OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression
Launched by HACKENSACK MERIDIAN HEALTH · May 19, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The OBWELL clinical trial is studying new ways to help mothers who are experiencing postpartum depression (PPD), especially those with babies in the Neonatal Intensive Care Unit (NICU). PPD is more serious than the typical "baby blues" and can affect a mother’s daily life and her relationship with her baby. This trial will compare two types of therapy—Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT)—to see which one is more effective. It will also explore whether combining the two therapies over eight weeks works better than doing just one type alone.
To participate in this trial, mothers must be at least 18 years old and have given birth within the last year to a baby currently in the NICU. They should be able to speak English and have signs of depression. However, those with certain serious conditions, like substance dependency or severe mental health issues, will not be eligible. If you join the study, you can expect to receive therapy over a four-week period, with a chance to be part of a longer treatment plan. This research aims to find better ways to support mothers dealing with PPD, which is important for both their well-being and their baby's health.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Mother of NICU infant
- • Older than age 18
- • English-speaking
- • Gave birth more than 24 hours ago and less than 12 months prior to enrollment
- * Depression as assessed by:
- • Current/Prior diagnosis of Major Depressive Disorder OR EPDS score above 10 OR EPDS score below 10 AND Endorsement of "sometimes" or "often" on item #10 on the EPDS\* ("I have had thoughts of harming myself")
- Exclusion Criteria:
- • A diagnosis of Substance Dependency or Substance Use
- • Acute suicidal or infanticidal ideation
- • Current psychosis
- • Medical history of cognitive impairment
- • Infant death of current NICU admission
- • Marked non-compliance with intervention (e.g, non-attendance of more than one session during a 4-week intervention or failure to complete study assessments),
- • Are in medical treatment that would prevent participation (i.e., medical treatment that requires inpatient hospitalization and thus would prevent participation of study visits.)
About Hackensack Meridian Health
Hackensack Meridian Health is a leading healthcare organization based in New Jersey, dedicated to advancing medical research and improving patient care through innovative clinical trials. As a prominent sponsor of clinical research, Hackensack Meridian Health is committed to fostering collaboration between researchers, healthcare professionals, and patients to develop and evaluate cutting-edge therapies and interventions. With a focus on enhancing health outcomes and addressing pressing medical needs, the organization leverages its extensive network of hospitals, specialty care centers, and research facilities to advance clinical knowledge and contribute to the global body of medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hackensack, New Jersey, United States
Patients applied
Trial Officials
Yeraz Markarian, PhD
Principal Investigator
Hackensack Meridian Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported