PREPP: Preventing Postpartum Depression

Preventing Postpartum Depression: A Dyadic Approach Adjunctive to Obstetric Care

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03283254

Acronym

PREPP

Enrollment

216

Registered

2017-09-14

Start date

2018-02-12

Completion date

2024-02-28

Last updated

2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Depression (PPD)

Keywords

Postpartum Depression Treatment

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 3 coaching sessions and 2 check-in sessions 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.

Interventions

BEHAVIORALPractical 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.

BEHAVIORALEnhanced 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Masking description

The person administering the outcome measures is blind to participant group.

Intervention model description

Two groups: One receives PREPP prevention intervention and the other group receives Enhanced Treatment as Usual (psychoeducation about Postpartum Depression, referral and monitoring)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy pregnant women between 18-45 years old (based on self report) 2. A score of ≥19 on the Predictive Index of Postnatal Depression (PIPD), indicating risk for developing postpartum depression or score of ≥7 on the Edinburgh Postnatal Depression Scale 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.)

Design outcomes

Primary

Measure	Time frame	Description
Sleep Efficiency (SEact) of the Mothers	28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum	Sleep Efficiency (SEact) was measured by an activity monitor worn by the participants continuously over 7 days. SEact is reported as a percent of time spent asleep during the total time spent in bed.
Score on the Edinburgh Postnatal Depression Scale (EPDS)	Baseline, 6 weeks, 12 weeks, and 16 weeks 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)	Baseline, 6 weeks, 12 weeks, and 16 weeks 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	Baseline, 6 weeks, 12 weeks, and 16 weeks 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 on 24 items scored either on a 3-point (0-2) or 5-point (0-4) Likert-type scale. Total scores range from 0 to 74 with a lower score indicating a better outcome.
Score on the PHQ-9	Baseline, 6 weeks, 12 weeks, and 16 weeks 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.
Hamilton Anxiety Scale (HRSA)	Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum	The scale consists of 14 items designed to assess the severity of a patient's anxiety. The patient is rated by on 14 items scored on a 5-point (0-4) Likert-type scale. Total scores range from 0 to 56 with a lower score indicating a better outcome.

Secondary

Measure	Time frame	Description
Length of Longest Sleep at Night for Infants Over 4 Days	6 weeks and 16 weeks 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 minutes of sleep is averaged over a span of 4 days. A higher number indicates a better outcome.
Total Sleep Time (TSTact) in the Mothers	28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum	TSTact was measured by an activity monitor worn by the participants continuously over 7 days.
Total Nocturnal Sleep Duration - Brief Infant Sleep Questionnaire (BISQ)	6 weeks and 16 weeks postpartum	The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days
Total Daytime Sleep Duration - Brief Infant Sleep Questionnaire (BISQ)	6 weeks and 16 weeks postpartum	The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days.
Total Number of Instances of Waking up at Night - Brief Infant Sleep Questionnaire (BISQ)	6 weeks and 16 weeks postpartum	The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days.
Total Settling Time to Fall Asleep for the Night - Brief Infant Sleep Questionnaire (BISQ)	6 weeks and 16 weeks postpartum	The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days.
Daily Minutes of Infant Crying Over 4 Days	6 weeks and 16 weeks 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 minutes for the crying behavior is averaged over a span of 4 days, with a higher number indicating a worse outcome.

Other

Measure	Time frame	Description
Total Daily Minutes of Sleep Reported on the Self-Reported Sleep Log (Mother)	28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum	Self-reported sleep time was recorded by participants each night over a span of 7 days.

Countries

United States

Participant flow

Pre-assignment details

Only mothers were enrolled, and infants were assessed for efficacy

Participants by arm

Arm	Count
Practical Resources for Effective Postpartum (PREPP) Participants received the experimental PREPP intervention.	88
Enhanced Treatment as Usual Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant.	87
Total	175

Baseline characteristics

Characteristic	Practical Resources for Effective Postpartum (PREPP)	Total	Enhanced Treatment as Usual
Age, Continuous	31.15 years STANDARD_DEVIATION 5.51	30.66 years STANDARD_DEVIATION 6.19	30.16 years STANDARD_DEVIATION 6.8
Ethnicity (NIH/OMB) Hispanic or Latino	54 Participants	108 Participants	54 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants	67 Participants	33 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Asian	3 Participants	7 Participants	4 Participants
Race (NIH/OMB) Black or African American	15 Participants	26 Participants	11 Participants
Race (NIH/OMB) More than one race	7 Participants	10 Participants	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	40 Participants	92 Participants	52 Participants
Race (NIH/OMB) White	22 Participants	37 Participants	15 Participants
Region of Enrollment United States	88 participants	175 participants	87 participants
Sex: Female, Male Female	88 Participants	175 Participants	87 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 88	0 / 87
other Total, other adverse events	0 / 88	0 / 87
serious Total, serious adverse events	0 / 88	0 / 87

Outcome results

Primary

Hamilton Anxiety Scale (HRSA)

The scale consists of 14 items designed to assess the severity of a patient's anxiety. The patient is rated by on 14 items scored on a 5-point (0-4) Likert-type scale. Total scores range from 0 to 56 with a lower score indicating a better outcome.

