Clinical trial NCT03615261: Wellness For 2: A Feasibility and Acceptability Pilot
Official title: Promoting Healthy Brain Development Via Prenatal Stress Reduction: An Innovative Precision Medicine Approach: An Intervention Feasibility and Acceptability Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Prenatal Stress
Keywords: prenatal maternal stress
mindfulness
stress reduction
health sensing
mhealth
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2018-08-03
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants engaged in the Mothers \& Babies Intervention while wearing a biosensor.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Usability/Wearability Feedback
timeFrame: At post-intervention (approx. week 13)
measure: Intervention Acceptability
timeFrame: After each of the 12 MB sessions (approx. weekly during weeks 2-13)
Secondary outcomes:
measure: Intervention fidelity
timeFrame: After each of the 12 MB sessions (approx. weekly during weeks 2-13)
measure: Ecological Momentary Assessment Subjective Stress Ratings
timeFrame: Five times daily for approx. weeks 1-13, and one week per month afterward until birth
measure: Objective stress response
timeFrame: Continuously during the intervention (approx. weeks 2-13)
measure: Perceived Stress (State Trait Anxiety Inventory)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Perceived Stress (Life events scale distress rating)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Perceived Stress (Perceived stress scale)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Depression symptoms (behavioral activation depression scale)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Perceived stress (Prenatal Distress Questionnaire)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Depression symptoms (PROMIS depression)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Depression symptoms (negative mood regulation scale)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Depression symptoms (MOS social support survey)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Depression symptoms (Experiences Questionnaire)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Depression symptoms (Edinburgh depression scale)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Depression symptoms (Prenatal Health Behavior Scale)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Intervention skills (five facet mindfulness questionnaire)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
measure: Intervention skills (MB skills use survey)
timeFrame: Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Lauren S Wakschlag, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Talge NM, Neal C, Glover V; Early Stress, Translational Research and Prevention Science Network: Fetal and Neonatal Experience on Child and Adolescent Mental Health. Antenatal maternal stress and long-term effects on child neurodevelopment: how and why? J Child Psychol Psychiatry. 2007 Mar-Apr;48(3-4):245-61. doi: 10.1111/j.1469-7610.2006.01714.x.
citation: Kinsella MT, Monk C. Impact of maternal stress, depression and anxiety on fetal neurobehavioral development. Clin Obstet Gynecol. 2009 Sep;52(3):425-40. doi: 10.1097/GRF.0b013e3181b52df1.
citation: O'Connor TG, Heron J, Golding J, Glover V; ALSPAC Study Team. Maternal antenatal anxiety and behavioural/emotional problems in children: a test of a programming hypothesis. J Child Psychol Psychiatry. 2003 Oct;44(7):1025-36. doi: 10.1111/1469-7610.00187.
citation: de Bruijn AT, van Bakel HJ, van Baar AL. Sex differences in the relation between prenatal maternal emotional complaints and child outcome. Early Hum Dev. 2009 May;85(5):319-24. doi: 10.1016/j.earlhumdev.2008.12.009. Epub 2009 Jan 21.
citation: Grizenko N, Fortier ME, Zadorozny C, Thakur G, Schmitz N, Duval R, Joober R. Maternal Stress during Pregnancy, ADHD Symptomatology in Children and Genotype: Gene-Environment Interaction. J Can Acad Child Adolesc Psychiatry. 2012 Feb;21(1):9-15.
citation: Mendelson T, Leis JA, Perry DF, Stuart EA, Tandon SD. Impact of a preventive intervention for perinatal depression on mood regulation, social support, and coping. Arch Womens Ment Health. 2013 Jun;16(3):211-8. doi: 10.1007/s00737-013-0332-4. Epub 2013 Mar 2.
citation: Tandon SD, Leis JA, Mendelson T, Perry DF, Kemp K. Six-month outcomes from a randomized controlled trial to prevent perinatal depression in low-income home visiting clients. Matern Child Health J. 2014 May;18(4):873-81. doi: 10.1007/s10995-013-1313-y.
citation: Tandon SD, Perry DF, Mendelson T, Kemp K, Leis JA. Preventing perinatal depression in low-income home visiting clients: a randomized controlled trial. J Consult Clin Psychol. 2011 Oct;79(5):707-12. doi: 10.1037/a0024895.