Lōvu Platform for Perinatal Mental Health
(IUFU Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 the long-term goal to identify technology-based interventions to improve maternal mental health in the Intermountain West. The investigator's 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.
Who Is on the Research Team?
Nathan Blue, MD, MPh
Principal Investigator
University of Utah, Department of OBGYN
Are You a Good Fit for This Trial?
This trial is for pregnant individuals receiving prenatal care at the University of Utah. It aims to improve mental health during and after pregnancy. Specific inclusion or exclusion criteria are not listed, but participants should be able to use digital tools.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage with the Lōvu app for mental health monitoring and support, with data transmitted weekly to the clinical team
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lōvu platform
Trial Overview
The study compares standard prenatal care with care that includes access to the Lōvu platform, a technology designed to support maternal mental health. Participants are randomly assigned to one of these two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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, participants 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.
Mental health screening via PHQ-9, GAD-7, EPDS, and NIDA Quick Screen (these are all validated surveys) at least three times during the pregnancy: early in pregnancy, at least once later in pregnancy, and then at least once in the postpartum period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
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