A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women

Highlights

• We compared digital CBTI (fully automated program) to sleep education control.

• Digital CBTI reduces insomnia symptoms and extends sleep during pregnancy.

• Digital CBTI in pregnancy may protect against sleep loss after childbirth.

• Perinatal depression and cognitive arousal were not reduced by digital CBTI.

• Tailoring CBTI to the perinatal experience may be necessary for new moms.

Abstract

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.

Introduction

Sleep disturbance and insufficient sleep are endemic to pregnant women [[1], [2], [3], [4], [5], [6]]. Over half of pregnant women meet the diagnostic criteria for insomnia disorder [7] or endorse clinically significant insomnia symptoms [1,5,8]. Compelling evidence including prospective data indicate that these sleep disturbances increase across pregnancy and are most severe in the third trimester [2,4,[8], [9], [10]], although some evidence suggests that the prevalence of insomnia is unchangingly high across pregnancy [1]. Insomnia and insufficient sleep during pregnancy are associated with negative maternal outcomes such as depression and suicidal ideation [7,[11], [12], [13], [14], [15]], cognitive-emotional dysregulation [12,16,17], and reduced quality of life [17] among myriad other consequences [10]. Despite alarmingly high rates of prenatal insomnia and known associated complications, empirically supported treatment options for insomnia have been very limited for pregnant women [18].

In the broader US adult population, individuals with insomnia often seek treatment via prescription and/or over-the-counter (OTC) sleep aids [19,20]. However, the Food and Drug Administration (FDA) categorizes most prescription sleep-promoting medications as pregnancy Category C or D and thus are not considered safe for use during pregnancy [21]. The FDA designates common OTC sedating antihistamine medications, namely doxylamine and diphenhydramine, as Category A or B, respectively. These medications are typically recommended for use during pregnancy for allergy symptoms and nausea. However, no large randomized controlled trials (RCTs) have been conducted to thoroughly examine the efficacy and safety profiles of these OTC antihistamines for mother and child based on medication dosage and duration needed to alleviate perinatal insomnia [21,22]. Therefore, no sleep aids, prescription or OTC, are presently considered safe and efficacious for insomnia during pregnancy. Even so, over 90% of pregnant women self-treat insomnia symptoms with OTC antihistamines [21].

Cognitive-behavioral therapy for insomnia (CBTI), the guideline recommended treatment for insomnia [23], is highly effective and confers benefits over pharmacotherapy including superior long-term insomnia outcomes [24,25]. Recent evidence has begun to support the efficacy of CBTI during pregnancy. An open-label trial showed medium to large effect sizes in reducing sleep disturbances including latency to sleep and wake after sleep onset for pregnant women who completed a five-week CBTI group therapy program [26]. Randomized controlled trials (RCTs) also support CBTI efficacy in this population. CBTI delivered in individual and group formats produce superior treatment effects on insomnia symptoms during pregnancy compared to control [27,28]. Not only is CBTI efficacious in pregnancy, but pregnant women perceive CBTI as a more credible treatment option than pharmacotherapy and acupuncture [22], thus supporting its potential for patient engagement and real-world uptake.

Despite emerging efficacy and positive appraisals for CBTI for prenatal insomnia, access to this treatment is severely limited. Few US adults with insomnia have access to behavioral sleep medicine specialists who provide CBTI treatment [29,30]. This limited access is due to a shortage of CBTI practitioners and, further complicating matters, uneven geographic distribution of certified practitioners clustered in select urban areas [29]. Efforts to increase CBTI access have leveraged web and mobile health technology and clinical trials is the general US adult population show efficacy for CBTI delivered automated mobile health apps [[31], [32], [33], [34], [35], [36], [37], [38], [39]].

Despite the critical need for safe alternatives to pharmacological treatment in this population and the shortage of healthcare providers capable of delivering CBTI, the efficacy of web-based CBT-I in this population has not been established. Not only do pregnant women face the same access barriers as insomnia patients in the broader population [29,30], but pregnant women also have additional unique logistical barriers including managing other recurring prenatal health appointments, reserving medical leave for other prenatal and postnatal appointments, and preserving personal time off for maternity leave. Thus, it is critical to increase access to insomnia treatment for pregnant women that maximizes flexibility while preserving efficacy. As digital CBTI has proven highly efficacious at improving sleep in broader adult populations [40], leveraging this technology to increase reach and accessibility of insomnia care for pregnant women has immense potential to improve sleep and mental wellbeing in this vulnerable population.

The present study was a single-site RCT comparing digital CBTI and digital sleep education control for the treatment of clinically significant insomnia symptoms in pregnant women nearing/entering the third trimester. We targeted pregnant women in mid-to-late pregnancy based on evidence that prenatal sleep quality is worst in the third trimester [2,4,[8], [9], [10]]. We examined acute treatment effects in the prenatal period as well as longer term effects in early postpartum, which is a transition period of sleep instability for mother and child. We hypothesized that pregnant patients receiving digital CBTI would report greater improvements in sleep (decreased insomnia symptoms, decreased sleep disturbance, increased sleep duration), depressive symptoms, and nocturnal cognitive arousal relative to control patients. In addition, we hypothesized that these treatment group differences would be maintained six weeks after childbirth.