Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse
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|ClinicalTrials.gov Identifier: NCT00602732|
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : March 28, 2014
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Longitudinal Interval Follow-up Examination (LIFE) [ Time Frame: Measured at Year 1 ]
- Revised Conflict Tactic Scale (CTS2) [ Time Frame: Measured at Year 1 ]
- Edinburgh Postnatal Depression Scale [ Time Frame: Measured at Year 1 ]
- The Davidson Trauma Scale [ Time Frame: Measured at Year 1 ]
- The Arizona Social Support Interview Schedule [ Time Frame: Measured at Year 1 ]
- Parenting Stress Index [ Time Frame: Measured at Year 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602732
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02905|
|Principal Investigator:||Caron Zlotnick, PhD||Butler Hospital|