None listed
Conditions
Brief summary
Pregnancy and postpartum periods are critical times for the ~300,000 families who welcome a newborn in Australia annually. During pregnancy, ~70% of birthing parents report sleep disturbance, and our pilot data showed that 1 in 3 experience symptoms of insomnia that may require clinical attention. As women cope with these significant sleep disruptions, they may also develop unhelpful sleep-related cognitions/behaviours, which can perpetuate sleep problems well into the postpartum period. The use of Cognitive Behavioural Therapy for Insomnia has been shown to result in significantly reduced prenatal insomnia, and benefits to sleep and sleep-related functioning were evident in a long-term follow up at 2 years postpartum (Bei et al., 2021). However, these evidence-based sleep interventions are not currently part of routine perinatal care in Australia. Therefore the SHINE RCT aims to evaluate the effectiveness, cost-effectiveness, and implementation potential of a scalable CBT-based Healthy Sleep program for the pregnancy and postpartum period to expedite its translation to the wider community. There are 3 specific aims: 1. To evaluate the effectiveness of the CBT program against an active control condition. 2. To conduct a health economic evaluation comparing CBT to usual care, examining (1) whether cost savings from reduced health service utilisation offset the direct cost of the intervention, and (2) if not cost-saving, whether the hypothesised improvements in sleep and daytime functioning are worth the additional cost of the intervention. 3. To explore barriers and enablers to wider implementation to promote future successful implementation and sustainability.
Interventions
The Healthy Sleep program uses therapist-assisted self-help Cognitive Behavioural Therapy for Insomnia (CBT-I) to address maladaptive sleep-related cognitions and behaviors, which play key roles in the maintenance of poor sleep during the perinatal periods. Content is adapted from our previous intervention (Bei et al., 2021, https://doi.org/10.1017/S0033291721001860), and aims to address 3 types of perinatal sleep complaints identified in the literature: (1) symptoms of insomnia, (2) pregnancy and infant-related sleep disturbance, and (3) daytime impairments (e.g., sleepiness, fatigue). Feedback on intervention content, format, readability, visual appeal, mode of delivery was sought and incorporated from a Community Reference Group. The following evidence-based therapeutic components are included: (1) General skills to increase resilience to sleep challenges: sleep hygiene, addressing unhelpful thoughts and beliefs about sleep, relaxation, and managing night-time worries. (2) Identifying and managing insomnia symptoms (e.g., stimulus control, time-in-bed restriction), and when to seek professional help. (3) Fostering realistic expectations and normalise some sleep loss via early education on sleep patterns of new parents and infants. (4) Mindfulness-based strategies targeting physical discomfort, pain, and cognitive arousal. (5) Age-appropriate and evidence-based infant sleep/settling skills to reduce awakenings and increase maternal sense of control. (6) Prioritising one’s own sleep and rest. (7) Smart naps based on circadian principles. (8) Managing sleepiness/fatigue. (9) Enlisting support. (10) Avoiding supine going-to-sleep position in pregnancy to reduce risk for late stillbirth. Content of the intervention is delivered via the following means, combined: - A 60-min standardised telephone or telehealth session is delivered by a trained researcher at program entrance, within 2 weeks of enrolment in pregnancy, to (a) introduce core components (factors contributing to sleep, managing insomnia and sleep deprivation, addressing unhelpful thoughts/beliefs about sleep), (b) discuss personalised strategies using intervention materials (additional components that are relevant to each individual will be added, such as sleep restriction, managing nighttime worries, managing physical discomfort), and (c) motivate adherence and sustainable behavioural change. Only key components and those relevant to the individual (i.e., not all components) will be delivered in this session. - Up to 3 optional mini-consultations via phone or telehealth (~15 minutes) before childbirth if required; - 1 mini-consultation via phone or telehealth (~ 30 minutes) when the newborn is 3 months. - Partner or another person who will also be involved in caring for the newborn is encouraged to attend at least one of the above consultations. - Multimedia intervention materials (including written text, images, audio, and videos) are delivered digitally via email at enrolment, 5 weeks after enrolment, and 2 weeks, 1.5 months, 3 months, and 6 months postpartum. These electronic materials are timed according to probable sleep challenges at each stage of the perinatal period (e.g., managing insomnia, physical discomfort, and expectation of postpartum sleep at late pregnancy, managing daytime sleepiness during early postpartum). Each electronically delivered module is designed to be succinct and easy to read on a computer, tablet, or phone, and will take no more than 10 minutes to read. Content accessing information such as email opening rate will be captured to assess compliance. - Participants who require additional support applying intervention materials can request brief email or telephone clarification from our team. - All sessions will be audio recorded for assessing treatment fidelity.
Sponsors
Study design
Eligibility
Inclusion criteria
(a) Expectant mothers and birthing parents who are aged 18 years or older; (b) At least 26 weeks but no more than 32 weeks gestation at enrolment; (c) Able to communicate (read/write/speak) in English; (d) Have regular access to email and the internet. (e) Currently live in Australia (f) Score above 7 on the Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001)
Exclusion criteria
a) Participants with stable use (five or more times per month) of medications or substances (prescription and over-the-counter) that directly affect sleep; non-stable use will be assessed on a case-to-case basis. Stable use of psychotropic medications for the treatment of non-sleep-related conditions (e.g., antidepressants, anxiolytics) is not exclusionary and any changes in doses will be documented. b) Participants with unstable medical conditions (e.g., severe diabetes, reflux) that directly and significantly affect sleep will be excluded. Medical conditions that do not directly or significantly impact sleep are not exclusionary. c) Participants with mental health conditions that significantly affect sleep, including severe current posttraumatic stress disorder, current substance abuse/dependence disorders, lifetime bipolar or psychotic disorders, and current suicidal ideation/self-harm behaviours or individuals who pose a risk of harm to others. d) Participants who self-report a current diagnosis of the following sleep disorders, with symptoms significantly affecting sleep: - Sleep apnoea: loud snoring, or observed gasping or pauses in breathing, or previously diagnosed with apnoea/hypopnea index >15/hr but not or inadequately treated; - Periodic limb movement disorder with arousal index > 15 per hour; - Self-reported diagnosis of restless legs syndrome (RLS) occurring three times/week, with duration of at least one month and onset prior to pregnancy. Not exclusionary if RLS increased or emerged during pregnancy (as long as pre-pregnancy frequency was no more than once a week); - Severe circadian rhythm disorders: Irregular Sleep Wake Disorder, Non-24-Hour Sleep-Wake Syndrome, Advance Sleep-Phase Syndrome (if habitual bed time is earlier than 8 pm and habitual wake time is earlier than 4 am. Occasional deviation from this schedule is allowed.), Delayed Sleep-Phase Syndrome (if habitual bed time is later than 3 am and habitual wake time is later than 11 am. Occasional deviation from this schedule is allowed.) - Narcolepsy; - Other previously diagnosed sleep disorders if severe, assessed on a case-to-case basis. e) Participants who are undertaking fixed night shift work (between midnight and 5 am) or rotating work schedules that require night shifts at enrolment;