Evaluating the Effectiveness of Brief Interpersonal Psychotherapy for Pregnant Women With Depression
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|ClinicalTrials.gov Identifier: NCT00292903|
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : September 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Brief interpersonal psychotherapy Behavioral: Facilitated referral for treatment as usual||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
Behavioral: Brief interpersonal psychotherapy
IPT-B sessions 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.
|Active Comparator: B||
Behavioral: Facilitated referral for treatment as usual
F-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic.
- Depressive symptoms [ Time Frame: Measured throughout treatment and at Months 2 and 6 postpartum ]
- Treatment attendance [ Time Frame: Measured at Week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292903
|United States, Pennsylvania|
|Magee Womens Hospital|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Nancy K. Grote, PhD||University of Pittsburgh, School of Social Work|