OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

NCT06991166 | Recruiting

• 1 other identifier: Pro2024-0204
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Post Partum Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Post Partum Depression post initial psychotherapy

  Quantitative assessment of treatment effectiveness in reducing PPD symptoms will be conducted with the Edinburgh Postnatal Depression Scale (EPDS), a 10-item validated self-report scale. Total scores on the EPDS range from 0 to 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. The measures will be administered at the following timepoints: Week 0 Baseline: At study entry prior to starting group psychotherapy in the Outpatient Behavioral Health practice Week 4: After completing the first 4-week intervention of the two-intervention sequence, prior to "crossing over"

  At 4 weeks

Secondary Outcomes (2)

• Postpartum Depression after both types of psychotherapy

  At 8 weeks

• Postpartum Depression at follow up

  At 6 months

Study Arms (2)

4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention

EXPERIMENTAL

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.

Behavioral: Cognitive behavioral therapy (CBT) psychotherapy group/telehealth; Behavioral: Interpersonal therapy (IPT) psychotherapy group/telehealth

4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention

EXPERIMENTAL

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.

Behavioral: Cognitive behavioral therapy (CBT) psychotherapy group/telehealth; Behavioral: Interpersonal therapy (IPT) psychotherapy group/telehealth

Interventions

Interpersonal therapy (IPT) psychotherapy group/telehealth BEHAVIORAL

Type of psychotherapy. IPT focuses on improving interpersonal communication and deficits, processing grief, and role transitions

4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention; 4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention

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

4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention; 4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Mothers with babies at the NICU
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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")

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• New Jersey Health Foundation: collaborator

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 37546054 BACKGROUND

• 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.

  PMID: 27780317 BACKGROUND

• 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.

  PMID: 30450956 BACKGROUND

• 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.

  PMID: 31795733 BACKGROUND

• 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.

  PMID: 29914574 BACKGROUND

• 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.

  PMID: 24269903 BACKGROUND

• 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.

  PMID: 32174474 BACKGROUND

• 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.

  PMID: 20863477 BACKGROUND

• 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.

  PMID: 11264336 BACKGROUND

• Beck, J.S.(2021) Cognitive Behavior Therapy : Basics and Beyond, Third Edition, NY: Guilford Press

  BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Cognitive Behavioral Therapy; Psychotherapy, Group; Telemedicine; adenylate isopentenyltransferase

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioenvironmental Therapy; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Yeraz Markarian, PhD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Giuliano, LMSW

CONTACT

5519964450; Melissa.Giuliano@hmhn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 26, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)