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Completed

NCT Number: NCT02057627

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

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.

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Key information

Conditions

Postpartum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MGH Insiitute of Health Professions

Boston, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perinatal Dyadic Psychotherapy

Behavioral

8-session mother-infant psychotherapy (Perinatal Dyadic Psychotherapy) delivered by nurse-interventionists in participant's homes over 3 months

Placebo Comparator

Behavioral

Standard care plus depression monitoring by phone

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. 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)

  2. 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. 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)

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 7, 2014
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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