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NCT02057627 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Spaulding Rehabilitation Hospital.

Completed
Registry status
NA
Development phase
42
Enrollment target

NCT02057627 is a NA study that has completed, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 42 participants.

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The verdict

NCT02057627, a NA study, has completed, sponsored by Spaulding Rehabilitation Hospital.

COMPLETED
Registry status
NA
Development phase
42 participants
Enrollment target

Study 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.

Interventions

  • BEHAVIORAL Placebo Comparator
  • BEHAVIORAL Perinatal Dyadic Psychotherapy

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2010-06
Est. Completion 2012-07
Phase NA

Sponsor

Spaulding Rehabilitation Hospital

101 total trials

What the Registry Record Tells You About NCT02057627

The ClinicalTrials.gov registry entry for NCT02057627 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spaulding Rehabilitation Hospital, which has 101 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.

NCT02057627 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02057627 about?

NCT02057627 is a clinical study titled "Mother-Infant Intervention for Postpartum Depression and Associated Mother-Infant Relationship Dysfunction". 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 optim...

What is the current status of trial NCT02057627?

This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2010-06. Estimated completion is 2012-07.

What interventions are being tested in trial NCT02057627?

The interventions under investigation include: Placebo Comparator (BEHAVIORAL), Perinatal Dyadic Psychotherapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT02057627?

This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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