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Completed

NCT Number: NCT00292903

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief interpersonal psychotherapy

Behavioral

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.

Facilitated referral for treatment as usual

Behavioral

F-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic.

Primary outcomes

  1. Depressive symptoms

    Time frame: Measured throughout treatment and at Months 2 and 6 postpartum

  2. Treatment attendance

    Time frame: Measured at Week 12

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Feb 16, 2006
Registry last updated
Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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