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Voice app aims to ease postpartum depression for NICU moms

NCT ID NCT07214597

Symptom relief Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a smartphone app called VoiceLove that lets mothers of babies in the NICU record voice messages for their infant. Researchers want to see if using the app helps reduce symptoms of postpartum depression compared to standard care. About 150 mothers will take part, and the study will also check how easy the app is to use and how it affects family communication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Patient Participation postpartum depression

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Engagement, patient Length of stay Parental anxiety Postpartum depression (PPD) Self efficacy Usability

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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