OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Hackensack Meridian Health
Study ID
NCT06991166
Status
Recruiting
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Conditions

  • Post Partum Depression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive behavioral therapy (CBT) psychotherapy group/telehealth — BEHAVIORAL
    Type of psychotherapy. CBT focuses on identifying and changing unhelpful beliefs and behavioral patterns that lead to negative emotions (e.g., depression, anxiety, grief, shame) in order to break the emotion-thought-behavior cycle
  • Interpersonal therapy (IPT) psychotherapy group/telehealth — BEHAVIORAL
    Type of psychotherapy. IPT focuses on improving interpersonal communication and deficits, processing grief, and role transitions

Study Details

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.

Key Dates

Start date
Sep 15, 2025
Status verified
Feb 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Post Partum Depression post initial psychotherapy [ Time Frame: At 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hackensack University Medical CenterHackensackNew Jersey07601
Yeraz Markarian, PhD
[email protected]
551-996-4450

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By research site
Hackensack University Medical Center· Hackensack, NJ

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