A scalable cognitive behavioural program to promote healthy sleep during pregnancy and postpartum periods: protocol of a randomised controlled trial (the SEED project)

Abstract

Background Poor sleep, including symptoms of insomnia are common during pregnancy and postpartum periods. Poor sleep during the perinatal period is linked to impaired daytime functioning, mood disturbance, and risk for chronic insomnia. Cognitive behavioural therapy (CBT) is consistently shown to be efficacious in treating insomnia, but it is largely inaccessible to new mothers, and surprisingly, not part of current perinatal care. This study aims to evaluate the feasibility and efficacy of a scalable CBT-based intervention for better sleep quality. Methods In this single-blind randomised controlled trial, eligible nulliparous women are randomised in a 1:1 ratio to either the intervention (CBT) or active control (healthy diet) condition. The interventions are provided from the third trimester till 6 months postpartum. The primary outcome is maternal sleep quality and secondary outcomes are maternal sleep-related impairment, mood, health-related quality of life, relationship satisfaction, and mother-infant-relationship, all assessed using validated instruments at 30- (baseline) and 35 weeks gestation (pregnancy endpoint), and 1.5, 3, and 6 months (postpartum endpoint) after childbirth, with follow-up assessments conducted at 1-year and 2-year postpartum. Discussion This study has the potential to address the need for an evidence-based, non-pharmacological sleep intervention tailored for the pregnancy and postpartum periods. The intervention is designed to maximise reach and minimise cost, with the potential to scale up and incorporate in routine perinatal care. With outcomes measured at 8 time points, from the third trimester of pregnancy to 2-year postpartum, this study has the potential to examine both short- and long-term impact on maternal sleep and wellbeing. Trial registration ACTRN12616001462471 ; retrospectively registered on 19/10/2016. Electronic supplementary material The online version of this article (10.1186/s12884-019-2390-8) contains supplementary material, which is available to authorized users.

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

“…The (Bei et al, 2019) for details; (d) work night shift; (e) mental health conditions: major depressive disorder (current); posttraumatic stress disorder (current); panic disorder if associated with nocturnal panic attacks >4 times in the past month; bipolar disorder (lifetime); psychotic disorders (lifetime); substance use disorders (during pregnancy).…”

<p>Examining Sleep and Mood in Parents of Children with Sleep Disturbances</p>

“…It has been shown that CBT-I helps with adult sleep by increasing sleep drive and altering maladaptive behaviors even when there are environmental factors outside the individual's control. 41 Similarly, mindfulness-based sleep interventions can reduce cognitive arousal and improve insomnia severity. 42 Both therapies may have potential utility for parents experiencing sleep disturbances or higher presleep arousal.…”

Does breastfeeding influence sleep? A longitudinal study across the first two postpartum years

“…This is a secondary data analysis of a single‐blinded randomized controlled trial comparing behaviourally‐based sleep and diet interventions (Australian New Zealand Clinical Trial Registry: ACTRN12616001462471). The protocol 32 and primary outcome paper 33 have been published elsewhere. The study was approved by the Royal Women’s Hospital (RWH) and the Monash University Human Research Ethics Committees.…”