Wellness For 2: A Feasibility and Acceptability Pilot

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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