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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postpartum Depression

Intervention / Treatment
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* Behavioral: Perinatal Dyadic Psychotherapy
* Behavioral: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perinatal Dyadic Psychotherapy<br>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<br>* 8-session mother-infant psychotherapy (Perinatal Dyadic Psychotherapy) delivered by nurse-interventionists in participant's homes over 3 months<br>|
| Placebo Comparator: Standard care plus depression monitoring<br>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<br>* Standard care plus depression monitoring by phone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) |  | 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) | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) |  | 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) |