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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00384943
Other study ID # FRSQ 024018
Secondary ID
Status Completed
Phase N/A
First received October 4, 2006
Last updated October 4, 2006
Start date November 2001
Est. completion date November 2004

Study information

Verified date October 2006
Source McGill University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of an aerobic home-based exercise program for the treatment of postpartum depression.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date November 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Moderate-intensity Exercise


Locations

Country Name City State
Canada McGill University Health Centre Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
McGill University Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in depressed mood scores immediately following the 3 month intervention and at 3 and 6 months post-treatment,
Primary as measured by the Edinburgh Postnatal Depression Scale and the Hamilton Rating Scale for Depression.
Secondary Changes in fatigue levels (measured by the multidimensional fatigue inventory), sleep patterns, anxiety and health status.
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