Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282776
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2006-01-25
Brief Title:
Identification and Therapy of Postpartum Depression
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Identification and Therapy of Postpartum Depression
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR 82-SEMS | OTHER | National Institute of Mental Health | httpsreporternihgovquickSearchR01MH071825 |
| R01MH071825 | NIH | None | None |