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Behavioral Intervention

LHMoms Support for Postpartum Depression (LHMoms Trial)

N/A

Waitlist Available

Led By Uma Reddy, MD, MPH

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Birthing individuals aged 18 years or older

Be older than 18 years old

Must not have

Individuals unable to conduct visits and complete surveys via computer or phone

Younger than 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post hospital discharge

Awards & highlights

No Placebo-Only Group

Summary

"This trial introduces a new method of care called LHMoms which provides continuous support and connections between the community and healthcare for new mothers. The care starts before leaving the hospital after giving birth and continues for

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this study involves a care intervention rather than medication, there may not be direct side effects; however, participants might experience emotional or psychological impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years or older and can become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am under 18 years old.

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

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I am currently on hemodialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post hospital discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post hospital discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Edinburgh Postnatal Depression Scale (EPDS) score

Heart Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LHMoms Intervention ArmExperimental Treatment1 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 ControlActive Control1 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.

0 / 5Eligibility criteria met