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

Not Applicable

Completed

• Conditions: Postpartum Depression
• Interventions: Behavioral: Placebo Comparator; Behavioral: Perinatal Dyadic Psychotherapy

• Registration Number: NCT02057627
• Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care plus depression monitoring	Placebo Comparator	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.
Perinatal Dyadic Psychotherapy	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)

Primary Outcome Measures

Name	Time	Method
Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention	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)	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	baseline, 3 months (post-intervention) and 6 months (follow-up)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

MGH Insiitute of Health Professions; 🇺🇸 Boston, Massachusetts, United States