OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

Phase

N/A

Condition

Depression

Treatment

Cognitive behavioral therapy (CBT) psychotherapy group/telehealth

Interpersonal therapy (IPT) psychotherapy group/telehealth

Clinical Study ID

NCT06991166

Pro2024-0204

Ages > 18
Female

Study Summary

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

Inclusion

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

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 onesession during a 4-week intervention or failure to complete study assessments),
Are in medical treatment that would prevent participation (i.e., medical treatmentthat requires inpatient hospitalization and thus would prevent participation ofstudy visits.)

Study Design