search
Back to results

Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention for PPD
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression focused on measuring prevention, postpartum depression

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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 (ฮฑ blockers, ฮฒ blockers, corticosteroids
  • Chronic-use asthma medications (e.g. beta2-adrenoceptor agonists)
  • Smoking during pregnancy
  • Illicit drug/alcohol use during pregnancy
  • Taking any psychotropic medications

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral Intervention for PPD

Treatment As Usual

Arm Description

Behavioral Intervention for PPD delivered over 3 in-person sessions.

Referred to Treatment in the Community.

Outcomes

Primary Outcome Measures

Hamilton Rating Scales of Depression
Assessing severity of depression; clinician rated 24 questions 13 items are scored on a 5 point scale ranging from 0=not present to 4=severe 11 items are scored from 0-2 A composite score is created by the sum of the scores from all items. Scores can range from 0-74 0-7: normal 8-13: mild depression 14-18: moderate depression 19-23: severe depression 24: very severe depression Higher summed values indicate a greater severity of depression

Secondary Outcome Measures

Full Information

First Posted
June 22, 2011
Last Updated
March 25, 2022
Sponsor
New York State Psychiatric Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01379781
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
prevention, postpartum depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Intervention for PPD
Arm Type
Experimental
Arm Description
Behavioral Intervention for PPD delivered over 3 in-person sessions.
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Referred to Treatment in the Community.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention for PPD
Other Intervention Name(s)
Preventative Behavioral Intervention for PPD.
Intervention Description
We 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.
Primary Outcome Measure Information:
Title
Hamilton Rating Scales of Depression
Description
Assessing severity of depression; clinician rated 24 questions 13 items are scored on a 5 point scale ranging from 0=not present to 4=severe 11 items are scored from 0-2 A composite score is created by the sum of the scores from all items. Scores can range from 0-74 0-7: normal 8-13: mild depression 14-18: moderate depression 19-23: severe depression 24: very severe depression Higher summed values indicate a greater severity of depression
Time Frame
6 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 (ฮฑ blockers, ฮฒ blockers, corticosteroids Chronic-use asthma medications (e.g. beta2-adrenoceptor agonists) Smoking during pregnancy Illicit drug/alcohol use during pregnancy Taking any psychotropic medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine E Monk, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression

We'll reach out to this number within 24 hrs