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

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

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression; Perinatal Depression
• Intervention / Treatment: Behavioral: Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention; Behavioral: On-Demand + Discussion board (DB); Behavioral: Arm 2; Behavioral: On Demand (OD) + Video Conference (VC); Behavioral: On Demand (OD) + Video Conference (VC); Behavioral: Arm 3

Detailed Description

This type1 hybrid effectiveness-implementation project is conducted within healthcare settings and underserved populations (rural, urban, and Latino) and for individuals who are at risk for perinatal depression (PD), which allows the team to refine the approach in preparation for a future effectiveness trial for the prevention of PD in diverse communities using accessible Digital Mental Health Technology (patient education portal, FB discussion boards, synchronous videoconference support sessions). The plan is to adopt a randomized preference trial design to assess the impact of patient preference and sociocultural factors (including race, ethnicity, and geographic residence) on engagement and preliminary results. This information is crucial for a subsequent trial and for ultimately taking the intervention to scale. The study design using the IRLM reflects scientific rigor that can be reproduced by other investigators. The implemented strategies specifically developed to optimize implementation success, and to measure the implementation outcomes of these strategies and include valuable input from key informants, stakeholders, and the Community Advisory Board at regular intervals throughout the project time period.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gwen Latendresse, PhD CNM; Phone Number: (801) 587-9636; Email: gwen.latendresse@nurs.utah.edu
• Study Contact Backup: Name: Julie Neuberger, BS; Phone Number: 801-587-3930; Email: julie.neuberger@nurs.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah
      • Contact: Julie Neuberger, BS; Phone Number: 801-587-3930; Email: julie.neuberger@nurs.utah.edu
      • Contact: Gwen Latendresse, PhD CNM; Phone Number: 801-587-9636; Email: gwen.latendresse@nurs.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Choice 1; Options; On-Demand (OD) alone or On-Demand (OD) with a facilitated discussion board (DB)	Behavioral: Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention; 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),; Other Names: Arm 1; On-Demand (OD); Behavioral: On-Demand + Discussion board (DB); 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.
Other: Choice 2; Options: On-Demand (OD) + Discussion board (DB) or OD + Video Conference (VC)	Behavioral: Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention; 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),; Other Names: Arm 1; On-Demand (OD); Behavioral: Arm 2; 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); Other Names: On-Demand (OD) + Discussion Board (DB); Behavioral: On Demand (OD) + Video Conference (VC); 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.; Behavioral: On Demand (OD) + Video Conference (VC); Access to asynchronous, on-demand multi-media MBCT content (digital audio-video files and downloadable content), as well as synchronous Videoconference (VC)
Other: Choice 3; Options; Om-Demand (OD) or On-Demand (OD) + Video Conference (VC)	Behavioral: Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention; 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),; Other Names: Arm 1; On-Demand (OD); Behavioral: On Demand (OD) + Video Conference (VC); 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.; Behavioral: On Demand (OD) + Video Conference (VC); Access to asynchronous, on-demand multi-media MBCT content (digital audio-video files and downloadable content), as well as synchronous Videoconference (VC); Behavioral: Arm 3; 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.; Other Names: On Demand (OD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociocultural Determinants and Behavior	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 EPDS score between 9-20. Life events, cultural/ethnical/racial group membership, history of depression, mental stigma	6, 12 & 18 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation Outcome; Patient engagement	EPDS screening- Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Using score 9-13. Evaluate preference & engagement in an 8-week remote-access MBCT or a program;;multimedia on- demand (OD) alone, or OD with a facilitated discussion board (DB) or OD with facilitated, synchronous videoconference sessions (VC).	6, 12 & 18 months)
Exploratory analysis of patient symptom	EPDS Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Usinf score 9-20. Conduct an exploratory analysis of PD symptom trajectory for all paired study groups. The Edinburgh Postnatal Depression Scale (EPDS) will be completed at five timepoints (pre- and post- intervention, and 2-, 4-, and 6-months post-intervention) to model change over time.	6, 12 & 18 months)

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Gwen Latendresse, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Behavioral Symptoms; Infant, Newborn, Diseases; Mood Disorders; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum; Asphyxia Neonatorum
• Other Study ID Numbers: 00159109; RF1NR020841 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No