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Maternal Mental Health Access - MaMa (MaMa)

Primary Purpose

Postpartum Depression, Perinatal Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention
On-Demand + Discussion board (DB)
Arm 2
On Demand (OD) + Video Conference (VC)
Arm 3
On Demand (OD) + Video Conference (VC)
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postpartum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Choice 1

Choice 2

Choice 3

Arm Description

Options; On-Demand (OD) alone or On-Demand (OD) with a facilitated discussion board (DB)

Options: On-Demand (OD) + Discussion board (DB) or OD + Video Conference (VC)

Options; Om-Demand (OD) or On-Demand (OD) + Video Conference (VC)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2023
Last Updated
September 20, 2023
Sponsor
University of Utah
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT06049433
Brief Title
Maternal Mental Health Access - MaMa
Acronym
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Perinatal Depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Choice 1
Arm Type
Other
Arm Description
Options; On-Demand (OD) alone or On-Demand (OD) with a facilitated discussion board (DB)
Arm Title
Choice 2
Arm Type
Other
Arm Description
Options: On-Demand (OD) + Discussion board (DB) or OD + Video Conference (VC)
Arm Title
Choice 3
Arm Type
Other
Arm Description
Options; Om-Demand (OD) or On-Demand (OD) + Video Conference (VC)
Intervention Type
Behavioral
Intervention Name(s)
Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention
Other Intervention Name(s)
Arm 1, On-Demand (OD)
Intervention Description
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),
Intervention Type
Behavioral
Intervention Name(s)
On-Demand + Discussion board (DB)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Arm 2
Other Intervention Name(s)
On-Demand (OD) + Discussion Board (DB)
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
On Demand (OD) + Video Conference (VC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Arm 3
Other Intervention Name(s)
On Demand (OD)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
On Demand (OD) + Video Conference (VC)
Intervention Description
Access to asynchronous, on-demand multi-media MBCT content (digital audio-video files and downloadable content), as well as synchronous Videoconference (VC)
Primary Outcome Measure Information:
Title
Implementation outcome; Feasibility and acceptability
Description
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
Time Frame
(6, 12 & 18 months)
Secondary Outcome Measure Information:
Title
Sociocultural Determinants and Behavior
Description
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
Time Frame
6, 12 & 18 months)
Other Pre-specified Outcome Measures:
Title
Implementation Outcome; Patient engagement
Description
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).
Time Frame
6, 12 & 18 months)
Title
Exploratory analysis of patient symptom
Description
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.
Time Frame
6, 12 & 18 months)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant and or postpartum women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gwen Latendresse, PhD CNM
Phone
(801) 587-9636
Email
gwen.latendresse@nurs.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Neuberger, BS
Phone
801-587-3930
Email
julie.neuberger@nurs.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwen Latendresse
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwen Latendresse, PhD CNM
Phone
801-587-9636
Email
gwen.latendresse@nurs.utah.edu
First Name & Middle Initial & Last Name & Degree
Julie Neuberger, BS
Phone
801-587-3930
Email
julie.neuberger@nurs.utah.edu

12. IPD Sharing Statement

Learn more about this trial

Maternal Mental Health Access - MaMa

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