Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression
Condition: Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effectiveness of antidepressant medication alone and
      interpersonal psychotherapy alone in treating women with postpartum depression.
    

Detailed description: 
      Postpartum depression (PPD) occurs in approximately 13% of postpartum women. The impact of
      PPD is significant, including emotional distress for the woman as well as disturbances in
      infant development. Common signs of depression after childbirth may include anxiety,
      irritability, low energy, and lack of concern for self or infant. If left untreated, PPD may
      last for more than 1 year, causing strain on family life and the mother's relationship with
      her infant. Infants of depressed mothers are also at a higher risk for developmental delays,
      behavioral problems, and difficulty eating and sleeping. Despite the public health
      significance of PPD, relatively little research has been done to determine the most effective
      treatments. Specifically, there is a lack of research concerning the use of antidepressant
      medication for treating PPD. Interpersonal psychotherapy (IPT), which focuses on
      interpersonal issues related to depression, has been more thoroughly studied for the
      treatment for PPD, but it has not been compared to the other treatment. This study will
      evaluate the effectiveness of antidepressant medication alone and IPT alone in treating women
      with PPD.

      Participation in this double-blind study will last 9 months. Participants will first undergo
      initial assessments, which include interviews about depressive symptoms, self-report forms
      about medical history, blood tests, and a pregnancy test. Participants will then be randomly
      assigned to one of three treatments: sertraline, placebo, or IPT. All three treatments will
      be administered over 13 weeks. Participants assigned to take sertraline or placebo will
      attend nine 30-minute sessions over the 13-week treatment period. During these sessions,
      participants will be administered the study medication and will be assisted with parenting
      issues and skills by a psychiatrist. Participants receiving IPT will attend weekly 50-minute
      sessions over the 13-week treatment period. These sessions will focus on improving
      relationships with others, setting goals, and increasing coping skills. All participants will
      also complete interviews and questionnaires about their depression once a month. Following
      the 13 weeks of treatment, participants will undergo follow-up assessments at Months 3 and 6
      post-treatment. Follow-up assessments will repeat initial interviews and questionnaires and
      will include a form about the infant's nature.
    

Intervention name(s): Sertraline; Placebo; Interpersonal psychotherapy (IPT); Clinical management; Mothercrafting
Intervention type(s): Drug; Drug; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific "mother-crafting" techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.; Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific "mother-crafting" techniques as those taking sertraline.; IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills.; Clinical management includes treatment as usual for those receiving medication for depression.; Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postpartum; Depression; Medication Therapy; Zoloft; Sertraline; Interpersonal Psychotherapy