant up to 28 weeks' gestation, and they either had elevated insomnia symptom severity or met the criteria for insomnia caseness as determined by self-report questionnaires. Participants completed outcome measures at 10 weeks (postintervention) and 18 weeks (follow-up) after randomization. All study visits were completed remotely, and the intervention was delivered digitally. Data were analyzed between December 12, 2018, and July 2, 2019.
Digital CBT-I consisted of 6 weekly sessions of approximately 20 minutes each. Standard treatment reflected standard care. Women receiving standard treatment had no limits placed on the receipt of nonstudy treatments, including medication and psychotherapy.
All outcomes were assessed remotely using self-report questionnaires administered via online survey. The primary outcome was the change in insomnia symptom severity (measured by the Insomnia Severity Index) from baseline to postintervention. Secondary outcomes were sleep efficiency and nightly sleep duration (defined by sleep diary), global sleep quality (measured by the Pittsburgh Sleep Quality Index), depressive symptom severity (measured by the Edinburgh Postnatal Depression Scale), and anxiety symptom severity (measured by the Generalized Anxiety Disorder Scale-7). For each outcome, we also examined the change from baseline to follow-up.
The 208 participants had a mean (SD) age of 33.6 (3.7) years and a mean (SD) gestational age of 17.6 (6.3) weeks at baseline. Most of the participants were white (138 [66.3%]), married or cohabiting (196 [94.2%]), had a college degree (180 [86.5%]), and earned $100 000 or more per year (141 [67.8%]). Women randomized to receive digital CBT-I experienced statistically significantly greater improvements in insomnia symptom severity from baseline to postintervention compared with women randomized to receive standard treatment (time-by-group interaction, difference = -0.36; 95% CI, -0.48 to -0.23; χ2 = 29.8; P < .001; d = -1.03). Improvements from baseline to postintervention for all secondary outcomes, with the exception of sleep duration, were statistically significant. A similar pattern of results was evident for the change from baseline to follow-up.
In this trial, digital CBT was an effective, scalable, safe, and acceptable intervention for improving insomnia symptoms during pregnancy.
ClinicalTrials.gov identifier: NCT02805998.
尽管产前失眠普遍存在且会产生不良后果，但关于改善孕期失眠症状干预措施的研究却很匮乏。
比较数字认知行为疗法治疗失眠（CBT-I）与标准治疗对有失眠症状孕妇的疗效。
设计、地点和参与者：这项随机临床试验于2016年11月23日至2018年5月22日招募孕妇。在通过在线自我报告问卷评估 eligibility 的2258名女性中，208名被随机分配接受数字CBT-I（n = 105）或失眠的标准治疗（n = 103）。参与者妊娠至28周，她们要么失眠症状严重程度升高，要么根据自我报告问卷符合失眠病例标准。参与者在随机分组后10周（干预后）和18周（随访）完成结局测量。所有研究访视均远程完成，干预通过数字方式进行。数据于2018年12月12日至2019年7月2日进行分析。
数字CBT-I包括每周6次，每次约20分钟的课程。标准治疗反映标准护理。接受标准治疗的女性在接受非研究治疗（包括药物治疗和心理治疗）方面没有限制。
所有结局均通过在线调查管理的自我报告问卷进行远程评估。主要结局是从基线到干预后失眠症状严重程度的变化（通过失眠严重程度指数测量）。次要结局是睡眠效率和夜间睡眠时间（由睡眠日记定义）、整体睡眠质量（通过匹兹堡睡眠质量指数测量）、抑郁症状严重程度（通过爱丁堡产后抑郁量表测量）和焦虑症状严重程度（通过广泛性焦虑障碍量表-7测量）。对于每个结局，我们还检查了从基线到随访的变化。
208名参与者在基线时的平均（标准差）年龄为33.6（3.7）岁，平均（标准差）孕周为17.6（6.3）周。大多数参与者是白人（138 [66.3%]）、已婚或同居（196 [94.2%]）、拥有大学学位（180 [86.5%]）且年收入10万美元或以上（141 [67.8%]）。与随机接受标准治疗的女性相比，随机接受数字CBT-I的女性从基线到干预后失眠症状严重程度有统计学上显著更大的改善（时间-组交互作用，差异 = -0.36；95% CI，-0.48至-0.23；χ2 = 29.8；P <.001；d = -1.03）。除睡眠时间外，所有次要结局从基线到干预后的改善均具有统计学意义。从基线到随访的变化也有类似的结果模式。
在这项试验中，数字CBT是改善孕期失眠症状的一种有效、可扩展、安全且可接受的干预措施。
ClinicalTrials.gov标识符：NCT02805998。
