Study of Home-Based Exercise to Alleviate Postpartum Depression
The purpose of this study is to evaluate the effectiveness of an aerobic home-based exercise program for the treatment of postpartum depression...
Brief Summary
Official Title: “Decreasing Health Care Utilization With Alternative Approaches for the Treatment of Depression: A Randomized Trial of Exercise for Postpartum Depression”
The purpose of this study is to evaluate the effectiveness of an aerobic home-based exercise program for the treatment of postpartum depression.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Detailed Clinical Trial Description
Postpartum depression occurs in 10-16% of women, with depressive symptoms lasting up to one year post delivery. Women affected by depression in the postpartum have been shown to be at higher risk for developing a recurrent depressive disorder. While the direct and indirect costs associated with postpartum depression are unknown, those associated with depression have been found to exceed 43 billion dollars in the United States alone. Moreover, maternal depression can negatively impact the mother-infant relationship and infant development.
Despite the high prevalence of postpartum depression, the condition often goes undiagnosed and untreated by primary care providers. Alternative non-medical interventions for treating postpartum depression have not been widely investigated, leaving women and health care providers with few evidence-based options for treatment. If this exercise program is shown to be effective, then this intervention can be an alternate treatment option for alleviating depressed mood for women in the postpartum period. This nonpharmacological approach may be particularly attractive as many women are reluctant to take medication in the postpartum.
Intervention(s) in this Clinical Trial
- Behavioral: Moderate-intensity Exercise
Outcome Measures for this Clinical Trial
Primary Measures
- Change in depressed mood scores immediately following the 3 month intervention and at 3 and 6 months post-treatment,
- as measured by the Edinburgh Postnatal Depression Scale and the Hamilton Rating Scale for Depression.
Secondary Measures
- Changes in fatigue levels (measured by the multidimensional fatigue inventory), sleep patterns, anxiety and health status.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- women 4 to 38 weeks following childbirth
- score of 10 or more on the Edinburgh Postpartum Depression Scale
- understand English or French
- no current alcohol or substance abuse,
- not currently participating in regular moderate or high intensity exercise (30 minutes, at least 3 times per week)
Exclusion Criteria:
- obstetrical or concomitant diseases which would have precluded participation in an exercise program.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: McGill University Other
Overall Clinical Trial Officials and Contacts
Deborah Da Costa, PhD Principal Investigator McGill University
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00384943
Study ID Number: FRSQ 024018
ClinicalTrials.gov Identifier: NCT00384943
Health Authority: Canada: Ethics Review Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00384943
