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

NCT02057627 | Completed

• 1 other identifier: 1R21HD065156-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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)

Study Arms (2)

Perinatal Dyadic Psychotherapy

EXPERIMENTAL

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

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.

Behavioral: Placebo Comparator

Interventions

Perinatal Dyadic Psychotherapy BEHAVIORAL

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

Perinatal Dyadic Psychotherapy

Placebo Comparator BEHAVIORAL

Standard care plus depression monitoring by phone

Standard care plus depression monitoring

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• First-time, English-speaking mothers of healthy singleton newborns
• Positive screen (\> 10) on Edinburgh Postnatal Depression Scale

You may not qualify if:

• Suicidal ideation
• Currently receiving depression treatment
• Meets criteria for bipolar disorder and/or lifetime or current psychotic disorder

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

MGH Insiitute of Health Professions

Boston, Massachusetts, 02129, United States

Location

Related Publications (1)

• 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.

  PMID: 23562990 RESULT

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Janice H Goodman, PhD

  MGH Institute of Health Professions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 7, 2014
• Study Start: June 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

US (1)