Smart Bassinet for Postpartum Depression

(SHINE Trial)

Overseen By Michele L Okun, Ph.D.

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Colorado Springs

Must not be taking: Psychotropic, Sleep medications

Disqualifiers: Depression, Co-sleeping, Tobacco, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

342 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smart bassinet to determine if it can improve sleep for new mothers and their babies, potentially reducing postpartum depression and anxiety. Participants will use either the smart bassinet, which responds to a baby's fussing with calming motions and sounds, or a standard bassinet. The study will also examine how these bassinets affect the immune system and certain genetic markers related to depression. Pregnant women with a military connection who use a bassinet and do not currently have depression might be suitable for this trial. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance postpartum care.

Will I have to stop taking my current medications?

Yes, if you are currently using psychotropic or sleep medications, you will need to stop taking them to participate in this trial.

What prior data suggests that the Smart Bassinet is safe for infants and mothers?

Research shows that the Smart Bassinet is generally well-received by users. In studies, most parents found that the bassinet helped their babies sleep better, which also improved the parents' sleep and mood. These studies reported no harmful effects. The bassinet's gentle rocking and soothing sounds help babies feel safe. This feature seems safe and helpful for both babies and their mothers. While more research is needed to fully understand long-term safety, current findings suggest it is a safe option for improving sleep and mood after childbirth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart Bassinet for postpartum depression because it offers a novel approach to enhancing maternal well-being by improving infant sleep. Unlike traditional bassinets, the Smart Bassinet is equipped with responsive technology that gently sways and produces soothing white noise to calm a fussing baby. This can lead to more sleep for both the baby and the caregiver, potentially alleviating stress and symptoms of postpartum depression. By creating an environment that mimics the womb, it aims to foster a sense of security for infants, which is a unique feature not found in standard bassinets.

What evidence suggests that the Smart Bassinet is effective for postpartum depression?

Research has shown that using a Smart Bassinet, which participants in this trial may receive, can improve sleep for both babies and mothers. The bassinet responds to a baby's fussing with gentle movements and sounds, helping babies sleep more soundly. Better sleep for mothers may reduce symptoms of postpartum depression. This is particularly important for military families, who often experience higher rates of mood disorders after childbirth. Early findings suggest that a Smart Bassinet might lower the risk of these mood disorders by enhancing sleep quality. ^{1 2 6 7 8}

Who Is on the Research Team?

Michele L Okun

Principal Investigator

University of Colorado, Colorado Springs

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can communicate during the screening process.

Access to a computer, smart phone or tablet with internet service

I am willing to use the assigned bassinet.

Exclusion Criteria

I have sleep problems like narcolepsy or sleep apnea that I haven't treated.

Presence of depression assessed over the phone using the Structured Clinical Interview for DSM Disorders - Clinical Version, Mood Disorders Section (SCID-I). Current active suicidal ideation, medical or psychiatric instability, or active substance abuse or dependence during the last 90 days. Actively depressed women will be excluded.

Plans to co-sleep with infant. Co-sleeping would prohibit extensive use of a bassinet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants are randomly assigned to use either the Smart Bassinet or the HALO Bassinet and are followed monthly for 6 months

6 months

Monthly online questionnaires and data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smart Bassinet

Trial Overview

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.

How Is the Trial Designed?

Group I: Smart Bassinet (SB) Experimental Treatment 1 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 Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Colorado, Colorado Springs

Lead Sponsor

Trials

20

Recruited

5,500+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

About 20% of women will experience major depressive disorder at some point in their lives, with the peripartum period being a critical time for worsening symptoms or relapse.

Effective management of depression in pregnant and postpartum women is complex and requires a team approach involving obstetricians, psychiatrists, and pediatricians to ensure the health of both the mother and the developing fetus or breastfeeding infant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When depression complicates childbearing: guidelines for screening and treatment during antenatal and postpartum obstetric care. Muzik, M., Marcus, SM., Heringhausen, JE., et al.[2021]

Depression, particularly antepartum and postpartum depression, is a significant global health issue, affecting over 15% of the population and more than 22% of women of childbearing age, highlighting the need for early detection.

Obstetricians are encouraged to routinely screen for depression from the planning stages of pregnancy to create a mood profile that can help identify risks for postpartum depression and potential suicide, aiming to minimize the need for pharmacological treatments and their side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening depressive patients in pregnancy with the pregnancy mood profile. Campagne, DM.[2005]

Postpartum major depression is often unrecognized and can be distinguished from 'baby blues' by its severity and associated risks, particularly in women with a history of depression; screening with the Edinburgh Postnatal Depression Scale is recommended.

Treatment options include psychotherapy and selective serotonin reuptake inhibitors, with no specific antidepressant proving superior; untreated postpartum depression can negatively impact mother-infant bonding and the child's future mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum major depression. Hirst, KP., Moutier, CY.[2022]

There is a significant lack of information available to women about postnatal depression (PND) compared to the abundant resources on pregnancy and childbirth, highlighting a gap in support for new mothers.

The article emphasizes the need for further research on the clinical presentation, risk factors, and treatment outcomes for women suffering from PND, as well as their responses to health professional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postnatal depression: a review of current literature. Williamson, V., McCutcheon, H.[2019]

Among 497 adolescents and young adults studied, those who initiated immediate postpartum contraceptive implants had a significantly lower rate of positive postpartum depression screens at 6 weeks (4.1%) compared to those using other contraceptive methods (9.5%).

The study suggests that initiating immediate postpartum implants may be associated with better mental health outcomes in terms of postpartum depression, highlighting the importance of offering effective contraceptive options to young mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between Immediate Postpartum Etonogestrel Implants and Positive Postpartum Depression Screens in Adolescents and Young Adults. Drake, E., Grush, K., Sheeder, J., et al.[2020]

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The intervention group will receive: 1. A Snoo smart sleep bassinet 2. A Willow wearable breast pump 3. Access to Maven Clinic for 24/7 on-demand perinatal care ...