Recruiting

Maternal Mental Health Access - MaMa

This hybrid effectiveness-implementation project will allow the team to evaluate and refine implementation in preparation for future multisite trials to ultimately move the Evidence-Based Intervention (EBI) to scale among diverse populations. The plan is to enroll 120 at-risk pregnant and postpartum women from rural, urban, and Latino populations. Using a randomized preference design to also evaluate patient and sociocultural factors in participation and symptom trajectory. Using the Implementation Research Logic…

ClinicalTrials.gov IDNCT06049433
PhaseNA
Enrollment120
SponsorUniversity of Utah
Age18 Years
SexFEMALE
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Conditions studied

Postpartum Depression, Perinatal Depression

About this study

This hybrid effectiveness-implementation project will allow the team to evaluate and refine implementation in preparation for future multisite trials to ultimately move the Evidence-Based Intervention (EBI) to scale among diverse populations. The plan is to enroll 120 at-risk pregnant and postpartum women from rural, urban, and Latino populations. Using a randomized preference design to also evaluate patient and sociocultural factors in participation and symptom trajectory. Using the Implementation Research Logic Model, the team will evaluate the implementation feasibility and acceptability of a remote-access and on-demand MBCT PD prevention intervention that is integrated within maternal clinical care settings using an existing patient portal. Successful achievement of the study aims will result in a refined implementation protocol for future studies that are sufficiently powered to evaluate the effectiveness of an integrated Digital Mental Health Technology and to estimate the cost/benefit ratio

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * 18+ years of age, who at the time of screening * Have a viable pregnancy or are postpartum (up to 1 year) * Identified as at-risk for PD (any one of the following: * EPDS score equal to or greater than 9 or less than 21 * History of depression/anxiety * 2 or more significant life events) * English- or Spanish-speaking * Currently attending a UHealth clinic or rural public health partner clinic. Exclusion Criteria: * Have a substance use disorder * Current diagnosis of serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression (including EPDS \> 20) * Severe anxiety, suicidality, or currently taking any medications for a mental health condition.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.