Clinical Trials Directory

Trials / Completed

CompletedNCT02057627

Mother-Infant Intervention for Postpartum Depression and Associated Mother-Infant Relationship Dysfunction

Dyadic Intervention for Women at Risk for Postpartum Depression and Their Infants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Spaulding Rehabilitation Hospital · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

Summary

Maternal depression and mother-infant relationship dysfunction have reciprocal effects on each other. An integrated approach addressing both problems simultaneously may improve outcomes. Perinatal Dyadic Psychotherapy (PDP) was developed to prevent/decrease postpartum depression and facilitate optimal mother-infant relationships. The purpose of this pilot study is to determine the feasibility, acceptability, and preliminary efficacy of PDP. Depressed first-time mothers (meeting diagnostic criteria for depression and/or with high depression symptom levels) and their 6-week-old infants will be randomized to receive either the PDP intervention or a control condition. The PDP intervention consists of 8 home-based, nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based, mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented component focused on promoting positive mother-infant interactions. Control mothers will receive usual care plus depression monitoring by phone. Data will be collected at baseline, post-intervention, and 3 month follow-up. Assessments included maternal depression (diagnosis and severity), maternal anxiety (diagnosis and severity), parenting stress, and mother-infant interaction.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPerinatal Dyadic Psychotherapy8-session mother-infant psychotherapy (Perinatal Dyadic Psychotherapy) delivered by nurse-interventionists in participant's homes over 3 months
BEHAVIORALPlacebo ComparatorStandard care plus depression monitoring by phone

Timeline

Start date
2010-06-01
Primary completion
2012-07-01
Completion
2012-07-01
First posted
2014-02-07
Last updated
2016-04-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02057627. Inclusion in this directory is not an endorsement.