Translating Research Into Practice for Postpartum Depression

Not Applicable

• Conditions: Postpartum Depression
• Interventions: Behavioral: Usual care; Behavioral: Screening and follow up

• Registration Number: NCT00548743
• Lead Sponsor: Olmsted Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-09
• Status Verified: 2007-10
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-24
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-04
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Usual care	Usual care
1	Screening and follow up	Intervention arm

Primary Outcome Measures

Name	Time	Method
Level of depressive symptoms and level of parenting comfort	12 months postpartum

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Olmsted Medical Center; 🇺🇸 Rochester, Minnesota, United States