No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Supportive Care
Participants needed
150 (estimated)
Sponsor
Vanderbilt University Medical Center · Other
Who this trial is looking for
This trial is looking for mothers of infants in the NICU who are experiencing postpartum depression. Participants will use the VoiceLove app to help improve their mental health during their baby's hospital stay.
Are You a Good Fit for This Trial?
You may be able to join if
I am the biological mother of an infant in the NICU.
I am at least 18 years old.
I speak English.
I am on postpartum day 4 or less.
My infant is expected to stay in the NICU for at least 2 weeks.
My infant is a singleton (not a multiple birth).
I agree to my partner participating (if applicable).
You may not be able to join if
My infant has been readmitted to the NICU.
I do not have access to an Android or iOS smartphone.
I am unwilling to download the VoiceLove app.
I do not have a personal email address.
I was incarcerated at the time of delivery or postpartum.
I am unable to provide informed consent.
I am not the intended parent of the infant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 (E…
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.
Trial Locations
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City
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Status
Eligibility Criteria
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…
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
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