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Evaluating the Effectiveness of Brief Interpersonal Psychotherapy for Pregnant Women With Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00292903
First received: February 15, 2006
Last updated: September 6, 2012
Last verified: September 2012

February 15, 2006
September 6, 2012
March 2004
December 2007   (final data collection date for primary outcome measure)
  • Depressive symptoms [ Time Frame: Measured throughout treatment and at Months 2 and 6 postpartum ] [ Designated as safety issue: No ]
  • Treatment attendance [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
  • Treatment attendance at 12 weeks post baseline
  • Depression symptoms at base line, post treatment, 2-month postpartum, and 6 month-postpartum
Complete list of historical versions of study NCT00292903 on ClinicalTrials.gov Archive Site
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Evaluating the Effectiveness of Brief Interpersonal Psychotherapy for Pregnant Women With Depression
Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression

This study will compare the effectiveness of brief interpersonal psychotherapy versus standard treatment for pregnant women with depression.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • 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.
  • 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.
  • Experimental: A
    Intervention: Behavioral: Brief interpersonal psychotherapy
  • Active Comparator: B
    Intervention: Behavioral: Facilitated referral for treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Between 8 and 32 weeks of gestation at time of study entry
  • A score above 12 on the Edinburgh Postnatal Depression Scale
  • Speaks English
  • Resides in the Pittsburgh, PA, area
  • Access to a household telephone

Exclusion Criteria:

  • Currently receiving treatment for depression (i.e., medication or psychotherapy)
  • History of a prior manic episode
  • Alcohol or drug abuse or dependence within 6 months of study entry
  • Psychotic disorder or organic mental disorder
  • Suicidal, homicidal, or requires hospitalization
  • Severe sexual and/or physical aggression in relationship with partner or husband
  • Significant medical illness such as epilepsy, autoimmune disorder, liver dysfunction, or unstable endocrine disease
  • Severe cognitive deficits that would prevent treatment with psychotherapy
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00292903
MH30915, 5R01MH084897-03, DSIR 83-ATSO
Not Provided
Nancy K. Grote, PhD, University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Nancy K. Grote, PhD University of Pittsburgh, School of Social Work
University of Pittsburgh
September 2012

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