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Phase 2 N=130 Randomized Treatment

The Effect of Exercise on Preventing PostPartum Depression

PostPartum Depression

Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Structured Clinical Interview for DSM-IV Axis I Disorders — 7.94; 8.20 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Wellness Control (Behavioral); Exercise Intervention (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
University of Minnesota
Primary completion
Nov 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Structured Clinical Interview for DSM-IV Axis I Disorders
7.94; 8.20
SECONDARY
7-Day Physical Activity Recall Interview
123.3; 129.8
SECONDARY
Edinburgh Postnatal Depression Scale
7.02; 4.69
SECONDARY
PHQ-9
5.22; 3.08

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00961402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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