N/A
N=54
Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression
Postpartum Depression
Bottom Line
View on ClinicalTrials.gov: NCT01379781 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Hamilton Rating Scales of Depression — 12.09; 17.17 units on a scale — p=.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Intervention for PPD (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Rating Scales of Depression |
12.09; 17.17 | .01 sig |
Summary
Postpartum depression (PPD) is undertreated and the consequences of this are substantial for women and children. Studies show that infant cry/fuss and sleep behavior are associated with PPD, and that parenting interventions can change infant behavior, yet these findings have never been applied to PPD. In this study, the investigators are teaching parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to women likely to develop PPD to see if the investigators can prevent the onset of this disorder.
Eligibility Criteria
Inclusion Criteria
- Healthy, non-smoking pregnant women
- Ages 18-35
- Score of 28 or higher on the Predictive Index of Postnatal Depression
- Low to normal obstetric risk
- Before 34 weeks gestation
Exclusion Criteria
- High Risk pregnancy
- Taking medications that affect the cardiovascular system (α blockers, β blockers, corticosteroids
- Chronic-use asthma medications (e.g. beta2-adrenoceptor agonists)
- Smoking during pregnancy
- Illicit drug/alcohol use during pregnancy
- Taking any psychotropic medications
Data sourced from ClinicalTrials.gov (NCT01379781). 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.