Study of Home-Based Exercise to Alleviate Postpartum Depression

Postpartum Depression Clinical Trial

Official title:

Decreasing Health Care Utilization With Alternative Approaches for the Treatment of Depression: A Randomized Trial of Exercise for Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384943
• Other study ID #: FRSQ 024018
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

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.