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Randomized Controlled Trial
. 2023 Jan;53(2):513-523.
doi: 10.1017/S0033291721001860. Epub 2021 Jul 7.

Improving perinatal sleep via a scalable cognitive behavioural intervention: findings from a randomised controlled trial from pregnancy to 2 years postpartum

Bei Bei  1   2   3 , Donna M Pinnington  1   2   3 , Nina Quin  1   2   3 , Lin Shen  1 , Michelle Blumfield  4 , Joshua F Wiley  1 , Sean P A Drummond  1 , Louise K Newman  3 , Rachel Manber  5
Affiliations
Randomized Controlled Trial

Improving perinatal sleep via a scalable cognitive behavioural intervention: findings from a randomised controlled trial from pregnancy to 2 years postpartum

Bei Bei et al. Psychol Med. 2023 Jan.

Abstract

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.

Keywords: Sleep; cognitive behavioural therapy; insomnia; perinatal; postpartum; pregnancy.

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Conflict of interest statement

Conflict of Interests

SPAD reports personal fees from Zelda Therapeutics, personal fees from Jazz Pharmaceuticals, outside the submitted work; this is unrelated to the work carried out in this manuscript. RM received royalties from Guilford Press and New Harbinger for books on insomnia treatment; RM is also a paid Deputy Editor in Chief of the journal SLEEP; these are unrelated to the work carried out in this manuscript. Other authors have nothing to disclose.

Figures

Figure 1
Figure 1. Consort Diagram of Participant Flow
Note. CBT = Cognitive Behavioural Therapy condition, CTRL = active control condition. T2 = 35 weeks’ gestation, T3 (2 weeks postpartum) with no assessment is not shown, T4 = 6 weeks postpartum, T5 – T8 =3, 6, 12, 24 months postpartum, respectively.
Figure 2
Figure 2. Model Estimated Means and 95% Confidence Interval for Sleep-Related Measures in the Intention-to-Treat Sample
Note. See Supplement Table S1 for numeric summary. All models adjusted for baseline levels of the outcome. ES = effect size. CBT = Cognitive Behavioural Therapy condition, CTRL = active control condition. DBAS = Dysfunctional Beliefs and Attitudes about Sleep Scale.
See this image and copyright information in PMC

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