Identification and Therapy of Postpartum Depression
2 other identifiers
interventional
628
1 country
1
Brief Summary
This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 depression
Started Aug 2006
Longer than P75 for phase_3 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2006
CompletedFirst Posted
Study publicly available on registry
January 27, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedOctober 7, 2013
September 1, 2013
5.6 years
January 25, 2006
September 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Depressive symptoms, social functioning, and health
Measured at Months 3, 6, and 12 postpartum
Preferences for depression treatment
Measured at baseline and Month 12
Study Arms (2)
TAU
ACTIVE COMPARATORParticipants will receive treatment as usual
DCM
EXPERIMENTALParticipants will receive care management for postpartum depression
Interventions
Depression Care Manager calls postpartum women and encourages women to seek appropriate depression care. In this context the depression care manager helps the women to identify barriers to appropriate care, her preferred method of care, and resources available. Calls are made initially at 2 calls per month, followed by one call per month and calls every other month for women who are doing well. Women assigned to this group receive research assessments at 3, 6, and 12 months postpartum. They also receive information about community and health plan resources available for women with depression.
Participants receive treatment as usual for postpartum depression. Women assigned to this arm receive research assessments at 3, 6, and 12 months postpartum. At the baseline home visit where diagnostic assessments are completed women are given information about community and health plan resources if they choose to seek care for depression symptoms. Women are also given phone contact numbers for the research program.
Eligibility Criteria
You may qualify if:
- weeks postpartum
- English-speaking
- Score of at least 10 on the Edinburgh Postnatal Depression Scale
You may not qualify if:
- DSM-IV diagnosis of bipolar disorder or psychotic episode
- Active substance abuse within 6 months prior to study entry
- Has not received obstetrical care
- History of a suicide attempt within 6 months of study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's Behavioral HealthCARE Program, Suite 410, 3501 Forbes Ave
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (5)
Burchfield TN, Yang A, Wisner KL, Clark CT. Rates of Major Depressive Disorder and Bipolar Disorder in Black and White Postpartum Women. J Clin Psychiatry. 2024 Nov 20;85(4):23m15023. doi: 10.4088/JCP.23m15023.
PMID: 39566056DERIVEDWisner KL, Sit DKY, McShea M, Luther JF, Eng HF, Dills JL, Moses-Kolko EL, Wisniewski SR. Telephone-Based Depression Care Management for Postpartum Women: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Nov-Dec;78(9):1369-1375. doi: 10.4088/JCP.15m10563.
PMID: 28796940DERIVEDClark CT, Sit DK, Driscoll K, Eng HF, Confer AL, Luther JF, Wisniewski SR, Wisner KL. DOES SCREENING WITH THE MDQ AND EPDS IMPROVE IDENTIFICATION OF BIPOLAR DISORDER IN AN OBSTETRICAL SAMPLE? Depress Anxiety. 2015 Jul;32(7):518-26. doi: 10.1002/da.22373. Epub 2015 Jun 8.
PMID: 26059839DERIVEDWisner KL, Sit DK, McShea MC, Rizzo DM, Zoretich RA, Hughes CL, Eng HF, Luther JF, Wisniewski SR, Costantino ML, Confer AL, Moses-Kolko EL, Famy CS, Hanusa BH. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013 May;70(5):490-8. doi: 10.1001/jamapsychiatry.2013.87.
PMID: 23487258DERIVEDSit D, Seltman H, Wisner KL. Seasonal effects on depression risk and suicidal symptoms in postpartum women. Depress Anxiety. 2011 May;28(5):400-5. doi: 10.1002/da.20807. Epub 2011 Mar 4.
PMID: 21381158DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine L. Wisner, MD, RN
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry, Obstetrics and Gynecology and Reproductive Sciences, Epidemiology and Women's Studies
Study Record Dates
First Submitted
January 25, 2006
First Posted
January 27, 2006
Study Start
August 1, 2006
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
October 7, 2013
Record last verified: 2013-09