Clinical trial NCT06991166: OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression
Official title: OBWELL: Evaluating the Effectiveness of an Innovative Psychotherapeutic Intervention to Treat Postpartum Depression Among High-Risk Mothers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Partum Depression
Keywords: Post Partum Depression
Cognitive behavioral therapy
interpersonal therapy
psychotherapy
NICU
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: New Jersey Health Foundation
First posted: 2025-05-26
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 \[1\].

One-third of women in the U.S. with PPD are identified in clinical settings, yet only half of those begin psychotherapy treatment \[2\]. Unfortunately, mothers whose newborns are in the Neonatal Intensive Care Unit (NICU) are at high risk for developing PPD \[3,4\], necessitating early identification and evidence-based treatment. Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are the two most effective psychotherapy treatments for PPD \[5,6\], 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 criteria: Inclusion Criteria:

* 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")

Exclusion Criteria:

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

Primary outcomes:
measure: Post Partum Depression post initial psychotherapy
timeFrame: At 4 weeks
Secondary outcomes:
measure: Postpartum Depression after both types of psychotherapy
timeFrame: At 8 weeks
measure: Postpartum Depression at follow up
timeFrame: At 6 months
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Yeraz Markarian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saharoy R, Potdukhe A, Wanjari M, Taksande AB. Postpartum Depression and Maternal Care: Exploring the Complex Effects on Mothers and Infants. Cureus. 2023 Jul 4;15(7):e41381. doi: 10.7759/cureus.41381. eCollection 2023 Jul.
citation: Cox EQ, Sowa NA, Meltzer-Brody SE, Gaynes BN. The Perinatal Depression Treatment Cascade: Baby Steps Toward Improving Outcomes. J Clin Psychiatry. 2016 Sep;77(9):1189-1200. doi: 10.4088/JCP.15r10174.
citation: Wyatt T, Shreffler KM, Ciciolla L. Neonatal intensive care unit admission and maternal postpartum depression. J Reprod Infant Psychol. 2019 Jul;37(3):267-276. doi: 10.1080/02646838.2018.1548756. Epub 2018 Nov 19.
citation: Bonacquisti A, Geller PA, Patterson CA. Maternal depression, anxiety, stress, and maternal-infant attachment in the neonatal intensive care unit. J Reprod Infant Psychol. 2020 Jul;38(3):297-310. doi: 10.1080/02646838.2019.1695041. Epub 2019 Dec 4.
citation: Stamou G, Garcia-Palacios A, Botella C. Cognitive-Behavioural therapy and interpersonal psychotherapy for the treatment of post-natal depression: a narrative review. BMC Psychol. 2018 Jun 18;6(1):28. doi: 10.1186/s40359-018-0240-5.
citation: Stuart S, Koleva H. Psychological treatments for perinatal depression. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):61-70. doi: 10.1016/j.bpobgyn.2013.09.004. Epub 2013 Oct 7.
citation: Burger M, Hoosain M, Einspieler C, Unger M, Niehaus D. Maternal perinatal mental health and infant and toddler neurodevelopment - Evidence from low and middle-income countries. A systematic review. J Affect Disord. 2020 May 1;268:158-172. doi: 10.1016/j.jad.2020.03.023. Epub 2020 Mar 6.
citation: Stevenson MD, Scope A, Sutcliffe PA, Booth A, Slade P, Parry G, Saxon D, Kalthenthaler E; group cognitive behavioural therapy for postnatal depression advisory group. Group cognitive behavioural therapy for postnatal depression: a systematic review of clinical effectiveness, cost-effectiveness and value of information analyses. Health Technol Assess. 2010 Sep;14(44):1-107, iii-iv. doi: 10.3310/hta14440.
citation: Klier CM, Muzik M, Rosenblum KL, Lenz G. Interpersonal psychotherapy adapted for the group setting in the treatment of postpartum depression. J Psychother Pract Res. 2001 Spring;10(2):124-31.
citation: Beck, J.S.(2021) Cognitive Behavior Therapy : Basics and Beyond, Third Edition, NY: Guilford Press