Clinical trial NCT06049433: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Perinatal Depression
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-09-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

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.

Primary outcomes:
measure: Implementation outcome; Feasibility and acceptability
timeFrame: (6, 12 & 18 months)
Secondary outcomes:
measure: Sociocultural Determinants and Behavior
timeFrame: 6, 12 & 18 months)
Other outcomes:
measure: Implementation Outcome; Patient engagement
timeFrame: 6, 12 & 18 months)
measure: Exploratory analysis of patient symptom
timeFrame: 6, 12 & 18 months)
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Gwen Latendresse
role: PRINCIPAL_INVESTIGATOR
References: