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临床试验/NCT03615261
NCT03615261已完成不适用

Promoting Healthy Brain Development Via Prenatal Stress Reduction: An Innovative Precision Medicine Approach: An Intervention Feasibility and Acceptability Pilot

Northwestern University2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Usability/Wearability Feedback

研究概览

简要总结

The investigators are studying strategies and tools that women can use to manage stress and wellness during pregnancy. The purpose of this project is to test a technology-enhanced version of a wellness intervention for women during their pregnancy (the Mothers and Babies course; MB). The technology that the investigators will test includes wearable heart rate sensors, smartphone text message surveys, and intervention materials delivered through text message.

详细描述

Perinatal "early life" stress (ELS) has significant consequences for mothers and their infants.(1-3) Prolonged prenatal stress places pregnant women at increased risk for depression, health risk behaviors, and poor overall health and quality of life. Likewise, fetal exposure to stress places infants at greater risk of neurodevelopmental disruptions.(4,5)

Prior clinical trials led by co-PI Darius Tandon have demonstrated that pregnant women, particularly those in low income environments, demonstrate positive health and parenting benefits as a result of receiving prenatal stress reduction interventions.(6-8) The stress-reduction intervention proposed in the overarching Promoting Healthy Brains Project (PHBP), the Mothers and Babies course (MB), is a scalable, manualized evidence-based cognitive-behavioral intervention that can be adapted to meet client needs (e.g., setting, dose, timing, modality) without compromising fidelity. However, as there is substantial heterogeneity in maternal responsiveness to prenatal stress-reduction interventions, MB in its current form may be too low-intensity to improve fetal outcomes. Although a few studies have examined impact of interventions like MB on developmental outcomes, the extant evidence base does not provide strong support for intervention effects. Further, state-of-the-art neurodevelopmental methods have not been employed to detect how manipulation of early exposure to stress may effect brain:behavior patterns in early life. Advancing this is the overarching goal of the PHBP.

A crucial component of the proposed work involves an enhanced version of the 12-session, one-on-one version of MB with 1) mindfulness training content; 2) inter-session text messages prompting skills reinforcement, self-monitoring, and homework reminders; 3) adaptive, real-time stress monitoring that will optimize the intervention by identifying the key point at which to deliver just-in-time stress intervention content to individual participants.

The investigators will ask pregnant women to wear a long-wearing, unobtrusive wireless ECG sensor (BioStamp Research Connect; BioStamp). BioStamp sensor data will be used to detect physiological responses to stress (i.e., heart rate variability; HRV) to build a system that can be used to trigger real-time stress reduction intervention. BioStamp, a lightweight, rechargeable, and easy to use wearable device is equipped to passively and continuously measure HRV and motion. Unlike traditional "wired" ECG monitors, BioStamp can be worn under typical daily-living conditions (e.g., sleeping, showering, physical activity), with only minimal obtrusion in daily life (e.g., re-charging, re-applying adhesive).

Led by PI Laurie Wakschlag, the overarching PBHP will harness multidisciplinary expertise from Northwestern's Institute for Innovations in Developmental Sciences (DevSci), Lurie Children's Hospital, Center for Community Health, McCormick School of Engineering, and Feinberg School of Medicine & Northwestern Medicine (Ob/Gyn, Preventive Medicine, Medical Social Sciences, and Pediatrics) to 1) adapt and pilot MB enhanced with mindfulness training content, and just-in-time feedback to participants regarding their in-the-moment stress responses, and 2) experimentally test the effects of the optimized intervention on maternal wellbeing pre- and postnatally, and postnatal neurodevelopmental health trajectories.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 10-18 weeks gestation
  • singleton pregnancy
  • receiving prenatal care from a Northwestern University prenatal care clinic & planning to deliver at Northwestern Hospitals
  • English-speaking
  • must own a smartphone
  • must be willing to receive text messages and respond to short online surveys using their smartphone
  • must also agree to wear a wireless adhesive sensor daily
  • must have WiFi internet access for the duration of their participation in the study

排除标准

  • have known chronic medical or pregnancy complications that may place their infant at risk for neurological disorders (e.g., HIV; acute cytomegalovirus infection (CMV); toxoplasmosis; zika virus; Phenylketonuria (PKU); chromosomal anomalies; metabolic disorder; substance use disorders)
  • have significant mental health disorders (e.g., schizophrenia, bipolar disorder, psychosis) which could interfere with study adherence
  • unable to wear the BioStamp Sensor due to known skin sensitivity (e.g., allergy to adhesives or silicone), current skin irritation, or broken skin at the placement site
  • pacemaker or other sensitive medical device
  • unable to provide informed consent, complete MB sessions, or complete study assessments in English
  • currently participating in another MB course at the time of recruitment

结局指标

主要结局

Usability/Wearability Feedback

时间窗: At post-intervention (approx. week 13)

Participants will also be asked to provide survey feedback regarding the sensor's usability and wearability, and responding to the Environmental Momentary Assessments (EMAs).

Intervention Acceptability

时间窗: After each of the 12 MB sessions (approx. weekly during weeks 2-13)

All participants will complete a brief intervention rating checklist after completing each MB module (3 total). Additional acceptability information will be ascertained during the exit interview and survey at the end of the intervention to assess participants' overall ratings of the MB course, whether they would recommend the intervention to similar women, and suggestions for intervention modifications.

次要结局

  • Objective stress response(Continuously during the intervention (approx. weeks 2-13))
  • Perceived Stress (State Trait Anxiety Inventory)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Perceived stress (Prenatal Distress Questionnaire)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Depression symptoms (negative mood regulation scale)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Intervention skills (MB skills use survey)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Ecological Momentary Assessment Subjective Stress Ratings(Five times daily for approx. weeks 1-13, and one week per month afterward until birth)
  • Perceived Stress (Life events scale distress rating)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Depression symptoms (Edinburgh depression scale)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Perceived Stress (Perceived stress scale)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Depression symptoms (PROMIS depression)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Depression symptoms (MOS social support survey)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Depression symptoms (Experiences Questionnaire)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Depression symptoms (Prenatal Health Behavior Scale)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Intervention skills (five facet mindfulness questionnaire)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)
  • Intervention fidelity(After each of the 12 MB sessions (approx. weekly during weeks 2-13))
  • Depression symptoms (behavioral activation depression scale)(Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheila Krogh-Jespersen

Assistant Director

Northwestern University

研究点 (2)

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