Effects of Using a Smart Bassinet on the Mental Health of Military-Affiliated Pregnant Women: Protocol for a Randomized Controlled Sleep Health and Mood in Newly Expectant Military Mothers (SHINE) Trial

Background: Postpartum mood and anxiety disorders (PMADs) 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 PMADs include sleep disturbances, defined as sleep deprivation, insomnia, or poor sleep quality, which are more are common among military-affiliated pregnant women. Objective: This study describes a protocol for a new randomized controlled trial that aims to ameliorate the risk for PMADs through improving infant sleep or maternal sleep during the first 6 postdelivery months in a sample of military-affiliated women. Methods: This study is a 6-month, parallel-arm, randomized controlled trial. Pregnant women (N=342) in the third trimester will be randomized at 1:1 ratio to use a smart bassinet (SB) or a standard commercially available bassinet (HALO BassiNest Swivel Sleeper 3.0; traditional bassinet [TB]) for up to 6 months after delivery. Participants will have their infants sleep in the bassinet, complete monthly web-based questionnaires, and record sleep data with diary and actigraphy for both the participants and their infants for 1 week each postpartum month. Blood samples will also be collected at baseline (late pregnancy) and at 3 months and 6 months post partum 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 SB has a significant impact on immune functioning-a marker that physiologically connects sleep and mood symptoms. Results: Recruitment for this study began in January 2025. Six separate mixed 2 (treatment vs control) x 6 (assessment period) multivariate analysis of variance and analysis of variance models will be conducted to test the hypotheses that SB will have a greater impact on infant and maternal sleep than TB, SB will be associated with a greater reduction in postpartum mood symptoms than TB, and immune system function will be less dysregulated in birthing individuals using SB compared to those using TB. Lastly, we will evaluate whether the elevated risk demonstrated by previously identified postpartum depression epigenetic biomarkers in the TTC9B and HP1BP3 genes can be modified with an SB. We hypothesize that the elevated risk will be reduced Conclusions: At the conclusion of this project, we will have gained a thorough understanding of the capability of SB to positively affect infant and maternal sleep compared to the traditional sleep arrangement and its impact on maternal mood through 6 months Trial Registration: ClinicalTrials.gov NCT06544941; https://clinicaltrials.gov/study/NCT06544941