Clinical trial NCT00384943: Study of Home-Based Exercise to Alleviate Postpartum Depression
Official title: Decreasing Health Care Utilization With Alternative Approaches for the Treatment of Depression: A Randomized Trial of Exercise for Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: postpartum depression
exercise
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2006-10-06
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Change in depressed mood scores immediately following the 3 month intervention and at 3 and 6 months post-treatment,
measure: as measured by the Edinburgh Postnatal Depression Scale and the Hamilton Rating Scale for Depression.
Secondary outcomes:
measure: Changes in fatigue levels (measured by the multidimensional fatigue inventory), sleep patterns, anxiety and health status.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University
name: Deborah Da Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References: