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Study of Home-Based Exercise to Alleviate Postpartum Depression

This study has been completed.

Sponsors and Collaborators: McGill University
Fonds de la Recherche en Santé du Québec
Information provided by: McGill University
ClinicalTrials.gov Identifier: NCT00384943
  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

MedlinePlus related topics:   Depression    Exercise and Physical Fitness    Postpartum Depression   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:   Decreasing Health Care Utilization With Alternative Approaches for the Treatment of Depression: A Randomized Trial of Exercise for Postpartum Depression

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
Ages Eligible for Study:   18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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


Study ID Numbers:   FRSQ 024018
First Received:   October 4, 2006
Last Updated:   October 4, 2006
ClinicalTrials.gov Identifier:   NCT00384943
Health Authority:   Canada: Ethics Review Committee

Keywords provided by McGill University:
postpartum depression  
exercise  

Study placed in the following topic categories:
Pregnancy Complications
Depression
Puerperal Disorders
Depression, Postpartum
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 29, 2008




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