About 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

A diagnosis of Substance Dependency or Substance Use

Acute suicidal or infanticidal ideation

Current psychosis

Medical history of cognitive impairment

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

72 Participants

are divided into 2 treatment groups

Group A: 4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth interventionExperimental treatment 2 interventions

Group B: 4-week interpersonal therapy (IPT) psychotherapy group/telehealth interventionExperimental treatment 2 interventions

Trial outcomes

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"

Time frame

At 4 weeks

Secondary outcomes

1

Postpartum Depression after both types of 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 measure will be administered at Week 8: After completing the second 4-week intervention and completing the entire 8-week two-intervention sequence.

Time frame

At 8 weeks

2

Postpartum Depression at follow up

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 measure will be administered at 6 months post enrollment.

Time frame

At 6 months

OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts