Smart Bassinet for Postpartum Depression

(SHINE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Michele L Okun

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Colorado Springs

Must not be taking: Psychotropic, Sleep medications

Disqualifiers: Depression, Co-sleeping, Tobacco, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\[s\] it aims to answer \[is/are\]: Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. \[primary hypothesis or outcome measure 2\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU. Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.

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.

How does the Smart Bassinet treatment differ from other treatments for postpartum depression?

The Smart Bassinet is a novel approach to managing postpartum depression by potentially providing a supportive environment for both mother and infant, unlike traditional treatments that primarily involve medication or psychotherapy. This treatment may offer a non-pharmacological option, which is beneficial for mothers who are breastfeeding and wish to avoid medication side effects. ^{1 2 3 4 5}

Research Team

Michele L Okun

Principal Investigator

University of Colorado, Colorado Springs

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Smart Bassinet (Behavioural Intervention)

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.

Participant Groups

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+

James E. Ryan

University of Virginia

Chief Executive Officer since 2018

J.D. from Harvard Law School

Nikki Hastings

University of Virginia

Chief Medical Officer since 2018

Ph.D. in Biomedical Engineering from University of Virginia

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Postpartum major depression. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

When depression complicates childbearing: guidelines for screening and treatment during antenatal and postpartum obstetric care. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

The Association between Immediate Postpartum Etonogestrel Implants and Positive Postpartum Depression Screens in Adolescents and Young Adults. [2020]

5. Australia pubmed.ncbi.nlm.nih.gov

Postnatal depression: a review of current literature. [2019]