Recruiting

VoiceLove

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07214597

Conditions

Postpartum Depression (PPD)

Self-Efficacy

Parental Anxiety

Engagement, Patient

Usability

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

VoiceLove mobile phone application

Study Details

Brief 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). 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.

Conditions

Postpartum Depression (PPD)

Self-Efficacy

Parental Anxiety

Engagement, Patient

Usability

Study ID

NCT07214597

Start date

Feb 4, 2026

Status verified date

Apr, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Infant:

1. Admitted to the neonatal intensive care unit (NICU)
2. Not readmitted after discharge from the NICU
3. Expected to survive at least 2 weeks
4. Expected to be admitted to the NICU for at least 2 weeks
5. Singleton gestation
2. Mother:

1. Age ≥ 18 years old
2. English speaking
3. Mother is the biological mother of the infant admitted to the NICU
4. Postpartum day 4 or less
3. Partner (NOTE: Partner enrollment is not required)

1. Mother agrees to partner's participation
2. Designated by mother as support person with infant access

Exclusion Criteria

1. Infant

a. Re-admission to NICU
2. Mother

1. No access to an Android or iOS smartphone
2. Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app
3. No personal email address
4. Incarcerated at time of delivery or postpartum
5. Inability to obtain informed consent

i. 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)
3. Partner (NOTE: Partner enrollment is not required)

1. Age < 18 years old
2. Not English speaking
3. Inability to obtain informed consent
4. No access to an Android or iOS smartphone that is different from the mother's smartphone
5. No access to an email address that is different from the mother's email address
6. Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Participants in this arm will be randomized to receive access to the VoiceLove app in addition to standard of care and surveys.

no intervention: Control Arm

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.

Interventions

VoiceLove mobile phone application

Access to VoiceLove app to facilitate secure, real-time communication between family members and NICU patients.

Primary outcome measure

  • Patient Engagement with the VoiceLove App [ Time Frame: 2-weeks post randomization. ]
  • Edinburgh Postnatal Depression Score (EPDS) at 2-weeks post randomization. [ Time Frame: 2-weeks post randomization. ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

Sarah Osmundson

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jun 17, 2026

Last verified

Apr, 2026

Keywords

  • Neonatal Intensive Care Unit
  • NICU
  • Postpartum Depression (PPD)
  • VoiceLove app
  • NURTURE
  • VoiceLove

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-06-17.