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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00961402
Other study ID # 0903S61462
Secondary ID R21MH085176
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2009
Est. completion date November 2011

Study information

Verified date October 2019
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the feasibility and efficacy of an exercise intervention for the prevention of postpartum depression. If efficacious, our intervention could be disseminated in "real world settings" in an effort to prevent postpartum depression.


Description:

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Study Design


Intervention

Behavioral:
Wellness Control
6-month wellness control
Exercise Intervention
6 month exercise intervention

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Structured Clinical Interview for DSM-IV Axis I Disorders This measure was used to determine if participants met the diagnostic criteria for postpartum depression. This is a yes/no diagnostic tool and our data indicate percentage who meet criteria for depression. 6 months
Secondary 7-Day Physical Activity Recall Interview Physical activity during previous 7 days. This measure does not have a range given it is directly dependent upon number of minutes of physical activity per week. The intensity ranges from moderate (similar to a brisk walk), hard (similar to a jog), and very hard (similar to a run). 6 months
Secondary Edinburgh Postnatal Depression Scale This scale is a continuous measure of postpartum depression. Range is 0-30 and a score of 10 or above may be considered depressed. Higher scores indicate higher depression. 6 Months
Secondary PHQ-9 Continuous measure of depression. Scoring is on a scale of 0-27 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression 6 Months
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