Virtual Group Therapy for Postpartum Depression

Overseen By Lindsay Cooper, MA

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Severe depression, Not at risk

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

Compensation: Varies

Number of Visits: 12

Duration: 10-20 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a virtual group therapy, called Mothers and Babies Virtual Group (MB-VG), to help prevent postpartum depression (PPD) in immigrant Latinas who are pregnant or have a child under 9 months old. The research will determine if virtual group sessions can reduce symptoms of depression and improve parenting skills. Participants will be divided into two groups: one will receive the virtual therapy, and the other will continue with regular family support services. This trial is ideal for Spanish-speaking Latinas who have shown signs of depression and have access to a smartphone, tablet, or computer. The goal is to make mental health support more accessible and reduce the impact of PPD.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in mental health support for postpartum depression.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on virtual therapy, so it's likely you can continue your medications, but please confirm with the trial organizers.

What prior data suggests that this virtual group therapy is safe for postpartum depression?

Research has shown that the Mothers and Babies Virtual Group (MB-VG) program is effective and well-received by immigrant Latina women. In a small study, participants reported improved mental health. No serious side effects were reported, indicating general safety. The study also found that the online format facilitates access to mental health support, particularly for those who face challenges accessing traditional care. Overall, the MB-VG program appears to be a safe option for women at risk of postpartum depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Mothers and Babies Virtual Group (MBVG) Intervention is unique because it leverages virtual technology to offer support for postpartum depression, making it more accessible for new mothers who may struggle to attend in-person sessions. Unlike traditional therapies that often require face-to-face interactions, this intervention is delivered via Zoom, allowing participants to join from the comfort of their homes. Researchers are excited about this approach because it not only reduces barriers to access, such as transportation and childcare, but also provides culturally tailored support by delivering sessions in Spanish. Additionally, the inclusion of a Resource Advocate or pediatrician in some sessions offers comprehensive support to address both emotional and practical needs of new mothers.

What evidence suggests that the Mothers and Babies Virtual Group Intervention is effective for postpartum depression?

Research has shown that the Mothers and Babies Virtual Group (MB-VG) program, which participants in this trial may receive, helps reduce symptoms of postpartum depression (PPD) in immigrant Latina women. A small initial study found that women who joined MB-VG experienced better mental health. This program uses cognitive-behavioral therapy and attachment theory, both known to help with depression. The online format of MB-VG provides easier access to support, especially for women facing challenges in accessing regular healthcare. While more research is needed, early results are promising for preventing PPD and boosting confidence in parenting. ^{1 2 3 4 6}

Who Is on the Research Team?

Darius Tandon, PhD

Principal Investigator

Northwestern University Feinberg School of Medicine

Rheanna Platt, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for pregnant immigrant Latinas or those with a child under 9 months old, who speak Spanish and are at least 16 years old. They must have mild depressive symptoms as indicated by specific scores on depression scales and access to a device for virtual sessions.

Inclusion Criteria

Have access to a device they can use for MB-VG sessions

Speak Spanish

I am 16 years old or older.

Exclusion Criteria

Individuals who score >14 on the EPDS are exhibiting moderately severe to severe depressive symptoms and will be excluded given our prevention focus

You are not at risk for postpartum depression, which means your EPDS scores are less than 5 and below the PDPI-R cutoff.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Mothers and Babies Virtual Group (MB-VG) intervention, consisting of 10 sessions delivered weekly or bi-weekly via Zoom.

10-20 weeks

10 sessions (virtual)

Follow-up

Participants are monitored for changes in depressive symptoms, parenting self-efficacy, and other outcomes at 3 and 6 months post-intervention.

6 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mothers and Babies Virtual Group Intervention

Trial Overview

The study tests the Mothers and Babies Virtual Group (MB-VG), an online group intervention based on cognitive-behavioral therapy aimed at preventing postpartum depression. Participants will either receive MB-VG or usual family support services to compare effectiveness.

How Is the Trial Designed?

Group I: Mothers and Babies Virtual Group Intervention Experimental Treatment 1 Intervention

Women randomized to the Mothers and Babies Virtual Group (MBVG) arm will receive the 10 session MBVG intervention. Sessions are delivered weekly or bi-weekly via Zoom, making 20 weeks the longest possible MB-VG cohort. Sessions were designed to last 60 minutes, with an additional 15 minutes for sessions including a Resource Advocate or pediatrician. Prior to the first session, a member of the research team will test Zoom connections with each participant. All MB-VG groups will be delivered in Spanish by a trained MB-VG facilitator, with a study team member available to provide tech support as needed. MB-VG sessions will be delivered in chronological order.

