300 Participants Needed

Virtual Group Therapy for Postpartum Depression

DT
LC
Overseen ByLindsay Cooper, MA
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: Northwestern University
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?

Postpartum depression (PPD) affects 10-20% of women, with immigrant Latinas disproportionately affected. PPD prevention and treatment is limited among immigrant Latinas due to an array of structural and cultural factors, suggesting the need to deliver interventions outside of traditional healthcare settings. Virtual interventions have the potential to reduce barriers to mental health services for immigrant Latinas, but there is little research on the effectiveness of virtual interventions to reduce PPD symptoms. Mothers and Babies is an evidence-based group intervention based on principles of cognitive-behavioral therapy and attachment theory aimed at PPD prevention. Mothers and Babies was adapted for delivery via a virtual group format (Mothers and Babies Virtual Group; MB-VG), with a pilot study suggesting good feasibility and acceptability as well as improved mental health outcomes for immigrant Latinas. The proposed project is a Type 1 Effectiveness-Implementation randomized controlled trial among pregnant individuals and new mothers at risk for PPD based on elevated depressive symptoms and/or other established risk factors who are enrolled in early childhood programs across Maryland. A total of 300 women will be enrolled; 150 will receive MB-VG while 150 will receive usual family support services. The project aims to evaluate: 1) the effectiveness of MB-VG to reduce depressive symptoms, prevent onset of PPD, and improve parenting self-efficacy and responsiveness; 2) implementation of MB-VG; and 3) contextual factors influencing MB-VG effectiveness and implementation. Trained early childhood center staff will deliver MB-VG sessions, with intervention participants receiving virtual group sessions via Zoom using any electronic device (smartphone, tablet, laptop). Maternal self-report surveys are conducted at baseline, 1 week, 3 months, and 6 months post-intervention, with structured clinical interviews also conducted at 3- and 6-months post-intervention. The study is the first to deliver a virtual PPD preventive intervention to immigrant Latinas and to evaluate its impact. Given its virtual delivery modality, MB-VG can be easily replicated and scaled to other family support programs and settings serving immigrant Latinas. If effective and implemented broadly, more immigrant Latinas will receive mental health services and fewer will suffer the negative consequences associated with PPD.

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.

Is virtual group therapy for postpartum depression safe?

The Mothers and Babies (MB) Course, which includes virtual group therapy, is recognized as a safe and evidence-based intervention for postpartum depression, recommended by the US Preventive Services Task Force.12345

How is the Mothers and Babies Virtual Group Intervention different from other treatments for postpartum depression?

The Mothers and Babies Virtual Group Intervention is unique because it offers therapy in a virtual group setting, making it more accessible for new mothers who may face barriers like childcare responsibilities. This approach can help improve social support and reduce symptoms of postpartum depression without the need for in-person attendance.46789

What data supports the effectiveness of the treatment Mothers and Babies Virtual Group Intervention for postpartum depression?

Research shows that group therapies using cognitive behavioral techniques can help improve mood and provide support for mothers with postpartum depression. Studies have found that such group interventions lead to significant improvements in depressive symptoms, social support, and mother-infant bonding.45789

Who Is on the Research Team?

DT

Darius Tandon, PhD

Principal Investigator

Northwestern University Feinberg School of Medicine

RP

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.
See 3 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Mothers and Babies Virtual Group InterventionExperimental Treatment1 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 ServicesActive Control1 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.

Find a Clinic Near You

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

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.
Development and outcomes of a therapeutic group for women with postnatal depression.Naysmith, C., Wells, M., Newson, S., et al.[2018]
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.
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.
One-Day Workshop Beneficial for Postpartum Depression.Rosenberg, K.[2022]

Citations

Development and outcomes of a therapeutic group for women with postnatal depression. [2018]
Innovation:CBT-based support groups for postnatal depression. [2018]
One-Day Workshop Beneficial for Postpartum Depression. [2022]
Group therapy and its barriers for women suffering from postpartum depression. [2019]
Evaluating the effectiveness of a brief group cognitive behavioural therapy intervention for perinatal depression. [2019]
Integrating SMS Text Messages Into a Preventive Intervention for Postpartum Depression Delivered via In-Home Visitation Programs: Feasibility and Acceptability Study. [2022]
Adaptation of an evidence-based postpartum depression intervention: feasibility and acceptability of mothers and babies 1-on-1. [2023]
Feasibility of online mindfulness-based interventions for families affected with postpartum depression and anxiety: study protocol. [2023]
Pilot RCT of a social media parenting intervention for postpartum mothers with depression symptoms. [2020]
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