NCT03615261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

October 4, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

July 23, 2018

Last Update Submit

October 1, 2021

Conditions

PregnancyPrenatal Stress

Keywords

prenatal maternal stressmindfulnessstress reductionhealth sensingmhealth

Outcome Measures

Primary Outcomes (2)

  • Usability/Wearability Feedback

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

    At post-intervention (approx. week 13)

  • Intervention Acceptability

    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.

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

Secondary Outcomes (16)

  • Intervention fidelity

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

  • Ecological Momentary Assessment Subjective Stress Ratings

    Five times daily for approx. weeks 1-13, and one week per month afterward until birth

  • 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 (Life events scale distress rating)

    Day 1, post-intervention (approx. week 13), 1 month prior to, and 1 month after delivery

  • +11 more secondary outcomes

Study Arms (1)

Mothers and Babies (Enhanced)

EXPERIMENTAL

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.

Behavioral: Mothers and Babies (Enhanced)

Interventions

Mothers and Babies (Enhanced)BEHAVIORAL

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.

Mothers and Babies (Enhanced)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

  • 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.

    PMID: 17355398BACKGROUND

  • 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.

    PMID: 19661759BACKGROUND

  • 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.

    PMID: 14531585BACKGROUND

  • 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.

    PMID: 19162414BACKGROUND

  • 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.

    PMID: 22299010BACKGROUND

  • 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.

    PMID: 23456540BACKGROUND

  • 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.

    PMID: 23793487BACKGROUND

  • 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.

    PMID: 21806298BACKGROUND

Study Officials

  • Lauren S Wakschlag, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All participants engaged in the Mothers \& Babies Intervention while wearing a biosensor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 3, 2018

Study Start

July 30, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2021

Last Updated

October 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)