PREPP: Preventing Postpartum Depression (PREPP)

Preventing Postpartum Depression: A Dyadic Approach Adjunctive to Obstetric Care

The primary aim of this study is to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2) improve the quality of the mother-infant interaction and subsequent child development. Specifically, the study team will investigate: (1) the effectiveness of the intervention compared to usual care; (2) if the effects of the intervention can be detected in the assessments of the quality of mother-infant interaction; (3) if there are prenatal and/or postnatal biomarkers that can help identify infants whose behavior is more likely to play a role in their mothers' depression; (4) if these markers differentiate which infants will be most responsive to the intervention(s); and (5), if assessments of brain function at birth and at 4-6 weeks of age provide biological nodal points for identifying the effects of the intervention on infant brain development. Participants will be recruited during their 2nd trimester, and will be randomly separated into one of two groups: a group that receives coaching in parenting techniques (4 in-person coaching sessions and 1 phone session) or one that receives treatment as usual.

Study Overview

• Status: Active, not recruiting
• Conditions: Postpartum Depression (PPD)
• Intervention / Treatment: Behavioral: Practical Resources for Effective Postpartum Parenting (PREPP); Behavioral: Enhanced Treatment As Usual (ETAU)

Detailed Description

Of the nearly 4 million mothers delivering live births each year in the United States, approximately 560,000 - or 14% - will develop major or minor depression within the first four months postpartum, when the rate peaks. This number dwarfs prevalence rates for gestational diabetes (2-5%) and is comparable to preterm birth (11.4%). Postpartum depression (PPD) has substantial consequences: poorer maternal quality of life, significant emotional suffering, and suicide risk. PPD predicts diminished mother-infant bonding, and poor outcomes in social-emotional and, in some groups, cognitive development. PPD is undertreated in part because women are reluctant to seek treatment due to the stigma associated with mental health care, logistical barriers to at-tending added health care appointments, and disinclination to take medications while breastfeeding. Of preventive interventions, few embed services in obstetrical care or leverage the unique mother-infant dyadic orientation of the childbearing period. The investigators developed a novel intervention based on the conceptualization of maternal depression as a potential disorder of the mother-infant dyad, and one that can be approached through psychological and behavioral changes in the mother - commencing before birth - that affect her and the child. PREPP (Practical Resources for Effective Postpartum Parenting) enrolls distressed pregnant women at risk for PPD, spans late pregnancy to the 6 week postpartum check up, comprises four in-person 'coaching' sessions adjunctive to obstetrical (OB) prenatal and postnatal appointments, one phone session, and imparts (a) mindfulness and self-reflection skills, (b) parenting skills, and (c) psycho-education.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy pregnant women between 18-45 years old (based on self report)
2. A score of ≥21 on the Predictive Index of Postnatal Depression (PIPD), indicating risk for developing postpartum depression
3. A healthy, singleton pregnancy (based on self report)
4. English speaking (based on self report)
5. Receiving standard prenatal care (based on self report)

Exclusion Criteria:

