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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Brief interpersonal psychotherapy; Behavioral: Facilitated referral for treatment as usual

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Depressive symptoms	Measured throughout treatment and at Months 2 and 6 postpartum
Treatment attendance	Measured at Week 12

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Nancy K. Grote, PhD, University of Pittsburgh, School of Social Work

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (ACTUAL): December 1, 2007
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: February 15, 2006
• First Submitted That Met QC Criteria: February 15, 2006
• First Posted (ESTIMATE): February 16, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): September 10, 2012
• Last Update Submitted That Met QC Criteria: September 6, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Perinatal Depression; Interpersonal Psychotherapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: MH30915; DSIR 83-ATSO (National Institute of Mental Health); 5R01MH084897-03 (NIH)