Depression and Anxiety Trial, Recruiting NCT07214597 Sponsor: Vanderbilt University Medical Center Condition: Depression and Anxiety
Printed from Voxsanity (voxsanity.com.au) — NCT07214597 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Depression and Anxiety Trial, Recruiting

NCT07214597
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For the baby:

  • The baby is currently admitted to a Neonatal Intensive Care Unit (NICU)
  • The baby has not been discharged and readmitted to the NICU
  • The baby is expected to survive for at least 2 weeks
  • The baby is expected to stay in the NICU for at least 2 weeks
  • The baby was born as a single birth (not a twin, triplet, etc.)

For the mother:

  • The mother is 18 years old or older
  • The mother speaks English
  • The mother is the biological mother of the baby in the NICU
  • The mother is within 4 days of giving birth

For a support partner (optional — a partner does not have to join):

  • The mother agrees to her partner taking part in the trial
  • The partner has been chosen by the mother as a support person who is allowed to visit the baby

Who may not be able to join:

For the baby:

  • The baby has been readmitted to the NICU after a previous discharge

For the mother:

  • The mother does not have access to an Android or Apple (iOS) smartphone
  • The mother is unwilling to download the VoiceLove NICU app or accept its terms and conditions
  • The mother does not have a personal email address
  • The mother was incarcerated at the time of delivery or afterward
  • The mother's doctor does not allow her to take part in the trial
  • The mother is currently experiencing a severe mental health crisis or is too physically unwell to give informed consent (confirm with trial site)
  • The mother could not be approached to ask about joining the trial (confirm with trial site)
  • The mother does not plan to be the baby's parent (for example, she is placing the baby for adoption, is a surrogate, or will not have custody)

For a support partner (optional — a partner does not have to join):

  • The partner is under 18 years old
  • The partner does not speak English
  • The partner is unable to give informed consent
  • The partner does not have their own Android or Apple (iOS) smartphone separate from the mother's
  • The partner does not have their own email address separate from the mother's
  • The partner is unwilling to download the VoiceLove NICU app or accept its terms and conditions

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 5 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Sarah Osmundson, Vanderbilt University Medical Center

Phone: 615-936-2938

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Vanderbilt University Medical Center
Registry
ClinicalTrials.gov
Start date
4 February 2026
Est. completion
1 January 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Patient Engagement with the VoiceLove App; Edinburgh Postnatal Depression Score (EPDS) at 2-weeks post randomization.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

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Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov