Maternal Mental Health Access - MaMa

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Utah

About this trial

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

Eligibility criteria

Qualifiers

18+ years of age, who at the time of screening

Have a viable pregnancy or are postpartum (up to 1 year)

EPDS score equal to or greater than 9 or less than 21

History of depression/anxiety

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention
  • On-Demand + Discussion board (DB)
  • Arm 2
  • On Demand (OD) + Video Conference (VC)
  • Arm 3
  • On Demand (OD) + Video Conference (VC)

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Utah

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator