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.
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
Infant
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
Vanderbilt University Medical Center
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator