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New treatment option for Postpartum Depression (PPD)
Official title NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)
ClinicalTrials.gov ID: NCT07214597
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Infant a. 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
- Incarcerated at time of delivery or postpartum
See the full eligibility criteria
- 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
- 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
- Infant a. 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
- Incarcerated at time of delivery or postpartum
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.