NCT00384943

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2001

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
Last Updated

October 6, 2006

Status Verified

October 1, 2006

First QC Date

October 4, 2006

Last Update Submit

October 4, 2006

Conditions

Postpartum Depression

Keywords

postpartum depressionexercise

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

Interventions

Moderate-intensity ExerciseBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • obstetrical or concomitant diseases which would have precluded participation in an exercise program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

Location

MeSH Terms

Conditions

Depression, PostpartumMotor Activity

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavior

Study Officials

  • Deborah Da Costa, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 6, 2006

Study Start

November 1, 2001

Study Completion

November 1, 2004

Last Updated

October 6, 2006

Record last verified: 2006-10

Locations

CA(1)