Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse
Condition: Depression, Postpartum; Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): The Reach Out for a Safe Environment (ROSE) program; Enhanced care as usual (ECU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): Reach Out Stay Strong: Essentials for New Mothers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Partner Abuse; Preventive Intervention; Postpartum Depression; Postpartum PTSD