PREPP: Preventing Postpartum Depression

Not Applicable

Completed

• Conditions: Postpartum Depression (PPD)
• Interventions: Behavioral: Practical Resources for Effective Postpartum Parenting (PREPP); Behavioral: Enhanced Treatment As Usual (ETAU)

• Registration Number: NCT03283254
• Lead Sponsor: Columbia University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-14
• Study Start: 2018-02-12
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 216

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)

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Practical Resources for Effective Postpartum (PREPP)	Practical Resources for Effective Postpartum Parenting (PREPP)	A psychotherapeutic preventive intervention that involves psychoeducation and cognitive behavioral techniques.
Enhanced Treatment as Usual	Enhanced Treatment As Usual (ETAU)	Psychoeducation about Postpartum Depression, referral to treatment in the community and monitoring

Primary Outcome Measures

Name	Time	Method
Score on the Edinburgh Postnatal Depression Scale (EPDS)	Through the 4th Month Postpartum	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).
Score on the Pittsburgh Sleep Quality Index (PSQI)	Through the 4th Month Postpartum	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).
Score on HRSD-24	Through the 4th Month Postpartum	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.
Hamilton Anxiety Scale (HRSA)	Through the 4th Month Postpartum	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.
Score on the PHQ-9	Through the 4th Month Postpartum	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.
Sleep Efficiency (SEact)	Through the 4th Month Postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Score on Brief Infant Sleep Questionnaire (BISQ) (baby)	Through the 4th Month Postpartum	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.
Cry Behavior (baby)	Through the 4th Month Postpartum	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).
Sleep Behavior (baby)	Through the 4th Month Postpartum	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).
Total Sleep Time (TSTact) (mother)	Through the 4th Month Postpartum	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.

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States