Study of Home-Based Exercise to Alleviate Postpartum Depression
Primary Purpose
Postpartum Depression
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Moderate-intensity Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Depression focused on measuring postpartum depression, exercise
Eligibility Criteria
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.
Sites / Locations
- McGill University Health Centre
Outcomes
Primary Outcome 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 Outcome Measures
Changes in fatigue levels (measured by the multidimensional fatigue inventory), sleep patterns, anxiety and health status.
Full Information
NCT ID
NCT00384943
First Posted
October 4, 2006
Last Updated
October 4, 2006
Sponsor
McGill University
Collaborators
Fonds de la Recherche en Santé du Québec
1. Study Identification
Unique Protocol Identification Number
NCT00384943
Brief Title
Study of Home-Based Exercise to Alleviate Postpartum Depression
Official Title
Decreasing Health Care Utilization With Alternative Approaches for the Treatment of Depression: A Randomized Trial of Exercise for Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
McGill University
Collaborators
Fonds de la Recherche en Santé du Québec
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of an aerobic home-based exercise program for the treatment of postpartum depression.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
postpartum depression, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Moderate-intensity Exercise
Primary Outcome Measure Information:
Title
Change in depressed mood scores immediately following the 3 month intervention and at 3 and 6 months post-treatment,
Title
as measured by the Edinburgh Postnatal Depression Scale and the Hamilton Rating Scale for Depression.
Secondary Outcome Measure Information:
Title
Changes in fatigue levels (measured by the multidimensional fatigue inventory), sleep patterns, anxiety and health status.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Da Costa, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of Home-Based Exercise to Alleviate Postpartum Depression
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