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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00282776 |
Purpose
This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Behavioral: Care Management for Postpartum Depression Behavioral: TAU |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Identification and Therapy of Postpartum Depression |
| Estimated Enrollment: | 616 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
TAU: Active Comparator
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.
|
|
DCM: Experimental
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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Katherine L. Wisner, MD, MPH | 412-246-6564 | wisnerkl@upmc.edu |
| Contact: Mary McShea, MS | 412-246-5349 | mcsheamc@upmc.edu |
| United States, Pennsylvania | |
| Women's Behavioral HealthCARE Program, Suite 410, 3501 Forbes Ave | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Mary McShea 412-246-5349 | |
| Principal Investigator: Katherine L Wisner, MD, MPH | |
| Principal Investigator: | Katherine L. Wisner, MD, RN | University of Pittsburgh |
More Information
| Responsible Party: | University of Pittsburgh ( Katherine Wisner, MD MS Principal Investigator ) |
| Study ID Numbers: | R01 MH71825, DSIR 82-SEMS |
| Study First Received: | January 25, 2006 |
| Last Updated: | August 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00282776 |
| Health Authority: | United States: Federal Government |
|
Postpartum Depression Telephone Care Management Screening for Postpartum Depression |
|
Pregnancy Complications Depression Puerperal Disorders Depression, Postpartum |
Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |
