Wellness For 2: A Feasibility and Acceptability Pilot (We2-P)

Northwestern University

Status: Completed

Conditions: Prenatal Stress; Pregnancy

Treatments: Behavioral: Mothers and Babies (Enhanced)

Study type: Interventional

Funder types: Other

Identifiers

NCT03615261

STU00205776B

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 17 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Mothers and Babies (Enhanced)

Experimental group

Description:

The course is a manualized stress-reduction intervention with an integrated tech suite designed for timely detection and response to stress. Based on Cognitive-Behavioral Therapy \& attachment theory, MB is divided into 3 sections: Pleasant Activities; Thoughts; Contact with Others. Each module has been enhanced with mindfulness as a strategy to help "center" participants and facilitate practice of skills. Participants receive skills training in each of the three sections as tools to improve and manage their mood. The MB course emphasizes developing \& strengthening the bond with the baby. The technology enhancement includes wearing a BioStamp sensor, and text message-based extra intervention content. Participants get worksheets linked to the 12 sessions.

Treatment:

Behavioral: Mothers and Babies (Enhanced)