Skip to main content
Clinical Trials/NCT02057627
NCT02057627
Completed
Not Applicable

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

Spaulding Rehabilitation Hospital1 site in 1 country42 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Depression
Sponsor
Spaulding Rehabilitation Hospital
Enrollment
42
Locations
1
Primary Endpoint
Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
July 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Spaulding Rehabilitation Hospital
Responsible Party
Principal Investigator
Principal Investigator

Janice H. Goodman

Associate Professor

Spaulding Rehabilitation Hospital

Eligibility Criteria

Inclusion Criteria

  • First-time, English-speaking mothers of healthy singleton newborns
  • Positive screen (\> 10) on Edinburgh Postnatal Depression Scale

Exclusion Criteria

  • Suicidal ideation
  • Currently receiving depression treatment
  • Meets criteria for bipolar disorder and/or lifetime or current psychotic disorder

Outcomes

Primary Outcomes

Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention

Time Frame: 3 months (post-intervention) and 6 months (follow-up)

Change from baseline on maternal depression diagnosis immediately following the 3 month intervention and at 3 months post-intervention as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)

Time Frame: baseline, 3 months (post-intervention) and 6 months (follow-up)

Change from baseline in maternal depressive symptom scores immediately following the 3 month intervention and at 3 months post-intervention as measured by the Edinburgh Postnatal Depression Scale

Time Frame: baseline, 3 months (post-intervention) and 6 months (follow-up)

Secondary Outcomes

  • Change from baseline in maternal anxiety diagnosis immediately following the 3 month intervention and at 3 months post-intervention per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)(baseline, 3 months (post-intervention) and 6 months (follow-up))
  • Change from baseline in maternal anxiety symptom level immediately following the 3 month intervention and at 3 months post-intervention as measured by the State-Trait Anxiety Inventory - State (STAI-State)(baseline, 3 months (post-intervention), 6 months (follow-up))
  • Maternal parenting stress immediately following the 3 month intervention and at 3 months post-intervention as measured by the Parenting Stress Index - Short Form (PSI-SF)(3 months (post-intervention) and 6 months (follow-up))

Study Sites (1)

Loading locations...

Similar Trials