The Effect of Exercise on Preventing PostPartum Depression
Condition: PostPartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Wellness Control; Exercise Intervention
Intervention description: 6-month wellness control; 6 month exercise intervention
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Exercise; PostParum Depression

Summary:

      The purpose of this study is to examine the feasibility and efficacy of an exercise
      intervention for the prevention of postpartum depression. If efficacious, our intervention
      could be disseminated in "real world settings" in an effort to prevent postpartum depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  We will recruit healthy, sedentary (defined as exercising 60 minutes or less per week)
             women who are at least 18 years of age and at least 28 weeks pregnant or less than one
             month postpartum (n=120). Participants will be required to obtain written consent from
             their healthcare provider to participate. This written consent will be obtained
             following delivery of the newborn. Participants will complete a telephone screening
             interview to assess eligibility. Current depressive episode will be assessed using the
             PHQ-9 (cut-off will be 10 or higher). As we have done in previous trials, we will have
             a protocol in place that deals with participants expressing suicidal ideation ranging
             from referring them to their healthcare provider and/or calling emergency assistance,
             depending on intent. To be included, participants must be willing to be randomly
             assigned to either of the two study arms. Additionally, participants will read and
             sign a consent form approved by the University of Minnesota and have all of their
             questions will be answered prior to participating.

        Exclusion Criteria:

          -  No healthcare provider consent to participate

          -  Pre-existing hypertension or diabetes

          -  Current participation in exercise (defined as exercising 60 or more minutes per week)

          -  Currently enrolled in another exercise or weight management study

          -  Less than 18 years of age

          -  Another member of household participating in the study

          -  Unable to speak, comprehend, read, or write fluently in the English language

          -  Unable to walk for 30 minutes continuously

          -  Musculoskeletal problems such as arthritis, gout, osteoporosis, or back, hip or knee
             pain that may interfere with exercising

          -  Exercise-induced asthma

          -  Any condition that would make exercise unsafe or unwise

          -  Taking medication that interferes with heart rate response to exercise such as beta
             blockers

          -  Hospitalization for a psychiatric disorder in the past six months

          -  Current depressive episode and/or currently receiving antidepressant medication or
             psychotherapy for depression (those who are depressed and who are not in treatment
             will be referred to their physician or psychiatrist for follow-up care)

        In addition to the initial exclusion criteria listed above, we will withdraw the exercise
        intervention and instruct the participant to contact their healthcare provider if the
        participant develops a medical issue in which exercise would be unsafe.