Background Sleep disturbance is common in gestational parents during pregnancy and postpartum periods. This study evaluated the feasibility and efficacy of a scalable cognitive behavioural therapy (CBT) sleep intervention tailored for these periods. Methods This is a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Nulliparous females without severe medical/psychiatric conditions were randomised 1:1 to CBT or attention- and time-matched control. All participants received a 1 h telephone session and automated multimedia emails from the third trimester until 6 months postpartum. Outcomes were assessed with validated instruments at gestation weeks 30 (baseline) and 35 (pregnancy endpoint), and postpartum months 1.5, 3, 6 (postpartum endpoint), 12 and 24. Results In total, 163 eligible participants (age M ± s.d. = 33.35 ± 3.42) were randomised. The CBT intervention was well accepted, with no reported adverse effect. Intention-to-treat analyses showed that compared to control, receiving CBT was associated with lower insomnia severity and sleep disturbance (two primary outcomes), and lower sleep-related impairment at the pregnancy endpoint (p values ⩽ 0.001), as well as at 24 months postpartum (p ranges 0.012–0.052). Group differences across the first postpartum year were non-significant. Participants with elevated insomnia symptoms at baseline benefitted substantially more from CBT (v. control), including having significantly lower insomnia symptoms throughout the first postpartum year. Group differences in symptoms of depression or anxiety were non-significant. Conclusions A scalable CBT sleep intervention is efficacious in buffering against sleep disturbance during pregnancy and benefitted sleep at 2-year postpartum, especially for individuals with insomnia symptoms during pregnancy. The intervention holds promise for implementation into routine perinatal care.

Study Objectives Insomnia Disorder diagnoses require persistent sleep complaints despite “adequate sleep opportunity”. Significant perinatal sleep disruption makes this diagnosis challenging. This longitudinal study distinguished between Insomnia Disorder and Perinatal Sleep Disruption and their sleep and mental health correlates. Methods 163 nulliparous females (age M±SD=33.35±3.42) participating in a randomised-controlled trial repeated the Insomnia Disorder module of the Duke Structured Interview for Sleep Disorders and PROMIS measures for sleep and mental health at 30 and 35 weeks’ gestation, and 1.5, 3, 6, 12, and 24 months postpartum (944 interviews, 1009 questionnaires completed). We compared clinical features when DSM-5 Insomnia Disorder criteria were: (1) met (Insomnia Disorder), (2) not met only because of the sleep opportunity criteria (Perinatal Sleep Disruption), and (3.) not met due to other criteria (Low Complaint). Results Proportions of Insomnia Disorder were 16.0% and 19.8% during early and late third trimester, and ranged 5.3-11.7% postpartum. If the sleep opportunity criteria were not considered, rates of Insomnia would be 2-4 times higher (21.4-40.4%) across time-points. Mixed effects models adjusting for covariates showed that compared to Low Complaint, both Insomnia Disorder and Perinatal Sleep Disruption scored significantly higher on insomnia and sleep disturbance scales, sleep effort, and sleep-related impairments (p-values<.01), but depression and anxiety were comparable (p-values>.12). Conclusion Assessing sleep complaints without considering sleep opportunity can result in over-diagnosis of Insomnia Disorder in the perinatal periods. Insomnia Disorder and perinatal sleep disruption were associated with adverse sleep and mood outcomes, and need to be carefully differentiated and appropriately addressed.