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

April 19, 2016 updated by: Janice H. Goodman, Spaulding Rehabilitation Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • MGH Insiitute of Health Professions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perinatal Dyadic Psychotherapy
The Perinatal Dyadic Psychotherapy 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. The 8 sessions take place over three months with weekly 4 sessions (weeks 1 through 4) followed by 4 every other week sessions (weeks 5 through 8)
Behavioral: Perinatal Dyadic Psychotherapy
8-session mother-infant psychotherapy (Perinatal Dyadic Psychotherapy) delivered by nurse-interventionists in participant's homes over 3 months
Placebo Comparator: Standard care plus depression monitoring
Standard care plus depression monitoring by phone on a schedule comparable to the intervention groups' home visits. Eight phone calls will take place over three months with weekly 4 calls (weeks 1 through 4) followed by 4 every other week calls (weeks 5 through 8). Phone monitoring will include administration of the Edinburgh Postnatal Depression Scale.
Behavioral: Placebo Comparator
Standard care plus depression monitoring by phone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spaulding Rehabilitation Hospital

Collaborators

Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Janice H Goodman, PhD, MGH Institute of Health Professions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 5, 2014

First Posted (Estimate)

February 7, 2014

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21HD065156-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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