Clinical trial NCT02057627: Mother-Infant Intervention for Postpartum Depression and Associated Mother-Infant Relationship Dysfunction
Official title: Dyadic Intervention for Women at Risk for Postpartum Depression and Their Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2014-02-07
Enrollment: 42
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: baseline, 3 months (post-intervention) and 6 months (follow-up)
measure: 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
timeFrame: baseline, 3 months (post-intervention) and 6 months (follow-up)
measure: Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention
timeFrame: 3 months (post-intervention) and 6 months (follow-up)
Secondary outcomes:
measure: 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)
timeFrame: baseline, 3 months (post-intervention) and 6 months (follow-up)
measure: 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)
timeFrame: 3 months (post-intervention) and 6 months (follow-up)
measure: 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)
timeFrame: baseline, 3 months (post-intervention), 6 months (follow-up)
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Insiitute of Health Professions
state: Massachusetts
Study officials:
affiliation: MGH Institute of Health Professions
name: Janice H Goodman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goodman JH, Guarino AJ, Prager JE. Perinatal dyadic psychotherapy: design, implementation, and acceptability. J Fam Nurs. 2013 Aug;19(3):295-323. doi: 10.1177/1074840713484822. Epub 2013 Apr 5.