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
  Purpose

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


Condition Intervention
Depression
Behavioral: Brief interpersonal psychotherapy
Behavioral: Facilitated referral for treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: March 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292903

Locations
United States, Pennsylvania
Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Nancy K. Grote, PhD University of Pittsburgh, School of Social Work
  More Information

No publications provided

Responsible Party: Nancy K. Grote, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00292903     History of Changes
Other Study ID Numbers: MH30915, 5R01MH084897-03, DSIR 83-ATSO
Study First Received: February 15, 2006
Last Updated: September 6, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Perinatal Depression
Interpersonal Psychotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014