RECRUITING

OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-15
Study Completion:2027-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06991166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Mother of NICU infant
  2. * Older than age 18
  3. * English-speaking
  4. * Gave birth more than 24 hours ago and less than 12 months prior to enrollment
  5. * Depression as assessed by:
  1. * A diagnosis of Substance Dependency or Substance Use
  2. * Acute suicidal or infanticidal ideation
  3. * Current psychosis
  4. * Medical history of cognitive impairment
  5. * Infant death of current NICU admission
  6. * 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),
  7. * Are in medical treatment that would prevent participation (i.e., medical treatment that requires inpatient hospitalization and thus would prevent participation of study visits.)

Contacts and Locations

Study Contact

Melissa Giuliano, LMSW
CONTACT
5519964450
Melissa.Giuliano@hmhn.org

Principal Investigator

Yeraz Markarian, PhD
PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health

Study Locations (Sites)

Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States

Collaborators and Investigators

Sponsor: Hackensack Meridian Health

  • Yeraz Markarian, PhD, PRINCIPAL_INVESTIGATOR, Hackensack Meridian Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-15
Study Completion Date2027-09-01

Study Record Updates

Study Start Date2025-09-15
Study Completion Date2027-09-01

Terms related to this study

Keywords Provided by Researchers

  • Post Partum Depression
  • Cognitive behavioral therapy
  • interpersonal therapy
  • psychotherapy
  • NICU

Additional Relevant MeSH Terms

  • Post Partum Depression