Transforming Maternal Mental Health Care

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07766174
Status
Recruiting
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Conditions

  • Perinatal Mental Health

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Lōvu platform — BEHAVIORAL
    Standard prenatal care + Lōvu platform. Participant receives a Bluetooth-enabled scale, BP cuff, and handheld fetal Doppler. Orientation to Lōvu app and device use. Lōvu-generated data (e.g., weight, BP, HR) will be visible to the Lovu team and sent to the UU clinical team weekly Participant-reported outcomes (satisfaction, usability) collected via System Usability Scale (SUS)
  • Standard Care Arm — BEHAVIORAL
    Standard prenatal care per UU clinical protocols Mental health screening via PHQ-9, GAD-7, EPDS, and NIDA Quick Screen at standard intervals (these are all validated surveys) Data collected from EHR.

Study Details

The overall objective of this pilot study is to assess the feasibility of a RCT comparing Lōvu-augmented with usual prenatal care at UU. This would be a critical next step toward our long-term goal to identify technology-based interventions to improve maternal mental health in the Intermountain West. Our central hypothesis is that Lōvu will be both feasible and have high patient and clinician satisfaction, and that Lōvu-generated data will be a promising substrate for AI-based mental health risk stratification.

Key Dates

First listed
Aug 14, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2031
Completion
Apr 30, 2032

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Lōvu-Augmented Arm
    The intervention is pragmatic in that the only thing patients are actually asked to do is enroll in Lovu, which is facilitated by the research and clinical personnel after randomization. After enrollment, they are not specifically instructed to do anything accept engage with Lovu as prompted (e.g. in response to reminders to measure BP and submit perinatal depression screening questionnaires) and to use Lovu as a resource for questions and concerns. The data generated by the participant's engagements with Lovu (vital sign measurements, questions, concerns, screening results) will be summarized and transmitted to the clinical team on a weekly basis ), which the team can make use of in clinical care. An example of a clinical impact would be that home BP monitoring with automated transmission of data to the clinical team can improve early detection of preeclampsia and other pregnancy complications.
  • Active Comparator: Standard Care Arm
    Mental health screening via PHQ-9, GAD-7, EPDS, and NIDA Quick Screen (these are all validated surveys) at least three times during your pregnancy: early in pregnancy, at least once later in pregnancy, and then at least once in the postpartum period.

Primary Outcome Measure

Feasibility Outcomes [ Time Frame: 12 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Utah HospitalSalt Lake CityUtah84132
Kelly Christensen
[email protected]
801-581-8425
Valerie Joseph
[email protected]

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By research site
University of Utah Hospital· Salt Lake City, UT

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