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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02057627
Enrollment
42
Registered
2014-02-07
Start date
2010-06-30
Completion date
2012-07-31
Last updated
2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Depression

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.

Interventions

BEHAVIORALPerinatal Dyadic Psychotherapy

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

BEHAVIORALPlacebo Comparator

Standard care plus depression monitoring by phone

Sponsors

Robert Wood Johnson Foundation
CollaboratorOTHER
Spaulding Rehabilitation Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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)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 Scalebaseline, 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-intervention3 months (post-intervention) and 6 months (follow-up)

Secondary

MeasureTime 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)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)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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026