University of Calgary, Calgary, Canada.
University of British Columbia, Okanagan Campus, Canada.
Trials. 2021 Aug 12;22(1):532. doi: 10.1186/s13063-021-05498-w.
Insomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health. There is limited research examining the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) during pregnancy. With increased distress and limited access to services during the COVID-19 pandemic, there is also an unprecedented need for telehealth delivery of treatment programs for pregnant women. The aims of this trial are to evaluate the impact of the Sleeping for Two adaptation of CBT-I in pregnancy (in-person or telehealth) versus treatment as usual (TAU) in reducing symptoms of insomnia (primary outcome), as well as increasing gestational length and reducing symptoms of depression (secondary outcomes).
A two-arm, single-blinded, parallel group randomized controlled trial (RCT) design with repeated measures will be used to evaluate the impact of CBT-I compared to TAU among a sample of 62 pregnant women, enrolled between 12 and 28 weeks of gestation, who self-identify as experiencing insomnia. Five weekly individual sessions of CBT-I will be delivered in person or via telehealth depending on physical distancing guidelines. Assessment of insomnia diagnosis by structured interview, self-reported insomnia symptom severity and sleep problems, and sleep quantity and quality as measured by a daily diary and actigraphy will occur at 12-28 weeks of pregnancy (T1), 1 week post-treatment (T2), and 6 months postpartum (T3).
CBT-I delivered in pregnancy has the potential to reduce symptoms of insomnia and depression and could lead to reduced risk of preterm birth, all of which can minimize risk of negative maternal and child health and developmental consequences in the short (e.g., infant death) and long terms (e.g., developmental delays). This RCT builds on a successful open pilot trial conducted by our team and will provide further evaluation of a novel evidence-based treatment for pregnancy-related insomnia, which can be widely disseminated and used to treat individuals that are most in need of intervention. Findings will enhance understanding of pregnancy-related sleep problems, as well as means by which to improve the health and sleep of mothers and their children.
ClinicalTrials.gov NCT03918057. Registered on 17 April 2019.
失眠和睡眠障碍在妊娠中很常见，对母婴健康都有潜在的重大影响。针对妊娠期认知行为疗法治疗失眠（CBT-I）的有效性的研究有限。在 COVID-19 大流行期间，由于焦虑加剧和服务获取受限，也前所未有地需要为孕妇提供远程医疗治疗方案。本试验旨在评估在减少失眠症状（主要结果）方面，妊娠期的“两人共眠”（in-person 或 telehealth）改编版 CBT-I 与常规治疗（TAU）相比的效果，以及增加妊娠期长度和减少抑郁症状（次要结果）。
采用 2 臂、单盲、平行组随机对照试验（RCT）设计和重复测量，将评估 CBT-I 与 TAU 对 62 名自我报告患有失眠症的孕妇样本的影响，这些孕妇在妊娠 12-28 周时入组。根据身体距离指导原则，每周进行 5 次个人 CBT-I 治疗。在妊娠 12-28 周（T1）、治疗后 1 周（T2）和产后 6 个月（T3）时，采用结构化访谈评估失眠诊断，自我报告的失眠严重程度和睡眠问题，以及通过每日日记和活动记录仪测量的睡眠量和质量。
在妊娠期间提供 CBT-I 有可能减轻失眠和抑郁症状，并降低早产风险，所有这些都可以最大限度地减少母婴健康和短期（例如婴儿死亡）和长期（例如发育迟缓）发育后果的风险。这项 RCT 是基于我们团队成功开展的一项开放试点试验，将进一步评估一种针对妊娠相关失眠的新型循证治疗方法，该方法可以广泛推广并用于治疗最需要干预的个体。研究结果将增强对妊娠相关睡眠问题的理解，以及改善母亲及其子女健康和睡眠的方法。
ClinicalTrials.gov NCT03918057。2019 年 4 月 17 日注册。