Time frame: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum

Population: Data for this outcome was only collected from participants who were able to attend a session to receive the intervention. Data was not collected from participants who did not attend a session.

Arm	Measure	Group	Value (MEAN)	Dispersion
Practical Resources for Effective Postpartum (PREPP)	Hamilton Anxiety Scale (HRSA)	Baseline	4.09 score on a scale	Standard Error 0.41
Practical Resources for Effective Postpartum (PREPP)	Hamilton Anxiety Scale (HRSA)	6 week	3.01 score on a scale	Standard Error 0.33
Practical Resources for Effective Postpartum (PREPP)	Hamilton Anxiety Scale (HRSA)	12 week	3.01 score on a scale	Standard Error 0.35
Practical Resources for Effective Postpartum (PREPP)	Hamilton Anxiety Scale (HRSA)	16 week	2.93 score on a scale	Standard Error 0.34
Enhanced Treatment as Usual	Hamilton Anxiety Scale (HRSA)	16 week	2.94 score on a scale	Standard Error 0.34
Enhanced Treatment as Usual	Hamilton Anxiety Scale (HRSA)	Baseline	3.63 score on a scale	Standard Error 0.37
Enhanced Treatment as Usual	Hamilton Anxiety Scale (HRSA)	12 week	3.30 score on a scale	Standard Error 0.38
Enhanced Treatment as Usual	Hamilton Anxiety Scale (HRSA)	6 week	3.09 score on a scale	Standard Error 0.34

Primary

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 on 24 items scored either on a 3-point (0-2) or 5-point (0-4) Likert-type scale. Total scores range from 0 to 74 with a lower score indicating a better outcome.

Time frame: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum

Arm	Measure	Group	Value (MEAN)	Dispersion
Practical Resources for Effective Postpartum (PREPP)	Score on HRSD-24	Baseline	4.09 score on a scale	Standard Error 0.39
Practical Resources for Effective Postpartum (PREPP)	Score on HRSD-24	6 week	3.23 score on a scale	Standard Error 0.34
Practical Resources for Effective Postpartum (PREPP)	Score on HRSD-24	12 week	2.99 score on a scale	Standard Error 0.34
Practical Resources for Effective Postpartum (PREPP)	Score on HRSD-24	16 week	2.74 score on a scale	Standard Error 0.31
Enhanced Treatment as Usual	Score on HRSD-24	16 week	2.73 score on a scale	Standard Error 0.31
Enhanced Treatment as Usual	Score on HRSD-24	Baseline	3.16 score on a scale	Standard Error 0.32
Enhanced Treatment as Usual	Score on HRSD-24	12 week	3.31 score on a scale	Standard Error 0.37
Enhanced Treatment as Usual	Score on HRSD-24	6 week	2.99 score on a scale	Standard Error 0.32

Primary

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).

Time frame: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum

Arm	Measure	Group	Value (MEAN)	Dispersion
Practical Resources for Effective Postpartum (PREPP)	Score on the Edinburgh Postnatal Depression Scale (EPDS)	Baseline	5.04 score on a scale	Standard Error 0.49
Practical Resources for Effective Postpartum (PREPP)	Score on the Edinburgh Postnatal Depression Scale (EPDS)	6 week	4.43 score on a scale	Standard Error 0.46
Practical Resources for Effective Postpartum (PREPP)	Score on the Edinburgh Postnatal Depression Scale (EPDS)	12 week	3.51 score on a scale	Standard Error 0.39
Practical Resources for Effective Postpartum (PREPP)	Score on the Edinburgh Postnatal Depression Scale (EPDS)	16 week	3.69 score on a scale	Standard Error 0.41
Enhanced Treatment as Usual	Score on the Edinburgh Postnatal Depression Scale (EPDS)	16 week	4.04 score on a scale	Standard Error 0.44
Enhanced Treatment as Usual	Score on the Edinburgh Postnatal Depression Scale (EPDS)	Baseline	4.36 score on a scale	Standard Error 3.51
Enhanced Treatment as Usual	Score on the Edinburgh Postnatal Depression Scale (EPDS)	12 week	3.74 score on a scale	Standard Error 0.42
Enhanced Treatment as Usual	Score on the Edinburgh Postnatal Depression Scale (EPDS)	6 week	4.04 score on a scale	Standard Error 0.42

Primary

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.

