Maternal Mental Health Access - MaMa
Recruiting · NCT06049433 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Utah
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- University of Utah - Salt Lake City, Utah, United States