Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06049433

Maternal Mental Health Access - MaMa

Led by University of Utah · Updated on 2024-12-06

120

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

N

National Institute of Nursing Research (NINR)

Collaborating Sponsor

AI-Summary

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

CONDITIONS

Official Title

Maternal Mental Health Access - MaMa

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older at the time of screening
  • Currently pregnant with a viable pregnancy or postpartum up to 1 year
  • At risk for perinatal depression as indicated by any of the following:
    • EPDS score between 9 and 20
    • History of depression or anxiety
    • Two or more significant life events
  • English or Spanish speaking
  • Currently attending a UHealth clinic or rural public health partner clinic
Not Eligible

You will not qualify if you...

  • Substance use disorder
  • Current diagnosis of serious mental illness such as psychosis, schizophrenia, bipolar disorder, or severe depression (including EPDS greater than 20)
  • Severe anxiety or suicidality
  • Currently taking any medications for a mental health condition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Utah

Salt Lake City, Utah, United States, 84132

Actively Recruiting

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Research Team

G

Gwen Latendresse, PhD CNM

CONTACT

J

Julie Neuberger, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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Maternal Mental Health Access - MaMa | DecenTrialz