Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID06544941

Improving Maternal Mental Health in Military-Affiliated Pregnant Women Using a Smart Bassinet: A Randomized Controlled Trial

Led by University of Colorado, Colorado Springs · Updated on 2025-02-10

342

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Colorado Springs

Lead Sponsor

U

University of Virginia

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to test how well a Smart Bassinet can prevent or reduce postpartum mood disorders by improving sleep for mothers and their infants. The study focuses on military-affiliated pregnant women and compares the Smart Bassinet to a standard commercially available bassinet. The trial explores the effects on infant and maternal sleep, maternal mood symptoms, immune function, and epigenetic markers linked to postpartum depression over six months. Participants will be randomly assigned to use either the Smart Bassinet, which responds to a baby's fussing with swaying and shushing sounds to soothe the infant, or a standard Halo Bassinest without these features. The study lasts six months postpartum, with mothers completing monthly online surveys and collecting sleep data using actigraph devices. Blood samples will be taken at enrollment and at three and six months postpartum to assess immune markers. Mothers will participate by filling out monthly questionnaires about sleep and mood and using sleep tracking devices for one week each month for both themselves and their infants. Blood samples will help evaluate immune system changes over time. Researchers will measure maternal mood, infant and maternal sleep patterns, and inflammation markers. The study also includes genetic testing to see if the Smart Bassinet influences known risk factors for postpartum depression.

CONDITIONS

Brief Title

Improving Maternal Sleep and Mental Health

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women with a single baby who have a military affiliation
  • Aged 18 to 45 years
  • Able to communicate during the screening process
  • Have access to a computer, smartphone, or tablet with internet service
  • Willing to use the bassinet they are assigned to
  • Willing to travel locally for blood draws
Not Eligible

You will not qualify if you...

  • Current active depression, suicidal thoughts, medical or psychiatric instability, or substance abuse in the past 90 days
  • Plans to co-sleep exclusively with the infant
  • Younger than 18 or older than 45 years
  • Multiple pregnancies, type 1 diabetes, or fetal anomalies
  • Current tobacco use
  • Untreated sleep disorders such as narcolepsy, periodic leg movement disorder, or sleep apnea
  • Current use of psychotropic or sleep medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (remote phone assessment)

Enrollment and Randomization

Duration - 1 day

Eligible participants are enrolled and randomly assigned to use either the Smart Bassinet or the HALO bassinet.

1 visit (remote or in-person)

Intervention and Monitoring

Duration - 6 months

Participants use their assigned bassinet and complete monthly online surveys and sleep data collection for both mother and infant over 6 months postpartum. Blood samples are collected at late pregnancy, 3 months, and 6 months postpartum to assess immune system function and epigenetic biomarkers.

Monthly online surveys and sleep data collection; 3 local blood draw visits

Trial Site Locations

Total: 1 location

1

University of Colorado Colorado Springs

Colorado Springs, Colorado, United States, 80918

Actively Recruiting

Loading map...

Research Team

M

Michele L Okun, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

A Longitudinal Online Survey of Patient-Reported Changes in ...

Postpartum Depression

Actively Recruiting

1 location

A Multi-Modal Combination Intervention to Promote Cognitive ...

Critical Illness

Actively Recruiting

1 location

A SMART Evaluation of an Adaptive Web-based AUD Treatment fo...

Alcohol Abuse

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Effects of Using a Smart Bassinet on the Mental Health of Military-Affiliated Pregnant Women: Protocol for a Randomized Controlled Sleep Health and Mood in Newly Expectant Military Mothers (SHINE) Trial.

Michele L Okun, Jennifer L Payne, Lauren M Osborne...

https://pubmed.ncbi.nlm.nih.gov/40209215