Maternal Mental Health Access - MaMa

ConditionsPostpartum Depression Perinatal Depression

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorUniversity of Utah

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18+ years of age, who at the time of screening

Have a viable pregnancy or are postpartum (up to 1 year)

EPDS score equal to or greater than 9 or less than 21

History of depression/anxiety

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention
Behavioral
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),
On-Demand + Discussion board (DB)
Behavioral
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.
Arm 2
Behavioral
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 (OD) + Video Conference (VC)
Behavioral
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.
Arm 3
Behavioral
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.
On Demand (OD) + Video Conference (VC)
Behavioral
Access to asynchronous, on-demand multi-media MBCT content (digital audio-video files and downloadable content), as well as synchronous Videoconference (VC)

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: Choice 1Other 2 interventions

Group B: Choice 2Other 3 interventions

Group C: Choice 3Other 3 interventions

Trial outcomes

Primary outcomes

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

Time frame

(6, 12 & 18 months)

Secondary outcomes

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

Time frame

6, 12 & 18 months)

Other outcomes

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).

Time frame

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.

Time frame

6, 12 & 18 months)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator

Source ClinicalTrials.gov

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