Improving Maternal Mental Health in Military-Affiliated Pregnant Women: Effectiveness of a Smart Bassinet
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Maternal Inflammation
研究概览
简要总结
The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question[s] it aims to answer [is/are]:
Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. [primary hypothesis or outcome measure 2]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU.
Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.
详细描述
The investigators propose to conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use the SB or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)).
The primary objective of this proposal is to randomly assign mother-infant dyads (N = 342) to the SB or the TAU condition and follow them monthly for 6 months. Mothers will complete online surveys monthly regarding infant sleep and behavior, maternal sleep, and maternal depressive symptoms. Prospective subjective and objective sleep data will also be collected from mother and infant for one week each month. This study represents the first empirical study to assess the efficacy of the SB to promote efficient infant sleep, and to assess longitudinal effects on maternal postpartum sleep and mood symptoms. This work is essential since few effective interventions are available that support infant sleep. A secondary objective is to explore maternal biomarkers of PPD, including markers of inflammation and epigenetic biomarkers, and determine if the SB intervention alters immune dysregulation and the risk associated with epigenetic biomarkers of PPD. The rationale stems from evidence regarding dysregulation of the immune system and inflammatory activity as potential mediating pathways between sleep disturbances and health.
This proposal will address the following aims:
Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. Hypothesis 1a: Infants who sleep in the SB will have better sleep (i.e., diary and Brief Infant Sleep Questionnaire as maternally reported) compared to TAU. Outcomes will include maternally reported sleep duration, awakenings, as well as objective assessed (actigraphy) wake after sleep onset (WASO), and sleep onset latency (SOL). Hypothesis 1b: Mothers of infants who sleep in the SB will have better subjectively reported (i.e., diary and Pittsburgh Sleep Quality Index) and objectively assessed (actigraphy) sleep compared to TAU. Outcomes will be the same as the infants.
Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep. Hypothesis 2a: Mothers of infants who sleep in the SB will have fewer postpartum depressive symptoms over time (i.e., Edinburgh Postnatal Depression Scale) compared to TAU. Hypothesis 2b: The SB improves infant sleep, which then predicts better maternal sleep, and thereby predicts lower maternal depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with a singleton gestation who have a military affiliation
- •Ages 18-45 years
- •Ability to communicate during the screening process
- •Access to a computer, smart phone or tablet with internet service
- •Willing to use bassinet they are randomized to
- •Willing to travel to a local Quest for blood draw
排除标准
- •Presence of depression assessed over the phone using the Structured Clinical Interview for DSM Disorders - Clinical Version, Mood Disorders Section (SCID-I). Current active suicidal ideation, medical or psychiatric instability, or active substance abuse or dependence during the last 90 days. Since this is a study about risk for recurrent PPMD, actively depressed women will be excluded.
- •Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet.
- •Under the age of 18 years or > 45 years. The goal is to include women of childbearing age.
- •Multiple gestations, Type 1 diabetes, congenital fetal anomalies. Women with these factors will likely have major disruption of sleep, require 2 bassinets, or a disrupted home life. These would skew the data and make interpretations and comparisons difficult.
- •Tobacco use (current). Smoking is associated with poor sleep and inflammation.
- •Self-reported, untreated comorbid sleep disorders including narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea. These disorders contribute to poor sleep and often require medications for treatment.
- •Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation.
研究组 & 干预措施
Smart Bassinet (SB)
The SB responds to an infant who is fussing or crying by initiating "swaying" movement and "shushing" sounds with white noise that incrementally increase until the infant calms or the caregiver shuts it off. It will help babies transition into life outside of the womb with ease, enabling them to feel safe and secure, which translates to more sleep.
干预措施: Smart Bassinet (Device)
HALO Bassinet (TAU)
The HALO is a commercially available bassinet that does not have any robotic/responsive actions incorporated within it.
干预措施: HALO (Device)
结局指标
主要结局
Maternal Inflammation
时间窗: late pregnancy, 3 & 6 months postpartum
Assessment of changes in maternal inflammation
Maternal Sleep
时间窗: 0-6 months postpartum
Assessment of sleep across the first 6 months postpartum
Maternal Mood
时间窗: 0-6 months postpartum
Assessment of depressive and anxiety symptoms across the first 6 months postpartum
Infant Sleep
时间窗: 0-6 months postpartum
Assessment of infant sleep across the first 6 months postpartum
次要结局
- Epigenetic biomarkers at the TTC9B and HP1BP3 genes(assess markers at Baseline (Late pregnancy))