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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief interpersonal psychotherapy
Facilitated referral for treatment as usual
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Perinatal Depression, Interpersonal Psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Magee Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Depressive symptoms
Treatment attendance

Secondary Outcome Measures

Full Information

First Posted
February 15, 2006
Last Updated
September 6, 2012
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00292903
Brief Title
Evaluating the Effectiveness of Brief Interpersonal Psychotherapy for Pregnant Women With Depression
Official Title
Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Perinatal Depression, Interpersonal Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Brief interpersonal psychotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Facilitated referral for treatment as usual
Intervention Description
F-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic.
Primary Outcome Measure Information:
Title
Depressive symptoms
Time Frame
Measured throughout treatment and at Months 2 and 6 postpartum
Title
Treatment attendance
Time Frame
Measured at Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy K. Grote, PhD
Organizational Affiliation
University of Pittsburgh, School of Social Work
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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