Clinical trial NCT01379781: Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression
Official title: Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: prevention
postpartum depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Of the over 4 million live births each year in the United States, nearly 800,000 - or 20% - of the mothers will develop major or minor depression within the first 3 months postpartum. This number dwarfs prevalence rates for gestational diabetes (2-5%) and preterm birth (12.7%). Existing clinical approaches to postpartum depression (PPD) use standard pharmacologic and psychological interventions to reduce women's symptoms. Nevertheless, PPD is undertreated, in part because women are reluctant to seek treatment due to stigma associated with mental health care and disinclination to take psychotropic medications when breastfeeding. The consequences of this are substantial. Untreated PPD is associated with diminished quality of life and significant emotional suffering for women, and, through compromised caregiving, poor outcomes in children's cognitive and social-emotional development. Although maternal risk factors for PPD are well known, protocols for prevention based on commonly used depression interventions are only beginning to be evaluated. Building on developmental data showing the profound bi-directionality of emotional and behavioral influences between mother and infant, the investigators are testing a novel PPD intervention protocol that challenges the standard, individually-focused treatment paradigm. Our intervention is based on the conceptualization of PPD as a potential disorder of the dyad, and one that can be approached through behavioral change in and affective engagement with mother and child. 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. The investigators aim to collect data on a novel PPD risk-reducing protocol based on a dyadic behavioral approach to PPD in which the investigators treat at-risk women by promoting maternally-mediated behavioral changes in their infants. The investigators will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits, then evaluate infant behavior at 6 and 14 weeks, and maternal mood at 6, 10, and 14 weeks postpartum. The investigators will fully exploit the investigative opportunities of this intervention study by using state-of-the-art EEG and fetal monitoring to characterize early biomarkers associated with infant behavior and behavior change. This study has the potential to have a major impact on clinical research, and to transform the standard care of PPD in that (1) the intervention will have high rates of treatment compliance because (a) the protocol sessions can be incorporated into usual perinatal medical visits, (b) parenting skills will appeal to women as a non-psychiatric intervention, (c) the clinical approach will have face validity given the dyadic focus of the perinatal period; (2) its aim is prevention; (3) it fosters both maternal and child well being; (4) it will expand the risk factors for PPD to include neurobehavioral markers in the perinate.

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

Primary outcomes:
measure: Hamilton Rating Scales of Depression
timeFrame: 6 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Catherine E Monk, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: