Effectiveness of Group Interpersonal Psychotherapy in Treating Women With Prenatal Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of group interpersonal psychotherapy for
      preventing postpartum depression in pregnant women with depression and for improving healthy
      outcomes in their babies.
    

Detailed description: 
      The pregnancy and postpartum periods are times of remarkable emotional and physical change
      for a woman, making pregnant women more vulnerable to mood swings and depressive symptoms. It
      is estimated that approximately 10% to 15% of pregnant women experience depression, which can
      cause severe psychological distress for the woman as well as disturbances in infant
      development. Infants of depressed mothers are at a higher risk for developmental delays,
      behavioral problems, and difficulty eating and sleeping. Moreover, new data indicate that
      prenatal depression also may adversely affect brain development of the child even before
      birth. Despite the high prevalence rates of prenatal depression and its negative
      consequences, few studies have tested the effectiveness of interpersonal psychotherapy (IPT),
      a treatment for depression that focuses on interpersonal issues and relationships, during
      pregnancy. The administration of group prenatal IPT for depression may be effective in
      enhancing women's prenatal and postpartum moods and improving fetal and newborn functioning.
      This study will compare the effectiveness of group IPT with that of treatment as usual (TAU)
      for preventing postpartum depression in pregnant women with depression and for improving
      healthy outcomes in their babies. The study will also compare the fetal and newborn
      development of babies of healthy mothers with that of babies of depressed mothers.

      This study will involve both healthy participants and participants with depression. All
      participants will start with an initial assessment visit between the 22nd and 23rd weeks of
      pregnancy. For participants who have shown signs of depression based on an initial phone
      interview, the initial visit will last about 2 hours and will include questions about medical
      and psychiatric history, depressive symptoms, and lifestyle habits and an examination of
      uterine blood flow using a Doppler ultrasound machine. Participants who do not show signs of
      depression will not undergo these assessments on the initial visit.

      Participants found to be depressed on the first visit will then be assigned randomly to
      receive group IPT or TAU. Participants assigned to group IPT will attend 12 weekly
      psychiatrist-led sessions that will focus on overcoming relationship problems associated with
      depression. The first two and last sessions will be alone with the psychiatrist and the
      remaining sessions will be with a group of five to eight other pregnant women. Participants
      assigned to TAU will be referred to outpatient treatment, which may include cognitive
      behavioral psychotherapy, insight-oriented psychotherapy, and/or antidepressant medication.
      TAU participants receiving psychotherapy will attend 12 weekly treatment sessions comparable
      to the IPT group sessions; treatment for TAU participants receiving antidepressant medication
      may last longer than 12 weeks. During the treatment period, all participants will fill out
      weekly forms about their moods and will have monthly interviews with a psychiatrist. Upon
      completion of treatment, participants will have a 30-minute final evaluation meeting.

      All participants, including healthy participants, will be asked to attend two sessions
      focused on their babies' development, one occurring between the 36th and 38th weeks of
      pregnancy and one shortly after giving birth. During the first developmental session,
      participants will complete a questionnaire about mood; undergo heart rate, breathing, and
      blood pressure monitoring; undergo an ultrasound; and perform a word matching task. The
      second developmental session will occur between 20 and 30 hours after birth of the baby and
      will include a newborn testing session that will consist of physiological and neurobehavioral
      assessments. Healthy participants' study participation will be over upon completion of the
      second developmental session. Depressed participants will be contacted by phone once every 2
      weeks for 6 months after giving birth.
    

Intervention name(s): Group interpersonal therapy (IPT); Treatment as usual (TAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Group IPT will include weekly treatment sessions with a psychiatrist for 12 weeks. The sessions will focus on overcoming relationship problems associated with depression. The first two and last sessions will be alone with the psychiatrist and the remaining sessions will be with a group of five to eight other pregnant women.; TAU will include referrals to outpatient treatment, which may include cognitive behavioral psychotherapy, insight-oriented psychotherapy, and/or antidepressant medication. TAU participants receiving psychotherapy will attend 12 weekly treatment sessions comparable to the IPT group sessions; treatment for TAU participants receiving medication for their depression may last longer than 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prenatal Depression; Postpartum Depression; Fetal Development; Interpersonal Therapy