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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057627
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : April 20, 2016
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Janice H. Goodman, Spaulding Rehabilitation Hospital

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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Behavioral: Perinatal Dyadic Psychotherapy Behavioral: Placebo Comparator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dyadic Intervention for Women at Risk for Postpartum Depression and Their Infants
Study Start Date : June 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Behavioral: Perinatal Dyadic Psychotherapy
8-session mother-infant psychotherapy (Perinatal Dyadic Psychotherapy) delivered by nurse-interventionists in participant's homes over 3 months

Placebo Comparator: 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.
Behavioral: Placebo Comparator
Standard care plus depression monitoring by phone




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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 Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057627


Locations
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United States, Massachusetts
MGH Insiitute of Health Professions
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Robert Wood Johnson Foundation
Investigators
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Principal Investigator: Janice H Goodman, PhD MGH Institute of Health Professions
Publications of Results:
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Responsible Party: Janice H. Goodman, Associate Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02057627    
Other Study ID Numbers: 1R21HD065156-01 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications