Improving Maternal Mental Health in Military-Affiliated Pregnant Women Using a Smart Bassinet: A Protocol for a Randomized Controlled Trial (Sleep Health and Mood in Newly Expectant Military Mothers “SHINE”) (Preprint)

BACKGROUND The number of females in the U.S. military constitutes 17.3% of the total force (2021), with an additional 1.1 million military (female) spouses. Postpartum mood and anxiety disorders (PMAD) are higher among pregnant military service women (26%) and military spouses (12.2%) compared to the civilian population (10-15%). This is partly due to military-specific factors, including deployment, which are known to increase risk. Important risk factors for PMAD include sleep disturbances, defined as sleep deprivation, insomnia, or poor sleep quality, and they are more are common among military-affiliated pregnant women. OBJECTIVE The goal of this paper is to describe the protocol for a new randomized controlled trial that aims to ameliorate risk for PMAD through improving infant sleep, and/or maternal sleep during the first six months post-delivery in a sample of military-affiliated women. METHODS This study is a 6-month, parallel arm, randomized controlled trial (RCT). Pregnant women (N = 342) in the third trimester will be randomized at a 1:1 ratio to use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinet Swivel Sleeper 3.0) (traditional bassinet group (TBG)) for up to 6 months post-delivery. Participants will have their infants sleep in the bassinet, complete monthly online questionnaires, and record sleep data with diary and actigraphy for both the participant and their infant for 1 week each postpartum month. Blood samples will also be collected at baseline (late pregnancy), 3 months and 6 months postpartum to assess immune functioning. The primary outcomes for this study will be postpartum mood (depressive and anxiety symptoms) and infant and maternal sleep. In addition, we are evaluating whether the SB has a significant impact on immune functioning, a marker that physiologically connects sleep and mood symptoms. RESULTS Recruitment for this study began in October 2024. Six separate mixed 2 (treatment versus control) x 6 (assessment period) MANOVA and ANOVA models will be conducted to test the hypotheses that the SB will have a greater impact on infant and maternal sleep than TBG; the SB will be associated with a greater reduction in postpartum mood symptoms than TBG; and that immune system function will be less dysregulated in birthing individuals using the SB compared to TBG. Lastly, the investigators will evaluate whether the elevated risk demonstrated by previously identified postpartum depression (PPD) epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. We hypothesize that the elevated risk will be reduced in the SB condition compared to TBG. CONCLUSIONS At the conclusion of this project, we will have gained a thorough understanding of the capability of the SB to positively affect infant and maternal sleep compared to a traditional sleep arrangement, and its impact on maternal mood through 6 months postpartum in military-affiliated women. The promotion of sleep health in both mothers and infants may be an accessible and amenable method to prevent PMAD. CLINICALTRIAL ClinicalTrials.gov HT94252410690