Identification and Therapy of Postpartum Depression

• ClinicalTrials.gov Identifier: NCT00282776
• Recruitment Status: Completed
• First Posted: January 27, 2006
• Last Update Posted: October 7, 2013
• Sponsor: University of Pittsburgh
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Katherine Wisner, University of Pittsburgh

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.

Condition or disease	Intervention/treatment	Phase
Depression	Behavioral: Care Management for Postpartum Depression; Behavioral: TAU	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 628 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Identification and Therapy of Postpartum Depression
• Study Start Date: August 2006
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: TAU; Participants will receive treatment as usual	Behavioral: 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.
Experimental: DCM; Participants will receive care management for postpartum depression	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Depressive symptoms, social functioning, and health [ Time Frame: Measured at Months 3, 6, and 12 postpartum ]
2. Preferences for depression treatment [ Time Frame: Measured at baseline and Month 12 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Pennsylvania

Women's Behavioral HealthCARE Program, Suite 410, 3501 Forbes Ave

Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Katherine L. Wisner, MD, RN; University of Pittsburgh

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Katherine Wisner, Professor of Psychiatry, Obstetrics and Gynecology and Reproductive Sciences, Epidemiology and Women's Studies, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00282776
• Other Study ID Numbers: R01MH071825 ( U.S. NIH Grant/Contract ); R01MH071825 ( U.S. NIH Grant/Contract ); DSIR 82-SEMS ( Other Identifier: National Institute of Mental Health )
• First Posted: January 27, 2006
• Last Update Posted: October 7, 2013
• Last Verified: September 2013

Keywords provided by Katherine Wisner, University of Pittsburgh:

Postpartum Depression; Telephone Care Management; Screening for Postpartum Depression

Additional relevant MeSH terms:

Depression, Postpartum; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications