Postpartum Depression (PPD)NURTURENCT07214597
NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)
A study testing VoiceLove mobile phone application in people with Postpartum Depression (PPD) and Self-Efficacy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression (PPD), Self-Efficacy, Parental Anxiety
- What is being tested?
- VoiceLove mobile phone application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Infant:
- Admitted to the neonatal intensive care unit (NICU)
- Not readmitted after discharge from the NICU
- Expected to survive at least 2 weeks
- Expected to be admitted to the NICU for at least 2 weeks
- Singleton gestation
Show all 14Show fewer
- Mother:
- Age ≥ 18 years old
- English speaking
- Mother is the biological mother of the infant admitted to the NICU
- Postpartum day 4 or less
- Partner (NOTE: Partner enrollment is not required)
- Mother agrees to partner's participation
- Designated by mother as support person with infant access
Who cannot join
- Infant
- Re-admission to NICU
- Mother
- No access to an Android or iOS smartphone
- Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app
- No personal email address
Show all 16Show fewer
- Incarcerated at time of delivery or postpartum
- Inability to obtain informed consent
- Patient's clinician refuses enrollment of the patient ii. Patient is either mentally (acute psychosis) or physically (intubated or critically ill in the ICU) unable to provide informed consent f. Unable to approach the patient (staffing, patient unavailable) g. Mother is not the intended parent (plans adoption, is a surrogate, will not have custody of the infant)
- Partner (NOTE: Partner enrollment is not required)
- Age < 18 years old
- Not English speaking
- Inability to obtain informed consent
- No access to an Android or iOS smartphone that is different from the mother's smartphone
- No access to an email address that is different from the mother's email address
- Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Makenna Woods, 615-936-2938, makenna.woods.1@vumc.org
Sarah Osmundson
About this study
Official title: NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE): A Randomized Controlled Trial
The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS). The estimates from this study will be used for a future definitive Phase III trial. Secondary aim: Assess feasibility, acceptability, and patterns of communication and engagement among mothers, partners, and NICU clinicians during the NICU hospitalization, measured through app usage metrics, satisfaction surveys, and qualitative interviews. Additionally, we will evaluate effects of infant length of stay.
Read the detailed description
This study is a randomized control trial that will test VoiceLove, a secure mobile app designed to help families communicate with their infants in the Neonatal Intensive Care Unit (NICU).
Postpartum depression (PPD) is a major depressive disorder and is one of the most frequent childbirth complications. Mother-infant separation during the initial postpartum period, such as infant admission to the neonatal intensive care unit (NICU), impacts mother-infant bonding and increases PPD risk, which is 40% higher in mothers with children admitted to the NICU. The impact of PPD is substantial: reported poor quality of life, high-risk behaviors such as substance abuse or self-harm, and long-term impairments in child cognitive and emotional development. PPD impact on child development has potential to be magnified in the already vulnerable preterm infant population. Care in the NICU is, by design, focused on the health of the infant and ill-equipped to address parental mental health. High stress and burnout among NICU staff combined with limited resources for development of psychosocial programs targeting the parents of NICU patients underscore the need for simple, low-cost, and easily implemented interventions aimed at improving parental connectedness and reducing postpartum mental health disorders.
Lack of parental connectedness to their neonate during a NICU stay and low social support are two of the most powerful risk factors for developing PPD. Risk of PPD is decreased when parents have more contact, either physical or verbal, with their infant and a higher perceived social support system. When physical contact is not possible, voice contact may help foster feelings of connectedness to both the infant in the NICU, and to the parents' social circle. The medical team is another critical source of support poised to increase parental mental health. Mothers of infants in the NICU report increased depressive symptoms when their perception of nurse support is low, while increased communication between parents and the medical team improves parental well-being. Increased social support from loved ones and the medical care team is well positioned to significantly reduce PPD severity in parents of NICU infants. Thus, facilitation of communication between parents and healthcare providers, as well as between their friends and family, presents a low-cost, low effort means to dramatically impact parental mental health and well-being during a NICU admission.
VoiceLove Inc has developed a novel HIPAA-compliant mobile application that offers programmatic support and curated digital content (e.g., lullabies, music, environmental sounds) for infant-family interactions and enables expanded family engagement in hospital settings. VoiceLove mobile app circumvents barriers to communication through an electronic venue for direct patient-family-clinician interaction. Specifically for clinicians, VoiceLove is a safe and time-efficient tool for direct communication with absent family members, allowing more time for direct patient care.
- Conditions
- Postpartum Depression (PPD), Self-Efficacy, Parental Anxiety, Engagement, Patient, Usability, Length of Stay
- Being tested
- VoiceLove mobile phone application
- Keywords
- Neonatal Intensive Care Unit, NICU, Postpartum Depression (PPD), VoiceLove app, NURTURE, VoiceLove
- Medical subject headings
- Depression, Postpartum, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoiceLove mobile phone applicationDevice
Also called VoiceLove app
Access to VoiceLove app to facilitate secure, real-time communication between family members and NICU patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants in this arm will be randomized to receive access to the VoiceLove app in addition to standard of care and surveys. Receives: Device: VoiceLove mobile phone application |
| Control Arm | No intervention | Participants in this arm will be randomized to standard of care only and will not have access to the VoiceLove app. They will also complete surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Engagement with the VoiceLove App
To assess the feasibility of using the VoiceLove app, we will measure how much patients in the intervention group engage with the app using metrics such as average app use per day at 2-weeks post randomization.
Measured: 2-weeks post randomization.
Edinburgh Postnatal Depression Score (EPDS) at 2-weeks post randomization.
The EPDS is a 10-question assessment of postpartum depression measured continuously on a scale of 1 to 30, whereas a higher score is a higher indication of postpartum depression.
Measured: 2-weeks post randomization.
Secondary outcomes (9)
EPDS Score at 6-weeks post randomization
The EPDS is a 10-question assessment of postpartum depression measured continuously on a scale of 1 to 30, whereas a higher score is a higher indication of postpartum depression.
Measured: 6-weeks post randomization.
Prevalence of high risk for postpartum depression (EPDS score ≥ 13) at 2- and 6-weeks.
Edinburgh Postnatal Depression Score (EPDS) ≥ 13. The EPDS is a 10-question assessment of postpartum depression measured continuously on a scale of 1 to 30, whereas a higher score is a higher indication of postpartum depression.
Measured: 2- and 6-weeks post randomization
PROMIS Informational Support at 2- and 6-weeks post randomization
Patient-Reported Outcomes Measurement Information System (PROMIS). According to HealthMeasures, the following describes the PROMIS Informational Support: "Quality of social support refers to functional aspects of supportive relationships, i.e., interpersonal relationships that serve particular functions. This includes the interactive process by which emotional, instrumental or informational support is obtained from one's social network. It also includes companionship, feeling cared for and valued as a person, communication with others, and feelings of belonging and trust. Measures of social support generally seek information about a person's perception of the availability or adequacy of resources provided by others.
The bank assesses perceived availability of helpful information or advice. The item bank does not use a time frame (e.g. over the past seven days) when assessing informational support. Informational Support instruments are available for adults (ages 18+)."
Measured: 2- and 6-weeks post randomization
PROMIS Self-Efficacy at 2- and 6-weeks post randomization
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy is described as the following according to HealthMeasures: "an individual's confidence in his/her ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. The PROMIS adult Self-Efficacy item banks assess self-reported current level of confidence in managing chronic conditions, including confidence in managing daily activities, managing emotions, managing medications and treatments, managing social interactions and managing symptoms. The self-efficacy item banks are universal rather than disease-specific. The respondent should be an adult (age 18+) and have at least one chronic health condition."
Measured: 2- and 6-weeks post randomization
Generalized Anxiety Disorder 7-item (GAD 7) at 2- and 6-weeks post randomization
The Generalized Anxiety Disorder 7-item (GAD 7) is a seven item questionnaire, whereas a higher score is a higher indication of generalized anxiety disorder.
Measured: 2- and 6-weeks post randomization
Post Traumatic Stress Disorder Checklist (PCL-5) at NICU discharge
According to the National Center for PTSD, the Post Traumatic Stress Disorder Checklist (PCL-5) is described as the following: "The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including:
- Monitoring symptom change during and after treatment
- Screening individuals for PTSD
- Making a provisional PTSD diagnosis The gold standard for diagnosing PTSD is a structured clinical interview such as the Clinician-Administered PTSD Scale (CAPS-5). When necessary, the PCL-5 can be scored to provide a provisional PTSD diagnosis."
