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Sponsored by: |
Olmsted Medical Center |
Information provided by: | Olmsted Medical Center |
ClinicalTrials.gov Identifier: | NCT00548743 |
This is a study to assess the impact of introducing screening and planned follow up for postpartum depression. All women ages 18 to 45 who speak English or Spanish who come to the enrolled community family medicine offices will either be given usual care or screened using the Edinburgh Postnatal Depression Screening tool. If the EDPS score is high the women will be given the PHQ-9 to more clearly identify the specific likelihood of being depressed. Women who are determined to be depressed will be treated with medication or counseling based on the preference of the women and their physicians. Women will be followed through nurse initiated phone calls and visits to the physicians office.
Outcomes include the level of depression symptoms, measure of comfort with parenting, and satisfaction with partner relationships comparing baseline levels with those at 6 and 12 months from the usual care and intervention sites. These data will be collected by questionnaire. In addition, with the women's permission, medical records will be reviewed.
Condition | Intervention |
Postpartum Depression |
Behavioral: Screening and follow up Behavioral: Usual care |
MedlinePlus related topics: | Depression Parenting Postpartum Depression |
Study Type: | Interventional |
Study Design: | Screening, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Practice Based Clinical Trial of Screening, Diagnosis and Follow up Management for Postpartum Depression in Family Medicine Practices. |
Estimated Enrollment: | 3000 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | August 2010 |
Arms | Assigned Interventions |
1: Experimental
Intervention arm
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Behavioral: Screening and follow up
Two stage screening with EPDS and PHQ-9, treatment for depression at physician's discretion and follow up phone calls and visits
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2: Placebo Comparator
Usual care
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Behavioral: Usual care
usual care for identification and management of postpartum depression
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A randomized controlled trial of screening and management of postpartum depression that includes a second phase assessing the maintenance of the intervention in the original intervention sites and a switch from usual care to intervention in the control sites.
Planned enrollment includes 29 family medicine practices and 3000 women over a period of four years. All follow up and management is initiated within the family medicine practices to improve generalizability and likelihood for dissemination.
In addition to the patient centered outcomes, exploratory analyses will look at the uptake and degree of implementation and maintenance of the intervention based on characteristics of the practice including size, location, affiliation with larger group, type of practice and whether or not the practice is a community health center or residency practice.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Able to speak and read English or Spanish
Exclusion Criteria:
Contact: Barbara P Yawn, MD MSc | 507 287 2758 | byawn@olmmed.org |
Contact: Susan M Bertram, RN MSN | 888 292 7164 | sbertram@olmmed.org |
United States, Minnesota | |||||
Olmsted Medical Center | Recruiting | ||||
Rochester, Minnesota, United States, 55904 | |||||
Principal Investigator: Barbara P Yawn, MD MSc |
Olmsted Medical Center |
Principal Investigator: | Barbara P Yawn, MD MSc | Olmsted Medical Center |
Describes study for sites not for patients 
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Study ID Numbers: | 5 R01 HS014744-02 |
First Received: | October 22, 2007 |
Last Updated: | December 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00548743 |
Health Authority: | United States: Institutional Review Board |
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