Psychotherapy for Postpartum Depression

Overseen By Melissa Giuliano, LMSW

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hackensack Meridian Health

Disqualifiers: Substance use, Suicidal ideation, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

72 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Yeraz Markarian, PhD

Principal Investigator

Hackensack Meridian Health

Eligibility Criteria

This trial is for mothers with Postpartum Depression (PPD) whose newborns are in the Neonatal Intensive Care Unit (NICU). Participants should be experiencing PPD symptoms that affect daily life. The study seeks to include those who have not yet started psychotherapy treatment.

Inclusion Criteria

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')

English-speaking

Exclusion Criteria

Current psychosis

Medical history of cognitive impairment

Infant death of current NICU admission

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive either a 4-week CBT or IPT intervention

4 weeks

Telehealth sessions

Crossover Treatment

Participants cross over to the second 4-week intervention (IPT or CBT)

4 weeks

Telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessment at 6 months post enrollment

Treatment Details

Interventions

• Cognitive Behavioral Therapy (CBT)
• Interpersonal Therapy (IPT)

Trial Overview The OBWELL trial tests Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) delivered via telehealth over 4 weeks. It compares their effectiveness separately and explores if an 8-week sequential combination of both therapies offers greater benefits for treating PPD in NICU mothers.

Participant Groups

Group I: 4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention Experimental Treatment 2 Interventions

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.

Group II: 4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

New Jersey Health Foundation

Collaborator