Measured: at infant's NICU discharge, up to six (6) months.
NICU length of stay
Length of stay for the infant admitted to the Neonatal Intensive Care Unit (NICU) until they are discharged from the NICU.
Measured: from NICU admission to NICU discharge, up to six (6) months.
Infant birth weight at NICU discharge
Weight of the infant admitted to the Neonatal Intensive Care Unit (NICU) at time of their NICU discharge.
Measured: from NICU admission to NICU discharge, up to six (6) months.
App Usability and Satisfaction Scale at 2- and 6-weeks post randomization
A 5-point Likert scale and open-ended survey intended to analyze responses from those randomized to the intervention group.
Measured: 2- and 6-weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start4 Feb 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infant/mother dyads will be randomized in a 1:1 ratio stratified by infant gestational age at delivery (\<28 vs ≥28 weeks) and depression/anxiety diagnosis of the mother (measured by baseline EPDS ≥13). Gestational age is strongly associated with infant length of NICU stay. To reduce the risk of selection bias, we will use allocation concealment employing a computer-generated, permuted-block randomization scheme with varying block size. The block size and randomization list will only be known to the biostatistician creating the randomization list and will not be shared with investigators or any other study personnel. This list will be directly uploaded into REDCap's randomization module. Treatment assignment will be known by study participants, research personnel, and medical team given the unblinded nature of the intervention. Randomization procedure details, including stratification and block sizes, will be reported in trial publications. Randomization assignments are accessible 27/4.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sarah Osmundson, Vanderbilt University Medical Center
- Investigators
- Sarah Osmundson, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214597
- Sponsor's protocol ID
- 251461
- Other IDs
- 4R42MH135602-02
- Acronym
- NURTURE
- Status last verified
- Apr 2026
- First submitted
- 4 Sep 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Will need to investigate feasibility
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07214597
- Acronym / sponsor ID
- NURTURE / 251461
- Conditions
- Postpartum Depression (PPD), Self-Efficacy, Parental Anxiety, Engagement, Patient, Usability, Length of Stay
- Keywords
- Neonatal Intensive Care Unit, NICU, Postpartum Depression (PPD), VoiceLove app, NURTURE, VoiceLove
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS). The estimates from this study will be used for a future definitive Phase III trial. Secondary aim: Assess feasibility, acceptability, and patterns of communication and engagement among mothers, partners, and NICU clinicians during the NICU hospitalization, measured through app usage metrics, satisfaction surveys, and qualitative interviews. Additionally, we will evaluate effects of infant length of stay.
Detailed description
This study is a randomized control trial that will test VoiceLove, a secure mobile app designed to help families communicate with their infants in the Neonatal Intensive Care Unit (NICU).
Postpartum depression (PPD) is a major depressive disorder and is one of the most frequent childbirth complications. Mother-infant separation during the initial postpartum period, such as infant admission to the neonatal intensive care unit (NICU), impacts mother-infant bonding and increases PPD risk, which is 40% higher in mothers with children admitted to the NICU. The impact of PPD is substantial: reported poor quality of life, high-risk behaviors such as substance abuse or self-harm, and long-term impairments in child cognitive and emotional development. PPD impact on child development has potential to be magnified in the already vulnerable preterm infant population. Care in the NICU is, by design, focused on the health of the infant and ill-equipped to address parental mental health. High stress and burnout among NICU staff combined with limited resources for development of psychosocial programs targeting the parents of NICU patients underscore the need for simple, low-cost, and easily implemented interventions aimed at improving parental connectedness and reducing postpartum mental health disorders.
Lack of parental connectedness to their neonate during a NICU stay and low social support are two of the most powerful risk factors for developing PPD. Risk of PPD is decreased when parents have more contact, either physical or verbal, with their infant and a higher perceived social support system. When physical contact is not possible, voice contact may help foster feelings of connectedness to both the infant in the NICU, and to the parents' social circle. The medical team is another critical source of support poised to increase parental mental health. Mothers of infants in the NICU report increased depressive symptoms when their perception of nurse support is low, while increased communication between parents and the medical team improves parental well-being. Increased social support from loved ones and the medical care team is well positioned to significantly reduce PPD severity in parents of NICU infants. Thus, facilitation of communication between parents and healthcare providers, as well as between their friends and family, presents a low-cost, low effort means to dramatically impact parental mental health and well-being during a NICU admission.
