Depression Prevention for Pregnant Women on Public Assistance
Condition: Depression, Postpartum; Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effectiveness of an interpersonal therapy treatment called the
      Postpartum Prevention Program in preventing the development of postpartum depression in
      pregnant women who are financially disadvantaged.
    

Detailed description: 
      Postpartum depression (PPD) occurs in approximately 10% to 16% of mothers who have recently
      delivered babies. The impact of PPD is profound, causing considerable emotional pain for the
      mother as well as possible disturbances in infant development and later child adjustment. If
      left untreated, the mother's depression may cause strain on family life and her relationship
      with her child. Further research is needed to discover treatments to effectively reduce the
      risk of experiencing PPD. Despite preliminary findings that suggest that psychosocial
      treatments may prevent postpartum mood disturbances, few studies have examined the effects of
      preventive therapy to reduce PPD in women at risk for PPD. An area of even greater neglect is
      the testing of such a treatment for financially disadvantaged women, who represent a group at
      high risk for PPD and a group less likely to access treatment for depression than
      middle-class women. The Postpartum Prevention Program (PPP), an interpersonal therapy program
      targeting factors that may play a significant role in the development of PPD, may be helpful
      in reducing the occurrence of PPD. This study will compare the effectiveness of PPP to
      enhanced care as usual (ECU) in preventing PPD in financially disadvantaged women who are
      pregnant.

      Participation in this single-blind study will last until 1 year after delivery. All potential
      participants will answer an initial questionnaire concerning stresses that may increase the
      risk of depression, including relationship and emotional difficulties. Selected participants
      will then undergo an interview about symptoms of depression, emotional difficulties, and
      alcohol and drug use. Participants identified as having depression will be provided
      appropriate referrals for treatment and their study participation will end. Participants
      invited to continue with the study will be randomly assigned to receive PPP or ECU.
      Participants assigned to receive PPP will attend four weekly 90-minute group sessions prior
      to delivery and one individual 50-minute booster session within 2 weeks of delivery. During
      these sessions, participants will learn ways to manage stress and negative feelings and how
      to access social support resources. Participants assigned to ECU will receive the usual
      medical care provided for pregnant women, educational material on PPD, and a list of
      referrals and resources.

      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; 3 weeks after delivery; and 3, 6,
      and 12 months after delivery. Participants will also be seen briefly at the hospital at the
      time of delivery and 3, 6, and 12 months after delivery to assess mother-infant
      relationships. All questionnaires and assessments will take between 60 and 90 minutes to
      complete.
    

Intervention name(s): The Postpartum Prevention Program (PPP); Enhanced care as usual (ECU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): PPP includes interpersonal therapy sessions as well as distribution of educational material on postpartum depression. The group sessions will take place during the participant's last trimester of pregnancy. There will be four weekly sessions prior to delivery and one booster session within the first 2 weeks of the postpartum period.; ECU includes the usual medical care provided for pregnant women at the Women's Primary Care Center at Women and Infants Hospital as well as the provision of educational material and a list of treatment resources for postpartum depression. Participants will also receive more intensive follow-up in terms of their mental health status than is typically provided in usual practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preventive Intervention; Postpartum Depression; Women on Public Assistance