Group II: Usual Family Support Services Active Control 1 Intervention

Women randomized to the usual family support services arm will receive family support services from the early childhood center in which they are enrolled but no MB-VG intervention.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Palo Alto University

Collaborator

Trials

14

Recruited

8,100+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

The study evaluated the feasibility and acceptability of adding SMS text messages to the Mothers and Babies (MB) Course for postpartum depression prevention, involving 28 diverse pregnant women.

Participants found the SMS messages very useful and understandable, with 89% responding to self-monitoring texts, indicating that this digital tool can effectively enhance existing interventions for women at risk for postpartum depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating SMS Text Messages Into a Preventive Intervention for Postpartum Depression Delivered via In-Home Visitation Programs: Feasibility and Acceptability Study. Barrera, AZ., Hamil, J., Tandon, D.[2022]

This study aims to assess the feasibility and acceptability of online mindfulness-based interventions (MBI) for parents experiencing postpartum depression and anxiety (PPDA), with both mothers and their partners participating in separate 8-week online groups.

The research will evaluate various factors such as participant attendance, technical difficulties, and overall satisfaction, providing insights into how accessible and effective online MBIs can be for families affected by PPDA, especially in the context of challenges heightened by the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of online mindfulness-based interventions for families affected with postpartum depression and anxiety: study protocol. Tabi, K., Bhullar, M., Fantu, L., et al.[2023]

A pilot study involving 24 mothers with postpartum depression showed that a parenting intervention delivered via social media (Facebook) significantly improved parenting competence and reduced depression severity compared to an in-person group.

The social media intervention had a high attendance rate of 83%, while the in-person group had only 3%, indicating that online delivery may be a more accessible and effective option for mothers facing barriers to traditional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot RCT of a social media parenting intervention for postpartum mothers with depression symptoms. Boyd, RC., Price, J., Mogul, M., et al.[2020]

The Mothers and Babies (MB) 1-on-1 intervention, adapted from a group format, was well-received by clients, with 82% finding it enjoyable and 91.6% reporting they fully understood the material, indicating high acceptability.

Home visitors demonstrated strong implementation fidelity, covering 87.9% of the sessions, suggesting that the adapted intervention is feasible for delivery in a one-on-one setting and warrants further investigation for its effectiveness in reducing depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of an evidence-based postpartum depression intervention: feasibility and acceptability of mothers and babies 1-on-1. Darius Tandon, S., Leis, JA., Ward, EA., et al.[2023]

In a study of 34 women with perinatal depression, 80% experienced significant improvement in their depressive symptoms after participating in a 9-week group cognitive behavioral therapy (CBT) program.

The group CBT also led to meaningful improvements in social support, mother-infant bonding, and partner relationship quality, suggesting it is an effective and resource-efficient treatment option for women with perinatal depression and psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of a brief group cognitive behavioural therapy intervention for perinatal depression. Van Lieshout, RJ., Yang, L., Haber, E., et al.[2019]

Group support based on cognitive behavioral therapy (CBT) for postnatally depressed mothers significantly improved their self-esteem and self-worth.

This approach addresses barriers to treatment, potentially reducing high dropout rates seen in traditional group or clinic-based therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovation:CBT-based support groups for postnatal depression. Alexander, P.[2018]

A one-day online workshop utilizing cognitive behavioral therapy significantly improved symptoms of postpartum depression and anxiety, as well as enhancing social support and the mother-infant relationship.

This approach offers an efficient way to increase access to treatment for postpartum depression, suggesting it could be a valuable addition to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Day Workshop Beneficial for Postpartum Depression. Rosenberg, K.[2022]

The 'Gruen' Postpartum Depression Group Therapy, a ten-week intervention, significantly reduced depression scores in postpartum mothers, as measured by the Beck Depression Inventory II.

Participants found psychoeducation to be the most beneficial aspect of the therapy, highlighting the importance of providing information and support to mothers who may struggle to attend traditional therapy due to childcare responsibilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group therapy and its barriers for women suffering from postpartum depression. Ugarriza, DN.[2019]

A therapeutic group intervention for mothers with postnatal depression in Oxfordshire showed that most participants experienced improvements in their mood and reported high satisfaction with the program.

The group utilized cognitive behavioral techniques and provided both professional and peer support, suggesting that such interventions can be effective in helping mothers manage postnatal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and outcomes of a therapeutic group for women with postnatal depression. Naysmith, C., Wells, M., Newson, S., et al.[2018]

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