VoiceLove Inc has developed a novel HIPAA-compliant mobile application that offers programmatic support and curated digital content (e.g., lullabies, music, environmental sounds) for infant-family interactions and enables expanded family engagement in hospital settings. VoiceLove mobile app circumvents barriers to communication through an electronic venue for direct patient-family-clinician interaction. Specifically for clinicians, VoiceLove is a safe and time-efficient tool for direct communication with absent family members, allowing more time for direct patient care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infant/mother dyads will be randomized in a 1:1 ratio stratified by infant gestational age at delivery (<28 vs ≥28 weeks) and depression/anxiety diagnosis of the mother (measured by baseline EPDS ≥13). Gestational age is strongly associated with infant length of NICU stay. To reduce the risk of selection bias, we will use allocation concealment employing a computer-generated, permuted-block randomization scheme with varying block size. The block size and randomization list will only be known to the biostatistician creating the randomization list and will not be shared with investigators or any other study personnel. This list will be directly uploaded into REDCap's randomization module. Treatment assignment will be known by study participants, research personnel, and medical team given the unblinded nature of the intervention. Randomization procedure details, including stratification and block sizes, will be reported in trial publications. Randomization assignments are accessible 27/4.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: VoiceLove mobile phone applicationParticipants in this arm will be randomized to receive access to the VoiceLove app in addition to standard of care and surveys. |
| Control Arm | No intervention | –Participants in this arm will be randomized to standard of care only and will not have access to the VoiceLove app. They will also complete surveys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Infant:
- Mother:
- Partner (NOTE: Partner enrollment is not required)
Key exclusion criteria (16 listed)
- Infant
- Mother
- Partner (NOTE: Partner enrollment is not required)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VoiceLove mobile phone applicationAlso: VoiceLove appAccess to VoiceLove app to facilitate secure, real-time communication between family members and NICU patients. | Device | Intervention Arm |
Primary outcome
Patient Engagement with the VoiceLove App
Time frame: 2-weeks post randomization.
To assess the feasibility of using the VoiceLove app, we will measure how much patients in the intervention group engage with the app using metrics such as average app use per day at 2-weeks post randomization.
Edinburgh Postnatal Depression Score (EPDS) at 2-weeks post randomization.
Time frame: 2-weeks post randomization.
The EPDS is a 10-question assessment of postpartum depression measured continuously on a scale of 1 to 30, whereas a higher score is a higher indication of postpartum depression.
9 secondary outcomes
EPDS Score at 6-weeks post randomization
Time frame: 6-weeks post randomization.
Prevalence of high risk for postpartum depression (EPDS score ≥ 13) at 2- and 6-weeks.
Time frame: 2- and 6-weeks post randomization
PROMIS Informational Support at 2- and 6-weeks post randomization
Time frame: 2- and 6-weeks post randomization
PROMIS Self-Efficacy at 2- and 6-weeks post randomization
Time frame: 2- and 6-weeks post randomization
Generalized Anxiety Disorder 7-item (GAD 7) at 2- and 6-weeks post randomization
Time frame: 2- and 6-weeks post randomization
Post Traumatic Stress Disorder Checklist (PCL-5) at NICU discharge
Time frame: at infant's NICU discharge, up to six (6) months.
NICU length of stay
Time frame: from NICU admission to NICU discharge, up to six (6) months.
Infant birth weight at NICU discharge
Time frame: from NICU admission to NICU discharge, up to six (6) months.
App Usability and Satisfaction Scale at 2- and 6-weeks post randomization
Time frame: 2- and 6-weeks post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided. Will need to investigate feasibility
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Osmundson principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VoiceLove mobile phone application in people with Postpartum Depression (PPD) and Self-Efficacy, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Makenna Woods (615-936-2938, makenna.woods.1@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Engagement with the VoiceLove App (time frame: 2-weeks post randomization.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.