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

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Mass General Brigham

Status

Completed

Conditions

Postpartum Depression

Treatments

Behavioral: Perinatal Dyadic Psychotherapy
Behavioral: Placebo Comparator

Study type

Interventional

Funder types

Other

Identifiers

NCT02057627
1R21HD065156-01

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

Female

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups, including a placebo group

Perinatal Dyadic Psychotherapy
Experimental group
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)
Treatment:
Behavioral: Perinatal Dyadic Psychotherapy
Standard care plus depression monitoring
Placebo Comparator group
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.
Treatment:
Behavioral: Placebo Comparator

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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