1. Digital cognitive behavioral therapy for insomnia (CBT-I) resulted in significant decreases in severity of insomnia, depressive, and anxiety symptoms compared to standard treatment in pregnant women at no greater than 28 weeks’ gestation.
Evidence Rating Level: 2 (Good)
It is estimated that approximately 14% of pregnant women experience moderate-to-severe symptoms of insomnia. While often viewed as harmless, insomnia can negatively impact the quality of life of woman as well as increase risk of adverse birth outcomes. Given that there are limited treatment options for clinically significant symptoms, research must focus on interventions that are unlikely to increase odds of complications or negative outcomes. This randomized clinical trial evaluated the effectiveness of digital cognitive behavioral therapy for insomnia (CBT-I) in adult women meeting criteria for an insomnia disorder who reported no greater than 28 weeks’ gestation (n = 208, mean [SD] age = 33.6 [3.7] years; mean baseline gestational [SD] age = 17.6 [6.3] weeks). CBT-I involved six weekly sessions lasting approximately 20 minutes each, available via website or iOS app. It possessed five main components: sleep restriction, stimulus control, relaxation techniques, cognitive therapy, and sleep hygiene and education. A total of 103 women were randomly assigned to standard treatment (ST) and 105 women were randomly assigned to the CBT-I group – 68 women (64.8%) completed all six sessions. Women were predominantly Caucasian, married or cohabiting, possessed a college degree, and earned more than $100,000 per year. Participants completed the seven-item Insomnia Severity Index (ISI) as well as logged their own sleep efficiency, duration, quality, and disorder via diaries. Depressive symptoms were assessed with the 10-item Edinburgh Postnatal Depression Scale (EPDS) and anxiety symptoms were assessed with the Generalized Anxiety Disorder Scale-7. Participants were given no limitations related to adjunct treatments during treatment, including psychotherapeutic and pharmacological interventions. A mean of 7.97 [2.08] weeks were required to complete all six sessions of CBT-I. Women in the CBT-I group experienced significantly greater improvements in insomnia symptom severity between baseline and postintervention compared to ST (time-by-group interaction difference -0.36, 95% CI 00.48 to -0.23, χ2 = 29.8, p<0.001, d = -1.03). Remission (defined as ISI <7) rates were higher among the CBT-I group than ST (difference 21.7%, χ21 = 9.8, p = 0.002). Caseness, global sleep quality, and sleep efficiency were all significantly greater in the CBT-I group; sleep duration did not significantly differ between groups (p = 0.07). The CBT-I group also experienced greater reductions in severity of depressive symptoms (difference -0.21, 95% CI -0.30 to -0.11, p<0.001) and anxiety symptoms (difference -0.188, 95% CI -0.26 to -0.10, p<0.001). Remission rates of these symptoms were significantly higher in the CBT-I group (difference 13.8%, χ21 – 3.9, p = 0.048). Three adverse outcomes occurred in the ST group (2 miscarriages, 1 stillbirth) but were reported as unrelated to the study. Three adverse outcomes also occurred in the CBT-I group (3 miscarriages in first trimester, one of these prior to beginning treatment), for which investigators cannot rule out the impact of treatment in spite of other likely explanations. Overall, this study suggests that digital CBT-I is an effective non-pharmacological intervention for pregnant women (<28 weeks’ gestation) experiencing insomnia, as well as co-occurring depressive and anxiety symptoms. Remission rates following CBT-I are also promising beyond overall improvement of symptom severity, even with the availability of other treatment options.
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