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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods of delivering a mental health program for women experiencing postpartum depression. The goal is to identify the most effective way to offer support using remote and on-demand tools, such as discussion boards and video conferences, integrated with regular maternal care. Participants will help researchers assess the effectiveness of these methods in managing symptoms. The trial seeks pregnant or postpartum women who have experienced depression, anxiety, or major life changes and are attending specific health clinics. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health solutions and enhance support for postpartum women.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that digital mental health tools, like those in this trial, are generally safe and easy to use. For example, the FDA has approved the MamaLift Plus app, which helps manage postpartum depression, indicating it meets safety standards for treating mild to moderate postpartum depression.

For the On-Demand and Video Conference options, studies indicate that these tools are well-received and easy to use. Women who used these digital tools for postpartum depression reported positive experiences and found them practical for regular use. This is important because when a treatment is easy to use, adherence increases, which can improve mental health.

Overall, while specific data on side effects for every digital tool might not exist, existing evidence supports their general safety. Many users find them a convenient way to manage mental health, making them a promising option for those dealing with postpartum depression.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for postpartum depression because they offer flexible, on-demand mental health support tailored to new mothers. Unlike traditional therapy, which usually requires scheduled appointments, these options allow mothers to access resources at their convenience, either through an online platform alone or with added support from discussion boards or video conferences. This adaptability not only makes mental health care more accessible but also integrates seamlessly into the busy lives of new mothers, potentially improving engagement and outcomes.

What evidence suggests that this trial's treatments could be effective for postpartum depression?

Research shows that about 10% of women experience postpartum depression (PPD) after childbirth. Studies have found that Mindfulness-Based Cognitive Therapy (MBCT) can help prevent PPD. In this trial, participants will access different digital versions of MBCT. One option includes On-Demand (OD) access alone or with a facilitated discussion board (DB). Another option combines On-Demand (OD) access with Video Conference (VC) support. These digital methods, which have shown promise in reducing symptoms of depression during and after pregnancy, are included in maternal care to assist women at risk. Telehealth, such as video calls, can effectively manage PPD by providing easy access to mental health support.12678

Who Is on the Research Team?

GL

Gwen Latendresse

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Choice 3Experimental Treatment3 Interventions
Group II: Choice 2Experimental Treatment3 Interventions
Group III: Choice 1Experimental Treatment2 Interventions

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:

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+

Published Research Related to This Trial

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]
A randomized clinical trial involving 639 pregnant women found that a 16-week supervised exercise program did not significantly reduce postpartum depression symptoms compared to a control group, with no notable difference in depression scores or rates between the two groups.
Low compliance (only 40.4% of participants engaged in at least 70% of exercise sessions) may have impacted the results, suggesting that future research should focus on strategies to improve adherence to exercise during pregnancy.
Efficacy of Regular Exercise During Pregnancy on the Prevention of Postpartum Depression: The PAMELA Randomized Clinical Trial.Coll, CVN., Domingues, MR., Stein, A., et al.[2020]
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]

Citations

1.samhsa.govsamhsa.gov/
Home | SAMHSA - Substance Abuse and Mental Health ...SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.
Perinatal Depression - StatPearls - NCBI BookshelfPerinatal depression is a mood disorder that affects individuals during pregnancy or within 1 year after childbirth. According to the Diagnostic and ...
Exploring predictors and prevalence of postpartum depression ...Postpartum depression (PPD) affects around 10% of women, or 1 in 7 women, after giving birth. Undiagnosed PPD was observed among 50% of mothers.
Perinatal mental healthWorldwide about 10% of pregnant women and 13% of women who have just given birth experience a mental disorder, primarily depression.
The Efficacy of Be a Mom, a Web-Based Intervention to ...Background: Postpartum depression (PPD) is treatable and preventable, but most women do not seek professional help for their perinatal ...
Maternal Mental Health Conditions and StatisticsPostpartum Depression / PPD / Postpartum: An umbrella term describing mood changes following pregnancy. Perinatal mood disorders (PMDs) or ...
NCT06049433 | Maternal Mental Health Access - MaMaThe plan is to enroll 120 at-risk pregnant and postpartum women from rural, urban, and Latino populations.
National Maternal Mental Health Hotline | MCHB - HRSAThe National Maternal Mental Health Hotline offers free, confidential, 24/7 support in English and Spanish for pregnant and postpartum individuals ...
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