Translating Research Into Practice for Postpartum Depression

Official Title: “Practice Based Clinical Trial of Screening, Diagnosis and Follow up Management for Postpartum Depression in Family Medicine Practices.”

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.

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.

Intervention(s) in this Clinical Trial

• 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
• Behavioral: Usual care
  • usual care for identification and management of postpartum depression

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Intervention arm
• Placebo Comparator: 2
  • Usual care

Primary Measures

• Level of depressive symptoms and level of parenting comfort
  • Time Frame: 12 months postpartum
    

Secondary Measures

• Percent eligible women screened and of those screen positive, percent treated and followed according to protocol
  • Time Frame: 12 months for each women
    

Inclusion Criteria:

• 5 to 12 weeks postpartum
• Able to speak and read English or Spanish
• 18 to 45 years of age

Exclusion Criteria:

• Significant cognitive impairment and unable to answer screening questions

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Olmsted Medical Center Other

Overall Clinical Trial Officials and Contacts

Barbara P Yawn, MD MSc Principal Investigator Olmsted Medical Center  

Overall Contact: Barbara P Yawn, MD MSc 507 287 2758 byawn@olmmed.org

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00548743

Study ID Number: 5 R01 HS014744-02

ClinicalTrials.gov Identifier: NCT00548743

Health Authority: United States: Institutional Review Board

Describes study for sites not for patients