Study of Home-Based Exercise to Alleviate Postpartum Depression

October 4, 2006 updated by: McGill University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G1A4
        • McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Changes in fatigue levels (measured by the multidimensional fatigue inventory), sleep patterns, anxiety and health status.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Collaborators

Fonds de la Recherche en Santé du Québec

Investigators

  • Principal Investigator: Deborah Da Costa, PhD, McGill University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

October 4, 2006

First Submitted That Met QC Criteria

October 4, 2006

First Posted (Estimate)

October 6, 2006

Study Record Updates

Last Update Posted (Estimate)

October 6, 2006

Last Update Submitted That Met QC Criteria

October 4, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRSQ 024018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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