120 Participants Needed

Maternal Mental Health Access for Postpartum Depression

(MaMa Trial)

GL
JN
Overseen ByJulie Neuberger, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

Yes, if you are currently taking any medications for a mental health condition, you cannot participate in this trial.

What data supports the effectiveness of the treatment Maternal Mental Health Access for Postpartum Depression?

Research shows that digital mental health tools, like the Mothers and Babies Online Course, are useful and well-received for managing postpartum depression. These tools help women learn skills to manage mood changes during and after pregnancy, making them a promising option for those with limited access to traditional mental health resources.12345

Is the Maternal Mental Health Access for Postpartum Depression treatment safe for humans?

The available research suggests that digital tools like MamaLift Plus and the Mothers and Babies Online Course are considered acceptable and practical for managing postpartum depression, but more research is needed to fully understand their safety and effectiveness.12346

How does the Maternal Mental Health Access treatment for postpartum depression differ from other treatments?

The Maternal Mental Health Access treatment is unique because it combines digital mental health technology with remote access mindfulness-based cognitive therapy (MBCT) specifically designed for postpartum depression prevention. It offers flexible options like on-demand content and video conferencing, making it accessible for women who may have limited access to traditional mental health services.23567

What is the purpose of 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

Research Team

GL

Gwen Latendresse

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for pregnant or postpartum women (up to 1 year after birth) who are at least 18 years old, speak English or Spanish, and attend certain clinics. They must be at risk for postpartum depression but not have severe mental health conditions like psychosis or bipolar disorder, substance use disorders, severe anxiety, suicidality, or be on current mental health medications.

Inclusion Criteria

Currently attending a UHealth clinic or rural public health partner clinic.
You have a higher chance of having Parkinson's disease if you meet any of these conditions: your EPDS score is 9 or higher or less than 21, you have a history of depression or anxiety, or you have experienced two or more significant life events.
Have a viable pregnancy or are postpartum (up to 1 year)

Exclusion Criteria

You have a problem with using drugs or alcohol.
I am currently taking medication for a mental health condition.
I have a serious mental health condition like schizophrenia or severe depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in an 8-week remote-access MBCT or multimedia on-demand program, with options for facilitated discussion boards or synchronous videoconference sessions

8 weeks

Follow-up

Participants are monitored for changes in depressive symptoms using the EPDS at multiple timepoints post-intervention

18 months

Treatment Details

Interventions

  • Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention
  • On-Demand + Discussion board (DB)
  • On Demand (OD) + Video Conference (VC)
Trial Overview The study tests a remote-access maternal mental health intervention that includes On-Demand content plus Video Conferencing (VC), and another with On-Demand content plus a Discussion Board (DB). It aims to prevent postpartum depression among diverse populations in different settings.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Choice 3Experimental Treatment3 Interventions
Options; Om-Demand (OD) or On-Demand (OD) + Video Conference (VC)
Group II: Choice 2Experimental Treatment3 Interventions
Options: On-Demand (OD) + Discussion board (DB) or OD + Video Conference (VC)
Group III: Choice 1Experimental Treatment2 Interventions
Options; On-Demand (OD) alone or On-Demand (OD) with a facilitated discussion board (DB)

Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention is already approved in United States for the following indications:

🇺🇸
Approved in United States as Maternal Mental Health Access for:
  • Prevention of postpartum depression

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

Findings from Research

In a 6-month project involving 273 mothers, a screening protocol for postpartum depression (PPD) was successfully implemented, achieving an 83.5% screening rate during well-child visits.
Of the mothers who screened positive for PPD, 73.1% were referred to mental health services, and 63.2% attended their referral, demonstrating effective follow-up and support for those in need.
Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics.Cohen, M., Stephens, CTD., Zaheer, A., et al.[2022]
A pilot randomized controlled trial involving 111 predominantly Spanish-speaking pregnant women showed that an Internet-based intervention aimed at preventing postpartum depression (PPD) did not reach statistical significance in reducing PPD risk, but the results trended in a positive direction.
The intervention appeared to be more beneficial for pregnant women with higher levels of prenatal depression symptoms, suggesting that Internet-based resources could effectively support at-risk populations in managing their mental health.
Online prevention of postpartum depression for Spanish- and English-speaking pregnant women: A pilot randomized controlled trial.Barrera, AZ., Wickham, RE., Muñoz, RF.[2022]
The Mothers and Babies Online Course (eMB) was designed to prevent postpartum depression (PPD) and was accessed by 208 users, including 37% perinatal women and 63% health providers, highlighting its potential to reach those with limited access to mental health resources.
User feedback indicated that while the lessons were rated positively for usefulness, engagement was low, with only 4.4% of participants completing all eight lessons, suggesting a need for improvements in content delivery to enhance user interaction and effectiveness.
Mothers and Babies Online Course: Participant Characteristics and Behaviors in a Web-Based Prevention of Postpartum Depression Intervention.Barrera, AZ., Morris, SY., Ruiz, A.[2022]

References

Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. [2022]
Online prevention of postpartum depression for Spanish- and English-speaking pregnant women: A pilot randomized controlled trial. [2022]
Mothers and Babies Online Course: Participant Characteristics and Behaviors in a Web-Based Prevention of Postpartum Depression Intervention. [2022]
Consumer acceptance of using a digital technology to manage postpartum depression. [2022]
Efficacy of Regular Exercise During Pregnancy on the Prevention of Postpartum Depression: The PAMELA Randomized Clinical Trial. [2020]
Postpartum depression: current status and future directions. [2022]
A pilot randomized controlled trial of a lay telephone coaching and web-based intervention for postpartum depression and anxiety: The MPOWER study. [2023]
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