Identification and Therapy of Postpartum Depression - Tabular View

Tracking Information

First Received Date ^ICMJE

January 25, 2006

Last Updated Date

August 19, 2008

Start Date ^ICMJE

August 2006

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Depressive symptoms, social functioning, and health [ Time Frame: Measured at Months 3, 6, and 12 postpartum ] [ Designated as safety issue: Yes ]
Preferences for depression treatment [ Time Frame: Measured at baseline and Month 12 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Depressive symptoms
Preferences for depression treatment (measured at Months 3, 6, and 12)
Social and everyday functioning
General health

Change History

Complete list of historical versions of study NCT00282776 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Identification and Therapy of Postpartum Depression

Official Title ^ICMJE

Identification and Therapy of Postpartum Depression

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Behavioral: Care Management for Postpartum Depression
Behavioral: TAU

Study Arms / Comparison Groups

Active Comparator: Participants will receive treatment as usual
Experimental: Participants will receive care management for postpartum depression

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

616

Estimated Completion Date

March 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Katherine L. Wisner, MD, MPH	412-246-6564	wisnerkl@upmc.edu
Contact: Mary McShea, MS	412-246-5349	mcsheamc@upmc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00282776

Responsible Party

Katherine Wisner, MD MS Principal Investigator, University of Pittsburgh

Study ID Numbers ^ICMJE

R01 MH71825, DSIR 82-SEMS

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Katherine L. Wisner, MD, RN

University of Pittsburgh

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP