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OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

Key facts

Who runs it
Hackensack Meridian Health
Where
Hackensack, United StatesSee the site
Trial code
Status
Recruiting
People taking part
72 people, planned
Started
15 Sept 2025
Expected to end
1 Sept 2028
Type of study
Interventional, 2 groups
Treatments tested
  • Cognitive behavioral therapy (CBT) psychotherapy group/telehealth
  • Interpersonal therapy (IPT) psychotherapy group/telehealth
Record updated
8 September 2026

Who can take part

Age
18 years and older
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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")

Who cannot take part

  • Medical history of cognitive impairment
  • 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),
  • A diagnosis of Substance Dependency or Substance Use
  • Acute suicidal or infanticidal ideation
  • Current psychosis
  • Infant death of current NICU admission
  • Are in medical treatment that would prevent participation (i.e., medical treatment that requires inpatient hospitalization and thus would prevent participation of study visits.)

Where in United States

  • Hackensack University Medical CenterHackensack, United StatesContact: Yeraz Markarian, PhDTaking people

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • 4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth interventionTreatment being tested

    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.

    Treatment: Cognitive behavioral therapy (CBT) psychotherapy group/telehealth and Interpersonal therapy (IPT) psychotherapy group/telehealth

  • 4-week interpersonal therapy (IPT) psychotherapy group/telehealth interventionTreatment being tested

    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.

    Treatment: Cognitive behavioral therapy (CBT) psychotherapy group/telehealth and Interpersonal therapy (IPT) psychotherapy group/telehealth

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
OBWELL: Evaluating the Effectiveness of an Innovative Psychotherapeutic Intervention to Treat Postpartum Depression Among High-Risk Mothers
Record updated
8 September 2026