Maternal Mental Health Access - MaMa

Official title

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

Overview

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

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.

Interventions

• 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 o
• 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.
• 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)
• 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 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.
• 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)

Primary outcome measures

• Implementation outcome; Feasibility and acceptability [Time frame: (6, 12 & 18 months)]

Secondary outcome measures (1)

• Sociocultural Determinants and Behavior [Time frame: 6, 12 & 18 months)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Utah — Salt Lake City

Identifiers

NCT: NCT06049433 · 00159109 · RF1NR020841

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