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Study of Home-Based Exercise to Alleviate Postpartum Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00384943
First Posted: October 6, 2006
Last Update Posted: October 6, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by:
McGill University
  Purpose
The purpose of this study is to evaluate the effectiveness of an aerobic home-based exercise program for the treatment of postpartum depression.

Condition Intervention
Postpartum Depression Behavioral: Moderate-intensity Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Decreasing Health Care Utilization With Alternative Approaches for the Treatment of Depression: A Randomized Trial of Exercise for Postpartum Depression

Resource links provided by NLM:


Further study details as provided by McGill University:

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.

Estimated Enrollment: 90
Study Start Date: November 2001
Estimated Study Completion Date: November 2004
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384943


Locations
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
McGill University
Fonds de la Recherche en Santé du Québec
Investigators
Principal Investigator: Deborah Da Costa, PhD McGill University
  More Information

ClinicalTrials.gov Identifier: NCT00384943     History of Changes
Other Study ID Numbers: FRSQ 024018
First Submitted: October 4, 2006
First Posted: October 6, 2006
Last Update Posted: October 6, 2006
Last Verified: October 2006

Keywords provided by McGill University:
postpartum depression
exercise

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications


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