Time frame: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum

Arm	Measure	Group	Value (MEAN)	Dispersion
Practical Resources for Effective Postpartum (PREPP)	Score on the PHQ-9	Baseline	6.36 score on a scale	Standard Error 0.49
Practical Resources for Effective Postpartum (PREPP)	Score on the PHQ-9	6 week	5.21 score on a scale	Standard Error 0.44
Practical Resources for Effective Postpartum (PREPP)	Score on the PHQ-9	12 week	4.13 score on a scale	Standard Error 0.39
Practical Resources for Effective Postpartum (PREPP)	Score on the PHQ-9	16 week	4.50 score on a scale	Standard Error 0.41
Enhanced Treatment as Usual	Score on the PHQ-9	16 week	4.08 score on a scale	Standard Error 0.38
Enhanced Treatment as Usual	Score on the PHQ-9	Baseline	5.64 score on a scale	Standard Error 0.45
Enhanced Treatment as Usual	Score on the PHQ-9	12 week	5.19 score on a scale	Standard Error 0.47
Enhanced Treatment as Usual	Score on the PHQ-9	6 week	5.42 score on a scale	Standard Error 0.46

Primary

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).

Time frame: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum

Arm	Measure	Group	Value (MEAN)	Dispersion
Practical Resources for Effective Postpartum (PREPP)	Score on the Pittsburgh Sleep Quality Index (PSQI)	Baseline	7.01 score on a scale	Standard Error 0.37
Practical Resources for Effective Postpartum (PREPP)	Score on the Pittsburgh Sleep Quality Index (PSQI)	6 week	7.21 score on a scale	Standard Error 0.43
Practical Resources for Effective Postpartum (PREPP)	Score on the Pittsburgh Sleep Quality Index (PSQI)	12 week	5.73 score on a scale	Standard Error 0.4
Practical Resources for Effective Postpartum (PREPP)	Score on the Pittsburgh Sleep Quality Index (PSQI)	16 week	5.88 score on a scale	Standard Error 0.39
Enhanced Treatment as Usual	Score on the Pittsburgh Sleep Quality Index (PSQI)	16 week	6.06 score on a scale	Standard Error 0.4
Enhanced Treatment as Usual	Score on the Pittsburgh Sleep Quality Index (PSQI)	Baseline	6.55 score on a scale	Standard Error 0.35
Enhanced Treatment as Usual	Score on the Pittsburgh Sleep Quality Index (PSQI)	12 week	6.48 score on a scale	Standard Error 0.44
Enhanced Treatment as Usual	Score on the Pittsburgh Sleep Quality Index (PSQI)	6 week	8.16 score on a scale	Standard Error 0.47

Primary

Sleep Efficiency (SEact) of the Mothers

Sleep Efficiency (SEact) was measured by an activity monitor worn by the participants continuously over 7 days. SEact is reported as a percent of time spent asleep during the total time spent in bed.

Time frame: 28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum

Population: Data for this outcome could not be collected from participants who did not wear the activity monitor continuously for 7 days

Arm	Measure	Group	Value (MEAN)	Dispersion
Practical Resources for Effective Postpartum (PREPP)	Sleep Efficiency (SEact) of the Mothers	28-32 weeks gestation	71.90 percent	Standard Deviation 21.25
Practical Resources for Effective Postpartum (PREPP)	Sleep Efficiency (SEact) of the Mothers	34-39 weeks gestation	74.00 percent	Standard Deviation 22.67
Practical Resources for Effective Postpartum (PREPP)	Sleep Efficiency (SEact) of the Mothers	6 week postpartum	65.32 percent	Standard Deviation 25.55
Practical Resources for Effective Postpartum (PREPP)	Sleep Efficiency (SEact) of the Mothers	16 week postpartum	69.25 percent	Standard Deviation 22.24
Enhanced Treatment as Usual	Sleep Efficiency (SEact) of the Mothers	16 week postpartum	76.74 percent	Standard Deviation 17.91
Enhanced Treatment as Usual	Sleep Efficiency (SEact) of the Mothers	28-32 weeks gestation	73.44 percent	Standard Deviation 25.21
Enhanced Treatment as Usual	Sleep Efficiency (SEact) of the Mothers	6 week postpartum	71.14 percent	Standard Deviation 20.78
Enhanced Treatment as Usual	Sleep Efficiency (SEact) of the Mothers	34-39 weeks gestation	71.28 percent	Standard Deviation 24.31

Secondary

Daily Minutes of Infant Crying Over 4 Days

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 minutes for the crying behavior is averaged over a span of 4 days, with a higher number indicating a worse outcome.