Maternal Mental Health Access - MaMa
MaMa
Prevention of Perinatal Depression Among At-risk Individuals Through Integration of a Multimedia, Web-based Intervention Within the Healthcare System
2 other identifiers
interventional
120
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2023
CompletedFirst Submitted
Initial submission to the registry
August 23, 2023
CompletedFirst Posted
Study publicly available on registry
September 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedDecember 6, 2024
December 1, 2024
2.4 years
August 23, 2023
December 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Implementation outcome; Feasibility and acceptability
EPDS Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Using scores that are between 9-20 Qualitative; semi structured interview Quantitative; patient satisfaction survey, number of referrals for at-risk patients, patients registering on YoMingo. focus groups, individual interviews, questionnaires
(6, 12 & 18 months)
Secondary Outcomes (1)
Sociocultural Determinants and Behavior
6, 12 & 18 months)
Other Outcomes (2)
Implementation Outcome; Patient engagement
6, 12 & 18 months)
Exploratory analysis of patient symptom
6, 12 & 18 months)
Study Arms (3)
Choice 1
OTHEROptions; On-Demand (OD) alone or On-Demand (OD) with a facilitated discussion board (DB)
Choice 2
OTHEROptions: On-Demand (OD) + Discussion board (DB) or OD + Video Conference (VC)
Choice 3
OTHEROptions; Om-Demand (OD) or On-Demand (OD) + Video Conference (VC)
Interventions
The intervention uses a standardized, manualized program (UPLIFT - Using Practice and Learning to Increase Favorable Thoughts) based on Mindfulness-Based Cognitive Behavioral Therapy (MBCT) in the prevention of depression in various populations and settings. MBCT can be delivered individually and in groups and via electronic platforms, in diverse populations. We have adapted UPLIFT for this study, based on input from focus groups and in response to the ongoing pandemic, and under the direction of our team's mental health professionals. Adaptations include access to asynchronous, on-demand multi-media MBCT content (digital audio-video files and downloadable content),
Adaptations include access to asynchronous, on-demand multi-media MBCT content (digital audio-video files and downloadable content), as well as synchronous Videoconference (VC) reduced from 8 weekly one-hour sessions to 4 one-hour sessions every two weeks. a discussion board with the potential to build a sense of community in a similar way that synchronous VC groups provide.
The intervention uses a standardized, manualized program (UPLIFT - Using Practice and Learning to Increase Favorable Thoughts) based on Mindfulness-Based Cognitive Behavioral Therapy (MBCT) in the prevention of depression in various populations and settings. MBCT can be delivered individually and in groups and via electronic platforms, in diverse populations. On-demand multi-media MBCT content (digital audio-video files and downloadable content)
on-demand multi-media MBCT content (digital audio-video files and downloadable content), as well as synchronous Videoconference (VC) reduced from 8 weekly one-hour sessions to 4 one-hour sessions every two weeks. A discussion board with the potential to build a sense of community in a similar way that synchronous VC groups provide.
The intervention uses a standardized, manualized program (UPLIFT - Using Practice and Learning to Increase Favorable Thoughts) based on Mindfulness-Based Cognitive Behavioral Therapy (MBCT) in the prevention of depression in various populations and settings.
Eligibility Criteria
You may qualify if:
- + 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
- or more significant life events)
- English- or Spanish-speaking
- Currently attending a UHealth clinic or rural public health partner clinic.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- National Institute of Nursing Research (NINR)collaborator
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gwen Latendresse
University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 23, 2023
First Posted
September 22, 2023
Study Start
April 4, 2023
Primary Completion
August 30, 2025
Study Completion
December 30, 2025
Last Updated
December 6, 2024
Record last verified: 2024-12