Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
628 participants
INTERVENTIONAL
2006-08-31
2012-03-31
Brief Summary
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Detailed Description
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Participants in this single blind study will be randomly assigned to receive either enhanced treatment as usual or telephone-based care management for the first year postpartum. All participants will have a 90-minute in-home interview upon study entry to assess depressive symptoms, functional status, medical history, and post-pregnancy plans. Participants assigned to care management will receive two calls in the first month postpartum, followed by monthly calls for the remainder of the first postpartum year. During each 10- to 20-minute call, participants will be asked to provide information regarding current depressive symptoms, steps they have taken to seek depression-related care, and any barriers they have encountered in the process. In addition, a care manager will act as an advocate for the participants and assist in obtaining specialized services as necessary throughout the year. Participants assigned to receive enhanced treatment as usual will not receive monthly phone calls or tailored care management. All participants will receive follow-up calls at 3, 6, and 12 months postpartum to assess outcome measures; these calls will last about 30 minutes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TAU
Participants will receive treatment as usual
TAU
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.
DCM
Participants will receive care management for postpartum depression
Care Management for Postpartum Depression
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.
Interventions
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Care Management for Postpartum Depression
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.
TAU
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
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Inclusion Criteria
* English-speaking
* Score of at least 10 on the Edinburgh Postnatal Depression Scale
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Katherine Wisner
Professor of Psychiatry, Obstetrics and Gynecology and Reproductive Sciences, Epidemiology and Women's Studies
Principal Investigators
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Katherine L. Wisner, MD, RN
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Women's Behavioral HealthCARE Program, Suite 410, 3501 Forbes Ave
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
Wisner 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.
Clark 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.
Wisner 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.
Sit 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.
Other Identifiers
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