Identification and Therapy of Postpartum Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Care Management for Postpartum Depression
TAU
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Postpartum Depression, Telephone Care Management, Screening for Postpartum Depression
Eligibility Criteria
Inclusion Criteria: 4-6 weeks postpartum English-speaking Score of at least 10 on the Edinburgh Postnatal Depression Scale Exclusion Criteria: 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
Sites / Locations
- Women's Behavioral HealthCARE Program, Suite 410, 3501 Forbes Ave
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TAU
DCM
Arm Description
Participants will receive treatment as usual
Participants will receive care management for postpartum depression
Outcomes
Primary Outcome Measures
Depressive symptoms, social functioning, and health
Preferences for depression treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00282776
First Posted
January 25, 2006
Last Updated
September 30, 2013
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00282776
Brief Title
Identification and Therapy of Postpartum Depression
Official Title
Identification and Therapy of Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.
Detailed Description
Depression is a serious illness that can interfere with everyday life. Researchers believe that it is one of the most common complications during and after pregnancy. Depression after pregnancy is called postpartum depression and may be caused by a rapid change in hormone levels during and immediately after pregnancy. Postpartum depression can occur anytime within the first year after childbirth and can negatively affect both mothers and their children. Mothers with postpartum depression may experience low energy, difficulty concentrating, irritability, and inability to meet their children's needs for love and affection. As a result, women with postpartum depression may feel guilty and lose confidence in themselves as parents. Research shows that children of mothers with postpartum depression may have delays in language development, difficulty with emotional bonding to others, behavioral problems, lower activity levels, sleep problems, and distress. This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Postpartum Depression, Telephone Care Management, Screening for Postpartum Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
628 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual
Arm Title
DCM
Arm Type
Experimental
Arm Description
Participants will receive care management for postpartum depression
Intervention Type
Behavioral
Intervention Name(s)
Care Management for Postpartum Depression
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depressive symptoms, social functioning, and health
Time Frame
Measured at Months 3, 6, and 12 postpartum
Title
Preferences for depression treatment
Time Frame
Measured at baseline and Month 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
4-6 weeks postpartum
English-speaking
Score of at least 10 on the Edinburgh Postnatal Depression Scale
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L. Wisner, MD, RN
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Behavioral HealthCARE Program, Suite 410, 3501 Forbes Ave
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28796940
Citation
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.
Results Reference
derived
PubMed Identifier
26059839
Citation
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.
Results Reference
derived
PubMed Identifier
23487258
Citation
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.
Results Reference
derived
PubMed Identifier
21381158
Citation
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.
Results Reference
derived
Learn more about this trial
Identification and Therapy of Postpartum Depression
We'll reach out to this number within 24 hrs