NCT03283254: PREPP

PREPP: Preventing Postpartum Depression

Completed NA Results posted Last updated 26 September 2025

What this trial tests

NA trial testing Practical Resources for Effective Postpartum Parenting (PREPP) in Postpartum Depression (PPD) in 216 participants. Completed in 28 February 2024.

Timeline

12 February 2018

Primary endpoint
28 February 2024

28 February 2024

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	216
Start date	12 February 2018
Primary completion	28 February 2024
Estimated completion	28 February 2024
Sites	1 location across United States

Drugs / interventions tested

• Practical Resources for Effective Postpartum Parenting (PREPP)
• Enhanced Treatment As Usual (ETAU)

Conditions studied

• Postpartum Depression (PPD) — all drugs for Postpartum Depression (PPD) →

Sponsor

Columbia University

Who can join

Adults 18 to 45, female only, with Postpartum Depression (PPD). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Score on the Edinburgh Postnatal Depression Scale (EPDS) Primary · 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).

Baseline

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	5.04	± 0.49
Enhanced Treatment as Usual	4.36	± 3.51

6 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	4.43	± 0.46
Enhanced Treatment as Usual	4.04	± 0.42

12 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	3.51	± 0.39
Enhanced Treatment as Usual	3.74	± 0.42

16 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	3.69	± 0.41
Enhanced Treatment as Usual	4.04	± 0.44

Score on the Pittsburgh Sleep Quality Index (PSQI) Primary · 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).

Baseline

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	7.01	± 0.37
Enhanced Treatment as Usual	6.55	± 0.35

6 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	7.21	± 0.43
Enhanced Treatment as Usual	8.16	± 0.47

12 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	5.73	± 0.40
Enhanced Treatment as Usual	6.48	± 0.44

16 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	5.88	± 0.39
Enhanced Treatment as Usual	6.06	± 0.40

Score on HRSD-24 Primary · 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.

Baseline

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	4.09	± 0.39
Enhanced Treatment as Usual	3.16	± 0.32

6 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	3.23	± 0.34
Enhanced Treatment as Usual	2.99	± 0.32

12 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	2.99	± 0.34
Enhanced Treatment as Usual	3.31	± 0.37

16 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	2.74	± 0.31
Enhanced Treatment as Usual	2.73	± 0.31

Score on the PHQ-9 Primary · 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.

Baseline

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	6.36	± 0.49
Enhanced Treatment as Usual	5.64	± 0.45

6 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	5.21	± 0.44
Enhanced Treatment as Usual	5.42	± 0.46

12 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	4.13	± 0.39
Enhanced Treatment as Usual	5.19	± 0.47

16 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	4.50	± 0.41
Enhanced Treatment as Usual	4.08	± 0.38

Hamilton Anxiety Scale (HRSA) Primary · 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.

Baseline

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	4.09	± 0.41
Enhanced Treatment as Usual	3.63	± 0.37

6 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	3.01	± 0.33
Enhanced Treatment as Usual	3.09	± 0.34

12 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	3.01	± 0.35
Enhanced Treatment as Usual	3.30	± 0.38

16 week

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	2.93	± 0.34
Enhanced Treatment as Usual	2.94	± 0.34

Sleep Efficiency (SEact) of the Mothers Primary · 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.

28-32 weeks gestation

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	71.90	± 21.25
Enhanced Treatment as Usual	73.44	± 25.21

34-39 weeks gestation

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	74.00	± 22.67
Enhanced Treatment as Usual	71.28	± 24.31

6 week postpartum

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	65.32	± 25.55
Enhanced Treatment as Usual	71.14	± 20.78

16 week postpartum

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	69.25	± 22.24
Enhanced Treatment as Usual	76.74	± 17.91

Total Nocturnal Sleep Duration - Brief Infant Sleep Questionnaire (BISQ) Secondary · 6 weeks and 16 weeks postpartum

The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days

6 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	7.27	± 2.08
Enhanced Treatment as Usual	7.26	± 1.97

16 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	8.24	± 2.12
Enhanced Treatment as Usual	8.30	± 1.79

Total Daytime Sleep Duration - Brief Infant Sleep Questionnaire (BISQ) Secondary · 6 weeks and 16 weeks postpartum

The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days.

6 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	6.17	± 2.66
Enhanced Treatment as Usual	6.65	± 2.47

16 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	4.84	± 2.45
Enhanced Treatment as Usual	4.50	± 1.87

Total Number of Instances of Waking up at Night - Brief Infant Sleep Questionnaire (BISQ) Secondary · 6 weeks and 16 weeks postpartum

The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days.

6 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	2.61	± 1.05
Enhanced Treatment as Usual	2.71	± 1.17

16 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	1.77	± 1.08
Enhanced Treatment as Usual	1.85	± 1.26

Total Settling Time to Fall Asleep for the Night - Brief Infant Sleep Questionnaire (BISQ) Secondary · 6 weeks and 16 weeks postpartum

The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days.

6 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	41.23	± 35.04
Enhanced Treatment as Usual	31.35	± 20.16

16 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	31.21	± 22.50
Enhanced Treatment as Usual	32.23	± 30.07

Daily Minutes of Infant Crying Over 4 Days Secondary · 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.

6 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	164.72	± 81.32
Enhanced Treatment as Usual	117.35	± 72.46

16 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	98.75	± 66.58
Enhanced Treatment as Usual	101.25	± 48.23

Length of Longest Sleep at Night for Infants Over 4 Days Secondary · 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.

6 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	249.52	± 81.04
Enhanced Treatment as Usual	238.24	± 106.78

16 weeks

Group	Value	95% CI
Practical Resources for Effective Postpartum (PREPP)	291.52	± 71.91
Enhanced Treatment as Usual	277.67	± 74.33

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intergenerational psychiatry: a new look at a powerful perspective.
   Duarte CS, Monk C, Weissman MM, Posner J. · · 2020 · cited 43× · PMID 32394546 · DOI 10.1002/wps.20733
2. Practical resources for effective postpartum parenting (PREPP): a randomized controlled trial of a novel parent-infant dyadic intervention to reduce symptoms of postpartum depression.
   Grubb MD, Wilson CA, Zhang Z, Liu G, et al · · 2024 · cited 3× · PMID 39426626 · DOI 10.1016/j.ajogmf.2024.101526