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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 belowSelect...
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:Select...
I cannot use a computer or phone for visits or surveys.
Select...
I am under 18 years old.
Select...
I can communicate in English, Spanish, or Haitian Creole.
Select...
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
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.
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,498 Previous Clinical Trials
2,768,381 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,107 Total Patients Enrolled
NYC Health + HospitalsUNKNOWN
3 Previous Clinical Trials
63,381 Total Patients Enrolled
Northern Manhattan Perinatal PartnershipUNKNOWN
3 Previous Clinical Trials
424,240 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,092 Previous Clinical Trials
1,154,186 Total Patients Enrolled
1 Trials studying Cardiovascular Events
1,400 Patients Enrolled for Cardiovascular Events
Caribbean Women's Health AssociationUNKNOWN
Uma Reddy, MD, MPHPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
7,431 Total Patients Enrolled