N/A
N=175
PREPP: Preventing Postpartum Depression
Postpartum Depression (PPD)
Bottom Line
View on ClinicalTrials.gov: NCT03283254 ↗Enrolled (actual)
175
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Score on the Edinburgh Postnatal Depression Scale (EPDS) — 5.04; 4.36; 4.43; 4.04 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Practical Resources for Effective Postpartum Parenting (PREPP) (Behavioral); Enhanced Treatment As Usual (ETAU) (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on the Edinburgh Postnatal Depression Scale (EPDS) |
5.04; 4.36; 4.43; 4.04; 3.51; 3.74 | — |
| PRIMARY Score on the Pittsburgh Sleep Quality Index (PSQI) |
7.01; 6.55; 7.21; 8.16; 5.73; 6.48 | — |
| PRIMARY Score on HRSD-24 |
4.09; 3.16; 3.23; 2.99; 2.99; 3.31 | — |
| PRIMARY Score on the PHQ-9 |
6.36; 5.64; 5.21; 5.42; 4.13; 5.19 | — |
| PRIMARY Hamilton Anxiety Scale (HRSA) |
4.09; 3.63; 3.01; 3.09; 3.01; 3.30 | — |
| PRIMARY Sleep Efficiency (SEact) of the Mothers |
71.90; 73.44; 74.00; 71.28; 65.32; 71.14 | — |
| SECONDARY Total Nocturnal Sleep Duration - Brief Infant Sleep Questionnaire (BISQ) |
7.27; 7.26; 8.24; 8.30 | — |
| SECONDARY Total Daytime Sleep Duration - Brief Infant Sleep Questionnaire (BISQ) |
6.17; 6.65; 4.84; 4.50 | — |
| SECONDARY Total Number of Instances of Waking up at Night - Brief Infant Sleep Questionnaire (BISQ) |
2.61; 2.71; 1.77; 1.85 | — |
| SECONDARY Total Settling Time to Fall Asleep for the Night - Brief Infant Sleep Questionnaire (BISQ) |
41.23; 31.35; 31.21; 32.23 | — |
| SECONDARY Daily Minutes of Infant Crying Over 4 Days |
164.72; 117.35; 98.75; 101.25 | — |
| SECONDARY Length of Longest Sleep at Night for Infants Over 4 Days |
249.52; 238.24; 291.52; 277.67 | — |
| SECONDARY Total Sleep Time (TSTact) in the Mothers |
305.03; 291.34; 329.17; 274.50; 273.89; 249.66 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy pregnant women between 18-45 years old (based on self report)
- 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
- A healthy, singleton pregnancy (based on self report)
- English speaking (based on self report)
- Receiving standard prenatal care (based on self report)
Exclusion Criteria
- Multi-fetal pregnancy (based on self-report)
- Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)
- Acute medical illness or significant pregnancy complication (based on self-report)
- Currently in weekly, individual psychotherapy, including psychopharmacology (based on self report)
- Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)
Data sourced from ClinicalTrials.gov (NCT03283254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.