OBWELL: Evaluating the Effectiveness of an Innovative Psychotherapeutic Intervention to Treat Postpartum Depression Among High-Risk Mothers

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Contact Information
Primary
Melissa Giuliano, LMSW
Melissa.Giuliano@hmhn.org
5519964450
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 72
Treatments
Experimental: 4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention
After the first 4-week of CBT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then cross-over to the second 4-week of IPT intervention.
Experimental: 4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention
After the first 4-week of IPT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then cross-over to the second 4-week of CBT intervention.
Related Therapeutic Areas
Sponsors
Collaborators: New Jersey Health Foundation
Leads: Hackensack Meridian Health

This content was sourced from clinicaltrials.gov