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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Depression, Postpartum; Depression	Behavioral: The Reach Out for a Safe Environment (ROSE) program; Behavioral: Enhanced care as usual (ECU)	Phase 1

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Intervention for Low-income Pregnant Women With Partner Abuse
Study Start Date :	September 2005
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; Participants assigned to the ROSE program	Behavioral: The Reach Out for a Safe Environment (ROSE) program; 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.; Other Name: Reach Out Stay Strong: Essentials for New Mothers
Active Comparator: 2; Participants assigned to enhanced care as usual	Behavioral: Enhanced care as usual (ECU); 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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Longitudinal Interval Follow-up Examination (LIFE) [ Time Frame: Measured at Year 1 ]

Secondary Outcome Measures :

1. Revised Conflict Tactic Scale (CTS2) [ Time Frame: Measured at Year 1 ]
2. Edinburgh Postnatal Depression Scale [ Time Frame: Measured at Year 1 ]
3. The Davidson Trauma Scale [ Time Frame: Measured at Year 1 ]
4. The Arizona Social Support Interview Schedule [ Time Frame: Measured at Year 1 ]
5. Parenting Stress Index [ Time Frame: Measured at Year 1 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Rhode Island
Memorial Hospital
Providence, Rhode Island, United States, 02905

Sponsors and Collaborators

Butler Hospital

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Caron Zlotnick, PhD	Butler Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Butler Hospital
ClinicalTrials.gov Identifier:	NCT00602732 History of Changes
Other Study ID Numbers:	R34MH075013 ( U.S. NIH Grant/Contract ); DSIR 83-ATP
First Posted:	January 28, 2008
Last Update Posted:	March 28, 2014
Last Verified:	March 2014

Keywords provided by Butler Hospital:

Partner Abuse; Preventive Intervention; Postpartum Depression; Postpartum PTSD

Additional relevant MeSH terms:

Depression; Depressive Disorder; Depression, Postpartum; Behavioral Symptoms	Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications