Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06991166

OBWELL: Evaluating the Effectiveness of Psychotherapy to Treat Postpartum Depression in High-Risk Mothers

Led by Hackensack Meridian Health · Updated on 2026-02-11

72

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

H

Hackensack Meridian Health

Lead Sponsor

N

New Jersey Health Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare the effectiveness of two types of psychotherapy—Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT)—for treating postpartum depression (PPD) in mothers whose newborns are in the Neonatal Intensive Care Unit (NICU). PPD is a serious form of depression occurring after childbirth, distinct from typical "baby blues," with symptoms that can significantly affect daily life and health outcomes for both mother and baby. Since many women with PPD do not receive or start treatment, this study focuses on early identification and intervention in a high-risk group. Participants will undergo an initial 4-week intervention with either CBT or IPT delivered through group sessions via telehealth. After this first phase, they will complete an assessment including depression scales and social health factors. Then, participants will switch to the other therapy type for an additional 4 weeks. This sequential approach allows comparison between each therapy alone and their combination over 8 weeks. Throughout the study, mothers will complete assessments at 4 weeks, after the full 8-week intervention, and again at 6 months to measure levels of postpartum depression. These assessments include standardized depression questionnaires and evaluations of risk factors. The study is randomized and does not use masking. Total participation spans initial and follow-up evaluations to monitor the impact of the therapies on postpartum depression over time.

CONDITIONS

Brief Title

OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Mother of NICU infant
  • Age 18 years or older
  • English-speaking
  • Gave birth more than 24 hours ago and less than 12 months prior to enrollment
  • Depression confirmed by current or prior diagnosis of Major Depressive Disorder or EPDS score above 10 or EPDS score below 10 with endorsement of sometimes or often on self-harm thoughts item
Not Eligible

You will not qualify if you...

  • Diagnosis of Substance Dependency or Substance Use
  • Acute suicidal or infanticidal thoughts
  • Current psychosis
  • Medical history of cognitive impairment
  • Infant death during current NICU admission
  • Marked non-compliance with intervention (missing more than one session or failure to complete assessments)
  • Receiving medical treatment requiring inpatient hospitalization that prevents study participation visits

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Treatment

Duration - 8 weeks

Participants receive two sequential 4-week psychotherapy interventions via group or telehealth. The first 4-week intervention is either Cognitive Behavioral Therapy (CBT) or Interpersonal Therapy (IPT), followed by a cross-over to the other therapy for 4 weeks.

Weekly therapy sessions and assessments at week 4 and week 8

Follow-up

Duration - 6 months

Participants are monitored for postpartum depression status after completion of both psychotherapy interventions.

1 follow-up visit

Trial Site Locations

Total: 1 location

1

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Actively Recruiting

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Research Team

M

Melissa Giuliano, LMSW

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Cognitive-Behavioural therapy and interpersonal psychotherapy for the treatment of post-natal depression: a narrative review.

George Stamou, Azucena García-Palacios, Cristina Botella

https://pubmed.ncbi.nlm.nih.gov/29914574

Maternal perinatal mental health and infant and toddler neurodevelopment - Evidence from low and middle-income countries. A systematic review.

Marlette Burger, Munira Hoosain, Christa Einspieler...

https://pubmed.ncbi.nlm.nih.gov/32174474

Group cognitive behavioural therapy for postnatal depression: a systematic review of clinical effectiveness, cost-effectiveness and value of information analyses.

M D Stevenson, A Scope, P A Sutcliffe...

https://pubmed.ncbi.nlm.nih.gov/20863477