RECRUITING

Improving Maternal Sleep and Mental Health

Conditions

Postpartum Depression Postpartum Anxiety Sleep Disturbance Infant Behavior Maternal Behavior Inflammation Military Family sleep postpartum intervention depression anxiety

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Improving Maternal Mental Health in Military-Affiliated Pregnant Women: Effectiveness of a Smart Bassinet

Quick Facts

Study Start:2025-01-15

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06544941

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Pregnant women with a singleton gestation who have a military affiliation * Ages 18-45 years * Ability to communicate during the screening process * Access to a computer, smart phone or tablet with internet service * Willing to use bassinet they are randomized to * Willing to travel to a local Quest for blood draw	* 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. Since this is a study about risk for recurrent PPMD, actively depressed women will be excluded. * Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet. * Under the age of 18 years or \> 45 years. The goal is to include women of childbearing age. * Multiple gestations, Type 1 diabetes, congenital fetal anomalies. Women with these factors will likely have major disruption of sleep, require 2 bassinets, or a disrupted home life. These would skew the data and make interpretations and comparisons difficult. * Tobacco use (current). Smoking is associated with poor sleep and inflammation. * Self-reported, untreated comorbid sleep disorders including narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea. These disorders contribute to poor sleep and often require medications for treatment. * Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation.

Inclusion Criteria

Exclusion Criteria

* Pregnant women with a singleton gestation who have a military affiliation
* Ages 18-45 years
* Ability to communicate during the screening process
* Access to a computer, smart phone or tablet with internet service
* Willing to use bassinet they are randomized to
* Willing to travel to a local Quest for blood draw

* 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. Since this is a study about risk for recurrent PPMD, actively depressed women will be excluded.
* Plans to co-sleep with infant. The goal is to compare two bassinets; therefore co-sleeping would prohibit extensive use of a bassinet.
* Under the age of 18 years or \> 45 years. The goal is to include women of childbearing age.
* Multiple gestations, Type 1 diabetes, congenital fetal anomalies. Women with these factors will likely have major disruption of sleep, require 2 bassinets, or a disrupted home life. These would skew the data and make interpretations and comparisons difficult.
* Tobacco use (current). Smoking is associated with poor sleep and inflammation.
* Self-reported, untreated comorbid sleep disorders including narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea. These disorders contribute to poor sleep and often require medications for treatment.
* Current use of psychotropic or sleep medications. These are associated with altered sleep and inflammation.

Contacts and Locations

Study Contact

Michele L Okun, Ph.D.

CONTACT

412-302-8030

mokun@uccs.edu

Principal Investigator

Michele L Okun

PRINCIPAL_INVESTIGATOR

University of Colorado, Colorado Springs

Study Locations (Sites)

University of Colorado Colorado Springs

Colorado Springs, Colorado, 80918

United States

Collaborators and Investigators

Sponsor: University of Colorado, Colorado Springs

Michele L Okun, PRINCIPAL_INVESTIGATOR, University of Colorado, Colorado Springs

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-15

Study Completion Date2028-06

Study Record Updates

Study Start Date2025-01-15

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

sleep
postpartum
intervention
inflammation
depression
anxiety

Additional Relevant MeSH Terms

Postpartum Depression
Postpartum Anxiety
Sleep Disturbance
Infant Behavior
Maternal Behavior
Inflammation
Military Family