LHMoms Support for Postpartum Depression

(LHMoms Trial)

Not currently recruiting at 3 trial locations

Overseen By Roberta Wright-Washington, MS, MBS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Multifetal pregnancy, Hemodialysis, IV drugs, others

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

Compensation: Varies

Number of Visits: 11

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new care approach to prevent postpartum depression and promote heart health in new mothers. The program, called the LHMoms Intervention, is led by doulas and includes cognitive behavioral training and lifestyle support. The trial seeks participants who have recently given birth to a single baby and are from minority groups or on Medicaid. Participants will receive support from their doulas both before leaving the hospital and at home for six months. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could benefit new mothers in the future.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that the LHMoms Intervention is safe for postpartum individuals?

Research has shown that the treatments used in LHMoms, which address mental and social aspects, are generally safe for individuals with postpartum depression (PPD). A recent study found that treatments like cognitive behavioral training (CBT) are effective without causing major side effects. Additionally, similar treatments delivered through telemedicine have reduced depression, demonstrating their safety and effectiveness for mothers with PPD.

The LHMoms program incorporates elements from the Thinking Healthy Programme, which has succeeded in resource-limited countries. This supports the safety of the approach, as it has been implemented in various settings without major issues.

While specific safety data for the LHMoms program is not available, its components—such as CBT and support from doulas—are well-researched and not associated with serious side effects. Therefore, it is expected to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LHMoms Intervention for postpartum depression because it combines cognitive behavioral therapy (CBT) with cardiovascular health education, which is a unique approach not commonly found in current treatments. This intervention is delivered by doulas who also provide emergency detection in the first week post-discharge and facilitate home blood pressure monitoring, adding a layer of personalized care and support. Additionally, it includes an innovative educational component through the Patient-Activated Learning System (PALS), designed to engage individuals with low literacy and from racially marginalized backgrounds, making it a more inclusive and accessible treatment option.

What evidence suggests that the LHMoms Intervention is effective for postpartum depression?

Research has shown that programs aimed at helping mothers, such as the LHMoms program in this trial, can significantly reduce symptoms of postpartum depression (PPD). In one study, 66.7% of these programs resulted in a noticeable decrease in PPD symptoms. Another study found that participants in a similar program were less likely to exhibit signs of depression three weeks postpartum compared to those receiving regular care, with rates of 8.8% versus 15.3%. The LHMoms Intervention Arm in this trial incorporates cognitive behavioral training (CBT) and methods to improve heart health, both proven successful in other areas. These programs are particularly effective when they include community support, such as doulas, and use easily understandable educational materials. Meanwhile, the Attention Control arm will receive standard doula care focusing on general postpartum health topics. ^{6 7 8 9 10}

Who Is on the Research Team?

Uma Reddy, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for new moms who have recently given birth and are experiencing postpartum depression or heart conditions. The program starts before they leave the hospital and continues until six months after giving birth.

Inclusion Criteria

Delivery of singleton live birth

Minority race (self-identified Black), minority ethnicity (self-identified Latinx), and/or Medicaid beneficiary

I am 18 years or older and can become pregnant.

Exclusion Criteria

I cannot use a computer or phone for visits or surveys.

I am under 18 years old.

I can communicate in English, Spanish, or Haitian Creole.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Intervention

Doula-led emergency detection and home BP monitoring during the first 7 days post-discharge

1 week

In-person and virtual support

Treatment

11 sessions of doula-delivered CBT and cardiovascular health intervention from 1 week to 6 months post-discharge

6 months

11 sessions (combination of in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LHMoms Intervention

Trial Overview

The 'Living Healthy for Moms' (LHMoms) intervention, which provides continuous care from hospital to home for up to six months postpartum, is being tested against no additional intervention.

How Is the Trial Designed?

Group I: LHMoms Intervention Arm Experimental Treatment 1 Intervention

The LHM arm (N=300) will receive a CBT+ Cardiovascular Health (CVH) Intervention to reduce CV risk. LHM employs a cognitive behavioral training (CBT) + cardiovascular health (CVH) intervention delivered by doulas and integrating a healthy lifestyle intervention to reduce CV risk. The LHM intervention integrates the following key elements: (1) doula-led emergency detection in the first 7 days post-discharge; (2) home BP monitoring (HBPM); and (3) 11-sessions of the doula-delivered intervention to prevent PPD and reduce CV risk from 1 week to 6 months post-discharge, supported by (4) education through the Patient-Activated Learning System (PALS), a novel education platform used to engage low-literacy, racially marginalized individuals. LHM is based on the Thinking Healthy Programme (THP), an intervention originally designed to treat PPD in low and middle-income countries using community health workers.

Group II: Attention Control Active Control 1 Intervention

The attention control arm (N=300) will receive standard doula care and the same number of telephone or video-delivered sessions and will last the same amount of time on general postpartum health topics not related to CV health or depression. Attention control participants will not receive doula-initiated outreach during the first 7 days.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

NYC Health + Hospitals

Collaborator

Trials

4

Recruited

64,000+

Northern Manhattan Perinatal Partnership

Collaborator

Trials

4

Recruited

425,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Caribbean Women's Health Association

Collaborator

Trials

1

Recruited

600+

Northern Manhattan Perinatal Partnership

Collaborator

New York City Health and Hospitals Corporation

Collaborator

Trials

33

Recruited

8,500+

Published Research Related to This Trial

A new prediction model for postpartum depression (PPD) was developed and validated using data from Danish population registers, involving 6,402 cases for development and 2,379 for validation, highlighting the importance of factors like previous psychiatric history and maternal age.

