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

NCT ID: NCT02057627

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-07-31

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.

Detailed Description

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Conditions

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Postpartum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Perinatal Dyadic Psychotherapy

Intervention Type BEHAVIORAL

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

Standard care plus depression monitoring

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.

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type BEHAVIORAL

Standard care plus depression monitoring by phone

Interventions

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Perinatal Dyadic Psychotherapy

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

Intervention Type BEHAVIORAL

Placebo Comparator

Standard care plus depression monitoring by phone

Intervention Type BEHAVIORAL

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Janice H. Goodman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janice H Goodman, PhD

Role: PRINCIPAL_INVESTIGATOR

MGH Institute of Health Professions

Locations

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MGH Insiitute of Health Professions

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23562990 (View on PubMed)

Other Identifiers

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1R21HD065156-01

Identifier Type: NIH

Identifier Source: org_study_id

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