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Behavioural Intervention

Smart Bassinet for Postpartum Depression (SHINE Trial)

N/A

Waitlist Available

Led By Michele L Okun

Research Sponsored by University of Colorado, Colorado Springs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18-45 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up late pregnancy, 3 & 6 months postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a Smart Bassinet's effectiveness in preventing postpartum mood disorders by improving maternal and infant sleep. The researchers will conduct a study with 342 participants who will be randomly assigned

Who is the study for?

This trial is for military-affiliated pregnant women in the US. Participants should be willing to use a smart bassinet or traditional bassinet, complete monthly questionnaires, and allow sleep data collection from both mother and baby. Blood samples will also be taken at specified times postpartum.

What is being tested?

The study tests if a Smart Bassinet can improve infant and maternal sleep, thereby reducing postpartum depression and anxiety symptoms. It's a randomized controlled trial comparing the Smart Bassinet with a standard one over six months.

What are the potential side effects?

There are no direct side effects mentioned for using the Smart Bassinet or standard bassinet; however, participation involves regular questionnaires, wearing an actigraph to monitor sleep, and providing blood samples.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 45 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ late pregnancy, 3 & 6 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~late pregnancy, 3 & 6 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and late pregnancy, 3 & 6 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Infant Sleep

Maternal Inflammation

Maternal Mood

+1 more

Secondary study objectives

Epigenetic biomarkers at the TTC9B and HP1BP3 genes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Smart Bassinet (SB)Experimental Treatment1 Intervention

The SB responds to an infant who is fussing or crying by initiating "swaying" movement and "shushing" sounds with white noise that incrementally increase until the infant calms or the caregiver shuts it off. It will help babies transition into life outside of the womb with ease, enabling them to feel safe and secure, which translates to more sleep.

Group II: HALO Bassinet (TAU)Active Control1 Intervention

The HALO is a commercially available bassinet that does not have any robotic/responsive actions incorporated within it.

0 / 1Eligibility criteria met