Maternal Mental Health Access for Postpartum Depression

(MaMa Trial)

Overseen By Julie Neuberger, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Mental health medications

Disqualifiers: Substance use disorder, serious mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{2 3 5 6 7}

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

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

Group I: Choice 3 Experimental Treatment 3 Interventions

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

Group II: Choice 2 Experimental Treatment 3 Interventions

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

Group III: Choice 1 Experimental Treatment 2 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The MamaLift Plus app was evaluated by 14 participants over a 2-week period and was found to be an acceptable and highly usable tool for managing postpartum depression (PPD).

Participants indicated that the app is practical for weekly use, suggesting it could be a valuable resource for individuals with limited access to traditional mental health care, highlighting the need for further research in digital behavioral health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer acceptance of using a digital technology to manage postpartum depression. Tang, JJ., Malladi, I., Covington, MT., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Postpartum depression (PPD) affects 13% to 19% of new mothers, highlighting the need for effective screening and intervention during the high-risk period of the first six months after delivery.

While medications can improve depression symptoms, studies show no significant differences in outcomes between those receiving medication and those on placebo, suggesting the importance of psychological interventions and integrated mental health care in routine primary care for postpartum women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum depression: current status and future directions. O'Hara, MW., McCabe, JE.[2022]

The MPOWER study found that a web-based intervention (WBI) combined with telephone coaching significantly increased participant engagement, with intervention group members logging in to the website an average of 11 more times than those without coaching.

While the results suggest a moderate beneficial effect on reducing symptoms of postpartum depression and anxiety, further research with a larger randomized controlled trial is necessary to confirm the effectiveness of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of a lay telephone coaching and web-based intervention for postpartum depression and anxiety: The MPOWER study. Schwartz, H., McCusker, J., Da Costa, D., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Online prevention of postpartum depression for Spanish- and English-speaking pregnant women: A pilot randomized controlled trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Mothers and Babies Online Course: Participant Characteristics and Behaviors in a Web-Based Prevention of Postpartum Depression Intervention. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Consumer acceptance of using a digital technology to manage postpartum depression. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Regular Exercise During Pregnancy on the Prevention of Postpartum Depression: The PAMELA Randomized Clinical Trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Postpartum depression: current status and future directions. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of a lay telephone coaching and web-based intervention for postpartum depression and anxiety: The MPOWER study. [2023]