OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHackensack Meridian Health

About this trial

Postpartum Depression (PPD) is defined as depression that occurs after childbirth, with intense symptoms that last longer than "baby blues". PPD differs greatly from "baby blues", a term used to describe the typical sadness, worry and tiredness that women experience after childbirth, which often resolves within a week or two on its own. The symptoms of PPD interfere with many aspects of daily living and can have unhealthy short-term and long-term outcomes, both for the mother and baby.

One-third of women in the U.S. with PPD are identified in clinical settings, yet only half of those begin psychotherapy treatment. Unfortunately, mothers whose newborns are in the Neonatal Intensive Care Unit (NICU) are at high risk for developing PPD, necessitating early identification and evidence-based treatment. Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are the two most effective psychotherapy treatments for PPD, yet no randomized controlled clinical trials were found that directly compared the two types of treatment or determined whether combining the two approaches is more helpful for PPD than either approach alone.

This clinical trial aims to compare the effectiveness of a 4-week intervention of either CBT or IPT for PPD in NICU mothers and to determine whether a sequential 8-week intervention (IPT then CBT, or CBT then IPT) is more beneficial.

Eligibility criteria

Qualifiers

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

Disqualifiers

A diagnosis of Substance Dependency or Substance Use

Acute suicidal or infanticidal ideation

Current psychosis

Medical history of cognitive impairment

Trial design

Treatments tested in this trial

  • Cognitive behavioral therapy (CBT) psychotherapy group/telehealth
  • Interpersonal therapy (IPT) psychotherapy group/telehealth

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hackensack Meridian Health

Lead sponsor

New Jersey Health Foundation

Collaborator