RECRUITING

Maternal Mental Health Access - MaMa

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Prevention of Perinatal Depression Among At-risk Individuals Through Integration of a Multimedia, Web-based Intervention Within the Healthcare System

Quick Facts

Study Start:2023-04-04
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06049433

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18+ years of age, who at the time of screening
  2. * Have a viable pregnancy or are postpartum (up to 1 year)
  3. * Identified as at-risk for PD (any one of the following:
  4. * EPDS score equal to or greater than 9 or less than 21
  5. * History of depression/anxiety
  6. * 2 or more significant life events)
  7. * English- or Spanish-speaking
  8. * Currently attending a UHealth clinic or rural public health partner clinic.
  1. * Have a substance use disorder
  2. * Current diagnosis of serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression (including EPDS \> 20)
  3. * Severe anxiety, suicidality, or currently taking any medications for a mental health condition.

Contacts and Locations

Study Contact

Gwen Latendresse, PhD CNM
CONTACT
(801) 587-9636
gwen.latendresse@nurs.utah.edu
Julie Neuberger, BS
CONTACT
801-587-3930
julie.neuberger@nurs.utah.edu

Principal Investigator

Gwen Latendresse
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

University of Utah
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Gwen Latendresse, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-04
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2023-04-04
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Postpartum Depression
  • Perinatal Depression