1. Multi-fetal pregnancy (based on self-report)
2. Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)
3. Acute medical illness or significant pregnancy complication (based on self-report)
4. Currently in weekly, individual psychotherapy, including psychopharmacology (based on self report)
5. Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Practical Resources for Effective Postpartum (PREPP); A psychotherapeutic preventive intervention that involves psychoeducation and cognitive behavioral techniques.	Behavioral: Practical Resources for Effective Postpartum Parenting (PREPP); A preventive psychotherapy intervention for PPD: Participants in this arm of the study receive PREPP (Practical Resources for Effective Postpartum Parenting). PREPP is a brief preventive intervention for Postpartum Depression that focuses on the birthing parent-infant dyad and consists of 5 sessions that take place during pregnancy through 6 weeks postpartum carried out by study clinicians referred to as 'coaches.' The sessions of this preventive psychotherapy are comprised of three components: (a) mindfulness and self-reflection skills, (b) parenting skills and (c) psycho-education.; Other Names: PREPP
Active Comparator: Enhanced Treatment as Usual; Psychoeducation about Postpartum Depression, referral to treatment in the community and monitoring	Behavioral: Enhanced Treatment As Usual (ETAU); Psychoeducation, Clinical Assessment, Potential Referral: Participants receive "usual care" along with Postpartum Depression psychoeducation and enhanced support for finding perinatal mental healthcare treatment when appropriate by meeting with a study clinician specifically assigned to provide ETAU in this study at three times that are aligned with PREPP sessions that span from pregnancy to 6 weeks postpartum. At the first contact, participants meet with their assigned ETAU clinician and are given information about PPD, a brief clinical mental health assessment, and a referral for treatment if warranted or requested; the second session is a follow-up mental health clinical assessment with the study clinician and a referral for treatment if warranted or requested; at the third session, participants meet again with their study clinician and receive a mental health assessment, review relevant psychoeducation on PPD and are referred to treatment when appropriate.; Other Names: ETAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on the Edinburgh Postnatal Depression Scale (EPDS)	Maternal mood: Postpartum Depression Symptoms will be measured by Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item questionnaire that was developed to identify women who have postpartum depression. Items of the scale correspond to various clinical depression symptoms, such as guilt feeling, sleep disturbance, low energy, anhedonia, and suicidal ideation. Overall assessment is done by total score, which is determined by adding together the scores for each of the 10 items. Scores range from 0 to 30, with higher scores indicate more depressive symptoms (worse outcome).	Through the 4th Month Postpartum
Score on the Pittsburgh Sleep Quality Index (PSQI)	Maternal perception of sleep quality: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. A total of 19 individual items generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Scores range from 0 to 21, where lower scores indicate a healthier sleep quality (better outcome).	Through the 4th Month Postpartum
Score on HRSD-24	The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The patient is rated by a clinician on 24 items scored either on a 5-point Likert-type scale. Scores range from 0 to 15 with a lower score indicating a better outcome.	Through the 4th Month Postpartum
Score on the PHQ-9	The nine-item Patient Health Questionnaire (PHQ-9) is a depressive symptom scale and diagnostic tool introduced in 2001 to screen adult patients in primary care settings. The instrument assesses for the presence and severity of depressive symptoms and a possible depressive disorder. It is scored by simply adding up the individual items' scores. Scores range from 0 to 27 with a lower score indicating a better outcome.	Through the 4th Month Postpartum
Hamilton Anxiety Scale (HRSA)	The scale consists of 14 items designed to assess the severity of a patient's anxiety. Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe (worse outcome). All of these scores are used to compute an overarching score that indicates a person's anxiety severity.	Through the 4th Month Postpartum
Sleep Efficiency (SEact)	Maternal sleep: ActiGraphy data will be analyzed first and the derived aggregated measures will be used in the model with the self-reported sleep measures.	Through the 4th Month Postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on Brief Infant Sleep Questionnaire (BISQ) (baby)	The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over prior one week that includes domains such as nocturnal sleep duration, night wakings, method of falling asleep.Scores on each subscale and the total score are scaled from 0 to 100, with higher scores indicating a better outcome.	Through the 4th Month Postpartum
Cry Behavior (baby)	Cry behavior will be measured by The Baby Day Diary, which is a 24-hour diary of infant and parental behavior for days. The number of hours for the crying behavior is averaged over a span of 4 days. Possible scores range from 0 hours to 24 hours (worse outcome).	Through the 4th Month Postpartum
Sleep Behavior (baby)	Sleep behavior will be measured by The Baby Day Diary, which is a 24-hour diary of infant and parental behavior for days.The number of hours of sleep is averaged over a span of 4 days. Possible scores range from 0 hours to 24 hours (better outcome).	Through the 4th Month Postpartum
Total Sleep Time (TSTact) (mother)	Maternal sleep: ActiGraphy data will be analyzed first and the derived aggregated measures will be used in the model with the self-reported sleep measures.	Through the 4th Month Postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Sleep Hours reported on the Self-Reported Sleep Log (mother)	Self-reported sleep behaviors (including bedtime, time to fall asleep, wake time, etc.) recorded on the days/nights that the actigraphy data is collected. This would be averaged over a span of 7 days.	Through the 4th Month Postpartum

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Study Director: Elizabeth Werner, PhD, Columbia University; Principal Investigator: Catherine Monk, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Postpartum Depression Treatment
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 7428; R01HD092062 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data may be made available to other researchers.
• IPD Sharing Time Frame: After the completion of the study
• IPD Sharing Access Criteria: Permission of the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No