A scalable cognitive behavioural program to promote healthy sleep during pregnancy and postpartum periods: protocol of a randomised controlled trial (the SEED project).
Cognitive behavioural therapy
Insomnia
Perinatal
Postpartum
Pregnancy
Sleep
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
22 Jul 2019
22 Jul 2019
Historique:
received:
17
11
2018
accepted:
30
06
2019
entrez:
24
7
2019
pubmed:
25
7
2019
medline:
14
1
2020
Statut:
epublish
Résumé
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. 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. 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. ACTRN12616001462471 ; retrospectively registered on 19/10/2016.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ACTRN12616001462471 ; retrospectively registered on 19/10/2016.
Identifiants
pubmed: 31331286
doi: 10.1186/s12884-019-2390-8
pii: 10.1186/s12884-019-2390-8
pmc: PMC6647256
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
254Subventions
Organisme : Australasian Sleep Association
ID : Rob Pierce Grant-in-Aid and Helen Bearpark Scholarship
Organisme : Faculty of Medicine, Nursing and Health Sciences, Monash University
ID : Strategic Grant Scheme
Organisme : National Health and Medical Research Council
ID : APP1140299
Organisme : Department of Education and Training
ID : Australian Postgraduate Award
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