Viewing Study NCT00292903


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Study NCT ID: NCT00292903
Status: COMPLETED
Last Update Posted: 2012-09-10
First Post: 2006-02-15
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Evaluating the Effectiveness of Brief Interpersonal Psychotherapy for Pregnant Women With Depression
Sponsor: University of Pittsburgh
Organization:

Study Overview

Official Title: Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression
Status: COMPLETED
Status Verified Date: 2012-09
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 compare the effectiveness of brief interpersonal psychotherapy versus standard treatment for pregnant women with depression.
Detailed Description: Depression is a serious condition affecting millions of people each year. In fact, it is estimated that approximately one in every four women will be treated for a mood disorder, such as depression, at some point in her life. As effective treatment options continue to develop, many women diagnosed with depression are able to resume normal lives and may choose to become pregnant. Also, some women become depressed when pregnant. Interpersonal psychotherapy involves treating psychological difficulties by analyzing problems, talking about possible solutions, and learning more helpful ways of thinking and acting. Brief interpersonal psychotherapy (IPT-B) is a well-tested psychotherapy for depression that has been shortened and modified. The purpose of this study is to evaluate the effectiveness of IPT-B to reduce depressive symptoms in women during pregnancy and to prevent the continuation or recurrence of their depression postpartum.

Participants in this open-label study will be randomly assigned to receive either IPT-B or a facilitated referral for treatment as usual (F-TAU) at an outpatient clinic or community mental health center. Participants assigned to IPT-B will be scheduled to attend eight treatment sessions along with their prenatal clinic visits within a 16-week period. Each treatment session will begin with a brief 1-minute evaluation to assess participants' level of depression and will end with a brief evaluation of the session. Participants will attend follow-up sessions every 2 weeks until 3 months postpartum and then monthly until 6 months postpartum. These sessions will include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment. Participants assigned to receive F-TAU will be provided with verbal and written information regarding their depressive symptoms. They will also receive a referral for treatment at a behavioral health clinic. Participants receiving F-TAU will be assessed via telephone at Weeks 6 and 12. All participants will be assessed via telephone at Months 2 and 6 postpartum to measure their level of depression.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
5R01MH084897-03 NIH None https://reporter.nih.gov/quic… View
DSIR 83-ATSO None None View