None listed
Conditions
Brief summary
Sleep disturbance is experienced by the majority of child-bearing women during the pregnancy and post-partum periods. Physiological changes related to pregnancy and birth-giving (e.g., hormonal changes), and post-partum nighttime infant care are common factors that reduce/disrupt sleep opportunity. In addition, some women (~17%) experience clinically significant insomnia symptoms. The resulting sleep complaints have been associated with a range of poor maternal outcomes (e.g., mood disturbance, worse birth outcomes, poorer maternal-infant attachment). Integrated behavioral and educational interventions have been consistently shown to improve sleep, and have lasting effects on sleep and wellbeing. Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective insomnia treatment, and recently has been tailored to, and piloted on, women with comorbid postpartum depression and insomnia with significant improvements to sleep and mood. Given the proven efficacy of CBT-I and the need to prioritize treatment accessibility in the community, the lack of a flexible delivery service platform for healthy sleep strategies represents a significant gap in clinical translation. Given the high prevalence of sleep disturbance in perinatal periods, a platform that can be easily integrated into routine perinatal care, as well as being accessible to a broad community is desirable. However, expectant mothers in most of Australia are not currently receiving evidence-based information and recommendations to prepare and support them through the many changes to sleep/wake cycles during the transition into motherhood. This study will adapt an existing evidence-based perinatal sleep intervention for use in an Australian public hospital setting and include features that allow for sustainable integration into routine care, promoting eventual wider dissemination. The primary aims of the study are to obtain pilot data on 1) the feasibility of integrating this adaptation in outpatient perinatal care, and 2) its treatment effect on sleep and wellbeing in mothers and infants. To achieve this aim, a comparison group, Diet SEED will be used. A secondary aim of the study is exploratory, and assesses potential benefits of Diet SEED on participants' diet. From a diet perspective, the Sleep SEED group will be treatment as usual (as outpatients). Currently, diet related information is given to women in a text-dense booklet. By adapting content of this booklet to digestible sizes that are delivered at important perinatal milestones, Diet SEED has the potential to improve women's diet behaviors significantly compared to treatment as usual. Therefore, to achieve this aim, dietary measures will be compared between Sleep and Diet SEED groups.
Interventions
A summary of the Sleep SEED core content is as follows:
a) general information and skills for better sleep (e.g., typical sleep patterns of new parents and infants, sleep hygiene, relaxation and mindfulness exercise, dealing with nighttime worries);
b) fostering healthy attitudes and expectations about sleep during perinatal periods;
c) managing sleep challenges specific to perinatal period (e.g., physical discomfort, pain, sleep deprivation, daytime consequences of poor sleep);
d) infant sleep
A summary of the Sleep SEED core content is as follows: a) general information and skills for better sleep (e.g., typical sleep patterns of new parents and infants, sleep hygiene, relaxation and mindfulness exercise, dealing with nighttime worries); b) fostering healthy attitudes and expectations about sleep during perinatal periods; c) managing sleep challenges specific to perinatal period (e.g., physical discomfort, pain, sleep deprivation, daytime consequences of poor sleep); d) infant sleep and settling skills; e) identifying and managing symptoms of insomnia (e.g., self-monitoring, stimulus control, sleep scheduling, bed restriction). At program entry, participants will receive a one-on-one program orientation (up to 1 hour) via telephone (recorded for quality control) by a registered psychologist or clinical psychology trainee under regular supervision of a registered clinical psychologist. The individual delivering the orientation will be trained by the chief investigator to follow pre-scripted protocol, which covers the following aspects: a) overview and rationale of the program, including an introduction to the program's core principles (e.g., cognitive behavioral principles), an overview of topics covered, and introduction to the core components; b) structure of the program and logistics; c) importance of practice and regular strategies. Following the program orientation, participants will receive intervention materials via emails at 6 different time points: T1: 26-32 weeks gestation T2: 35-36 weeks gestation T3: 2 weeks postpartum T4: 1.5 months postpartum T5: 3 months postpartum T6: 6 months postpartum The intervention materials are tailored to, and delivered at, critical perinatal milestones that have specific challenges to sleep (e.g., physical discomfort in late pregnancy). The emails will contain text, graphics, and audio download links on relevant information. Adherence to the intervention is assessed after each intervention phase via self-report surveys. If participants require additional information or support with the program, telephone consultation will be available from a clinical psychologist.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
a) Nulliparous (first time mothers); b) Age >= 18; c) Singleton pregnancy; d) Able to understand intervention materials in English and complete surveys in English; e) Have regular accessing to email and internet.
Exclusion criteria
a) Participants who use medication or substances that directly affect sleep; b) Unstable medical conditions that directly affect sleep; c) Participants who show the following symptoms of sleep disturbance: sleep apnea, previously diagnosed Periodic Limb Movement Disorder, Restless Legs Syndrome; d) Circadian rhythm disorders (based on DUKE): Irregular Sleep Wake Disorder, Non-24-Hour Sleep-Wake Syndrome, Advance Sleep-Phase Syndrome, Delayed Sleep-Phase Syndrome, Fixed night shift work between midnight and 5 a.m. or rotating work scheduled that required night shifts during course of pregnancy or participation; e) Other previously diagnosed sleep disorders; f) Mental health conditions as determined by the M.I.N.I. International Neuropsychiatric Interview 7.0 (referred for appropriate management): 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 abuse/dependence disorders (during pregnancy).
Outcome results
None listed