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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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