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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00602732
First received: January 22, 2008
Last updated: March 27, 2014
Last verified: March 2014

January 22, 2008
March 27, 2014
September 2005
December 2013   (final data collection date for primary outcome measure)
Longitudinal Interval Follow-up Examination (LIFE) [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00602732 on ClinicalTrials.gov Archive Site
  • Revised Conflict Tactic Scale (CTS2) [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Edinburgh Postnatal Depression Scale [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • The Davidson Trauma Scale [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • The Arizona Social Support Interview Schedule [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Parenting Stress Index [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse
Intervention for Low-income Pregnant Women With Partner Abuse

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Depression, Postpartum
  • Depression
  • 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
  • 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.
  • Experimental: 1
    Participants assigned to the ROSE program
    Intervention: Behavioral: The Reach Out for a Safe Environment (ROSE) program
  • Active Comparator: 2
    Participants assigned to enhanced care as usual
    Intervention: Behavioral: Enhanced care as usual (ECU)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00602732
R34 MH075013, R34MH075013, DSIR 83-ATP
Yes
Butler Hospital
Butler Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Caron Zlotnick, PhD Butler Hospital
Butler Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP