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Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse

Primary Purpose

Depression, Postpartum, Depression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
The Reach Out for a Safe Environment (ROSE) program
Enhanced care as usual (ECU)
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression, Postpartum focused on measuring Partner Abuse, Preventive Intervention, Postpartum Depression, Postpartum PTSD

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to speak and read English sufficiently to complete the study procedures
  • Willing and able to receive public assistance
  • Identified as having experienced physical assault based on responses to CTS2 within 1 year prior to study entry
  • 35 weeks or less gestation

Exclusion Criteria:

  • Meets current criteria for major depressive disorder or post-traumatic stress disorder

Sites / Locations

  • Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants assigned to the ROSE program

Participants assigned to enhanced care as usual

Outcomes

Primary Outcome Measures

Longitudinal Interval Follow-up Examination (LIFE)

Secondary Outcome Measures

Revised Conflict Tactic Scale (CTS2)
Edinburgh Postnatal Depression Scale
The Davidson Trauma Scale
The Arizona Social Support Interview Schedule
Parenting Stress Index

Full Information

First Posted
January 22, 2008
Last Updated
March 27, 2014
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00602732
Brief Title
Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse
Official Title
Intervention for Low-income Pregnant Women With Partner Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the effectiveness of an interpersonally oriented treatment program called Reach Out for a Safe Environment in preventing depression and post-traumatic stress disorder in low-income pregnant women who have experienced recent partner abuse.
Detailed Description
Each year, approximately 324,000 pregnant women experience partner abuse (PA). With the emotional highs and lows that accompany new motherhood, pregnancy is often a challenging process for many women. Experiencing PA, while already going through a vulnerable time during pregnancy, may have harmful effects on the well-being of the woman and her infant. Women affected by PA are at an increased risk for certain physical and psychological problems, including depression and post-traumatic stress disorder (PTSD). Furthermore, the emotional distress from PA may impair a woman's ability to seek out the necessary support to ensure the safety of herself and her children. There have been few research efforts to develop an effective treatment to reduce the psychological impact of PA on pregnant women and even fewer efforts that target low-income women, who make up a large portion of affected women. The Reach Out for a Safe Environment (ROSE) program is an interpersonally oriented treatment developed to address factors that may contribute to postpartum mental health difficulties associated with PA. This study will evaluate the effectiveness of the ROSE program in preventing depression and PTSD in low-income pregnant women who have experienced recent PA. Participation in this single-blind study will last approximately 29 weeks. All potential participants will answer an initial questionnaire concerning their history of physical, sexual, or emotional abuse in the past year. Selected participants will then undergo an interview about symptoms of depression, reactions to trauma, emotional difficulties, and alcohol and drug use. Participants invited to continue in the study will then be randomly assigned to the ROSE program or enhanced care as usual (ECU). Participants assigned to the ROSE program will attend four weekly 90-minute group sessions prior to delivery and one individual 50-minute booster session within 4 weeks of delivery. During these sessions, participants will learn ways to manage stress and negative feelings and how to access helpful resources. Participants will also complete two questionnaires about emotional difficulties per week for the duration of the program. Participants assigned to ECU will receive the usual medical care provided for pregnant women and will receive educational material on depression. All participants will complete questionnaires and interviews about their emotional difficulties, relationships with others, and use of services for these difficulties prior to treatment assignment, 4 weeks after treatment assignment, 4 weeks after delivery, and 3 months after delivery. Participants in the ROSE program will additionally complete a questionnaire about their perceptions of the program after the fourth treatment session and after the booster session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum, Depression
Keywords
Partner Abuse, Preventive Intervention, Postpartum Depression, Postpartum PTSD

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants assigned to the ROSE program
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants assigned to enhanced care as usual
Intervention Type
Behavioral
Intervention Name(s)
The Reach Out for a Safe Environment (ROSE) program
Other Intervention Name(s)
Reach Out Stay Strong: Essentials for New Mothers
Intervention Description
Participants in the ROSE program will receive a course on managing stress and negative feelings and will learn how to access resources for help. The ROSE program involves four 90-minute group sessions over a 4-week period prior to delivery. Participants will also attend one 50-minute booster session within 4 weeks prior to delivery of their babies.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced care as usual (ECU)
Intervention Description
Participants in ECU will receive the usual medical care provided for pregnant women at their prenatal clinic. Participants will also receive educational material and a list of treatment resources for depression.
Primary Outcome Measure Information:
Title
Longitudinal Interval Follow-up Examination (LIFE)
Time Frame
Measured at Year 1
Secondary Outcome Measure Information:
Title
Revised Conflict Tactic Scale (CTS2)
Time Frame
Measured at Year 1
Title
Edinburgh Postnatal Depression Scale
Time Frame
Measured at Year 1
Title
The Davidson Trauma Scale
Time Frame
Measured at Year 1
Title
The Arizona Social Support Interview Schedule
Time Frame
Measured at Year 1
Title
Parenting Stress Index
Time Frame
Measured at Year 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to speak and read English sufficiently to complete the study procedures Willing and able to receive public assistance Identified as having experienced physical assault based on responses to CTS2 within 1 year prior to study entry 35 weeks or less gestation Exclusion Criteria: Meets current criteria for major depressive disorder or post-traumatic stress disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caron Zlotnick, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

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Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse

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