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

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perinatal Dyadic Psychotherapy
Placebo Comparator
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • MGH Insiitute of Health Professions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Perinatal Dyadic Psychotherapy

Standard care plus depression monitoring

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

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)
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
Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
February 5, 2014
Last Updated
April 19, 2016
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02057627
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Robert Wood Johnson Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perinatal Dyadic Psychotherapy
Arm Type
Experimental
Arm Description
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)
Arm Title
Standard care plus depression monitoring
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Perinatal Dyadic Psychotherapy
Intervention Description
8-session mother-infant psychotherapy (Perinatal Dyadic Psychotherapy) delivered by nurse-interventionists in participant's homes over 3 months
Intervention Type
Behavioral
Intervention Name(s)
Placebo Comparator
Intervention Description
Standard care plus depression monitoring by phone
Primary Outcome Measure Information:
Title
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)
Title
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)
Title
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 Outcome Measure Information:
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice H Goodman, PhD
Organizational Affiliation
MGH Institute of Health Professions
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH Insiitute of Health Professions
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23562990
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.
Results Reference
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Mother-Infant Intervention for Postpartum Depression and Associated Mother-Infant Relationship Dysfunction

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