NCT00951717

Brief Summary

This study will test an intervention that aims to prevent postpartum depression by providing new mothers with information on and resources for dealing with the disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
590

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

1.3 years

First QC Date

August 3, 2009

Last Update Submit

November 18, 2011

Conditions

Depression, PostpartumDepression

Keywords

Postpartum Depressive SymptomsPhysical SymptomsEmotional SymptomsInfant ColicSocial SupportBreastfeeding

Outcome Measures

Primary Outcomes (4)

  • Depressive symptoms

    Measured at baseline

  • Depressive symptoms

    Measured at 3 weeks

  • Depressive symptoms

    Measured at 3 months

  • Depressive symptoms

    Measured at 6 months

Secondary Outcomes (8)

  • Breastfeeding continuation rate

    Measured at baseline

  • Breastfeeding continuation rate

    Measured at 3 weeks

  • Breastfeeding continuation rate

    Measured at 3 months

  • Breastfeeding continuation rate

    Measured at 6 months

  • Physical functioning

    Measured at baseline

  • +3 more secondary outcomes

Study Arms (2)

Treatment as usual

NO INTERVENTION

Participants will receive standard postpartum education and discharge materials provided by the hospital and a list of community and Internet resources by mail.

Behavioral education

EXPERIMENTAL

Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail.

Behavioral: Behavioral education intervention

Interventions

Behavioral education interventionBEHAVIORAL

One education session with a social worker while at the hospital, provision of an educational pamphlet and summary sheet for partner, a needs assessment by the social worker 2 weeks after hospital discharge, and additional patient education and reinforcement of self-management skills, as needed

Behavioral education

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient in the Maternity Unit at Mount Sinai Hospital
  • Infant has a birth weight greater than or equal to 2,500 grams
  • Infant has a 5-minute Apgar score greater than or equal to 7
  • Self-identifies as White or minority other than Black or Hispanic; Black and Hispanic women will be referred to a parallel study with the same protocol at Mount Sinai Hospital
  • Speaks English
  • Has a working telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (4)

  • Bodnar-Deren S, Klipstein K, Fersh M, Shemesh E, Howell EA. Suicidal Ideation During the Postpartum Period. J Womens Health (Larchmt). 2016 Dec;25(12):1219-1224. doi: 10.1089/jwh.2015.5346. Epub 2016 May 26.

    PMID: 27227751DERIVED

  • Balbierz A, Bodnar-Deren S, Wang JJ, Howell EA. Maternal depressive symptoms and parenting practices 3-months postpartum. Matern Child Health J. 2015 Jun;19(6):1212-9. doi: 10.1007/s10995-014-1625-6.

    PMID: 25374288DERIVED

  • Howell EA, Bodnar-Deren S, Balbierz A, Loudon H, Mora PA, Zlotnick C, Wang J, Leventhal H. An intervention to reduce postpartum depressive symptoms: a randomized controlled trial. Arch Womens Ment Health. 2014 Feb;17(1):57-63. doi: 10.1007/s00737-013-0381-8. Epub 2013 Sep 10.

    PMID: 24019052DERIVED

  • Negron R, Martin A, Almog M, Balbierz A, Howell EA. Social support during the postpartum period: mothers' views on needs, expectations, and mobilization of support. Matern Child Health J. 2013 May;17(4):616-23. doi: 10.1007/s10995-012-1037-4.

    PMID: 22581378DERIVED

MeSH Terms

Conditions

Depression, PostpartumDepressionColicBreast Feeding

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehaviorInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFeeding Behavior

Study Officials

  • Elizabeth Howell, MD, MPP

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

US(1)