Postpartum Depression Clinical Trials

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NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE): A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• Infant:

‣ Admitted to the neonatal intensive care unit (NICU)

⁃ Born at VUMC

⁃ Index admission (NOT a re-admission)

⁃ Born between 23+0 and 31+6 weeks

⁃ Expected to survive at least 2 weeks

⁃ Singleton gestation

• 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

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Makenna Woods
makenna.woods.1@vumc.org
615-936-2938
Time Frame
Start Date: 2026-02-04
Estimated Completion Date: 2028-01
Participants
Target number of participants: 150
Treatments
Experimental: Intervention Arm
Participants in this arm will be randomized to receive access to the VoiceLove app in addition to standard of care.
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.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov