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Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

VoiceLove App for Postpartum Depression
(NURTURE Trial)

Overseen ByMakenna Woods

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Incarceration, Acute psychosis, Surrogacy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app called VoiceLove to determine its effectiveness in reducing postpartum depression in new mothers with babies in the Neonatal Intensive Care Unit (NICU). It compares the app's impact on depression with usual care methods. Researchers aim to assess whether the app is user-friendly and well-received by mothers, their partners, and NICU staff. Mothers with babies born very early (between 23 and 31 weeks) and currently in the NICU may be suitable for this trial. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance mental health support for NICU families.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the VoiceLove app is safe for postpartum depression treatment?

Research has shown that app-based treatments for postpartum depression are generally easy to use. Studies have found that mobile health (mHealth) apps, such as the VoiceLove app, are often well-received by users. These apps assist in tracking and managing symptoms of depression and anxiety in new mothers.

No specific reports of negative effects have emerged from using the VoiceLove app, suggesting it might be safe for most people. However, this study remains in an early stage, so researchers continue to learn about the app's effectiveness and safety. Other similar apps for postpartum depression have received FDA approval, indicating their safety for use.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial?

Unlike the standard care for postpartum depression, which often includes therapy and antidepressants, the VoiceLove app offers a digital, self-guided approach that mothers can use at any time. Researchers are excited about this app because it provides personalized support and resources directly through a smartphone, making it accessible and convenient for new mothers. The app aims to empower users by offering tools and exercises that can be integrated into daily life, potentially enhancing mental health outcomes without the need for traditional in-person therapy sessions.

What evidence suggests that the VoiceLove app is effective for postpartum depression?

Research has shown that telehealth tools, such as the VoiceLove app, can help lessen symptoms of postpartum depression. Evaluations often use the Edinburgh Postnatal Depression Scale (EPDS) to measure depression severity. Studies have found that these mobile apps can boost mood and reduce anxiety in new mothers. In this trial, participants in the intervention arm will access the VoiceLove app, designed to support mothers with babies in the Neonatal Intensive Care Unit (NICU), a particularly stressful time. Although researchers are still studying the app's full effects, early findings suggest it may help reduce postpartum depression symptoms.¹ ⁶ ⁷ ⁸ ⁹

Who Is on the Research Team?

Sarah Osmundson

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

The NURTURE trial is for mothers with newborns in the NICU who may be experiencing postpartum depression. Participants should be willing to use the VoiceLove mobile app and participate in surveys and interviews. Specific eligibility criteria are not provided, but typically include factors like age, health status, and consent.

Inclusion Criteria

Infant: Born at VUMC

Infant: Admitted to the neonatal intensive care unit (NICU)

Infant: Index admission (NOT a re-admission)

See 9 more

Exclusion Criteria

Infant: Re-admission to NICU

Mother: No access to an Android or iOS smartphone

Mother: No personal email address

See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization

Participants are randomized to either the intervention arm with the VoiceLove app or the control arm with standard care

1 week

Treatment

Participants in the intervention arm use the VoiceLove app to enhance communication and engagement during NICU stay

Up to 6 months

Continuous app usage monitoring

Follow-up

Participants are monitored for postpartum depression and anxiety using EPDS and GAD-7 at 2 and 6 weeks post-randomization

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

VoiceLove app

Trial Overview This Phase II trial tests if the VoiceLove app can help reduce postpartum depression compared to usual care. It measures effects using a depression scale (EPDS) and looks at how users engage with the app through usage data, satisfaction surveys, and interviews.

How Is the Trial Designed?

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

Participants in this arm will be randomized to receive access to the VoiceLove app in addition to standard of care.

Group II: Control ArmActive Control1 Intervention

Participants in this arm will be randomized to standard of care only and will not have access to the VoiceLove app.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC8532017/

Effectiveness of Telehealth Interventions for Women With ...The aim of this study is to evaluate the effectiveness of telehealth interventions in reducing depressive symptoms and anxiety in women with PPD.

2.clinicaltrials.govclinicaltrials.gov/study/NCT07214597

Study Details | NCT07214597 | NICU Utilization of Remote ...Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS).

3.withpower.comwithpower.com/trial/phase-postpartum-depression-ppd-11-2025-a70cb

VoiceLove App for Postpartum Depression (NURTURE Trial)Trial Overview This Phase II trial tests if the VoiceLove app can help reduce postpartum depression compared to usual care. It measures effects using a ...

4.jmir.orgjmir.org/2025/1/e69050

Evaluating the Efficacy of MamaLift Plus Digital ...This study examined the efficacy of a self-guided, mobile app-delivered, combined CBT, IPT, BAT, and DBT program in the postpartum population.

5.bmcpregnancychildbirth.biomedcentral.combmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-023-05749-5

App-based interventions for the prevention of postpartum ...This study explored whether psychosocial intervention applications (apps) are effective in preventing postpartum depression.

6.formative.jmir.orgformative.jmir.org/2023/1/e44500

Acceptability of an mHealth App for Monitoring Perinatal and ...This study aims to assess the acceptability of using mHealth to monitor and assess perinatal and postpartum depression and anxiety.

7.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC10235430/

App-based intervention for reducing depressive symptoms ...This intervention targets postpartum women with minor and major depression. Its aims are reducing depressive symptoms in the general sample and preventing major ...

8.frontiersin.orgfrontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1186963/full

The healthy moms and babies app to prevent postpartum ...Data from the initial assessment period indicated that 105 women (20.5%) obtained a low PHQ-9 score (0–4), another 167 participants (32.7%) ...

9.womensmentalhealth.orgwomensmentalhealth.org/posts/fda-approves-digital-therapeutic-for-the-treatment-of-postpartum-depression/

FDA Clears Digital Therapeutic for the Treatment of ...MamaLift Plus is a prescription-only digital therapeutic intervention for the treatment of mild to moderate postpartum depression using several different ...

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