The recalibrated Extended model, which includes 14 variables, showed strong performance in predicting PPD risk, suggesting it could be a valuable tool for identifying individuals who may benefit from preventive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum depression: a developed and validated model predicting individual risk in new mothers. Munk-Olsen, T., Liu, X., Madsen, KB., et al.[2022]

A study involving 42 high-risk mothers for postpartum depression showed that those receiving telephone-based peer support had significantly lower depressive symptoms at both 4 and 8 weeks compared to those receiving standard care.

The majority of mothers in the peer support group reported high satisfaction with the intervention, indicating that this approach could be a promising and acceptable method for reducing postpartum depression symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of peer support on postpartum depression: a pilot randomized controlled trial. Dennis, CL.[2022]

In a study of 6,790 women, 5.5% experienced postpartum depression four months after giving birth, with significant risk factors including psychological distress in late pregnancy and perceived social isolation.

The study found that women with psychological distress and social isolation during pregnancy had a one in three chance of developing postpartum depression, highlighting the importance of addressing psychosocial wellbeing during antenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum depression: identification of women at risk. Nielsen Forman, D., Videbech, P., Hedegaard, M., et al.[2022]

A study involving 701 women at high risk for postpartum depression found that those receiving telephone-based peer support reported high satisfaction levels (80.5%) and positive relationship qualities such as trust and acceptance.

The peer support provided emotional, informational, and appraisal support, indicating that this approach can be an effective preventive strategy against postpartum depression, especially when tailored to the needs of the mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum depression peer support: maternal perceptions from a randomized controlled trial. Dennis, CL.[2022]

Early detection of postpartum depression (PPD) is crucial as it significantly affects the mother-infant relationship, which can lead to risks in the infant's neurological and emotional development.

Comprehensive psychotherapeutic interventions that focus on improving the mother-infant relationship are recommended, highlighting the need for further research to establish effective, evidence-based treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-partum depression: a comprehensive approach to evaluation and treatment. Thompson, KS., Fox, JE.[2022]

Postnatal interventions are crucial for preventing the negative effects of postpartum depression on mother-infant relationships, highlighting the need for timely identification and modification of interaction difficulties.

The Baby Happiness, Understanding, Giving and Sharing (HUGS) Programme is a proposed intervention that integrates direct support for mother-infant interactions while considering broader factors like cognitive style and social support, aiming to improve overall relationship quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mother-infant interactions in postpartum depression: an early intervention program. Milgrom, J.[2015]

Mindfulness-Based Interventions (MBIs) delivered during pregnancy significantly reduce the severity of postpartum depression (PPD) symptoms in the first three months after childbirth, based on a systematic review of six randomized controlled trials involving pregnant women.

The effectiveness of MBIs was particularly notable in women who began the interventions with a low risk of developing PPD, suggesting that MBIs could be a beneficial preventive strategy for at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions During Pregnancy and Long-Term Effects on Postpartum Depression and Maternal Mental Health: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Trapani, S., Caglioni, M., Villa, G., et al.[2023]

A qualitative study involving 10 women with postpartum mood disorders revealed that their experiences in seeking help were influenced by various stressors, barriers, and enablers, highlighting the complexity of navigating mental health care during this critical period.

The findings emphasize the importance of a holistic care approach that addresses both the emotional and physical health of mothers, suggesting that better support systems could help women reclaim their mothering instincts affected by mental illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enablers and barriers to seeking help for a postpartum mood disorder. Foulkes, M.[2018]

In a 6-week study involving 38 postpartum women, sertraline was found to significantly improve depression response rates (59% vs. 26% for placebo) and remission rates (53% vs. 21% for placebo), indicating its efficacy in treating postpartum depression (PMD).

The benefits of sertraline were particularly notable in women whose depression began within 4 weeks of childbirth, supporting the DSM-5 criteria for postpartum onset major depressive disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression. Hantsoo, L., Ward-O'Brien, D., Czarkowski, KA., et al.[2022]

A study of 427 postpartum mothers found that higher satisfaction with both formal and informal social support is significantly associated with lower rates of postpartum depression (PPD), indicating the importance of support systems after childbirth.

Specifically, the study highlighted that both instrumental support (like help with childcare) and psychological support (like emotional encouragement) are crucial in preventing PPD, suggesting that both healthcare providers and family members play vital roles in supporting new mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between postpartum depression and social support satisfaction levels at four months after childbirth. Ando, H., Shen, J., Morishige, KI., et al.[2021]

The workbook-based intervention 'What Am I Worried About?' (WAWA) effectively reduced symptoms of postpartum depression, anxiety, and stress in a small sample of 34 postpartum women, showing medium effect sizes after four weeks.

Participants who received individual phone consultations reported slightly greater reductions in postpartum depression and stress compared to those in group sessions, indicating that personalized support may enhance the intervention's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cognitive-Behavioral Intervention for Postpartum Anxiety and Depression: Individual Phone vs. Group Format. Simhi, M., Sarid, O., Rowe, H., et al.[2021]

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]

A redesigned follow-up care program significantly reduced postpartum depression scores at six weeks, three months, six months, and twelve months postpartum, indicating its effectiveness in early identification and treatment.

Training public health nurses to recognize and support mothers with postpartum depression can lead to better mental health outcomes and lower parenting stress, suggesting a cost-effective approach to improving maternal care in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redesigned community postpartum care to prevent and treat postpartum depression in women--a one-year follow-up study. Glavin, K., Smith, L., Sørum, R., et al.[2011]

An interactive coaching intervention significantly improved maternal-infant responsiveness among 117 postpartum women, indicating its effectiveness in enhancing mother-infant interactions.

While the intervention did not reduce postpartum depressive symptoms, both treatment and control groups showed improvements in responsiveness and a decrease in depression scores over time, suggesting that factors beyond the intervention may contribute to these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting responsiveness between mothers with depressive symptoms and their infants. Horowitz, JA., Bell, M., Trybulski, J., et al.[2019]

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